Eastern Mediterranean Health Journal [2006; Vol.12, Issue Supp.1]

٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S6 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Fundamentals of Research Ethics – International and Regional Perspectives: Welcome address Adibul Hassan Rizvi1 1Director, Sindh Institute of Urology and Transplantation, Karachi, Pakistan (Correspondence to Adibul Hassan Rizvi: info@siut.org). I would like to welcome Professor Pirzada Qasim, the Vice-Chancellor of Karachi University, and all the delegates and thank you all for participating in this conference Fundamentals of Research Ethics – Inter- national and Regional Perspectives. I am especially grateful to the foreign partici- pants, who came despite discouragement by their governments. I am confident that you will appreciate how peaceful Pakistan is and that you will not hesitate to come again. I appreciate all the support provided by Karachi University and Professor Pirzada Qasim in developing the Institute of Urol- ogy and Transplantation (SIUT) by initi- ating the postgraduate programme for a Masters degree in surgery. The Institute has the honour to produce the first such Masters in the country. The MD in nephrology and the PhD and MPhil in basic sciences have followed this. All these programmes are on-going. Another unique development is the addition of Bachelors degrees in medi- cal technology, laboratory medicine, theatre technology, intensive care and dialysis. Young men and women, who are bright but could not gain admission in medical institu- tions due to having slightly lower grades, have joined these courses. Credit goes to Karachi University for starting this pro- gramme by providing financial assistance. After the establishment of the Centre of Biomedical Ethics and Culture (CBEC), the International Centre for Bioethics will be formed which will be affiliated with Karachi University. The Centre is the first such centre in the country, and the regional centre, the Institute of Biotechnology, in Karachi University will be the first of its kind catering to the needs of the region. The World Health Organization is expected to help with this programme. A postgraduate diploma programme will soon be started and the Masters in bioethics will follow. Surgeons always try to abide with eth- ics, but they tend not to be keen researchers. Ethicists are the real custodians of research and its safety, and are responsible for safe- guarding the interests of the common man in research. Research is for the benefit of mankind and the good results should be made accessible to everybody in this world. Both these factors make research meaning- ful. Ethics is an important component of research and without ethics, research will end in disasters such as Hiroshima and Nagasaki. Without ethics, research will produce biological warfare instead of anti- biotics. The whole world is gripped by the fear of bioterrorists. The United States of America spends about 9.5 billion US dollars against bioterrorism because research is being carried out without ethical control. It is quite possible that the wars being fought today are out of fear. Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S7 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما It is known that 80% of the people do not benefit from research results. For example, people are still dying of malaria and tuber- culosis, more so in the developing coun- tries, although the treatment is available. About 25 000 000 people have succumbed to AIDS, approximately 49 000 000 are suffering from this disease and 14 000 are dying or contracting AIDS every day in the African countries. It is also evident that 91% of them do not have access to treat- ment although treatment is available. The question arises, “Where does the problem lie?” It is known that the best research, be- cause its aplication is not controlled by ethics, is easily hijacked by multinationals, which can do so because they have the money. The poor continue to suffer as they will never be able to afford the drugs that have been tried out on them and given good results. This poverty gap is widening day by day and even a person with an average or modest income will not be able to buy the research products. Ethically, research becomes meaningless if the majority of the people cannot have access to its results. The economic disparity is evident in the developing world where health is a complex issue. It is not just treating a disease by dispensing medicines or providing surgical services. It includes disease prevention, health education and a healthy environ- ment, both physical and social. It includes access to safe water and good nutrition. The question is, “Why can’t people living in developing countries buy healthy food and be offered standard health facilities?” This question can be answered after analysing the differences between the developed and developing countries. Historically, many countries were colo- nized by the richer countries. They are economically deprived and have poverty as a dominant feature. The British medi- cal journal in 1999 drew attention to the economic disparity between developed and developing countries in the shape of a cham- pagne glass [1]. The world was divided into two regions on the basis of economic and technological inequalities. Economically the developing countries own only 25% of the total wealth, whereas they are inhabited by 80% of the world population. It has also been shown that the assets of the top three billionaires of the world are more than the combined Gross National Product of all the least developed countries inhabited by 600 000 000 people. The impact of poverty can be seen in the health budget of a developing country. An example is the health budget of Pakistan where only 3.4% is allocated for the health sector. This scenario is similar in most developing nations and the result of this meager allocation towards health is seen as the pathology of poverty depicted in deaths caused by acute infectious diseases. Malaria alone kills 3000 people daily or more than 1 000 000 each year. Diarrhoeal diseases claim roughly 2 200 000 lives annually. Almost 2 000 000 of the victims are small children and virtually all from develop- ing nations. Tuberculosis kills 1 700 000 people a year, mostly in Africa and South- East Asia. Acute respiratory infections are responsible for killing 4 000 000 people annually with a disproportionate number belonging to the world’s poorest nations. Measles claims 900 000 lives a year in developing countries and HIV/AIDS affects 3 000 000 people annually. Hepatitis B and C afflict 400 000 000 people, 30% of whom end up with end-stage liver disease. In reality, the difference is apparent when the landing of man on the moon is compared to a village girl walking with a pitcher on her head in search of drinking water (Figure 1). This large discrepancy is factual, but it is also accepted that health is a ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S8 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 birth right for every individual. We need to consider who will bear the cost of treatment, the patient or the government of a develop- ing country. If the situation in a developing country is analysed, it is evident that the priorities of the government on spending are unreal- istic and with poor governance. Investment is directed to the maximum towards debt servicing followed by defence services. The health sector is the worst sufferer with the least funds, making it impossible for people of a low economic status to obtain good health care. It is not possible for a person living below the poverty line with earnings of less than 1 US dollar a day to think about medical treatment, because he/she does not know where the next meal will come from. In this situation, medical care is a luxury. Rational thinking provides a solution to this problem. Neither the government alone nor the individual patient can shoulder this responsibility. This is a big challenge for every medical institution and SIUT took a bold step to find a way forward. It has been proved by SIUT that a government and community partnership can be successfully employed in a government-sector hospital where the patient is the beneficiary and receives standard treatment without any charges being levied. This requires suf- ficient autonomy of functioning with trans- parency to gain community confidence. The philosophy of SIUT is based on this triad of community, government and doctors, with doctors playing the role of catalyst. Here limited government grants are supplemented largely by public dona- tions for providing free treatment facilities to all patients. The achievements of SIUT are many. SIUT had a humble beginning as an eight- bed urology ward in 1972. It has grown in response to the needs of the people. Patients come for treatment from all over the country and the neighbouring regions of Afghanistan and expatriates from Middle Eastern countries. The number of patients has grown from 120 000 in 1997 to 404 000 in 2005. All services are free and include 27 outpatient clinics and inpatient facilities for nephrology, urology, transplantation Figure 1 The economic disparity between developing and developed countries Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S9 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما intensive care unit, medical intensive care unit, critical care unit, paediatric unit, gas- trointestinal and liver unit and day care ward. The number of patients in these units has increased from 6991 in 2000 to 13 957 in 2005. The very busy dialysis department has 130 units performing 350 dialysis sessions per day. Renal transplantation is a routine procedure and 130 transplants are carried out annually. Other surgeries take place in the 14 operation theatres which are all very well equipped. The high prevalence of stone disease in the region has called for non-invasive techniques of stone removal at SIUT. There are four modern lithotrip- tors performing on 12 patients daily. Also available are laser technology and lithoclast to remove urinary tract stones. SIUT has invested in technology. The centre for molecular medicine performs all sophisticated tests including serology, vi- rology and antigen detection by polymerase chain reaction. A reference laboratory pro- vides all required services round the clock with 2 million tests done in 2005. Facili- ties for radiology, computed tomography, magnetic resonance imaging, angiography, and colour Doppler are all available at the Institute. Children receive priority services in the paediatric urology, nephrology, hepatol- ogy and oncology units. Paediatric renal transplantation is an important section of the transplant activities in SIUT. Kidney recipients are provided regular follow-up services, laboratory tests and im- munosuppressive drugs at regular intervals. Similarly kidney donors are offered free annual check-ups and laboratory investiga- tions through a donor follow-up weekly clinic. Rehabilitation advice and facilities are provided through the medical social officers. Another important achievement of SIUT is the establishment of a school for medical technologists. It offers a three-year course for a Bachelor degree in medical technol- ogy. The future plans include an institute for transplant sciences and biotechnology located at Kathore. References 1. The champagne glass of world poverty. British medical journal, 1999, 318 (Edi- tor’s choice). ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S10 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Editorial “To eat an elephant” Farhat Moazam1 1Professor and Chairperson, Center of Biomedical Ethics and Culture (SIUT), Karachi, Pakistan (Correspondence to Farhat Moazam: bioethics@siut.org). Introduction In contrast to codes of conduct for health- care professionals that can be traced back to the Hammurabi civilization (2500 BC), contemporary bioethics is a recent phenom- enon born in the 1970s in the United States. This is a multidisciplinary field that began and has evolved in response to novel dilem- mas posed by rapid advances in science and biomedical technology. Since its incep- tion, bioethics, grounded in philosophi- cally derived principles, is being rapidly “globalized” to all parts of the world. This includes developing countries such as Paki- stan in which societies follow a different epistemology to determine what constitutes right and wrong in life as compared to that in many industrialized nations. There is a dawning realization that the shared history of a people, indigenous cultural norms, re- ligious beliefs, and socioeconomic realities influence moral comprehension, and that these must be taken into account if bioethics is to attain a true international character [1]. Countries in this part of the world can do a great deal to enrich the largely philosophi- cal, guidelines-based discourse in bioethics and research ethics. But this is only possible through methodically researched contribu- tions, constructive critique of our local conditions, and reasoned dialogues that address the moral diversity characterizing human lives. Center of Biomedical Ethics and Culture The Center of Biomedical Ethics and Cul- ture (CBEC) was inaugurated in Karachi on 8 October, 2005, and is the first such centre in Pakistan. The primary mission of the Center is to serve as an academic and intel- lectual resource in bioethics for the country and also for the region. Although there has been an increase in the number of seminars and lectures on bioethics held in Pakistan over the past decade, this is the only insti- tution to date that is dedicated to promot- ing and enriching national, regional and international discourse on issues related to bioethics, and focuses on establishing links with biomedical ethical centres and orga- nizations around the world. An important, and central, function of CBEC is to study the role of religious and cultural norms, as well as socioeconomic realities, in shaping indigenous value systems that are seminal components of moral comprehension in humans. In the first year of its life, CBEC has chosen to focus on various educational activities in order to build national capacity and develop future faculty and staff in bio- medical ethics for Pakistan. The conference and workshop Fundamentals of Research Ethics: International and Regional Per- spectives was the third to be organized in 2005. The first international conference Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S11 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما and workshop in April 2005 covered the philosophical and religious basis of the chain of human moral thought extending from the Greeks to Muslim scholars and then onto modern ethical theories. This was followed in August 2005 by a national seminar on stem cell research and cloning in which the science, ethics and religious (Judaic, Christian, Islamic and Buddhist) perspectives were covered. As Pakistan currently has only half a dozen formally trained individuals in bioeth- ics, in January 2006 CBEC will initiate the first postgraduate diploma course (PGD) in Biomedical Ethics in the country. The PGD will target mid-career, healthcare-related professionals drawn from all provinces of Pakistan. The one-year programme is structured to provide 23 credit hours to suc- cessful candidates through the University of Karachi. These will be credited towards a master degree in bioethics which we hope to offer as the next step in capacity building in bioethics. CBEC already has commitments for help in its postgraduate programmes from the Department of Religious Studies and the Center for Bioethics of the Univer- sity of Virginia, and from faculty members in the Department of Social Sciences at the University of Pennsylvania and the School of Public Health in Harvard University. Fundamentals of Research Ethics: International and Regional Perspectives The theme of the conference, Fundamen- tals of Research Ethics: International and Regional Perspectives, is self-explanatory. It offered an opportunity to listen to, and discuss and mix with an international group of scholars and educators who have many years of experience in bioethics and re- search ethics. Among the international speakers were: Dr Qiu Renzong, a Professor and Confucian moral philosopher from the Research Bio- ethics Center in Beijing; Dr Daniel Wikler and Dr Richard Cash, Professor and Senior Lecturer respectively from the School of Public Health in Harvard University in Boston, and Dr Haytham Al-Khayat, Senior Policy Adviser from the World Health Or- ganization’s Regional Office for the Eastern Mediterranean in Cairo. Equally important and perhaps unique was the “regional perspective” of this con- ference, which was provided by speakers who hold key positions related to the field of research ethics within the South Asian Association for Regional Cooperation. These include Dr Harun-Ar-Rashid of the Bangladesh Medical Research Council in Dhaka, Dr Nandini Kumar from the Indian Council of Medical Research in New Delhi, Dr Athula Sumitapala from the Sri Lankan Forum for Research and Development in Colombo, and Dr Huma Qureshi of the Pakistan Medical Research Council in Is- lamabad. These speakers presented their ex- periences and difficulties in efforts to foster ethical research in their own settings. These neighbouring countries share many value systems, cultural norms and socioeconomic realities with Pakistan and I believe that we can learn a great deal from one another. Conclusion I believe that the talks, discussions and interchange of ideas that occurred over the 2 days of the conference and which are published here in this Supplement of the Eastern Mediterranean health journal have served to heighten our awareness of the many ways, some subtle and others blatant, in which patients and research subjects can ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S12 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 be exploited, and are being exploited. It is no easy task to prevent human subject abuse in research; in fact it is a problem of great magnitude. This is especially so within the realities in which we live and practise in countries such as ours. But I am reminded of the story about how to eat an elephant. You eat it one bite at a time. The conference rep- resented the first bite, and I hope that it has helped to show how to take further bites. References 1. Moazam F, Jafarey A. Pakistan and biomedical ethics: report from a Muslim country. Cambridge quarterly of health- care ethics, 2005, 14(3):249–55. International Ethical Guidelines for Biomedical Research Involving Human Subjects The present text of the up-mentioned publication is the revised/up- dated version of The Council for International Organizations of Medi- cal Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability – of individuals, groups, communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects, applying ethical standards in local circumstances, and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries, and the implications for multinational or transnational research in which they may be partners. Further information on this publication can be obtained at: http://www. who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&codco l=84&codcch=2016 Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S13 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Research ethics: challenges in the Eastern Mediterranean Region M. Haytham Khayat1 1Senior Policy Adviser, WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt (Correspondence to M. Haytham Khayat: khayat@emro.who.int). SUMMARY The foundations of ethical principles in the Eastern Mediterranean Region can be found within the 3 major religions of the Region; Judaism, Christianity and Islam. Today, there are numerous ethical issues that have emerged as result of the technological advances of the 20th century and this paper addresses some of those related to biomedical research. The Islamic principles in relation to medicine and biomedical research are described, and in particular research involving human subjects. The paper also outlines the endeavours being made by the Islamic Organization for Medical Sciences to address such issues and draw up recommendations and rulings. Éthique de la recherche : défis dans la Région de la Méditerranée orientale RÉSUMÉ Les fondements des principes éthiques dans la Région de la Méditerranée orientale sont présents dans les trois principales religions de la Région : le Judaïsme, le Christianisme et l’Islam. Aujourd’hui, il y a de nombreuses questions éthiques qui découlent des progrès technologiques du XXe siècle et le présent article aborde certaines de ces questions qui concernent la recherche biomédi- cale. Les principes islamiques relatifs à la recherche médicale et biomédicale y sont décrits, notamment en ce qui concerne la recherche impliquant des sujets humains. L’article présente également les efforts déployés par l’Organisation islamique des Sciences médicales pour aborder ces questions et élaborer des recommandations et des jugements. PÇVF¶=L>É®Ø]?6œiÇJ™=±fm¼É·®C›L>ÈëbVJ¶= >Ʉ=¼NÉÂb»†  „=Í[qØ6Ù=Í[MØN¶=Á>[ÈaÙ=À[º>[ÃI>ºëǯºœ[iÇJ™=±fm¼É·®C›L>É®Ø]Ù=Ôa>Fºb»JjI¼É[·®Ý=›ÍÉ[i>i ÊÂÆ6½ØiÝ=Æ(ÍÉVÉj™=Æ(ÍÈaÇÃɶ=*›ÊQÇ[¶Ç¿³J¶=½èb[¯J·¶ÍFå²=ßÇà»[¶=ÍÉ®Ø]Ù=>È>v¯¶=x£EfßIL?bEb®Æ Í[ÉQǶÇÉF¶=Í[ÉFì¶=PÇVF¶>[EÍ[¯ù·£J™=>È>v¯¶=ÅdÂx£EÍÉNVF¶=Í®eǶ=Åd¹Æ>¿J[IÆ(ÀÈfn£¶=Áf¯¶=*f²dJj[IÆ ØiÝ=Ôa>F™=¼Â?Í®eǶ=fn[F¶=Î[·¢Ïßf[RàI[¶=´[·I>»çÉi×Æ(ÍÉQǶÇÉF¶=ÍÉFì¶=ÆÍÉFì¶=PÇVF¶>Eͯ·£J™=Íɺ* ¼[³ƒ=‘C¸[èqÇJ¶=Í[ɫɲÆ(>È>v¯¶=Åd¤ºÊ{>£J¶=›ÍÉFì¶=½Ç·£·¶ÍɺØiÝ=Í»Ÿ¿™=aÇÃQÍ®eǶ=XuÇI>»² e>»v™==d›L>ÉqÇJ¶=ÆÊ¢fn¶=*  ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S14 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 The basis of the ethical principles in the Region The Eastern Mediterranean Region of the World Health Organization (WHO) is the cradle of three of the major world religions; Judaism, Christianity and Islam. These three monotheistic religions are largely similar in bioethical values, which are the main source of health ethics in large areas of the world. Therefore, if we use some of the principles in one of these religions, it is as if we are speaking of the three of them together. The cardinal ethical principles of the medical and health professions form part of the cardinal principles of Islam as a way of life. These principles are: a respect for hu- man dignity and human liberty, justice and gracefulness (ihsan in Arabic) and of course non-maleficience. Human dignity is clearly pronounced in the Quranic verse: We have indeed dignified the children of Adam (70:17). By respect for human dignity we mean that a human being should be treated as a “person”, that is to say as an “individual who has rights to claim and duties to perform”. This entails independent decision-making and continuous protection of such independence as well as accepting full responsibility and accountability. This is clearly spelt out in the following verses of the Holy Quran. Regarding independent decision-making: Do whatever you may wish (41:40); You (the Prophet) are not the one to im- pose on them (88:22); You are not the one to compel them (50:45). Regarding taking full responsibility and accountability: Each individual is accountable for his deeds (52:21); Every soul is responsible for its deeds (74:38); Hearing, eyesight and mind, all of those he shall be accountable for (17:36). In Islam, freedom or liberty is even more important than life itself. God Almighty says in the Holy Quran: Oppression is even worse than murder (2:191) and Oppres- sion is more serious than murder (2:217). Oppression deprives a person of his liberty and murder deprives him of his life. If this is the case, then liberty is even more impor- tant than life itself. And this is not strange because we believe in Islam, as in the other monotheistic faiths, that God asked His angels to prostrate themselves before this creature that has the liberty to believe or disbelieve, to obey God or disobey Him, to do good or do evil. Islamic principles in relation to the practice of medicine The principle of human dignity is also among the most important principles in dealing with a patient. It implies in this connection recognition of a patient’s funda- mental right as a “person”; entitled to rights and committed to duties. Patients have a right to know all details relating to their case, to receive proper treatment, to have their medical secrets safeguarded, and to obtain adequate care. However, patients en- joying these rights should never cause harm to the community in which they live. The main social value or the main social virtue on which a Muslim’s conduct is based is collective rather than interpersonal, and this is an essential feature of the Islamic sys- tem. Although Islam clearly distinguishes between man as a separate entity and man as a member of the community, these two realities are nevertheless interrelated. From Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S15 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما this interrelationship stems the concept that all that is done for the community has its spiritual value for the individual and vice versa. In Islam, man is entitled to respect as a human being, irrespective of race or re- ligion. A verse in the Holy Quran says: Whoever restores a human being to life, it shall be as if he has restored all mankind (5:32). This restoration to life in Islam is not only physical, it goes beyond that to include psychological, spiritual and social. All members of a Muslim society, including non-Muslims are considered brothers in Islam or in humanity, and this brotherhood implies many duties. The Prophet Muham- mad (peace be upon him) used to say every day in his prayers, “I testify that human beings, all human beings, are brothers and sisters to each other.” In the words of the Prophet , “A brother cares for his brother and sister and protects him or her. He does not fail or forsake him or her.” One of the main principles in Islam is taking care of the aged. To use the words of the second Caliph Omar ibn Al-Khattab, “It is unfair to exploit the youth of a human being and then to forsake him when he becomes old.” The other two principles – justice and gracefulness – are also among those strong- ly stressed by Islam. They are mentioned together in the Holy Quran in the following verse: God enjoins justice and gracefulness (19:90), and they are highly regarded in contemporary medical ethics. By justice we mean equity, fairness in meeting needs and in delivering care. In the area of health, justice is reflected in maintaining as much as possible equity in the distribution of health resources and the provision of pre- ventive and curative opportunities without discrimination for sex, race, belief, political affiliation, and social or other consider- ations. All people, irrespective of any such factors, should have equal access to primary health care and preventive and curative services. Needless to say, this is precisely the essence of “Health For All”, the slogan and concept advocated by the World Health Organization. Gracefulness, ihsan, encompasses an additional value, namely the noble feeling that one should fulfil one’s duty towards one’s brothers and sisters in humanity, particularly those who are weak or helpless. It is even one’s duty to fight to obtain for them their forfeit rights: And why should you not fight for God’s sake in the cause of the deprived men, women and children? (4:75). Closely related to this is the duty of healthcare providers, who should acquaint their patients with their right of how to pro- mote their health and care for themselves before they seek the help of others. Grace- fulness also entails quality and perfection as far as possible, both in performance and in kindliness. To use the words of the Prophet , “God has ordained perfection on everything.” This is the source of the concept of quality assurance in providing health care. The word gracefulness also de- notes benevolence which implies the gentle compassionate touch that has been missing, or almost missing, from modern medical practice. It implies generosity, which makes a person wish for his brother or sister what he wishes for himself and give priority to others over himself, even when he suffers a dire need. Last but not least, ihsan denotes a living conscience and mindfulness of God in every action and behaviour, as implied by the statement of the Prophet , “Graceful- ness is to worship God as if you are eying him”. These cardinal noble values as well as the secondary values derived from them, are the main pillars on which biomedical ethics were built. In traditional Islamic societies, there was considerable interaction between the religious scholars and those ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S16 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 who practised the healing arts. This interac- tion was unfortunately disrupted during the colonial era leading to the adoption by the elite of Western values, while the traditional systems were relegated to the background. The value of a healing process that stresses humanity and generosity is well perceived in the following text, quoted from the 13th century physician Salahuddin Ibn Yusuf Al-Kahal (The ophthalmologist) and he addressed this to each of his students. This is in the 13th century. You should know, son, that this vocation is a bonus from God Almighty donated by Him to those who deserve it, as they will become intermediates between the patient’s and God’s healing. In doing your best to elicit a cure for the patients until you restore health to them, you have not only the confidence of people as a proficient and skilful man, but also the reward and recompense from God in the hereafter because the benefit that reaches out to human beings is very precious, particularly that which goes to the poor and powerless, not to mention integrity of character, which is the nature of generos- ity and clemency. Hence you should put on the suit of virtue and chastity, purity and kindliness, and fear of God, especially when examining the family members and keep their secrets, be philanthropic and pious, devoted to science and learning, heedless of bodily desires, keeping close to scientists, caring for your patient, keen to cure him/ her, attempting to bestow well-being on him/her, even if you have to give the poor patient some of your own money – give it. Ethics of research involving humans Research has a very important place in the Islamic civilization and in particular in the field of medicine, as a response to a state- ment of the Prophet  that “God has not put down a disease without putting down a cure for it. This cure will be known by those who search for it and will not be known by those do not search for it”. And this is the most important principle that urges people to carry out research in order to find the cure for a disease. As we know, in all soci- eties advances in medicine are indebted to research and to clinical trials and this is why research was considered a very important determinant in the Islamic civilization. But what about research involving hu- man subjects. This could be the most im- portant ethical aspect of health research. As we know, many declarations have been issued about this question such as the joint declaration of World Health Organization and Council for International Organiza- tions of Medical Sciences, and the Helsinki Declaration. The most problematic issue is the ques- tion of informed consent because freely given informed consent and the liberty to withdraw it at any stage is one of the important conditions for research involving human subjects and it was stressed in par- ticular at the Nuremberg court. However, the application of this important principle in practice presents many difficulties. It is difficult for a layman, especially in rural areas of developing countries, to grasp fully the nature of the experiment or the risks it incurs in being volunteer subjects for re- search. Volunteers, or so-called volunteers, are easily forthcoming from the poorer, more vulnerable sections of the popula- tion who would even risk suffering pain or bearable damage for small payments. This is true of many kinds of research, in ad- dition to research on issues such as organ transplantation and the like. It is evidently unethical to exploit a subject’s poverty and Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S17 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما vulnerability in this manner. Medical stu- dents, prison inmates and other such groups have frequently been used for medical ex- periments in exchange for different favours and advantages. An article published in the New England journal of medicine in December 2004 entitled “America’s gulag archipelago” spoke about a hospice in Mas- sachusetts in the 1950s where handicapped children were told that they would go on an enjoyable trip and would be given lots of delicious foods [1]. In fact, the chil- dren were unknowingly being used in a non-therapeutic experiment whereby they were given radioactive food to examine the effect of radioactive materials on human beings. Much later, each of them was given US$ 60 000 as reparation. This incident remained unknown until eventually it came to the attention of a journalist, who wrote a book about it which was published in 2004, just one year ago [2]. Children and most mentally handicapped or ill persons are evidently unable to give informed consent even if they are told. They should thus be excluded from research or the consent of their legal guardians obtained instead if their participation is indispensable. Pregnant women may be involved in clinical trials by chance or by design. This raises the important subject of ethical issues concerning the fetus and its development. But there is no final agreement on the cri- teria to be used in determining the stage at which the fetus becomes potentially viable. Some communities, religious groups and individuals, including physicians, strongly object to the use of the living human fetus or its tissues in scientific work. So what about exposing pregnant or nursing women to the kinds of research that might be harmful to their fetuses or infants? A consent by proxy is sometimes given by a tribal chief or a village headman on behalf of the whole tribe or village. In the developing world, many people, when they are asked to give their consent, prefer that the family should be told so that the family can give the consent. I think this is a well known situation in our communities and it means that the individuals are not giving their consent freely. Ethical issues regarding human life Harry Gensler, in his beautiful book Formal ethics, discusses the question of abortion as an example of how we are approaching our ethical issues [3]. Let us make the assump- tion that we can argue against abortion as follows. Killing innocent human life is seri- ously wrong. A fetus is an innocent human life. Therefore killing a fetus is seriously wrong. Is the second premise true? Is a fetus human life? Many people assume that the whole issue depends on this question. If a fetus is a human life, then abortion is wrong. However, many who are pro-abortion admit that the fetus is human life, but only in a trivial and irrelevant sense of the term. They say that the serious duty not to kill human life requires a stronger sense of the term and does not apply to the unborn. So they point to an ambiguity in the word “human”. When people disagree about whether a fe- tus is human life, what is the nature of this disagreement? Do both sides use the same sense of human and differ only on whether a fetus is human in this sense? I think not. Instead both sides use the word “human” differently. If you go to the dictionaries, hu- man has at least three senses. 1. A born or unborn member of the species Homo sapiens. 2. A born member of the species Homo sapiens. 3. An animal who reasons. ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S18 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 We use sense (1) in the biology labora- tory when we distinguish between a mouse fetus and a human fetus. We use sense (2) when we do a population study and count the number of humans in a city. Sense (3) is the traditional definition used to distinguish humans from other animals by their higher mental powers. A fetus is human in sense (1) but not in the senses (2) or (3). So whether a fetus is human depends on which sense of human we use. Is the fetus human life? This question has a clear answer if we say what sense of human we are using in the question. People have claimed human life to begin at one of six various points; conception, indi- vidualization (when a zygote can split or fuse with another), brain waves (when the fetus exhibits brain waves), viability (when a fetus could live apart), birth and rational- ity (when a child first thinks rationally). Here we do not have a factual dispute over when that emerges in the same clear sense of the term “a human”. Instead we have six ways to use the ambiguous term “human”. The real issue is this. Which sense of human should be used when we say killing innocent human life is seriously wrong? We arrive at different principles depending on which sense we pick. The principle concerning conception says that abortion at any point is seriously wrong. The principles concern- ing individualization and brain waves and viability permit earlier abortions but forbid later ones. The principle concerning birth permits any abortion but forbids infanticide. The principle concerning rationality permits both abortion and infanticide. Which of the six should we accept? So you see how complicated these ques- tions are if we are going to philosophize them, and how science sometimes cannot decide such things. This is why we should have some reference values that we should refer to and these reference values in the Eastern Mediterranean Region are conse- crated in the religious values. As I said, the populations of this Region whether Muslims, Jews or Christians have almost the same values that govern their lives and therefore they have the same principles that they can follow in reaching a ruling concerning such issues. Imam Al-Ghazali, the great Islamic jurist, theologian and mystic of the 12th century AD, had a discerning view, con- firmed by the most recent knowledge of the 20th century. He says that the life of the fetus has two distinct stages. In the first stage it is potential life which the mother does not feel. In the second stage, it is an apparent life, felt by the mother. Today we know that this takes place towards the end of the fourth month of pregnancy when the fetus has grown in size and its arms and legs have grown in length. It is able now to touch the wall of the uterus with its punches and kicks. Al-Ghazali says that life starts right at the beginning, “when the female egg is fertilized by the sperm and then at- taches itself to the uterus. To destroy such a fertilized egg is an offence, which becomes far more serious after the soul is breathed into it. But it culminates into a heinous crime after a live birth. This was practised by some Arabs who buried their daughters alive in pre-Islamic days.” (Al-Ghazali. Ihya Ouloom Al-Deen). Other Islamic views applicable to the unborn child confirm Al-Ghazali’s view- point. They include the rule that a women sentenced to death shall have a stay of execution if she is pregnant until she has given birth and suckled her baby, even if her pregnancy is illegitimate. Another rule is that causing a miscarriage, even by ac- cident, incurs a financial punishment, which is a form of blood money. Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S19 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Addressing biomedical ethical issues in the Region Many emerging issues have arisen from the technological advances that happened dur- ing the last century. This has led many peo- ple to try to identify how we can deal with such situations. Therefore, the Islamic Or- ganization for Medical Sciences, in collabo- ration with the World Health Organization Regional Office for the Eastern Mediter- ranean, has convened a series of meetings dealing with particular ethical issues. First, several experts are requested to prepare a paper about the issue from a scientific point of view. These are then distributed to many Islamic scholars, and sometimes Christian scholars, and a meeting convened so that both the experts and the scholars can meet and discuss the papers, and accordingly reach some kind of consensus for recom- mendations and rulings. All the papers, the discussions, the minutes of the meeting and the recommendations are published in one volume that is widely distributed. Up till now, more than 20 meetings have been held and the proceedings have been published and put on the Internet on the website of the Islamic Organization of Medical Sciences, Islamset [4]. This site enables many people to reach the right ruling or what is thought as the right ruling in such ethical issues. However, I think it is now necessary to try to summarize these volumes into a small handbook to be available for anybody who wishes to know the exact ruling concerning these ethical issues so that he/she can access it without having to go through all the dis- cussions and detailed complex text. I hope we can reach this produce of publication very soon, inshallah. The issues I am talking about include organ transplant, beginning and end of the human life, cloning, in vitro fertilization and such issues. I think that guidance on these issues is badly needed, not only for the people of this Region, but also for all people in the world. For example, when we discussed the question of AIDS, many im- portant points emerged, some of which were very new even to the world as a whole, and some of them had been used by other cul- tures in order to arrive at a ruling or decision concerning this issue. As for transplants, I would like to conclude by mentioning one of the rulings that emerged from one of the meetings concerning the responsibility of a community to ensure organs for transplanta- tion for those who need them. This depends on a ruling of the second Caliph Omar ibn Al-Khattab, who ruled that if a man living in a locality died of hunger, being unable to sustain himself, then the community should pay his blood money as if it has taken part in killing him. It may be ruled by the same to- ken that this same verdict applies if a person dies as a result of not being given a blood transfusion or an organ transplant provided that this does not have an adverse effect on the donor. Two statements of the Prophet  seem to be relevant in this respect. One is, “The faithful, in their mutual love, compas- sion and sympathy are like one body. If one part of it suffers a complaint, all other parts will rally in response.” The other is, “The faithful to one another are like the blocks in a whole building. They fortify one another.” And God described the faithful in the Holy Quran saying: They give priority over them- selves even though they are needy (59:9). This is even a step further than donating a kidney because the donor can dispense with one kidney and live normally with the other as routinely ascertained medically prior to donation, with the understanding, however, that those who carry out the surgery will take full care of the donor, post-operatively and in the future, as forgetting about him/ her is against Islam and against medical and biomedical ethics in general. ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S20 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Conclusion The subject of biomedical research ethics is so wide I could not but touch small parts of it. I believe it deserves much more study and we are very hopeful that the establishment of the Center of Biomedical Ethics and Cul- ture in Karachi, where we meet today, will be one of the milestones in this endeavour and that every support will be given to it from all parties that are keen to know the rulings of their religion and of their culture in the matter of biomedical research ethics. References 1. Fost N. America’s gulag archipelago. New England journal of medicine, 2004, 351(23):2369–70. 2. D’Antonio M. The state boys rebellion. New York, Simon and Schuster, 2004. 3. Gensler H. Formal ethics. London, Rout- ledge, 1996. 4. Islamic Organization for Medical Sci- ences. Available at: http://www.islamset. com/ (accessed 8 May 2006). Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S21 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Bioethics: a search for moral diversity Qiu Renzong1 1Professor and Director, Programme in Bioethics, Institute of Philosophy/Centre for Applied Ethics, Chinese Academy of Social Sciences, Beijing, China (Correspondence to Qiu Renzong: qiurenzong@hotmail.com). SUMMARY The concept of global, Asian and Chinese bioethics are discussed in this paper and the dif- ficulty in applying universal bioethics within different cultures and countries is addressed. The traditional beliefs and values in China are described with particular reference to medicine, and the implications for bioethics and research ethics within the country are considered. y ÍÉQǶÇÉF¶=L>É®Ø]Ù=6Ê®Ø]Ù=¥èÇ¿J¶=À¢OVF¶= ¨¾Æh[¿ÈeÇɲ  „=Í[qØ6Û=Æ(Í[ə>£¶=ÍÉQǶÇÉF¶=L>É®Ø]Ù=½ÇëºÍÉNVF¶=Í®eǶ=Åd¹Æ>¿[J[IL>EÇ£r[¶=Æ(ÍÉ¿Ér[¶=Æ(ÍÈÇÉ[i Á=b[·F¶=ÆL>[ª>¯N¶=¬·J‡›Íə>£¶=ÍÉQǶÇÉF¶=L>É®Ø]Ù=°ÉFìI>ÃÃQ=Çȶ=*¼ßÉ[å¯ ¶=‘CÍ[®eǶ=Åd[±çfìJ[[IÆ G[ì¶>E°õ·£J[I¶=´·I>»çÉi×Æ(r¶=›ÍÈbÉ·¯J¶=L=b¯J£™=Æ*L>[É®Ø]Ù=°[ÉFìIL>£FJ[Jj[º¹Æ>¿[[J[I>[»² ÍÉQǶÇÉF¶=r¶=›ÍÉNVF¶=L>É®Ø]Ù=Æ*  Bioéthique : à la recherche de la diversité morale RÉSUMÉ Le concept d’une bioéthique mondiale, asiatique et chinoise est discuté dans le présent article et la difficulté d’appliquer une bioéthique universelle dans des cultures et des pays différents y est abordée. Les croyances et valeurs traditionnelles en Chine sont décrites, notamment en ce qui concerne la médecine, et les implications pour la bioéthique et l’éthique de la recherche dans le pays sont examinées. ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم دلجلما ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S22 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Moral unity or moral diversity? The issue of moral unity or diversity arises from the fact that bioethics has expanded globally beyond Western countries. When bioethics was introduced in developed countries with a culture different from the Judeo–Christian culture in which bioethics was originally rooted, there arose a conflict or collision of cultures. But what has the result of this conflict or collision been? One conquers the other? Or the other closes its door and rejects everything? Is there a third way – for example, assimilating each other or seeking common ground while preserv- ing the differences? In other words, what should we envision about bioethics within global development? Or what is the role of traditional values in the globalization of bioethics? Confucius would say “Junzi (an ideal person) is broadminded, but does not identify with others.” In other word, junzi will respect another person’s point of view and keep harmonious relationship with him, but will not accept the other person’s point of view as his own. Knowledge is power. Modern technol- ogy is a great and fearful power. Wherever it invades, sometimes with weapons, some- times with commodities, tradition seems to have to give way to it. It creates a new culture everywhere. Almost all countries with traditional cultures, after defeat by the imperialist powers and failure in resistance, tried to modernize. They tried to intro- duce, apply and develop modern technology within their own country. However, this in turn has caused a conflict between tradition and modernity, or between traditional val- ues and modern values. When two cultures meet, the two do not simply merge into one, nor is each kept completely intact. Neither a traditionalist attitude nor a radically reform- ist one is appropriate or desirable. The situation in China In China, we have traditionalism. Examples of the traditionalist attitude include the Qing dynasty government, which dismantled the railway near Beijing because they worried about the impact of modern technology on the Chinese people, and also the Boxer movement when the people used gongfu to fight against the Western armies. But the efforts to keep Chinese tradition unchanged and to reject modern values failed. The opposite attitude is what we call radical reformism. Such advocates shouted the slogan “Down with Confucianism.” Should the traditional Chinese culture with its core of Confucianism be relegated to historical museums or the rubbish heap? The question raised in recent waves of reform is – can traditional values play an important or even indispensable role in the era of modern science and technol- ogy in the 21st century or even the third millennium? The fact is we must consider the traditional values and sometimes when applying modern technology, these values should be taken into account. If we neglect some basic traditional values, we may have to pay a high price. The following examples illustrate this point. Donor insemination in Shanghai Shanghai is a modern city in China, per- haps the most modern. A young couple in Shanghai had been married for many years without a child. They went to see a profes- sor who was an expert in infertility. The husband was diagnosed as being unable to ejaculate. The professor provided donor in- semination to him and his wife gave birth to a boy and they were very joyful. However, when the couple brought the child home, because they lived within the extended fam- Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S23 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما ily with three generations living together, the husband’s parents thought that the child did not look their son. The son had not told his family the truth and had simply said his illness was cured. They did not say that they had used the technology of donor insemina- tion. After disclosure of this information, the husband’s family rejected the child be- cause the boy did not have blood ties with the husband. The wife had to return to her mother’s house with her child. She sued the family in court, but the husband said that he had not known the truth and wanted to divorce her. Cornea transplantation in Beijing On October 13, 1998 when Dr G of the department of ophthalmology, hospital R in Beijing prepared to operate the next day, he found that the stored corneas were necrotic. He went to the hospital mortuary and removed two eyes from a dead female patient. After that he performed cornea transplantation for two patients and both of them recovered their sight. But at the crematory, the family of the dead woman discovered her eyes missing. It is very im- portant in China to keep the body intact before cremation and so the family sued Dr G for half a million Chinese dollars (RMB) compensation. However, the state prosecuting attorney (who is responsible for formally accusing suspects in the public interest) decided not to sue Dr G. Long-term care in Hong Kong Following the British model, long-term care for the elderly in Hong Kong is covered by the Government and provided by pub- lic healthcare institution. But Hong Kong residents protested against this and claimed that care should be provided by their fam- ily members. In practice, a compromise between them needs to be reached. Commercialization of medical care We are paying the cost for turning the art of ren (humanness/humaneness) in to the art of making money. Twenty years of market-oriented reform have been deemed “basically unsuccessful” and have led to unfairness and low efficiency in healthcare. Ninety per cent of the population is very dissatisfied with the healthcare provided and 60% of medical costs are personal out-of-pocket payments [1]. Before the health care reform that was launched 20 years ago, the main provider of health care was the Government. Coverage shrank to 43% in cities and 3.1% in villages in 2003 from 70.9% and 5.8% in 1999 [1]. The percentage of healthcare expenditure was more than 5% of GDP, but almost 50% of outpatients and 30% inpatients did not go to hospital because it was unaffordable [2]. The population in China is increasing but the numbers of outpatients and inpatients are decreasing. So there is clearly injustice and efficiency. This practice goes against the command- ments of the ancient doctors. For example, Liu Fang said, “Before treating patients, we should treat our hearts first.” And an ancient anonymous author wrote, “The Tao of prac- tising medicine is first to rectify ourselves and then properly use the medicine.” When a disciple came to the ancient doctor Li Gao to learn medicine from him, he asked the young man, “Do you want to learn to be a physician looking for money or to be a physician disseminating the Tao?” Xu Da- chun in his article “On ginseng” criticized those physicians who used ginseng to treat patients and were both killing the patients and plunging their families into bankruptcy [3]. He says, “It was unforgivable for a phy- sician to kill a patient with the improper use of a drug, but his deeds of killing a patient and plunging his/her family into bankruptcy ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم دلجلما ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S24 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 were more vicious than what a robber or a thief did.” In the present times, there are many places in China where physicians are killing their patients and bankrupting their families. How are global bioethics and Asian bioethics possible? Since 1990 there has been a lot of controver- sial discussion on global bioethics and more recently there has been discourse on Asian bioethics. My question is, how is global bioethics or Asian bioethics possible? The argument in favour of global bioethics are the following: i) to provide common moral grounds for the international community to be able to take action; ii) by nature humans are alike; iii) ethical relativism is wrong; and iv) different values, different cultures or different moral communities will converge with social, economic, political and cul- tural change. There are four counter argu- ments. First, common moral ground can be reached by sharing values and negotiation, not necessarily by creating global bioethics. Second, Confucius said, “By nature men are alike, through practices they have become far apart.” Third, the fact that ethical relativ- ism is wrong does not automatically justify global bioethics. Fourth, change does not necessarily lead to moral unity; moral diver- sity still exists. The arguments against global bioethics include: i) human beings are embedded in different groups, communities and cultures; ii) morality or the ethics of different moral communities or cultures is somehow incom- mensurable even though they share similar values; and iii) global bioethics may lead to concerns about ethical imperialism. Some bioethicists have raised questions and provided arguments regarding global bioethics. For example, Tangwa from Cameroon asks, “How is global bioethics possible in a world inhabited by different cultural groups whose material situation, power, ideas, experiences and attitudes dif- fer quite markedly and who are not, in any case, equally represented in globalization efforts and forums?” Benatar from South Africa argues that imperialism is not only a political force which existed during the age of the British Empire, but that it is an ongoing feature of hegemonic world views, civilizations and religions. British bioethi- cist, Alistair Campbell, wonders whether global bioethics is a dream or a nightmare? Is it a nightmare of a homogenized lowest common denominator ethics? Or, worse, of the cultural domination of world bioethics by one set of moral assumptions and style of reasoning? Even if the term global bioethics can be accepted, it has to be based on a respect for the richness of human cultures and the fragility of the physical and social environments that sustain human life. Just as there is no single global bioeth- ics, there is also no single Asian bioethics. Asia is a continent with the richest cultures. Cultures from all other parts of the world can be found in this continent—Islamism, Hinduism, Buddhism, Confucianism, Tao- ism, Judaism, Christianity, and many ab- original cultures. There are many different approaches, perspectives or paradigms of bioethics in Asia, but no single Asian bio- ethics. Even in China, there is no single Chinese bioethics. We have different ap- proaches too, although we share some val- ues among them. The conclusion we can reach is that there are some shared values between Western and Asian approaches to bioethics and among Asian approaches. We share very basic values such as beneficence, non- maleficence, respect and justice. We can find these values in Confucianism. All these Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S25 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما values could be put in the framework of Confucianism and I will discuss this later. These shared values constitute common ground for common action in this small world. But these shared values are inad- equate to constitute an overarching ethical theory that can be called universal ethics or global bioethics or Asian bioethics. Both ethical universalism and ethical relativism are undesirable because they would lead to worries about ethical imperialism and ethi- cal barbarism respectively. Bioethics and research ethics in Chinese culture Chinese culture has no tradition of human experimentation. After resisting it for many years, China has now accepted it and regu- lates it. However, some traditional values persist. Bioethics or research ethics have to be adapted to them, and it may in fact benefit them. Traditional Chinese medicine is based on the theory of the yin-yang and wu xing. Chinese medicine is holistic with a concept of web of causation in contrast to the West- ern idea of single linear causation. Modern medicine is based on the theory of atoms, molecules, reductionism, dualism and linear causation. So it may be difficult when we go to the countryside to talk about the research of genetics or some such. It is difficult for a patient/subject to comprehend what atoms or molecules are whereas it is easy for him/ her to understand yin-yang and wu xing. Chinese cosmos According to Chinese cosmology, the uni- verse and all of its inhabitants are composed of qi. Qi is a physico–psychological entity, with the capacity for creation, change and transformation, which has two basic forms, yin and yang. The generation, change and transformation of all things are produced by their interaction, their being yin and yang interaction. The universe and its inhabitants are uncreated and are rather participants in an organic whole that interacts in a self- generating cosmos. There is no ultimate cause, no creator, no external will or judge. The universe has always existed – there has never been a time when it did not exist – and therefore the question of a creative act simply could not logically arise. Confucian ethics Confucian ethics emphasize virtue, duty and context, whereas the Western counter- part of ethics focuses on norms, rights and principles. In China, ethics are entrenched in general philosophy and culture. The core of Chinese culture is three teachings; Confucianism, Taoism and Buddhism, this of course, is Chinese Buddhism. Chinese philosophy is distinguished by its commit- ment to the human condition with a deep engagement in society and politics and a strong focus on practical insights. Chinese philosophy has four key theses: 1. Sage within and king without. That is everybody can be a sage or Buddha, an ideal person. A sage’s virtues should be manifested in his actions and relation- ship with others. 2 Unity of nature and humankind. An ideal person would reach such a spiritual level where humans and nature are united as one. The care is for non-human animals and ecology as well as for humans. 3. Seeking the truth from within. The Tao of nature and the Tao of humans are the same. If we develop our own character to the acme of perfection, we can know the truth of the external world. The only barrier to prevent us from knowing na- ture is our own selfish desires. This is why traditionally in China we did not ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم دلجلما ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S26 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 develop experimentation, including hu- man experimentation, because the Chi- nese epistemology was different. 4. Reason and emotion are inseparable. Emotion can help reason. So in China we believe in making people understand the reason or principle, while moving them with affection. Chinese traditional epistemology is an introspectionist approach, which says that if the mind is stable, you will be able to see and hear clearly, your limbs will be strong, qi will be kept in your body. Guan Zi, a Tao- ist, said that if the mind is stable, the world will listen to you. Hui Neng, a Zen master, said, “Perfect wisdom is inherent in all people. It is only because they are deluded in their minds that they cannot attain en- lightenment by themselves. Calmness and wisdom are foundations of my method.” So they are introspectionist in the theory of knowledge. It follows from introspection- ism that observation and experiment are not indispensable to obtain knowledge. Chinese medicine – the art of ren Confucian physicians argue that medicine is the art of ren (humanness/humaneness), which requires rectifying yourself before treating patients and helping or doing good to patients. Confucian physicians argue that physicians should do good to as many peo- ple as possible, which includes parents, king and ordinary people, and treating patients equally. The last but not least is the belief in pursuing the Tao of medicine instead of the profits. Ren therefore requires overcoming ourselves (keji). In China there is a very close relation- ship between Confucianism and medicine. Confucian medicine is the mainstream of traditional Chinese medicine. It promotes medicine more than other philosophies. It values human life and health highly, empha- sizes care for others and only pays attention to this life, not the next. Medicine became an application of Confucianism in the field of healing art. Medicine is an essential part of Confucianism. Mastering medical knowledge is one of the requirements for practising ren. But what is the meaning of ren? This is a very crucial concept in Confucianism. Ren is love, compassion and care for others, the sentiment embodying regard for others and moral capacity to feel for others. We love others and are compas- sionate to others not because we benefit from it, but because we have the heart that cannot bear the suffering of others. Mencius said, “When we suddenly see a child about to fall into a well, we will have the feeling of alarm and compassion. This is not because we want to enter into good relations with the parents of the child, or because we want to gain praise from his neighbours and among our fellow colleagues and friends, or because we dislike the cry of the child, but because we have the heart which cannot bear the suffering others.” Ren is the extension of natural compas- sion that everyone feels in view of the hardships and misfortune of others. Ren can be and has to be cultivated and developed in interpersonal or social relationship, first within family. The method of actualizing ren is from near to far. Actualizing ren be- gins with family. Xiao, filial piety towards parents and ti, fraternity towards brothers/ sisters are the roots of ren. Confucius said, “If a man cannot even reciprocate the inti- mate human affection experienced within the family bond, it is not likely that the development of the person can be achieved in the less intimate environment outside the family circle.” The affection that is assumed to grow naturally in family should become the model for treating others in general, in society, including non-human animals. Mencius said, “I have no heart to eat the meat hearing its cry.” Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S27 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Thus filial piety is a very important value in Confucianism. The requirements of xiao include the study medicine in order to care for parents. Xiao in traditional inter- pretation also includes the requirement to keep the body intact. The body, including our hair and skin, are received from our parents. “We dare not cause any injury to it and this is the beginning of filial piety”, is one of the Confucian classics in the Book of filial piety. Another requirement of xiao is extending the life of ancestors. Mencius said, “There are three things that are not filial and to have no posterity is the greatest of them.” Ren should be cultivated in a physician’s heart. Confucius said, “If there is no ren in one’s heart, how useful is li (norms) for her/ him?” The relationship between physician and patient is more than the one between provider and client. It should be a fiduciary relationship. Chinese concept of personhood Another very important concept is that of personhood, the relational concept of per- sonhood. A person cannot be reduced to a set of human genes or human genome, as genetic essentialism claims. Even self- consciousness is not a sufficient condition. For an entity to become a person, it has to be in an interpersonal and social relationship. Even consciousness or self-consciousness is shaped within this relationship, not outside it. So according to Confucianism, a person begins with birth. Also according to Con- fucianism, a person is not independent, but rather is in an interdependent relationship with others, first parents and family mem- bers. Family thus plays an indispensable role in clinical decisions in the Chinese cul- tural context. There are two consequences of this concept. First, a person’s individual interests must be balanced with the inter- ests others. A person’s individual rights have to be balanced with his obligations or responsibilities. The Confucian relational concept of personhood implies that the self is enlarged to self-in-relationship. The individual and others are interrelated and interdependent. Chinese concept of rights According to Confucianism, a person is a role player. When a person becomes com- petent, he or she has to act responsibly. It is in one’s role relationship and role per- formance that one finds the source of one’s value and dignity as a person and the basis of one’s self-esteem, worth and fulfillment. Personhood is an achievement, rather than a given right or a right of birth. Consideration of rights is very useful in some cases but ethical dilemmas cannot be solved merely by this. Many rights are in conflict not only with different individuals but also within the same person. Exercise of rights depends on context. The rights approach focuses on which rights a person should enjoy, but is not concerned about whether a family or community has sufficient resources avail- able to meet the needs of all individuals when exercising their own rights, and who is obliged to provide the necessary means to allow these rights to be exercised. The rights approach does not consider the hu- man finitude. Implications for bioethics and research ethics in China The Chinese belief is that human life begins with birth, not the instance when the sperm penetrates the ovum; thus a human embryo or fetus has not become a person yet, al- though they should enjoy certain respect, such as that afforded a human corpse. Abor- tion becomes a moral issue only in so far as it brings harm to a pregnant women rather ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم دلجلما ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S28 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 than because it kills a fetus. Thus, embryo research or deriving stem cells from an em- bryo per se are not ethically problematic. The technologies, such as artificial in- semination by husband, in vitro fertiliza- tion, intracytoplasmic sperm injection and surrogate motherhood are acceptable in general but donor insemination is rejected in some traditional families as the case described earlier demonstrated. What about brain death and euthanasia? The meaning of human life is not mere existence but living in a way that benefits others. The heart is the central organ of the body. There is a strong affective or emotional tie between those who are irreversibly comatose and terminally ill with intractable pain and their kin. China is the only country that has not accepted brain death as legal yet, and euthanasia is illegal too. Organ and body are given by parents and it is not permitted to donate them even after death. Even when the dead body is eventually sent to the crematorium, it should be kept intact. There are only two exceptions to this: meeting a parent’s need or sacrificing for practising ren when the nation is in a crisis. Health and disease are not an individual prob- lem but a family one. The family plays an indispensable role in clinical decisions. Clinical decision is usually not a patient’s individual decision, rather a family decision incorporating the patient’s views. In sexist, poor families, women/girls are the lowest priority. So there is no mechanism to protect a vulnerable member in a traditional family. For example, a Chinese–American female patient was admitted to hospital in the US. When her doctor disclosed the medical information to her, she refused to listen and instead asked him to tell her husband and obtain consent from him Human experimentation Human experimentation violates the prin- ciple of xiao, filial piety; this is an ethical barrier in traditional Chinese culture. Hu- man experimentation is not necessary be- cause of the introspectionist approach to the theory of knowledge. It is an epistemologi- cal barrier. In addition, there is an aversion to human research or experimentation for historical reasons, in particular the inhuman experiments conducted by the Japanese 731 unit. There is also a barrier to informed con- sent. Because Western and Chinese people live in a different cosmos and speak differ- ent languages, so the information provided by one side is difficult to be understood by the other side; and the family has to play some role in the process of consent. But what kind of role should the family play? Furthermore, some Chinese in rural areas are reluctant to sign the informed consent form. They worry about what could ensue after signing? Peasants in rural areas have bad experiences with signing; for example, in some instances they have found that after they signed a contract, their ox or cow was taken away by their landlord. Family-assisted informed consent Zhai, in her unpublished pilot survey, re- ported that interviewees supported the view that respect for a person should include respect for the person’s culture, because culture is part of a person. Therefore in China, consent is not merely an individ- ual’s prerogative or responsibility. It is associated with the wider obligations to family. Family members have a responsibil- ity to assist their diseased kin in decision- making, whether it is participation in a clini- cal trial or not. We call this model family- assisted informed consent. Most people in her interviews thought that consent assisted by family members rather than consent by the individual alone was more valid, given the culture and situation in China. For their part, participants would like to take time to discuss the information with their fam- Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S29 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما ily members before they make the final decision. Furthermore, the Chinese did not accept the terms “research” or “experi- ment”, but would only accept “observation of medicine’s effect”. In rural areas, the consent of women was obtained after their negotiation with their family, their husband and/or mother-in-law in particular. In some cases, the village doctor signed the consent form because the subjects did not want to sign the form even though they consented to participation in the project [4]. Family in today’s China We have had 20 years’ experience of health care reform in China during which the sta- tus of the family has changed. Tao and her Hong Kong colleagues conducted a survey in mainland China [5]. The findings indi- cated that the Chinese interviewed did not support the isolated nuclear family thesis as an inevitable outcome of industrialization and modernization. However, this did not imply that the Chinese family in the tran- sitional economy had not undergone some adaptation to respond to the new social environment. Their conclusion was that the family is still highly treasured in Chinese society, even in the age of economic reform and rapid social changes. This is because the Chinese family embodies the value of mutual care, reciprocal support and human connectedness, which are values deeply engrained in the Chinese mind. As a rule, in the clinical context, a decision is made by the family including the patient him/herself but not the patient alone. Bioethics in China: the future Now what is the future? Bioethics/research ethics with its principles and practices will further develop in China but they should be interpreted within the Confucian framework and coloured with characteristics of the na- tive culture. Some traditional values will be abandoned, some reinterpreted or refined, some assimilated into practices or regula- tions and even adapted by other cultures. So ultimately bioethics/research ethics in China will incorporate features of our own culture. References 1. Health news, 1 July, 2005 (Ministry of Health, China). 2. Health news, 11 January, 2005 (Ministry of Health, China). 3. Shanghai College of Traditional Medicine: selection of ancient medical texts. Shang- hai, Shanghai Press of Science and Tech- nology, 1980:228–9. 4. Qiu RZ. Tension between modern values and Chinese culture. In: Bankowski Z, Levine RJ, eds. Ethics and research on human subjects: international guidelines. Geneva, Council for International Organi- zations of Medical Sciences, 1993. 5. Tao J, Chen Ho Mun. Chinese family and Chinese women in the transitional econ- omy. In: Qiu RZ, ed. Feminist philosophy and public policy. Beijing: Chinese Social Sciences Press, 2004. ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S30 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Research and developing countries: hopes and hypes Farhat Moazam1 1Professor and Chairperson, Center of Biomedical Ethics and Culture (SIUT), Karachi, Pakistan (Correspondence to Farhat Moazam: famoz@mindspring.com). SUMMARY The paper outlines the universal problem of ensuring ethical practices in human subject research, and focuses on specific difficulties faced in the developing world with particular reference to Pakistan. It discusses the influence of traditional and hierarchical social norms of physician– patient relationships in heightening these problems. Two emerging issues of specific concern in Paki- stan are described: an exponential rise in multinational clinical drug trials, and commercial ventures offering unproven stem cell “therapy” for all kinds of diseases. The importance of introducing ethical practices in research within the context of local cultural and socioeconomic realities is highlighted. Recherche et pays en développement : espoirs et boniments RÉSUMÉ Le présent article décrit le problème universel qui consiste à garantir des pratiques éthiques dans la recherche sur les sujets humains et s’intéresse aux difficultés spécifiques rencontrées dans le monde en développement, et plus particulièrement au Pakistan. Il examine l’influence qu’ont les normes sociales traditionnelles et hiérarchiques dans la relation médecin-patient pour intensifier ces problèmes. Deux nouvelles questions particulièrement préoccupantes au Pakistan y sont décrites : une augmentation exponentielle des essais pharmaceutiques cliniques multinationaux, et les projets commerciaux offrant des thérapies cellulaires à l’efficacité non prouvée pour tous genres de maladies. L’importance de l’introduction de pratiques éthiques dans la recherche dans le contexte des réalités culturelles et socioéconomiques locales est soulignée. Íɺ>¿¶=Á=b·F¶=›PÇVF¶=6¹Çj£™=½Ø³¶=ÆÍÉ£®=Ƕ=¹>ºÛ=E ¼õŸ£ºL>Ufª  „=Í[qØ6[¶=PÇ[VF¶=›Í[É®Ø]Ù=[[È>£™=Ì>[¢=fºÁ>»[u›Í[·ëN»J™=Í[ə>£¶=Í·³n™=‘CÍ®eǶ=Åd±çfìJ[I =Íɢǿ¶=L>EÇ£r¶=η¢hù²fIÆ(fnF¶=η¢ÏßfRàIÁ>Jj[²>E>»çÉ[i×Æ(abr¶==d›Íɺ>¿¶=Á=b·F¶=>ÃÃQ=ÇI¶* Åd[Âg=f[EC›xÈf[™=ÆG[ÉFì¶=[EÍ[®Ø£·¶ÍçÉFàI=fç[[J¶=ÆÍ[ÈbÉ·¯J¶=ÍÉ¢>»JQ×=[È>£™=M@I´¶d²Í®eǶ=o®>¿IÆ Lسn™=*Í[É»Â?>[»(Á>Jj[²>E›ÀáÉßIçbRßJáj[àºÀáÉßJçÉv[®¬[qǶ>EÍ[®eǶ=¹Æ>¿JIÆ>[»ÂÆ×?(Í[q>]6b[àÈ=hJ¶= >úëb[¯I[¶=zÆf[£¶=Æ(Í[ÈÆaÙ=Î[·¢L>Éj[¿‚=Ìaëb£JºL>ÃQ>ÃÈf¶=ÍÈfÈfj¶=He>RJ¶=ab¢›b¢>rJ™= L>[¿ëÉF¶>Ebß¿áj[àºß[¦âÐ>[¢ëa=(Í[É¢d‚=>[È؄=¥eg°Èf{À¢z=fºÙ=¤É–TØ¢Ð>¢a>EÍÈe>L>²fm*g[àIÆ ÍÉ»Â?ð=]?Í®eǶ=Ëa>r[J®×=ÆÊ¢>[»JQ×=Æ›>[¯N¶=¤[®=Ƕ=e>[{C›(PÇ[VF¶=›Í[É®Ø]Ù=L>[ie>»™=Ì>¢=fº L>£»JR»·¶*  Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S31 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Importance of and obstacles to ethical research The issue of ethical research and the difficul- ties we face in assuring ethical research in the background of deeply ingrained cultural norms and values that define our interac- tions both with patients and healthy human subjects are, in my opinion, especially im- portant for us, the healthcare professionals and investigators who live and work in developing countries such as Pakistan. In the May 2005 issue of Nature, Mar- tinson and his co-authors reported that one- third of all United States scientists had engaged in serious research misconduct in the past 3 years [1]. Along the same lines, in a recent interview to the Boston Globe, an American newspaper, Mr Greg Koski, Director of the US Government Office for Human Research Protection, expressed his concern about medical research involving human subjects in the United States [2]. Mr Koski stated that “medical research in the US is in a critical condition”. He compared it to a “nuclear reactor” that was facing meltdown. These concerns about unethical research are being expressed in a country that has played a major role in the development of guidelines for international research ethics, and probably has more institutional review boards and oversight mechanisms in place than any other country in the world. What is apparent, therefore, is that ensuring that human subject research is conducted in an ethical fashion is no easy matter anywhere in the world. Such com- ment also suggests that merely establishing ethics review committees, or becoming fa- miliar with international ethical guidelines that have been formulated and revised many times, and will undoubtedly be re-revised, are insufficient in themselves as safeguards against unethical research and exploitation of human subjects. Nonetheless, there is significant interna- tional effort at the moment to establish ethics review committees in developing countries, which are increasingly functioning as host countries for multinational, collaborative research. Without ethics review committees in place to approve proposals, it is difficult to embark on such research and impossible to publish the results in indexed journals. However, a committee is only as ethical as the members who constitute its body. In- numerable examples are available in the lit- erature that demonstrate that ethics review committees can end up serving as no more than official tools stamping “approved” on proposals when members are not united by shared values [3,4], which include a duty to protect the most vulnerable, but instead are primarily driven by personal gain. We can formulate impressive ethical guidelines, but these are only effective if researchers have a strong sense of moral responsibility, compassion and empathy towards those they recruit as research participants. The situation in Pakistan Conducting research in hierarchical, tradi- tional countries such as Pakistan adds yet another dimension to the difficulties in as- suring that it is done in an ethical manner; an “indigenous” layer of cultural norms makes it even more of an uphill task, but it is a task that we are morally bound to shoulder. The historical and social construct of the Pakistan culture, the socioeconomic realities (with similarities to other coun- tries in this region) and some of the deeply rooted values and customs pose challenges that are specific to this part of the world. We who live here know them, and only we can address them. ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S32 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Perhaps the most important factor that places human subjects at risk in this part of the world is the magnification of “power differentials” inherent in hierarchical so- cieties such as Pakistan. This difference is particularly pronounced in the interactions between physicians and scientists and those they take care of or enrol in research proj- ects. In Pakistan, scientists and physicians constitute the “elite” section of society. They are by and large the “English-speak- ing”, affluent, highly educated minority in a society where the majority of those they deal with in their professional lives are “Urdu-speaking”, poor, generally illiterate or misinformed and disadvantaged in many other ways. The authority and respect, made legiti- mate both culturally and religiously, that physicians and researchers are given in Pakistan is quite extraordinary. In most industrialized countries, professional– public interactions in healthcare and re- search domains rest on an egalitarian, con- tractual foundation in which the rights of the individual (human subject or patient) are central pillars. Moreover, legal mechanisms are available and made accessible in these societies as recourse to those who believe that their rights have been violated. Further- more, the general level of public education and knowledge makes this a mechanism that both patients and research subjects can, and do, tend to use. In Pakistan, and other countries in this region, we live in a different universe. The general public, whether healthy or ill, re- gards anyone connected to the medical pro- fession with a reverence that has long been lost in industrialized countries. Laypeople that physicians deal with professionally continue to perceive them, and often refer to them, as their maa-baap (mother or father) who knows what lies in their best interest. I have referred to this relationship in my writings as one characterizing a “relational morality”, a fiduciary relationship based on trust rather than one that is contractual in nature and rests on the rights of individuals [5]. A physician–researcher’s authority is further augmented by the position accorded to healers in Islam; they are considered to be the instrument of God’s mercy on earth, a statement that can be found in Al-Ruhawi’s 9th century treatise, Adab al-tabib [6]. In a country where patients frequently say that “up there is Allah, and down here is you, doctor sahib”, they are unlikely to suspect that a doctor has anything but their best interest at heart when he/she suggests a line of action to them. Added to this is the other reality in Pakistan – absent, weak or only-on-paper accountability processes both at institu- tional and governmental levels. The lack of accountability processes and the powerful power differential can serve as a lethal combination for human research subjects and patients alike, making the potential for abuse of both truly phenomenal. Through workshops held in Pakistan, healthcare professionals and scientists are becoming familiar with the Helsinki Declaration, the Council for International Organizations of Medical Sciences (CIOMS) and other research ethics guidelines. But knowledge of such guidelines is one thing; application of this knowledge within the specificity and context of existing cultural and professional practices and socioeconomic realities, is quite another. This is a matter we have neither reflected on sufficiently nor kept ad- equately in sight in developing countries. Emerging issues in Pakistan There are 2 emerging developments in Paki- stan related to medical research that I con- sider among the most troubling. These are Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S33 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما also issues that are emerging in many other developing countries of this region. Clinical drug trials We are beginning to see an exponential increase in clinical drug trials in Pakistan in which multinational pharmaceutical com- panies are major players. In a majority of collaborative trials, sponsors are from countries of the developed world while co- investigators and research subjects are drawn from African and Asian countries. In the case of drug trials, because it is the physicians who prescribe drugs, they are the ones being approached to serve as investiga- tors using their patients as research subjects. Drug trials now constitute the most com- mon form of research taking place in Paki- stan [7,8]. Almost two-thirds of research proposals that are reviewed every year by the ethics review committee of one of the teaching institutions in this country involve drug trials (personal communication). From 1995 to 1999, the proportion of new drugs approved for use in the United States on the basis of trials conducted out- side America increased from 9% to 27% [9]. In a report in the Washington Post in May 2005, Mr Yamada of the multinational GlaxoSmithKline is quoted as saying that the company’s “outsourced” clinical tri- als are expected to rise from 29% to 50% within 2 years [10]. This makes obvious economic sense. Countries of the develop- ing world offer many advantages, besides lower overhead costs, for conducting such research when compared to industrialized nations. Many South Asian countries such as Pakistan have large, illiterate popula- tions to draw on as subjects. Many have physicians who are well conversant with English and some of them have had part of their training in the United Kingdom or the United States. Above all, supervision and monitoring mechanisms are either weak, absent or amenable to manipulation. Conducting clinical drug trials in devel- oping countries is a necessity. We need to investigate, understand and develop effec- tive preventive and curative approaches to diseases that are endemic to this region. But the benefits of such research must accrue to the communities used for research. Well known to many is the “10/90 gap” described in the 2003–2004 Report of the Global Forum for Health Research [11]. The report highlights the fact that of the 73 billion US dollars America was investing annually in health research at the turn of the 21st century, less than 10% was being devoted to health problems that account for 90% of the global disease burden. In clinical drug trials, there are inherent conflicts of interest when physicians serve as investigators. These conflicts, which can lead to coercion and exploitation of patients, are compounded in societies such as Pakistan where physicians have immense authority and are revered as instruments of God’s mercy. In Pakistan, as elsewhere, healthcare institutions and physicians are increasingly succumbing to blatant finan- cial incentives – leased cars, international trips, help with education of children, and even plain cash – to participate in drug trials that would be questionable in other countries [12,13]. When our primary pro- fessional objectives become personal gain, academic or monetary, we convert research and healthcare into marketable commodi- ties. This is an unconscionable rejection of what the healthcare profession is all about. The hype of stem cell “therapy” The second development, which, in my opinion, needs serious attention from prin- cipled citizens, professionals and laypeople alike, are the burgeoning of private, com- ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S34 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 mercial enterprises that are beginning to present research that is still in its prelimi- nary stages as proven therapy or treatment for various diseases. Desperate patients and misinformed or unscrupulous physicians are being approached directly by such for- profit business enterprises. The latest example of the presentation of research that is promising but still in its early stages is related to stem cells. Autolo- gous stem cells that are drawn from patients and then re-infused into the patients follow- ing professed “retroversion” to totipotency are being increasingly offered as treatment for all manner of diseases. A recent news item in The Dawn (the leading English newspaper in Pakistan) reported a press conference in which a member of the Sindh government expressed moral outrage at people he described as “fake” spiritual healers and magicians [14]. In Urdu he referred to them as unscrupulous “amil, kamil aur jadoogar (magicians)”. He complained that not only poor patients but even educated people were being duped by their fake promises. The government offi- cial then promised that “wide action” would be taken against them soon, and the “wall chalkings” that they use as advertisements for their fictitious cures would be removed. The irony of this report, in light of the recent inauguration of a private company in Ka- rachi claiming the availability of “therapy with stem cells” for a multitude of diseases, will become clear later. But first let us return briefly to the status of stem cell research in a recent article by Braude, Minger and Warwick published in the British medical journal [15]. The authors are a professor of haematology, a professor of obstetrics and gynaecology and the director of a stem cell laboratory in the United Kingdom. They wrote with concern about the “escalating number of clinics offering stem cell cures for all sorts of ills”. This, they believe, was leading a promis- ing technology rapidly into the realm of quackery. They said, “Despite inadequate preliminary data on clinical safety or from animal experiments, trials using [stem] cells derived from autologous BM (bone mar- row) samples are already being conducted on patients ...” The urgency for treatment of severe diseases is the justification given for this practice. The authors note that urgency can never be used as an excuse for offering unproven therapy and exploiting desperate patients. And they are correct. And yet, commercial enterprises that offer treatment by using the patient’s own stem cells are beginning to spring up for problems as diverse as Parkinson disease, muscular dystrophy and other neurologi- cal disorders, thalassaemia, paralysis from strokes, depression and heart disease. These have been reported from Mexico, Brazil, Barbados, China, the Ukraine, Russia and India [16]. Now, this commercial enterprise has found its way into Pakistan through a private company, which was asked to stop its unethical practice in India in 2004. They have now found a haven in Pakistan. In an interview to Newsline, a Pakistani magazine, the researcher (and owner) of the private company in Karachi involved in this therapy described what she is able to do with stem cells [17]. She said the technique that was being used could “virtually be called the magic touch”. To translate this into Urdu, the technique she is offering is a form of jadoo (magic); by analogy she is therefore a jadoogar, an entity the govern- ment official previously mentioned had condemned as unacceptable in Pakistan. What is the difference then between the jadoogar that the honourable member of the Sindh government was so upset about and the treatment, the “magic touch”, be- ing offered openly through use of stem cells in Pakistan? The difference is that Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S35 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما whereas the jadoogar and spiritual healers generally hail from the poorer sections of society and advertise on city walls, physi- cians and scientists who promise stem cell treatment belong to the elite of the country, are patronized by the rich and the influential and advertise in the leading newspapers of the country. Conclusion Biomedical research has led to tremendous benefits for the human race, and it offers great hope for the future. However, it is being high-jacked by private, commercial enterprises that are willing to by-pass me- ticulous scientific methodology and ethical standards. Yet, the hyped up promises for therapy of all manner of diseases that they make can be extraordinarily seductive to those with serious diseases. Much of this appeal is due to the fact that we are in an era in which science wears a mantle woven with power, authority and credibility. Because of this, it takes courage to make a stand against it when it is abused for personal gain at the cost of the unwary, the uninformed and the disadvantaged in our societies. But a stand against unethical use of research must be made, whether this occurs through multinational drug trials or when untested research is touted as therapy. It is our moral responsibility as healthcare professionals and researchers to do so. To conclude, for those who appreciate the beauty of Urdu poetry, here is what Allama Iqbal has to say about our obliga- tion to move beyond the ease of acquiring rhetorical expertise in words to the struggle involved in achieving the heroism of a vir- tuous person who acts in moral ways. Guftaar kaa yey ghazi to bana Kirdar kaa ghazi bun na saka (Master was he when it came to smooth talk But as man of virtuous action? A naught). References 1. Martinson BC, Anderson MS, de Vries R. Scientists behaving badly. Nature, 2005, 435(7043):737–8. 2. Kranish M. System for protecting humans in research faulted. The Boston Globe, March 25, 2002. 3. Bernstein M. For subjects in Haiti study, free AIDS care has a price. New York Times, June 6, 1999 (Special Report). 4. Gilman RH, Garcia HH. Ethics review protocols for research in developing coun- tries: a basic presumption of guilt. Cana- dian Medical Association journal, 2004, 171(3):248–9. 5. Moazam F. Families, patients, and phy- sicians in medical decision-making: a Pakistani perspective. Garrison New York, Hastings Centre Report, Nov–Dec, 2000:28–37. 6. Levey M. Medical ethics of medieval Is- lam with special reference to Al-Ruhawi’s “Practical Ethics of the Physician” . Transactions of the American Philosophi- cal Society, 1967, 57(3). 7. Abdul Latif Shaikh A-L. Pharmaceutical research: paradox, challenge or a di- lemma. Paper presented at the Research Ethics Conference, Karachi, 29 Novem- ber, 2005. 8. Nundi S, Gulhati CM. A new colonial- ism? Conducting clinical trials in India. New England journal of medicine, 2005, 352:1633–6. ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S36 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 9. Daar AS, Singer PA. Human capital is key to research ethics. SciDev.Net, April 25, 2002 (http://www.scidev.net/con- tent/opinions/eng/human-capital-is-key- to-research-ethics.cfm, accessed 6 June 2006). 10. The Washington Post, May 2005. 11. 10/90 Report on Health Research 2003– 2004. Geneva, Global Forum for Health Research, 2004. 12. Relationship between doctors and the Pharma industry. Pulse, Pakistan, 2006, 7(3). 13. Sarmiento A. Medicine and industry: the payer, the piper and the tune. Annales CRMCC, 2000, 33(3):144–9. 14. Dawn, Pakistan, November 9, 2005. 15. Braude P, Minger SL, Warwick RM. Stem cell therapy: hope or hype? British medi- cal journal, 2005, 330:1159–60. 16. Alan Zarembo. Business not science. Sci-tech World, Dawn, Pakistan, May 28, 2005:4. 17. Rehan S. Miracle cure? Newsline, Paki- stan, 18(5):92–6. 8th World Congress of Bioethics. A Just and Healthy Society The Chinese Medical Association, the Chinese Society of Medical Eth- ics, and the International Association of Bioethics are holding the 8th World Congress of Bioethics from 6 to 9 August 2006 in Beijing, in conjunction with other important bioethics events. This Congress will offer a comprehensive examination of the full range of issues in bio- ethics, many generated by the latest developments in biotechnology and health systems and by the age-old dilemmas of medical practice and research. Further information can be found at the Congress web- site: www.chinamed.com.cn/IAB2006 Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S37 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما What is owed to the community before, during and following research: an ethical dialogue Richard A. Cash1 1Director, Programme on Ethical Issues in International Health Research, Harvard School of Public Health, Boston, Massachusetts, United States of America (Correspondence to Richard A. Cash: racash@ hsph.harvard.edu). SUMMARY The paper briefly outlines some of the ethical issues involved in community-based research particularly in developing countries. It focuses on informed consent, confidentially and the obligations to the community or its members who participate in the study. Most ethical guidelines are focused on the individual participants. Yet increasingly the community may be the unit of study. More attention will need to be directed towards developing guidelines for community-based research. Les obligations envers la communauté avant, pendant et après la recherche : un dialogue éthique RÉSUMÉ Le présent article décrit brièvement certaines des questions éthiques soulevées par la recherche communautaire, en particulier dans les pays en développement. Il porte essentiellement sur le consentement éclairé, la confidentialité et les obligations envers la communauté ou ses membres qui participent à l’étude. La plupart des lignes directrices éthiques sont centrées sur les participants pris individuellement. Pourtant, de plus en plus, la communauté peut constituer l’entité étudiée. Il sera nécessaire de consacrer davantage d’attention à l’élaboration de lignes directrices pour la recherche communautaire. =Ƕ=>Âb£EÆ?(>ÂÐ>¿M?Æ?(PÇVF¶=Ð=fQC¸F®¤»J=Å>GQ6Ê®Ø]?e=ÇU p>²ae>nJÈe  „=Í[qØ6›>»çÉ[i×Æ(Í[É£»J=PÇVF¶>[EÍ[¯·£J™=Í[É®Ø]Ù=>È>v[¯¶=¼[Â?(g>‹DEÍÉNVF¶=Í®eǶ=ÅdÂzf£JjI η¢Æ(Á>»J³¶=η¢Æ(Ì¿Jj™=ͯª=Ǚ=η¢hù²f[IÆ(Íɺ>¿¶=Á=b·F¶=Åa=f[ª?Ƥ[»J=Å>OVF¶>E»Ñ>¯¶=GQ=Æ Íi=eb¶=›ÁDze>nÈÀš*(¤[»J=Î[·¢PÇ[VF¶=ÍçFߧ߻[[¶½>»JÂ×=ÀºbÈh™=ÐØÈCη¢´¶d²Í®eǶ=ÅdÂO€Æ Íi=eb¶=›²e>n™=>rºÌ>¢=fºHÇQÆη¢bù²ÖI>»²* ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S38 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Issues in community-based research The Council for International Organizations of Medical Sciences (CIOMS) guidelines define community in the following man- ner: For the purposes of epidemiological studies, investigators may define groups as those who are composed of statistically, geographically, or otherwise associated individuals who do not normally interact socially [1]. A community then could be a group of individuals of a similar ethnicity, religion or with the same health problem. As they note, when such groups are arti- ficially created for scientific study, group members may not be readily identifiable as leaders or as representatives. There is also the dilemma as to who speaks for the com- munity of individuals. Lastly individuals may not be expected to risk disadvantages for the benefits of others. Some of the issues to consider with regard to community-based research are: informed consent, confidentially and the availability of or the responsibility for pro- viding services and the products of research to the community or its members who par- ticipate in the study. Informed consent A number of questions arise when consider- ing the issue of informed consent in com- munity-based research including: Is there such a thing as community consent? Can a community come together and consent for a particular activity as a community? Can an individual give consent for the community? For example, an investigator wishes to do a study on the impact of high-dose vitamin A on the incidence and severity of respiratory and diarrhoeal diseases. He goes to the com- munity, which is governed by a traditional chief and a group of male elders. To seek permission, all the citizens are brought to- gether in a festival-like environment and the study is described to one and all. Anyone can ask a question of the investigator about any aspect of the study, and many do. After all this discussion, the chief and the elders retire to their community hall and decide that it is acceptable to conduct the study. The next day, the group of investigators begins going to each and every house to get informed consent from the child’s caregiver (usually the mother). They are soon sum- moned by the chief who asks what they are doing getting individual consent when it was done the previous day for the entire village. He suggests that the investigators are trying to undermine his authority. The lead investigator explains that they must do this because the ethical review board of his university requires it. The chief responds that unless they are willing to accept the council’s ruling, they should go to some other community. The investigator writes to his Institutional Review Board (IRB), explains the situation and asks permission to let stand the decision of the chief and the council. In addition, the investigator argues that all the villagers say they will do what- ever the chief has asked as he is their leader and would do nothing to harm them. Fifteen years ago when this situation was presented to the funder’s IRB, the members accepted the position of the chief. If the same issue were posed today, it is unlikely that the IRB would accept anything but individual informed consent. What has changed over 15 years and has it changed for the better? Increasingly uni- versity IRBs are saying that the leadership can give permission but not consent, which must come from the individuals. CIOMS guidelines say that when it is not possible to request informed consent from every individual to be studied, the agreement of Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S39 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما a representative of a community or group should be sought, but the representative should be chosen according to the nature, traditions and political philosophy of the groups [1]. But who is a traditional ruler? Someone who simply inherits the title? The largest landowner? The richest member of the community? And do they represent all the people, especially the women of the community and/or those in the lowest socioeconomic group? The National Bio- ethics Advisory Commission of the United States takes a stronger position and says that in no case may permission from a com- munity representative or council replace the requirement of a competent individual’s voluntary informed consent [2]. Research- ers should strive to ensure that individuals agree to participate in research without coercion or undue inducements from com- munity leaders or representatives. But how often do we compromise on these issues? How often does a husband give consent for his wife? She may sign the document but it is nothing but a ritual to satisfy the investigator. A final point on informed consent: I be- lieve that the term informed consent should be changed to “understood” consent. This would compel the investigator and the IRBs to reflect on what information is essential for the subject to understand before he/she participates in the study. This would then encourage investigators to determine what is understood. When you take a course in school, your comprehension is usually assessed by taking a written or verbal ex- amination. You need to demonstrate your understanding of the subject. We need to bring the same approach to the consent process. This would lead to a more open and truthful approach than what is currently demanded by IRBs (primarily in developed countries) where investigators are asked to use language in the consent form that seems to fulfil legal requirements but does not ensure participant understanding. Confidentiality A second major issue of community-based research is that of confidentiality. We may need to take precautions to prevent identi- fication of the community under study to the outside world because of the potential of stigmatization and discrimination. A few years ago while travelling through Mumbai, I was struck by an article from a newspaper that carried an item about a village elder who told the following story. An investiga- tor had gone into his community to study the prevalence of HIV. The community had a tradition of providing dancing girls to the cabarets in Mumbai and the investigator suspected, not unreasonably, that given their occupation, that there was a likelihood of higher rates of HIV infection. He went through the proper clearances and conduct- ed a de-linked study and presented a com- munity profile so that individual persons could not be identified. He then presented the information at a scientific meeting, the result of which was picked up by a local newspaper. As the community was men- tioned in the presentation, the elder said that it would now be very difficult to marry off their young women as nobody would want someone from that village. How could we have insured that the confidentiality of this community was protected? Who would we go to? At scientific meetings investigators are urged to describe exactly where the study was conducted and there is a tradition of doing so. Currently, we have to depend on the good sense, the common sense, of the investigator in determining whether or not to disclose the community involved. ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S40 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Obligations to the research participants and community What of our obligations to the research par- ticipants and community once a study has been completed? Should anything (drugs, other interventions) be provided to research participants after the study has been com- pleted? What, if anything, should be made available to others in the community or country who may not have participated? If services are introduced into a study area, should they be continued after the study is completed and, if so, for how long? Do investigators have an obligation to keep that equipment available and running and to train staff to run it even though they will be unable to afford any future repairs? Should the donor be expected to pay for the equipment in years to come? What kind of arrangements should have been made be- forehand to ensure a reasonable transition or none at all? Some interventions do not require expensive equipment. A number of years ago I was involved in studies that tested the effectiveness of oral rehydration solutions for the treatment of diarrhoea. In this case we clearly had an obligation to teach treatment techniques to all local doc- tors and staff that would be staying on long after we had left. It is easy to leave without offering any- thing and villagers will most often agree to this. After all, the research group is provid- ing jobs and other benefits, including more money into the local economy. The golden rule of development is in full force: who- ever has the gold makes the rules. However, whatever is to be left behind—equipment, training, drugs, etc.—it should be negoti- ated with the community ahead of time. If new drugs are to be given, there is another obligation, it seems, to ensure that some form of surveillance is in place to detect any side-effects that may only become apparent once many people are taking the prod- uct. What is reasonable to give and what is unreasonable? Researchers and donors rightly point out that it is not their responsi- bility to make up for what the government and the ministry of health should provide. Yet investigators can act as a catalyst for change. By informing the community and the government of their findings and the im- plications for health care, they can stimulate change. This distribution of study results is in addition to the publication of findings in recognized journals, the information of which may never be read by or come to the attention of anyone in the country for years after the study has been completed. Conclusion There are a number of other issues not touched upon here, all of which affect the community. Other questions include: To what extent should the community set the research agenda? Should they be part of the dialogue? The researcher, after all, brings a good deal of expertise and should be aware of the health problems. Who is allowed access to community-based information? What is the potential harm if data are dis- closed to a third party and whom should we make the agreement with? Should a person(s) be allowed to block a study be- cause of perceived (rather than real) harm? Clearly more thinking is needed to con- sider the effects of research on the com- munity, whether it is in the area of informed consent, confidentiality or the sharing of results and products. Longitudinal studies demand it, genetics studies demand it, and the general public is increasingly concerned about these issues. Members of a com- munity may want to help, to do whatever is useful for themselves and the general pub- lic, but they want and need to be informed and to know that their interests are being looked after. Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S41 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما References 1. 1991 international guidelines for ethical re- view of epidemiological studies. Geneva, Council for International Organizations of Medical Sciences, 1991 (http://www.ci- oms.ch/frame_1991_texts_of_guidelines. htm, accessed 3 May 2006). 2. Washington DC, National Bioethics Advi- sory Commission. Strategic Initiative for Developing Capacity in Ethical Review (SID- CER) The Strategic Initiative for Developing Capacity in Ethical Review (SID- CER) is a network of independently established regional fora for ethical review committees, health researchers and invited partner organiza- tions. The primary objective of SIDCER is to contribute to human sub- ject protections globally by developing local capacity for ethical review of research involving human subjects and for developing policies on the ethics of health research. SIDCER vision is to ensure protection for all human participants in health research globally. SIDCER mission is to foster competent, independent, in-country decision-making for promoting responsible conduct of human research through its international network of fora, and to monitor the quality and effectiveness of ethical review worldwide, with mutual understanding and respect for cultural, regional and national differences. Further information about SIDCER can be found at: http://www.who. int/sidcer/en/ ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S42 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 h:Pharmaceutical research: paradox challenge or dilemma? ÍÉÑ=Æb¶=L=fvVJj™=η¢PÇVF¶=6;Í·v£º½?(úb€½?Í®e>«º _Ém¬Éì·¶=bF¢  „=Í[qØ6>¿¶=Á=b[·F¶=›ÍÉÑ=Æb¶=L=fvVJj™=η¢PÇVF¶=ÀºbÈb£¶=Ð=fQCÁÛ=¼JÈÁ>Jj[²>E¸[NºÍ[ɺ*¸[ê ¼[ÂÆ(OVF¶=¼ÃÉ·¢ÏßfRàÈÀÈdò·¶ÆÁ=b·F·¶ÄIbÑ>ªEÆOVF¶=Ð=fQCÌeÆfuEÁg=ÇJ¶=°É¯€e>FJ¢×=›d]ÖÈ b[UÎ[·¢Í[¶Æb¶=ÆÎ[uf™=b[É«Ib[®Á>Jj²>E›ÍÉÑ=Æb¶=PÇVF¶=ÁC;¼É·£J¶=ÌaÆb=L>Ò«¶=Ɛ[ëɺÙ=Àºð>F¶>¦ Êq=ÇJ¶=ÌeÆfu¤º(Ð=ÇiÍ[É¿{Ƕ=ÍÈa>[meÝ=¸Ñ×b[¶=a=b[¢CÆÌbɂ=ÍÈfÈfj¶=L>ie>»™=hÈh£JE*Á?G[‹>[»² ÄÉ·¢ž>«ƒ=ÆaÇn¿™=Ág=ÇJ¶=°É¯€›>»ÂeÆbE>Ãj«¾Í¢>¿r¶=Æͺdzƒ=½Ç¯I*  Pharmaceutical research: paradox, challenge or dilemma? Abdul Latif Sheikh1 1Director, Pharmacy, Nutrition and Central Sterile Services Department, Aga Khan University Hospital, Karachi, Pakistan (Correspondence to Abdul Latif Sheikh: latif.sheikh@aku.edu). SUMMARY A great deal of pharmaceutical research is nowadays carried out in developing coun- tries such as Pakistan. Is it, however, beneficial for the country and the participants, often the poorly educated and illiterate? Pharmaceutical research in Pakistan can bring benefits to both patients and country. Promotion of good clinical practice and the development of national guidelines are advocated. Government and industry both have a role to play to maintain the right balance. Recherche pharmaceutique : paradoxe, défi ou dilemme ? RÉSUMÉ Une grande partie de la recherche pharmaceutique est réalisée de nos jours dans des pays en développement tels que le Pakistan. Cependant, le pays et les participants, qui souvent sont les personnes ayant peu d’instruction et illettrées, en tirent-ils un quelconque bénéfice ? La recherche pharmaceutique au Pakistan peut procurer des avantages aux patients ainsi qu’au pays. La promotion des bonnes pratiques cliniques et l’élaboration de lignes directrices nationales sont préconisées. Le gouvernement et l’industrie ont tous deux un rôle à jouer pour maintenir le juste équilibre. Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S43 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Introduction Globalization of health research and the conduct of clinical trials involving human participants over the past few decades has highlighted a number of ethical issues, especially in those situations in which or- ganizations sponsoring research carry out studies in other countries. These may be done as a way of helping the host country address a public health problem; the re- search sponsor may consider the foreign location more convenient, more efficient, or less troublesome for a specific study; or the study may be carried out as a joint effort to address a specific health concern that is important in both countries. The pace and scope of international collaboration in biomedical research have increased during the past few years, and now questions about the ethics of designing, conducting, and following up clinical trials have re-emerged. There is concern that research done by scientists from the richer countries but carried out in poorer nations that are heavily burdened by disease may be seen as imposing ethically inappropri- ate burdens on the host country and on the participants themselves. The potential for exploitation has engendered efforts to ensure that those who participate in interna- tional clinical trials are protected. Pakistan is one of the developing coun- tries where balance still needs to be attained between supply and demand in health care. Health care spending is escalating at a rate of US$ 0.3 billion per annum, which trans- lates in to US$ 100 million per annum rise in pharmaceutical sales [1]. Unfortunately, the number of physicians per 1000 popula- tion remains static [1]. This is an indicator of the enormous burden of health care ex- penditure on the Indian subcontinent, where per capita annual income is equivalent to about $US 400. The public health system receives 0.8%–4.0% of the gross national product [2] (compared with 10%–15% in developed countries [3]). These hard facts, coupled with the general lack of third-party health insurance, mean that < 40% of our population has access to pharmaceuticals [1]. The major portion of our population, therefore, relies on alternative medicine, primarily practised by sidewalk practitio- ners, e.g. people practising the homeopathic system or unani tibb (Greek medicine); herbal or traditional healers; and spiritual healers (pirs, aamils, etc). The pharmaceutical industry and research The market in Pakistan The role of the pharmaceutical industry needs to be explored. The Pakistani pharma- ceutical market is estimated to be US $1.25 billion. There are 35 000 pharmaceuticals registered in the country [4]; prepackaged and formulated preparations are the main- stay of the industry. The usage, distribution, dispensing and administration monitoring aspects go unchecked, and the primary focus remains on production. The main share of the market is enjoyed by antibiotics (28%), followed by gastrointestinal drugs (14%) and respiratory medications (8%) . The market shares of multinational and indigenous companies are converging quite rapidly. It could be depicted as an approxi- mate 5% loss in local market share annually for the multinational companies, which are rapidly being overtaken by the local phar- maceutical companies. An analysis of the 7-year period 1998–2005 clearly shows a shift of market share from 30:70 to 50:50 for local and multinational companies. The annual growth rate for the Pakistani phar- maceutical market is estimated to be 5%, ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S44 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 with a 10% rise in institutional sales. This has a far-reaching impact on the research that is conducted in the country, and also on the quality of pharmaceuticals in clinical research. Challenge: research and development Most of the developing countries lack active research and development laboratories. The majority of industrial processing revolves around packaging and formulation. This, of course, leaves the pharmaceutical compa- nies, primarily the multinational companies but some local ones too, at an advantage and allows them to proliferate in this area: research and development remains solely their realm. The research and development of a drug needs 3–4 times more capital today compared to 10–15 years ago. The graphical representation of the research and development expenditure of developed na- tions, particularly Japan, the United States of America and the European countries, provides a fair idea about this rise. Between 1990 and 2004, expenditure on drug re- search and development in Europe rose from 7941 to 21 500 million euros. In the United States of America during the same period, it rose from 6015 to 27 095 million euros, and in Japan from 1990 to 2003 expenditure rose from 3941 to 6743 million euros.” While analysing the data, it should be remembered that marketing expenditures are always embedded with research and development activities. A breakdown of research and development activities of 9 top pharmaceutical companies shows that 30% of expenditure is used for discovery research and 35% for clinical evaluation; 22 % is accounted for by non-clinical evalu- ation [5]. This 22% of the expenditure could be linked to marketing investment. Additionally, when comparing the phar- maceutical industry with other industries, the research and development expenditure is proclaimed to be much higher [5]. This could be a result of the large marketing expenses component, which is obviously not an element of core research. Paradox The number of trials conducted in the devel- oping countries is lamentable: 90% of medi- cal research funds are spent on the richest, i.e. 10% of the world’s population [6], and research and development expenditure for diseases of poverty (e.g. malaria, tropical diseases, tuberculosis etc.) is regarded as high risk (failure) and providing low re- turns. Drug trials in developing countries are usually initiated outside the country and dominated by the partner from the de- veloped country, for example, Pharmacia- Upjohn has a research and development budget of US$ 2.2 billion per year, but only 6% is spent in Asia, mainly in Singapore, Taiwan, Hong Kong and Korea [7]. In his 1999 article, Silverstein says, “Many peo- ple of the Third World die of preventable, curable diseases. … malaria, tuberculosis, acute lower-respiratory infections claim- ing 6.1 million lives in 1998. People die because the drugs to treat those illnesses are nonexistent or are no longer effective, and they die because it doesn’t pay to keep them alive” [7]. This unequal equation of overlooking diseases of the poor can be well illustrated when one identifies the origin of research money: in the United States of America, 70% of research is funded by industry and only 30% by the National Institute of Health [8]. It would be interesting to know the fringe benefits involved in the sponsored trials fuelled by the research and develop- Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S45 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما ment expenditure. The following rates will definitely serve as an eye opener [9–11]: • paid speaking arrangements: ranging from $250 to $20 000/year; • paid consultancies: mostly less than $10 000 but may be up to $120 000/ year; • paid positions on advisory boards, eq- uity holdings: mostly over $10 000 and ranging up to $1 million/year. Apart from these overwhelming incen- tives, the “luncheons” should not be left unaddressed. Across the United States of America, as a part of their research efforts, drug companies sponsor close to 300 000 events for doctors every year, many of them far more generous than a free pizza [10]. Dilemma Millions of people die from preventable or curable diseases every week. But there is no market in the sense that, unlike Viagra, medicines for leishmaniasis are needed by poor people in poor countries. Pharmaceuti- cal companies judge that they would not get sufficient return on research investment, so why, they ask, should they bother? Their ob- ligation to shareholders, they say, demands that they put their effort into trying to find cures for the diseases of affluence and lon- gevity: heart disease, cancer, Alzheimer’s. Of the thousands of new compounds drugs companies have brought onto the market in recent years, less than 1% have been for tropical diseases [12]. Pharmaceutical companies may not be altruistic, but they may still have a powerful reason for sticking to ethical practices: “It’s not in anyone’s interest to do anything that would ultimately result in a drug being re- called,” said Kate Robins, a spokeswoman for Pfizer. “You wouldn’t spend a billion dollars if you’re going to cut corners and it’s going to ultimately be recalled. You’re going to go into places where you can hold up to standards that are international,” she said [13]. “There is no easier, softer way. There just isn’t.” Drug trials in developing countries Another area of concern regarding clinical trials is the vertical transmission trials con- ducted in a variety of developing countries by researchers from more-developed coun- tries. These illustrate a variety of ethical issues. Three crucial issues are the injustice of the use of placebo control groups, the coercion used to recruit participants, and the exploitation of developing countries. A 2002 study examined each of these issues separately. It developed a new standard for when placebo control groups are acceptable and concluded that the issue of coercive of- fers was not well founded. and that concerns about exploitation are better addressed by assurances about the future care of the par- ticipants in the trial than by assurances of availability of the drugs in the country in general [14]. Against this background, it is hard to tie in ethics with research. Essentially, research requires expertise, diligence, honesty and integrity. Ethical research is vital to gener- ate sound knowledge, but what does the ethical conduct of research involve? The concern regarding ethical consideration in research in developing countries could be expressed by the following questions. How does one obtain informed consent from people who cannot read and write? Who oversees the trials in areas where ethical review committees are unknown? Is the dis- ease under investigation similar in different countries (epidemiological data are required to answer this question)? Is the trial relevant to the country? Are the risk factors the ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S46 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 same, is the treatment relevant and are the outcomes approximately the same? Do the culture and infrastructure exist to carry out this trial [15]? The researcher may wish to stratify a method for obtaining genuine consent for participation, keeping in mind the standard of care locally and in developed countries. There is always an abundance of vulner- able communities in developing countries, and this is so in Pakistan. Limited economic development; inadequate community/cul- tural experience with, or understanding of, scientific research; limited availability of health care and treatment options; and limited ability of individuals in the commu- nity to provide informed consent are some factors requiring much attention. In many countries, it is important for researchers to obtain permission from local leaders before seeking individual informed consent, and to discuss other aspects of the research. Although it may be difficult to identify the members of the community who should be consulted and to determine the level of au- thority they should have to permit research- ers to approach potential participants, we believe that such consultations can be help- ful in improving both the informed consent process and the overall research design. Good clinical practice What is the importance of good clinical practice? Ideally speaking, it protects the right of study subjects with respect to integ- rity and confidentiality. Good clinical prac- tice also ensures that the data-driven results are credible. Scientifically, clinical trials are carried out for the testing of hypotheses, registering new drugs and devices, post- marketing surveillance in order to docu- ment efficacy and safety, and to obtain data for publication. Hence, the methodology of the clinical trial matters a lot. Study design, selection of appropriate subjects, adequate sample size, duration of the study and ef- fectiveness of follow-up are some important aspects that may reflect on the credibility of the results. Good clinical practice remains essential no matter where the study is conducted or who is conducting it. The prime concern is why developing countries are the favoured location for clinical trials. The large patient population, low incurred costs, a legislative vacuum or shortcomings, ignorance about legal and ethical issues and a strong desire among the developing countries to link up with institutions from rich countries at any cost could be the most likely reasons. The developing countries do need clinical trials to be conducted—for the development of new medicines and regimens suitable for the local environment; to verify safety and efficacy on different ethnic groups; for academic interest and stimulation; and to generate income for institutions as well as individual financial reward. These are im- portant considerations as far as developing countries are concerned. Good clinical practice in Pakistan In Pakistan, the government has definitely recognized the graveness of the issue, react- ing to it by forming in 2002/03 a Ministry of Health/World Health Organization com- mittee on good clinical practice, functioning as a Ministry of Health Research Cell. The final draft of the Pakistan good clinical practices has been sent to the World Health Organization for review. On the part of our pharmaceutical indus- try, some issues still need to be resolved: lack of infrastructure and the overwhelming contribution of multinational industries in trials disturbs the equilibrium. The way trials in Pakistan are conducted is deplorable. They are mostly phase IV (replicate) trials, which are more promo- Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S47 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما tional than evaluative. Company-sponsored clinical drug trials mostly use drugs sup- plied as samples. The majority of them are non-randomized, uncontrolled and open label. They are disguised as post-marketing surveillance, but in reality their anticipated outcome is to broaden the market share. The pharmaceutical companies have taken over the greater proportion of trials conducted; investigator-initiated trials and independent international publications are rare entities. As has already been mentioned, local institutions in developing countries, partic- ularly Pakistan, have an interest in tagging along on trials run by the multinationals; it is, however, worth noting the situation of our citizens participating in the clinical trials. Access to healthcare facilities and phar- maceuticals is still a dream for most of the population. The lack of third-party insur- ance and governmental healthcare coverage policies may encourage people to partici- pate in clinical trials as this may the only way they can obtain medical attention and get a chance to gain access to healthcare fa- cilities. These poorly educated, and mostly illiterate, persons do not understand the consequences of being research subjects. Role of the ethical review committee In such a scenario, where a person is not aware of his or her rights and safety once inducted into the study, the ethical review committee needs to play a strong role in the interests of the population. The dilemma is that the ethical review committee in a de- veloping country may overlook the impor- tance of the local value system and also the adequacy of resources. The committee may fail to acquire the representation of social scientists, ethicists and other allied health professionals; thus, ethical review commit- tees remain mostly physician-driven. Prob- lems which initially appear minor, such as inadequate translation of informed consent in national languages, may turn out to be a nightmare for the study participants. Involvement of clinicians Clinicians have a complex relationship with the pharmaceutical industry, and need to critically evaluate their handling of sam- ples and their contact with pharmaceutical company representatives to optimize this relationship and ensure quality patient care. Clinics with specific policies for interac- tions with drug companies appear to derive greater satisfaction from their encounters. Gifts, no matter how small, produce a sense of reciprocity in the recipient; this is why pharmaceutical companies provide pens, notepads, name badge holders, etc. Social science has documented the way that gift recipients feel impelled to do something in return for the giver. However, this creates a conflict of interests: the desire to cure the patient versus the subconscious need to repay the drug company’s generosity. While these 2 goals can be congruent, they may not be. Entitlement is also an issue: students and resident physicians feel entitled to a good lunch and cool gadgets from the drug companies. Role of the authorities On the part of the regulatory authorities, a revolutionary transformation is required to provide the infrastructure to support re- search, ensure standards of care and safety, develop guidelines/legislation and imple- ment standards. The Government of Paki- stan has taken the initiative to formalize a National Committee on Good Clinical Practice and Good Prescribing Practice. The committee is to be a guideline-formulating body and will be responsible for training the health care community by organizing courses and seminars. ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S48 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Conclusion Promotion of good clinical practice in coun- tries such as Pakistan requires mass aware- ness and education campaigns, training programmes or course development, the development of national guidelines, gov- ernment and health ministry involvement at all levels and regular monitoring to evaluate benefits and ensure progress. Pharmaceutical research is crucial to Pakistan. It brings benefit to the patients and wealth to the country. Government and industry have a definite role to play to keep the right balance between industrial policy and health policy. One should welcome and reward innovation, regulate less and better. The unprecedented movement between countries of people, goods and ideas has increased awareness of the imbalance in the global burden of disease among the citizens of developed countries. This is sometimes referred to as the 10/90 gap: less than 10% of global health care expenditure is devoted to conditions that account for 90% of the global burden of disease [16]. Initiatives to reduce the burden of dis- ease in developing countries are urgently needed. Clinical trials responsive to the health care needs of developing countries are one such initiative. It is, however, nei- ther necessary nor desirable to lower ethical standards in order to achieve this goal. On the contrary, standards should be main- tained, and adapted specifically to the needs of developing countries. References 1. EIU country data, 2003–04. New York, Economist Intelligence Unit Ltd, 2005. 2. World development report 1998/99: Knowledge for development, Washington DC, World Bank, 1999. 3. Budget 2001/02. Islamabad, Pakistan, Ministry of Finance, 2001. 4. Budget 2004/05 Pakistan: healthcare components. Islamabad, Ministry of Health, 2004/05. . 5. R&D performance metrics. Epsom, United Kingdom, Centre for Medicine Research (CMR), 2002. 6. The 10/90 report on health research 2000. Geneva, Global Forum for Health Re- search, 2000. 7. Silverstein, K. Millions for Viagra and pennies for the diseases of the poor. The nation, 19 July 1999. 8. The physician–pharmaceutical industry relationship. New York, No Free Lunch, (http://www.nofreelunch.org/downloads/ Nofreelunch%20Presentation.ppt, ac- cessed 8 June 2006). 9. Abbasi K, Smith R. No more free lunches. British medical journal, 2003, 326(7400):1155–6. 10. Moynihan R. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 1: Entan- glement. British medical journal, 2003, 326(7400):1189–92. 11. Lexchin J. Interactions between phy- sicians and the pharmaceutical in- dustry: what does the literature say? Canadian Medical Association journal, 1993;149(10):1401–7. 12. Hilton I. A bitter pill for the world’s poor. London, The Guardian, January 5, 2000. 13. Altman D. Drug trials: beyond the dark side International Herald Tribune, 8 March 2006 (http://www.iht.com/ar- ticles/2006/03/07/business/glob08.php, accessed 8 June 2006). Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S49 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما 14. Brody BA. Ethical issues in clinical trials in developing countries. Statistics in medi- cine, 2002, 21(19):2853–8. 15. Johnatty RN. Clinical trials in developing countries: discussions at the 9th Interna- tional Symposium on Long Term Clinical Trials, London, UK, 19–20 June 2000. Current controlled trials in cardiovascular medicine, 2000, 1(1):55–8. 16. Global Forum for Health Research. The 10/90 report on health research 2000. Ge- neva, World Health Organization, 2001. e-Health Code of Ethics On Wednesday, May 24, 2000 the e-Health Ethics Initiative introduced a code of ethics for health care sites and services on the Internet. The “e-Health Code of Ethics” will help people worldwide realize the poten- tial of the Internet for improving health and minimize its potential for doing harm. The e-Health Code is available in Arabic, Chinese, English, French, German and Spanish at: http://www.ihealthcoalition.org/. The Arabic version is also available on the EMRO website at: http://www. emro.who.int/his/medicalethics.htm ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S50 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Informed consent: views from Karachi Aamir Jafarey1 1Assistant Professor, Centre of Biomedical Ethics and Culture, Sindh Institute of Urology and Transplantation, Karachi, Pakistan (Correspondence to Aamir Jafarey: aamirjafarey@gmail.com). SUMMARY Little is known about the public’s perceptions about the process of obtaining informed con- sent for participation in medical research. A study was made of the views of patients, their attendants, parents, schoolteachers and office workers living in Karachi, Pakistan. Participants felt that informed consent was an important step in recruiting research participants but many felt that it was a trust-based process not requiring proper documentation. For recruiting women, both men and women believed it was important to approach women through their husbands and fathers. When there was a conflict with the opinions of family leaders, it was clear that the male participants’ opinion was valued more than that of the female participants by both men and women. Ì¿Jj™=ͯª=Ǚ=6ÊnI=f²ÀºfŸ¾L>ÃQÆ Ëf«£Qfº>¢  „=Í[qØ6²e>n[™=À[ºÌ¿Jj[™=ͯª=Ǚ=η¢¹Çrƒ=ÍÉ·»¢¹ÇUeÇû‚=Ð=eAÀ¢jɶ=eb¯¶=×C­f£¾× ÍÉFì¶=PÇVF¶=›*O[U>F¶=Ïf[Q?b®Æ[ieb™=Æ(eÇ[ºÙ=Ð>[ɶÆ?Æ(¼[¯ª=f[™=ÆÎ[uf™=Ð=eA¹Ç[UÍ[i=ea Á>Jj²>E(ÊnI=f²Á>³iÀº(GI>³™>E·º>£¶=Æ(le=b™>E*Ì¿Jj[™=Í[¯ª=Ǚ=Á?Í[i=eb¶=›ÁDze>n[™=ÏfÈÆ [»J£IÍ[É·»¢>þ?ÏfÈF²ab¢Á>²ÁCÆ(PÇVF¶=›²e>n™=GɦfI¸ÉFi›ͺ>ÂÌÇì]¸ëN“Í[¯N¶=Î[·¢b[ °ÉMÇJ¶=Àºð=N²Gõ·ìJI×Æ*‘CÀÃIÇ¢b[¶Ð>j[¿¶=Í[€>«ºä¼Jß[IÁ?ÌeÆfuÐ=ÇibUη¢Ð>j¿¶=ƹ>Qf¶=b¯J£ÈÆ ¼ÃÑ>EAÆ?¼ÃQ=Æg?¹Ø]ÀºPÇVF¶=›Ͳe>n™=*ÁD[ª(Ìf[iÙ=HeÐ=eA¤ºze>£Iµ>¿ÂÁ>²Á?PbU=cCÆ ¶ÍÉ»Â?ÁÇì£ÈÐ=ÇibUη¢Ð>j¿¶=ƹ>Qf¶=Ð>j¿¶=Ë?eÍÉ»Â?±Ç«I²e>n™=¹>Qf¶=Ë?f*  Consentement éclairé : points de vue de Karachi RÉSUMÉ On connaît mal les perceptions du public concernant le processus d’obtention du consen- tement éclairé pour la participation à la recherche médicale. Une étude a été réalisée sur les opinions des patients, de leurs soignants, des parents, des enseignants et des employés de bureau travaillant à Karachi (Pakistan). Les participants pensaient que le consentement éclairé était une démarche im- portante dans le recrutement des participants à la recherche mais nombre d’entre eux pensaient qu’il s’agissait d’un processus fondé sur la confiance qui ne nécessite pas de documentation en bonne et due forme. Pour le recrutement des femmes, les hommes et les femmes pensaient qu’il était important de contacter les femmes par l’intermédiaire des maris et des pères. Lorsqu’il y avait un conflit avec les opinions des chefs de famille, il était évident que les hommes et les femmes faisaient plus grand cas de l’opinion des participants hommes que de celle des participants femmes. Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S51 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Introduction As a general surgeon working at a univer- sity hospital in Karachi, Pakistan, I conduct outpatient clinics where I perform minor surgical procedures such as circumcisions. Assisting me in these clinics are junior residents from the Family Medicine Pro- gramme who are expected to learn not only minor surgical procedures but also the skills of communication with patients and fami- lies, especially while obtaining informed consent. I recall one particular occasion when a mother brought her child to be circum- cized. As usual, I started by explaining the procedure to the mother, telling her what I was going to do and what she was to expect afterwards and how to take care of the baby. After having done that I turned around to ask my resident to present the informed consent form to the mother to sign and document her permission, but the resident was nowhere to be found. A moment later the resident ap- peared from outside the room. “Where were you?” I enquired. “Getting the informed consent” he said, proudly displaying the signed consent form. “And how did you get this consent?” I asked. His response was prompt: “I asked the child’s father who is standing outside, to sign here” and he pointed towards the dotted line which now bore a most authoritative signature. And that was the informed consent—a signature on the dotted line. This process of getting the informed consent did not seem to upset the father, the resident, the mother or the nurse. I was the only person troubled by events as they had unfolded that afternoon. Attitudes to a large extent dictate prac- tice and our practice of obtaining informed consent may also largely be a result of our attitudes towards this concept of obtaining permission and who holds the authority to give permission. As an intern at a government hospital in Karachi in the late 1980s, I was accustomed to tearing a page out of a notebook and scrib- bling in Urdu “I hereby give my permission for any type of surgery to be performed on me under any type of anaesthesia. I have been told that in the course of the operation I may also die. I take full responsibility for the operation.” (Figure 1). The patient or attendant would affix a thumb-print at the bottom of the page and the intern would sign his name and that was the end of the process. This, sadly, is the practice even Figure 1 An example of a primitive informed consent document ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S52 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 today in that hospital and in many other hospitals across Pakistan. Consent documentations is just one aspect of the whole issue of obtaining in- formed consent and even in Karachi there are great variations in the practices that are followed. These range from basic forms that provide no information to the patient, up to elaborate International Standards Organiza- tion (ISO)-certified forms in both English and Urdu. However, even in the latter case, the common practice is that the patient signs on the English side even though the great majority of conversations with patients take place in Urdu. Another observation is that most people just listen and sign the form without any attempt to read what is written. They seem to trust their physician. This appears to have shaped the clinical practice and the attitudes of the physicians. A study of patients’ perceptions about informed consent Perceptions on what patients or the gen- eral public expect regarding the process of informed consent are generally based on either anecdotal evidence gathered from the patients or from information collected from physicians and researchers [1,2]. Little is known about the public’s perceptions about the process of obtaining informed consent for participation in medical research. A study was therefore designed to find out directly from the people living in Karachi their perceptions about the process of in- formed consent for participation in medi- cal research and for participation in health care decisions for therapy. This was an exploratory study, intended to point the way towards further studies in this area. The relationship between a patient and a physician is considered essentially a trust- based relationship with the sole motive of the physician being the benefit to this pa- tient. Research is different from therapy; the goals of the researcher are much broader and the participant is a means towards a greater objective and may or may not benefit from the interaction. There were two arms to the study, one looking at participation in medi- cal research and the other exploring partici- pation in the decision-making process for health care and therapy. This paper focuses only on the decision-making process for research situations. The study was funded by a grant from the Program on Ethical Issues in Inter- national Health Research at the Harvard School of Public Health. Study methods Prior ethical review of the study design was made by the relevant authorities. The Ethi- cal Review Committee of Harvard School of Public Health exempted the study from ethical review because there were no risks to the participants. The study protocol was submitted to ethical review boards of the various Karachi hospitals where the study was planned to be conducted and where approval was obtained in a timely fashion. There were, however, 2 ethical review com- mittees that approved the study on condi- tion that a staff member of their hospital was made a co-principal investigator in the study. This request in itself was deemed unethical by the principal investigator and the study was withdrawn from those institu- tions. The study was conducted at several other hospitals after due ethical approval and at other sites such as office buildings, schools and public waiting areas after ob- taining written approval of the local admin- istrators. Two research officers, with prior training in the process of conducting interviewer- Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S53 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما based questionnaire surveys were employed to conduct the study. Adults of both sexes, who could speak either Urdu or English, were selected and a verbal informed consent was obtained after explaining the nature of the study. People sitting in waiting areas of hospitals, both patients awaiting their turn and their attendants, parents and teachers in schools and office workers were included. The research assistants visited each site for 2–4 days depending on the size of the site and spent from 1–4 hours per day conduct- ing the interviews. The data were entered in Epi-info 6, cleaned and verified for ac- curacy. The study had some limitations. It was an exploratory study and did not probe deeply into the sociological reasons of some of the issues that it revealed. An in-depth qualitative analysis would be needed to look deeper at some of the concerns that have emerged as a result of this study. It was also limited to the English and Urdu speaking population and was confined to one major urban city. Groups of lower education sta- tus and older age were under-represented because participants were recruited from schools and educational institutions and banks and other workplaces. Study findings There were 337 people surveyed: 44% women and 56% men. Their educational status was classified as follows: 20% were educated to class 5 or less (junior school), 36% class 5–12 (middle to high school) and 44% were educated to over class 12 (above high school). The majority (70%) of the par- ticipants were aged 21–40 years age, 25% were 41–60 years and 5% were 61+ years. The questions asked and the responses are shown below. “In your opinion, how important is the process of informed consent before people can participate in medical research?” The first question sought respondents’ general views about informed consent. While 82% of respondents said that the process was important or essential, 16% said taking consent was an optional step and not always necessary. “How important is it for the participant to trust the researcher as his benefactor?” This question was intended to assess what respondents perceive of the researcher when they go ahead to sign the consent form and whether they actually consider their con- tract with the researcher to be a trust-based relationship in which they are relying on the researcher as their benefactor. Overall, 63% felt that the researcher was indeed their benefactor, 26% were unsure of the relationship and just 11% felt that they needed more than just blind trust to agree to participate in research. “How important is the process of docu- mentation of informed consent for the pro- tection of the participants?” The responses to this question showed that 61% of people believed documentation of informed con- sent was important and essential but 39% felt that it was either unnecessary or op- tional to document anything. “Do you think that the researcher should involve the family members or elders of an adult potential study participant in the process of obtaining an informed consent?” It is customary in many developing world communities to go through community gatekeepers to obtain access to the research subjects within the community. For this particular question, opinions were divided: 38% believed it was unnecessary to involve family members or elders in obtaining in- formed consent, 44% said it was important ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S54 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 or essential, whereas 18% said it was op- tional to involve the family elders. “In case the research participant is a woman, do you think that it is important to ask permission of her father or husband (in case of a married woman) before ap- proaching the woman?” The majority of the respondents clearly felt that it is impor- tant to involve the father or husband when enrolling a female research participant in a trial. Overall, 60% of the respondents felt it is essential that the father’s or husband’s permission be sought before approaching the woman and 17% said it was optional. Only 23% said that this practice was unnec- essary. Further analysis of the responses to this question revealed that there was no sig- nificant difference in the opinions expressed by male and female respondents regarding the involvement of father/husband of a female research participant. Cross-tabulat- ing against the educational status revealed that the respondents with the highest level of education were the least likely to ask for involvement of the father or husband. “If the research subject is a woman and the father and husband have already given permission to approach the family, how important is it still to obtain consent from the woman herself?” To further probe the issue of women’s autonomy, respondents were asked about obtaining consent from the woman herself. A majority (74%) said “yes” to this question, indicating that the opinion of the research participant was of paramount importance, no matter what the elders had said. “In case there is a difference of opinion between the study participant and the family leader (the father or the husband), what is the importance of the participant’s own opinion, if the participant is a man or if the participant is a woman?” This question ex- plored gender differences in opinion among respondents in cases of conflicts between the family elders and the participant. Ac- cording to the results, if the study partici- pant was a male and he had a conflict with the family, 74% felt that his opinion should prevail over the opinion of the family elders and 10% of the respondents said that his opinion was unnecessary (the remainder were unsure). If the study participant was a woman, however, only 26% of respondents now felt that it was unnecessary to follow the woman participants’ wishes and instead would honour the family elders’ directives, 53% felt that the woman participants’ opin- ion should be honoured while 11% were unsure. On further analysis, the views of men and women were similar to both sets of the question. Conclusion Most of the respondents in this study felt that informed consent was an important step in the process of recruitment of re- search participants but many felt that it was a trust-based process not requiring proper documentation. Local traditions and norms dictate that while recruiting women, it was important to approach women through their husbands and fathers. While it appears that both sexes have the same opinion on the issue, less educated people placed more emphasis on the father or husband’s in- volvement than better educated people. In situations where there was a conflict between the opinions of the family leaders and the participants, it was clear that the male participants’ opinion was valued more than the female participants’ opinion by both men and women. This study has raised several interesting issues which require a more in-depth sociological analysis to gain further insight. Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S55 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما 1. Jafarey AM, Farooqui A. Informed consent in the Pakistani milieu: The physician’s perspective. Journal of medical ethics, 2005, 31:93–6. References 2. Moazam F. Families, patients, and physi- cians in medical decision making: a Paki- stani perspective. Hastings center report, 2000, 30:28–37. Ethics and health In October 2002, the World Health Organization launched its Ethics and Health Initiative to provide a focal point for the examination of the ethi- cal issues raised by activities throughout the Organization, including the regional and country offices, and to develop activities regarding a wide range of global bioethics topics, from organ and tissue transplan- tation to developments in genomics, and from research with human beings to fair access to health services. Further information on WHO’s work in the area of biomedical ethics is available in Arabic, Chinese and English at: http://www.who.int/ethics/ar/index.html; http://www.who. int/ethics/zh/index.html; http://www.who.int/ethics/en/ ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S56 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Bioethics activities in India Nandini K. Kumar1 1Deputy Director-General, Indian Council of Medical Research, New Delhi, India (Correspondence to Nandini K. Kumar: nandkku@yahoo.com). SUMMARY The Indian Council of Medical Research formulates, coordinates and promotes biomedical research in India. In 1980, they formulated the first national ethical guidelines. They offer a number of different training programmes, from 1 day to 6 months. The council is developing a core curriculum for teaching bioethics, which would be applied uniformly in medical schools throughout the country. Drug development and ethics is also important in India, particularly now that the local pharmaceutical industry is expanding and so many drugs trials are outsourced to the country. The council is also very active in encouraging the development of ethics review committees. Activités de bioéthique en Inde RÉSUMÉ Le Conseil indien de la recherche médicale formule, coordonne et favorise la recherche biomédicale en Inde. En 1980, il a formulé les premières lignes directrices nationales en matière d’éthi- que. Il propose un certain nombre de programmes de formation différents, d’une durée allant d’un jour à six mois. Le Conseil est en train de mettre au point un programme de base pour l’enseignement de la bioéthique, lequel pourrait s’appliquer de manière uniforme aux écoles de médecine dans tout le pays. Le lien entre la mise au point de médicaments et l’éthique est important en Inde, d’autant plus que l’industrie pharmaceutique locale est en expansion et que le pays se voit confier la réalisation de nombreux essais pharmaceutiques. En outre, le conseil encourage activement la mise en place de comités d’examen éthique. b¿=›ÍÉQǶÇÉF¶=L>É®Ø]Ù=Íìn¾? e>»²ʾb¿[¾  „=Í[qØ6QǶÇÉF¶=ÍÉFì¶=PÇVF¶=°Éj¿IÆͦ>ÉqͻÒÍÉFì¶=PÇVF·¶b¿=k·…¤·ìvÈb[¿=›>[ÂhÈh£IÆÍÉ* ½>¢›k·=½>®b®Æ1980¹ÆÙ=Ê[®Ø]Ù={Ç[¶=Ëa>[meÝ=¸É¶b¶=ͦ>ÉrE(*²Sº=[¶=À[ºð=ab[¢¼[õŸ¾>[» fÃm?ÍJiƽÇȐE>ÃIbºKUÆ=fI¶=(Í«·J^™=ÍÉFÈebJ¶=*Ê[i=eaSÿ[ºa=b[¢Cη¢ð=bÂ>QÁÛ=k·=¸»£ÈÆ b[¿=Ð>‰?fÑ>i›Gì¶=L>É·²›bçUǺ¸³nEįÉFìIÀ³•(ÍÉQǶÇÉF¶=L>É®Ø]Ù=kÈebJ¶Êi>i?*Î[Ÿ€Æ ÍÈÆaÙ=¤É¿rIEͮأ¶=Í[ÉÑ=Æb¶=Í¢>¿r[¶=bÃn[IæK[®Æ›>»çÉ[i×Æ(b[¿=›ÌF[²Í[É»Â@EL>[É®Ø]Ù=EÆ ¤[»J=›Í[ÉQe>]ea>rº‘CÍÉÑ=Æb¶=He>RJ¶=ÀºbÈb£¶=±>ì¾äbºb¯¶ÎJU(ð=F²ð>¢>jI=ÍÉ¿{Ƕ=*œn[¿ÈÆ >ÂfÈÇìIÆÍÉ®Ø]Ù=L>£Q=f™=Á>‚Ð>n¾C¤ÉRnI›´¶d²k·=*  Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S57 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Introduction Our organization, the Indian Council of Medical Research (ICMR), is important in the region and in our country, mainly because it funds research in India. Set up in 1911 by the British as the Indian Research Fund Association, it was renamed in 1949 the Indian Council of Medical Research. Its main function is to formulate, coordinate and promote biomedical research in India through intramural as well as extramural research programmes. We have 27 perma- nent institutions spanning the country and 6 regional medical research centres at Di- brugarh, Assam;, Port Blair, Anadaman and Nicobar; Bhuvaneshwar, Orissa; Jabalpur, Madhya Pradesh; Belgaum, Karnataka; and Jodhpur, Rajasthan. The regional research centres concentrate on research pertaining to the diseases of their particular region, where there is often a lack of proper govern- ment infrastructure for health care delivery. Consequently, the ICMR also functions as a service provider in those regions. Our mandate is to undertake and support research, not only basic, applied or epide- miological research but also operational research in the area of public health using a variety of tools, including those of mod- ern biology. The ICMR fosters a research culture by improving funding, mainly for developing infrastructure. It also advocates and lobbies for certain methodologies which need to be used to carry out high-quality research; creates awareness about research, from the medical student stage to the high- est level; and concentrates on methods of applying the research for the benefit of the community. Sometimes the association also works to foster community support and promote an environment conducive to innovative research. Ethical guidelines History During ancient times, amongst the native cultures, people were influenced by the environment and they believed that the ele- ments of the body were part of the cosmos. This philosophy was common everywhere. There was also belief in spirits, so it was a spirito-religious concept which guided everyone. But in those days the popula- tion was much smaller and morality was engrained in everyone so there was not so much need for enforcing guidelines. Then things started changing. In India we had the traditional system, ayurveda, and later came unani medicine from Persia. Another tradi- tional system was siddha, which is mostly confined to the southern part of the country, and also has its roots in India centuries ago. These classical traditional systems are still recognized by the government. There were guidelines for how a physi- cian should conduct himself and practice and, even in those early days, it was ex- plained that the primary concern should be for the safety and the best interests of the patients. In the Caraka samhita, the ancient text of ayurveda, the physician was cautioned to avoid institutional entangle- ments that would compromise independent judgment. Current situation We see the same things being stipulated nowadays as ethical guidelines, but how to go about implementing ethical guidelines is the most important aspect. In 1980, 2 years before the proposed Council for Interna- tional Organizations of Medical Sciences guidelines were issued, ICMR brought out ethical guidelines which dealt with eth- ics committees; informed consent; clinical ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S58 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 trials and how to conduct yourself while doing them; and how to go about research when you are using children, the mentally disadvantaged and those with diminished autonomy [1]. Traditional medicine was also very much a part of it as well as publi- cation ethics. Those guidelines still hold true, but now modern technologies and new methods in biology have been introduced. So it was necessary to revise the guidelines and for- mulate new ones which would actually cover these new developments. That is how we brought out the “blue book”, which was released in 2000 [2] (the earlier one was the “pink book” [1]). All institutions involved in medical research involving human beings are expected to follow these guidelines. They are available on our website, http:// www.icmr.nic.in/, and the corresponding legislation is expected to go through parlia- ment during the winter session this year (2005). Every change of government has resulted in a change in the year of legisla- tion—it was first postponed from 2002 to 2004, but it should be passed in 2005. The guidelines actually became mandated indirectly because they were incorporated in the amendments to the Medical Council of India Act, 1956 of 11 March 2002 and the Drugs and Cosmetics Act, 1940 through Schedule-Y, revised and amended on 20 February 2005. So any violation is still punishable. The revised guidelines (blue book) state 12 general principles and these form the ICMR code. So for any new guidelines, e.g. for stem cell research, radiopharmaceuticals or bioterrorism, this forms a template; what- ever is actually relevant can be selected from these 12 points and incorporated. Specific principles also pertain to clinical research on human genetics and organ transplanta- tion, including fetal tissue transplantation. Some guidelines for stem cell research have also been incorporated, including some for embryonic tissue. There are also chapters on epidemiology and assisted reproductive technology in this particular edition of the guidelines. Two guidelines, Ethical issues surround- ing genetically modified food and Stem cell research and therapy are in draft stage, a joint effort between ICMR and the De- partment of Biotechnology, a government funding agency for biotechnology projects. When the guidelines for genetically modi- fied food were being formulated, it was very encouraging to see that, during the first meeting, the joint secretaries of 5 ministries came to attend, showing how important this was considered by the government. Other national guidelines have been for- mulated for accreditation, supervision and regulation of assisted reproductive technol- ogy clinics in India and for behavioural research on HIV/AIDS. If you register for federal-wide assur- ance in joint ventures with the United States of America (USA), alongside the require- ments of the American guidelines which you have to comply with, there are 2 inter- national guidelines, one Canadian and the other Indian, which are considered equally protective to human participants. We have a bioethics page at the ICMR website, where we have posted an institu- tional ethics committee survey question- naire, which was circulated to various institutions. There is model format for submission of applications by principal investigators to the ethics committee and a format for reviewers on what points they look for in approving a proposal. There are also guidelines for preparing standard operating procedures for ethics committees Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S59 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما which deal with human research. It also facilitates consultation on ethical issues. Education and training We get e-mail queries from researchers all over the country, from the student level up to international level. We have received a number of questions asking what the Indian position is. This prompted us to determine the status of bioethics education. Some uni- versities had actually started the process of preparing a syllabus for teaching bioethics but there was no concordance. The ICMR was given a planning grant from the National Institutes of Health in the United States of America to develop a bioethics curriculum. This was to include a core curriculum which would be applied uniformly throughout the country and which we hoped to provide to the Medical Council of India, the statuary body for medical education in modern medicine. We also got a training grant for applying this curriculum at various levels to show how it could help in the dissemination of bioethics educa- tion. Resource persons were identified to carry out countrywide training exercises for students, faculty, researchers and ethics committee members. This sponsored bioethics training pro- gramme has 3 main components. One is the sensitization programme, starting from undergraduate medical students to post- graduate medical and non-medical students, institution ethics committee members, re- searchers and faculty members, both na- tional and international. An international workshop is planned for 6–10 February 2006. For undergraduate students, we only have a 1-day programme at the moment, but as we conduct so many programmes on ethics our experience is that it is the undergraduate, untouched, students who are the most enthusiastic learners, then the postgraduates. We have found that univer- sity teaching staff, both medical and non- medical, are very erratic in their attention, especially as they become more senior. This can be frustrating at times, unless we keep them captive. It has been suggested that we have an informal type of programme, teaching modules through distance education. The Vice-Chancellor of the Indira Gandhi Na- tional Open University will be consulted about having the distance education model prepared. Preliminary, informal discussions have already been held. The second component under the training grant is short-term training for the trainers. It will start from the third and fourth year of the programme for 8 weeks for the faculty and researchers. The third component is a long-term 6-month course with the trainees moving from place to place wherever the core strength exists in the chosen topic. This is because we do not have a very strong core group such as the one at the Aga Khan University, an advantage that Pakistan has. Every 2 years we conduct the World Health Organization/ICMR training work- shops. A 3-day common module has been prepared, which we have carried out in health science universities or institutions in 6 states. The aim of this module was mainly to familiarize participants, who come from both medical and non-medical backgrounds, with the essential principles and practices of ethics in biomedical research. It should be noted that although gradu- ates from the traditional medical schools outnumber graduates from modern medi- cine, the modern medicine undergraduate students have some recourse to research methodologies whereas their counterparts do not. The postgraduate students, and even some of the academic staff, do not use ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S60 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 proper methodology in conducting research programmes and now these schools, which come under a separate department called the Department of AYUSH (ayurveda, yoga, unani, siddha and homeopathy), are asking us to hold ethics training programmes, first for the scientists of the councils and then for the professionals in the various institutions. We even had some of the undergraduate stu- dents dropping in on one of the workshops we held for undergraduate medical students. Their enthusiasm was very encouraging. India is huge: modern medicine alone has more than 200 institutions. It is an enormous job and ICMR is still quite small. But we are progressing. After these work- shops we had an evaluation workshop and concluded that it was necessary to produce teaching materials. We agreed on 12 topics/ chapters, each of which will be written by an expert. Most of this is now complete: only 1 or 2 chapters remain to be finished. There is also a case study compilation based on the Indian experience and a set of multiple- choice questions. Some of the universities are considering including medical ethics in the syllabus in the first 3 years. The sad part is that they are not going to examine the stu- dents on this particular module. We believe that there should be some sort of assessment or credit, and the multiple choice questions would help in the evaluation. This country is so vast that 6 universities is nothing compared to the vastness of the 29 Indian States. We have to make progress in a phased manner, but we expect that the people we have trained will carry the pro- gramme forward and have received many queries about holding such a workshop for trainers. Drug development and ethics As in all the developing countries right now, drug development is very important in India. The country is actually way ahead in this field, with generic formulations initially but now, because of the need to be TRIPS (trade-related aspects of intellectual prop- erty rights) compliant, research and devel- opment facilities have been increased both in the public and the private sector to bring out new Indian products with proprietary names. We produce all 3 types of drugs— synthetic, genomic and plant-based. For genomic-based drugs we have regulatory committees, but there is no proper regula- tion for the plant-based drugs. The regula- tory system is not as good as for synthetic drugs: the situation is not being monitored. Therefore, the guidelines that need to be fol- lowed are the ICMR ethical guidelines and the Indian good clinical practice guidelines [3], which are “Indianized” compared to the harmonized ICH (International Conference on Harmonization) good clinical practice guidelines. The Drugs and Cosmetics Act, 1940 has also been amended from time to time; the last few amendments included the tra- ditional medicine formulations. A separate chapter for ayurveda, siddha and unani medicines was introduced in Section 33-C in 1982. This relates to quality control of the formulations, the appointment of a drug technical advisory board and a drug consul- tative committee, provision for government inspectors and analysts, etc. Mandatory compliance with good manufacturing prac- tice and mandatory testing for heavy metals (arsenic, lead, mercury, cadmium) in export formulations are also included in the next amendment notified on 1 January 2006. The revised Schedule-Y of the act, noti- fied in January 2005, was very worrying for the industry. In fact, it has been compared with the American Federal Drug Adminis- tration requirements and found to be more stringent. Revised Schedule-Y concerns regulations and guidelines for request- Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S61 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما ing permission for the development (pre- clinical and/or clinical), import and manu- facture of new drugs to be marketed in In- dia. For drug trial approval, it is mandatory that the chairman of the institution ethics committee be from outside the institution, which is not the case in most of the trial sites. This poses a problem for regulatory clearances. The industry in India is worried, not because they have to carry out this research in India, but because these stringent guide- lines will have to be followed. The US Federal Drug Administration and the Office for Human Research Protections have the ethical and regulatory guidelines of dif- ferent countries on their websites. Anyone doing research in India, or any of the de- veloping countries, will find a link on these websites to the guidelines for each country that their researchers will need to follow. This applies to Indian companies as well as to multinational companies. To a great extent, this has stopped gross violations. There is a move now to make Schedule- Y more flexible, possibly by 2006; the bill for legislation of ethical guidelines of 2000 is in the offing. The Department of Biotechnology guidelines for recombinant products has a 3-tier system for approval: the Biosafety Committee, the Review Committee for Genetic Modification and the Genetic En- gineering Approval Committee. Efforts are being made to have a single window clearance system. There are of course biotechnology poli- cies from the central government and the state governments, besides the govern- ment’s science and technology policies, which are supposed to be conducive to conducting clinical trials in the country. For international collaborative studies, the Health Ministry Screening Committee ex- amines proposals. In the past, the ethics committee mem- bers would not give approval to a proposal before obtaining permission from the Drugs Controller General of India. Many times, proposals were rejected due to ignorance of the system rather than deliberate in- tent. Now of course the ethics committees give approval subject to the condition that the proposal gets approved by the Drug Controller General of India or the Health Ministry Screening Committee. This will cut down the time needed. Training We have a studentship programme at ICMR, and demand is increasing every year: it has now reached more than 1000 applications. We have to apply very stringent measures to cut down on the numbers as it is becom- ing difficult to handle. However, these are the people who need to be guided very well. The encouraging thing is that these student proposals are being reviewed by the ethics committee (of their institution). They have to submit an approval certificate from their ethics committee to us. With experience, and with the feedback they get from us, they can improve the format. It is imperative to have teaching and training programmes in ethics. This is one way in which we try to help researchers. The Medical Council of India has actually given instructions to include ethics in the general syllabus. Like other countries in the region, it used to be part of forensic medicine teaching. But what was taught was not enough, except in 1 institution in the country, St. John’s Medical College in Bangalore, which has more than 40 years of teaching ethics. At one time it was confined to their own college students, interns and ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S62 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 staff. Now, however, they are expanding this activity. Their syllabus was actually the one the Medical Council of India instructed all the medical colleges to use as the model for their programmes. The health universities, however, started their own programmes, all different, each with their own committee going about it in their own way. Under the Fogarty-funded programme awarded to ICMR, it is ex- pected that a uniform core curriculum will be developed. There is also a plan to extend the under- graduate course by 6 months for training in computers, English and ethics in the first year. The teaching of research ethics for researchers and scientists should be part of continuing medical education programmes as well, and we need to create organized workshops for students, investigators and ethics committee members. Distance educa- tion should very much be a part of this. In- formed consent and ethics committee review are the 2 pillars on which the rights and wel- fare of participants in research programmes rest. Informed consent is taken care of by the guidelines that we already have. How the ethics committees function To find out how the ethics committees functioned, in 2000, we circulated a ques- tionnaire to medical colleges and ICMR institutes. We got only 32 responses, includ- ing those from ICMR institutes, where the ethics committees were not functioning well at that time despite the fact that it was ICMR that brought out the first ethical guidelines in 1980. Some people did not even know that they (the guidelines) existed. That was one of the revelations we experienced. We discovered that there was no legal expert on most of the committees. Appoint- ment procedures were unethical and there was lobbying for appointment as members. Decision-making was either by consensus or by majority opinion. The number of proposals reviewed varied from 2 to 60 in a meeting. The institution which had 60 at that time now has more than 100 and they are reviewed in half a day! It would be difficult to complete reading this number of proposals. This is the situation in one of the premier institutions of our country. In most of the institutions, maintenance of the minutes of the meeting and record keeping were very poor. Of course, there was no charge or fees for review; the inde- pendence and competence of these ethics committees was, however, questionable in most cases. We then wanted to find out whether the situation changed after the release of the guidelines and the series of workshops on bioethics for faculty members, some of whom were also members of ethics com- mittees. This time (2003) we circulated a 20-point questionnaire to about 1200 in- stitutions, both public and private. By that time, the World Health Organization opera- tional guidelines had been released [4]. The questionnaire was drawn up based on that along with the ICMR guidelines and also previous experience. We got 223 responses. This was somewhat better than the earlier experience, but not that much when viewed in totality. Strangely, the colleges teaching the Ay- urveda system and homeopathy produced the highest response; that was something encouraging. About 179 institutions of the 223 that responded had ethics committees. We selected 40 of the 223 ethics commit- tees which we thought might be functioning Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S63 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما better and plan to do a survey with the aim of developing various training programmes and capacity-building programmes after we visit these committees to see how they function. That would amount to a sort of accreditation for the first time. Of course, this is in the future. First we have to make the ethics committees function properly and only then go for accreditation. We need to learn from the mistakes that we encounter in the process so that we are prepared to solve problems by the time the ethics committees are fully functioning. The state of Maharashtra has the highest number of institutions, and the greatest number of ICMR studentship proposals come from there. This shows that there is sizeable research agenda there, and, of course, the pharmaceutical companies are concentrated in this area. The other area of significant development is the state of Andhra Pradesh in the south-east, although the response from there was very low. There are also many biotechnology companies in Karnataka state, in the south-west. Uttar Pradesh state, in the north of the country, is also coming up with a lot of biotechnology companies and biotechnology parks. This gave us an insight into the current situation regarding responsiveness of ethics commit- tees to the call of research ethics. We are still analysing the results, but it appears that the lowest number of responses came from the eastern region. That was to be expected because the north-east is a disturbed area. It is unlikely that much research is going on and therefore there are fewer awareness programmes in those areas. We did go up to Sikkim, which is in the far north, to have a workshop, but it is not possible to go there on a regular basis, the terrain is difficult and dangerous. There are also a number of independent ethics committees in India. This started slowly in Mumbai but it is now starting to mushroom, mainly because a lot of clinical trials are being outsourced to this country and there are also institutions now offering diplomas in clinical research. On the one hand you have the multinational agencies and clinical research organizations flooding into India in great haste, and on the other hand the regulatory bodies, the funding bodies, are concerned about how to manage the situation and stem violations. Therefore, we have had a number of workshops where multiple stakeholders, including the media, are involved and we are learning from them what is needed. As a result, we now plan to have a clinical trials registry. We need to have strategies to develop sensitization programmes, update guide- lines, formulate new ones and seek interna- tional collaboration for capacity-building. We have plenty of such activities carried out under the regional initiatives by the World Health Organization in various forums and global initiatives through the National Insti- tutes of Health, the Wellcome Trust, the Bill and Melinda Gates Foundation and the Ford Foundation. The Forum for Ethical Review Committees in Asia and the Western Pacific The Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP) was set up in 2000, and has a meeting every year. It worked rapidly in 2 of the World Health Organization regions, the South East Asia Region and the Western Pacific Re- gion, to educate ethics committee members. Since the Secretary General of FERCAP was also a member of ICMR, we benefited enormously through her experience in for- mulating the guidelines for the functioning ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S64 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 of the ethics committee. In fact, the chapter in the ICMR 2000 guidelines on the ethical review mechanism was a result of that [2]. Then followed the translation of operational guidelines for ethics committees. A number of countries, e.g. Thailand, Indonesia, the Philippines, have opened up their national chapters under the FERCAP initiative. For the first time in 2002, we held an ICMR–FERCAP workshop for developing standard operating procedures for institu- tional ethics committees under the FER- CAP initiative. There were 43 items in total—how to submit the proposal; how to review the proposal; how to expedite the proposal, etc. These have now been reduced to 23 after a number of other workshops, but the list is not yet finalized. Till it is, we have posted on our website the guidelines for preparing standard operating procedures. These are expected to be followed by every ethics committee before they actually start reviewing proposals. The chapter for India was initiated in 2002 but has only recently been registered. So we will be starting the programme with these objectives: establish and foster com- munications between ethics committees in India; act as a national collaborating agen- cy; organize meetings and symposia; assist in the development and implementation of standard operating procedures; facilitate training opportunities; and coordinate with other global bodies. Now we have FERCAP, Latin America, Eastern Europe, the African countries, Canada and the United States of America as regional chapters. There are also a number of nongovernmental organi- zations and other public sector and private sector bodies, which have joined these for a under a common “Strategic Initiative for Developing Capacity for Ethical Review” (SIDCER). A number of colleagues from Pakistan have mentioned that they were very much in tune with the culture of the subcontinent but they could not come under the FERCAP region because of the Asia–Pacific regional distribution. They are part of the World Health Organization Eastern Mediterranean Region, but their cultures are totally dif- ferent; they would actually like to be part of this initiative, the Asia Pacific Region. Perhaps we will find a way. Conclusion In summary, what we have done is for- mulate guidelines, fund workshops and constitute the Central Ethics Committee, which is a national committee of the ICMR. We also have a national ethics committee at the Department of Biotechnology but when it comes to biomedical research, it is the ICMR's Central Ethics Committee on Hu- man Research only which sees proposals of national significance. If the institutional ethics committee comes across a problem which has a national significance, or if there is policy matter involved, then it is referred to us. Now, because of the outsourcing of research, samples are being sent to India because of the expertise that is available here. We actually have guidelines for ex- change of biological materials going out of the country, but not for what is coming into the country. This is an example of the issues which are discussed by the Central Ethics Committee. We have also produced the curricula and carried out sensitization programmes, an ethics committee survey, the FERCAP initiative and the Forum for Ethical Re- view Committees in India initiative and collaborated at an international level with Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S65 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما countries in Europe and North America and also South East Asia, mainly through World Health Organization initiatives. Collaboration with a number of coun- tries and networking is the sort of global and regional initiative that is required now. We have to join forces so that our people are not exploited. There have been a number of reports of unethical practices in our coun- try regarding stem cells. One proposal on stem cell research with an external agency was not permitted to go ahead in India on account of this because it was brought to the attention of the authorities concerned. Now we understand that it has been moved to another developing country where it is thought they found an easy outlet, taking advantage of the increasing demand for a cure generated by the helpless situation of terminally ill patients or those affected by degenerative disease. But even in India, we need to be more vigilant. Such things are happening and the ICMR cannot police everything: the popu- lation is very large—more than 1 billion. So education in bioethics, good clinical practice and drug vigilance are important. References 1. Policy statement on ethical considerations involved in research on human subjects. New Delhi, Indian Council of Medical Re- search, 1980. 2. Ethical guidelines for biomedical research for human subjects. New Delhi, Indian Council of Medical Research, 2000. 3. Good clinical practices. New Delhi, Min- istry of Health & Family Welfare, Govern- ment of India, 2001. 4. Operational guidelines for ethics com- mittees that review biomedical research. Geneva, World Health Organization, 2000 (TDR/PRD/ETHICS/2000.1). S66 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Regional perspectives in research ethics: a report from Bangladesh Harun-Ar-Rashid1 1Director, Bangladesh Medical Research Council, Dhaka, Bangladesh (Correspondence to Harun-Ar- Rashid: bmrc@citechco.net). SUMMARY Health research in Bangladesh is increasing and hence there is a need to consider the ethical issues with regard such research. This paper describes the measures being taken in Bangla- desh to address research ethics, such as the bioethics educational programmes and the ethics review committees functioning within the country. The role and work of the Central Ethics Review Committee and the regulatory guidelines are outlined. The paper also discusses the situation regarding research ethics within the South Asia region. Perspectives régionales sur l’éthique de la recherche : rapport du Bangladesh RÉSUMÉ La recherche en santé au Bangladesh s’accroît, d’où la nécessité de se pencher sur les ques- tions éthiques concernant cette recherche. Le présent article décrit les mesures prises au Bangladesh pour aborder l’éthique de la recherche, telles que les programmes de formation dans le domaine de la bioéthique et les comités d’examen éthique en place dans le pays. Le rôle et les travaux du Comité cen- tral d’examen éthique ainsi que les lignes directrices réglementaires y sont présentés. L’article examine également la situation concernant l’éthique de la recherche dans la région de l’Asie du Sud. ʻɷ®Ceǟ¿ºÀºPÇVF¶=L>É®Ø]?6oÈaا¿EÀºfÈf¯I bÉmf¶=ÁÆe>  „=Í[qØ6Í[É®Ø]Ù=>È>v[¯¶=e>[FJ¢×=›d]ÖIÁ?ÊvJ¯È>š(ð>iÇ»·ºð=ǔoÈaا¿E›ÍÉVr¶=PÇVF¶=bÃnI PÇVF¶=Åd¸N’ͯ·£J™=*¶=Í®eǶ=ÅdÂÆL>[É®Ø]Ù=¤[ºÊ{>[£J·¶oÈaا¿[E>ÃId[=[¶=E=b[J¶=à¬årßIÍÉNVF oÈaا¿[E›Í[·º>£¶=Í[É®Ø]Ù=Í£Q=f™=Á>‚Æ(ÍÉQǶÇÉF¶=L>É®Ø]Ù=¼É·£ISº=fE¸Nº7ÍÉNVF¶=*±çfì[[J[I>[»² Ý=¸Ñ×b¶=´¶d²Æ(>>»¢?ÆÍÉ®Ø]Ù=Í£Q=f»·¶ÍÈh²f™=Í¿R·¶=eÆasÉ^·I‘CÍ®eǶ=Íɻɟ¿J¶=ÍÈa>me*o®>¿IÆ >ÉiAHÇ¿Q¼É·®C›ÍÉNVF¶=L>É®Ø]Ù=ߤuÆ´¶d²ÍÉNVF¶=Í®eǶ=ÅdÂ*  Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S67 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Introduction Bangladesh is a developing country of South Asia with enormous health problems. Demand for health research in this country is constantly increasing. International col- laboration is growing rapidly. Bangladesh is getting the attention of international re- searchers because of the high prevalence of emerging and re-emerging infections, nutrition deficiencies, and family planning and reproductive health problems [1]. Un- der these circumstances Bangladesh needs a core group of highly trained professionals to provide guidance to the research com- munity on ethical questions regarding the conduct of research, bearing in mind the current and future research situation. The objective of this paper is to give an overview of the situation related to research ethics in Bangladesh. Bioethics educational programmes From 2003, the Bangladesh Medical Re- search Council has been conducting bio- ethics educational programmes under the International Bioethics Education and Ca- reer Development Award of the Fogarty In- ternational Centre of the National Institutes of Health, United States of America (USA). Under this education programme, which is called “Training on Research Bioethics” the BMRC conducts certificate and advanced courses on research bioethics. BMRC also organizes workshops on ethical issues in health research under its regular research programmes. The objectives of the bioethics educa- tional programmes are: 1. To improve the ethical practice in conducting health research through capacity-strengthening of the health pro- fessionals/researchers of Bangladesh in research bioethics. 2. To prepare a cohort of experts in Ban- gladesh in ethical review of research proposals who are capable of serving as members of the Ethics Review Commit- tees. The Training on Research Bioethics pro- gramme is supported by National Institutes of Health research grants and runs from 2003 to 2006. There are two components to this programme: the national compo- nent implemented in Bangladesh and the international component implemented in Kazakhstan. Under the national component, two courses are conducted. One is the Certificate Course on Research Bioethics. The duration of the course is 10 weeks and two courses per year are to be conducted. Thus 6 such courses will be conducted over a period of three years. Each course includes 20 par- ticipants which will result in the manpower development of 120 professionals. The second course is the Advanced Course on Research Bioethics. The course runs for 6 working days and one course will be conducted per year, giving a total of three courses over the three years. Our target is to train 30 health professionals (10 per course). Thus under this training programme, we are planning to train a total of 150 professionals in research ethics. Under the Bangladesh Medical Research Council regular programme, workshops on ethical issues in health research were con- ducted during 1999–2000 and 2000–2001. These were held for 5 days and 28 health professionals were trained. Under the Training on Research Bioeth- ics programme we conducted two Cer- tificate courses during 2003–2005 in which 78 participants were trained, and two Ad- vanced courses in which 23 participants S68 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما were trained. Thus a total of 101 health professionals have been trained in research bioethics through this training programme. The distribution of participants for the Certificate course as regards institution is shown in Table 1 and illustrates that professionals working in the postgraduate institutions and medical colleges repre- sented 55.1% of the total number trained. As regards profession and sex, 50% were public health experts or from the basic science and clinical departments and 55% were males. Ethics review committees At present in Bangladesh there is one cen- tral ethics review committee and nine in- stitutional committees. The Bangladesh Medical Research Council’s Ethics Review Committee is considered as the Central/Na- tional Ethics Review Committee [2]. The nine other ethics review committees are functioning in 9 institutions. These com- mittees are mostly attached to postgradu- ate medical institutes and there are two within two medical colleges. Of the nine, committees, five were recently formed. It is important to note that the participants who were trained through the Certificate and Advanced courses took the initiative to form these new ethics review committees in their own institutions. The nine committee are shown below (*recently formed ethics review committee). 1. Bangabandhu Sheikh Mujib Medical University (BSMMU)* 2. National Institute of Preventive & Social Medicine (NIPSOM)* 3. National Institute of the Kidney Dis- eases and Urology, Dhaka* 4. Institute of Child and Mother Health (ICMH) 5. Bangladesh Institute of Child Health (BICH) 6. Chittagong Medical College, Chit- tagong 7. Sir Salimullah Medical College, Dha- ka* 8. Rajshahi Medical College, Rajshahi* 9. Bangladesh Institute of Research for Promotion of Essential and Reproduc- tive Health and Technologies The International Centre for Diarrhoeal Diseases, Bangladesh (ICDDR’B) has its own Ethics Review Committee, which con- Table 1 Distribution of trainees of the Certificate Course on Research Bioethics of the Bangladesh Medical Research Council by institution, profession and sex Variable % (n = 78) Name of institute Postgraduate medical institutes 28.2 Medical colleges/schools 26.9 Directorate of Health Services/ district hospitals 19.2 Nursing institutes/training centres 11.5 Nongovernmental medical institutions 7.8 Dental colleges 6.4 Profession Public health experts 19.2 Basic science experts 12.8 Clinicians 17.9 Dentists 5.1 Pharmaceutical professionals 5.1 Nutritionists 6.4 Nurses 11.5 Health administrators/programme managers 9.0 Medical educationists 5.1 Reproductive health experts 3.8 Traditional medicine experts 3.8 Sex Female 45 Male 55 Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S69 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما siders research studies submitted by the scientists of the Centre. Central Ethics Review Committee and regulatory guidelines The Central Ethics Review Committee of the Bangladesh Medical Research Council is considered the National Ethics Review Committee [2]. According to the Council’s policy, each and every project proposal ap- proved by the Scientific Review Committee must also obtain the approval of the Ethics Review Committee before funding by the Council. This Committee provides approval for BMRC-funded research projects and also projects funded by organizations (both national and international) other than the BMRC, including multicentre collaborative studies and research studies leading to post- graduate degrees. The Central Ethics Review Committee was established in 1979. The Committee consists of 9–11 members – lawyers, lay- persons and religious leaders are included as members. The Committee is formed by the Executive Committee of the Bangladesh Medical Research Council under the guide- lines of the Council for formation of the Ethics Review Committee and has a tenure of three years. The Committee is registered in the Office for Human Resource Protec- tion in the USA as an official institutional review board and it has federal-wide assur- ance. Every year, the Central Ethics Review Committee evaluates around 100 research proposals and it meets every month. The Committee follows certain strategies for approval of research proposals submitted for its consideration. The research proposals are grouped into three categories: 1. Research studies involving non-invasive methods and interventions: The decision on these studies is taken on the basis of review by the members of the Commit- tee. 2. Research studies with invasive methods and/or interventions: These proposals require review of the ethical issues by technical experts. The number of re- viewers ranges from 1 to 3 and depends on the nature of the research study. 3. Research studies with policy impli- cations: These studies are discussed through scientific meetings with rel- evant experts in addition to review of the ethical issues by technical experts. Figure 1 shows the percentage of the research projects considered by the Central Ethics Review Committee during the pe- riod 2000–2005. It shows that the research proposals funded by agencies other than the Bangladesh Medical Research Council are steadily increasing; these are mostly from international agencies. The Central Ethics Review Committee has developed an appli- cation form to handle such research propos- als. The investigators apply using this form and should submit the umbrella proposal, the proposal summary, a summary of ethi- cal issues involved, the informed consent form for subjects (this must be in Bengali), the consent form for parents or guardians, where applicable, the procedure for main- taining confidentiality and the questionnaire or interview schedule for consideration by the Committee. The Central Ethics Review Commit- tee has formulated a national policy on human tissue transplantation. BMRC has also developed guidelines for the transfer of human biomedical materials abroad for research purposes [2]. The Ethics Review Committee is in the process of develop- S70 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما ing national ethical guidelines for health research involving human subjects. Regional perspectives The countries of the South Asia region are in different stages of development with re- gards to health research and research ethics, and therefore their priority needs are differ- ent as regards the establishment of research ethics review systems. The development of research ethics re- view systems in different countries of the region can be compared with Maslow’s law of hierarchy of needs (Figure 2) [3]. There are two basic stages of the law of hierarchy of needs: one is for survival and the other one is for achievement. There are countries in this region that are actually in the survival stage of develop- ment. They should ensure the basic needs – formation of a health research system, establishment of a medical/health research council or analogous body and subsequently an ethics review committee. Their next step is to ensure security needs, i.e. training of manpower, formation of a cohort of experts in research ethics, financial support and supply of an adequate number of research proposals for continuous functioning. It is important to note that there are countries where the numbers of sufficiently qualified technical experts are too limited for the development of an ethics review system. Development of the technical experts by training more experts and further taining of existing experts will enable the ethics re- view committee to function more correctly and effectively. There are countries that have achieved the social needs. At this stage the ethics Figure 1 Proportion of the research projects considered by the Ethics Review Committee of the Bangladesh Medical Research Council (BMRC) during 2000–2005 Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S71 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما review committee should be recognized by others, the health professionals and the researchers. Firstly it should be recognized by the national bodies and then it should have some recognition outside the country – international recognition. At the achievement stages, the next stage is fulfilling the ego needs. At this stage the ethics review committee should have developed its own guidelines and these guidelines should be used by other organizations, thus adding power to the ethics review committee. In Bangladesh, formulation of national ethical guidelines is underway. There are countries that have already formulated ethical guidelines and they have acquired the power. These coun- tries are working to have the guidelines legally enacted so that they will be followed by others on the basis of legal standing. This will place the ethics review committee in the self-actualization stage of the hierarchy. The countries that are in the upper level, i.e. at the level of achievement in the hierarchy of research needs, and those that are at the lower level of survival should establish a good network so that both can benefit from available experts, committees and centres in the region. Figure 2 Different stages of development with regards to health research ethics using the Maslow's hierarchy of needs model [3] S72 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Recommendations Capacity-strengthening is recognized as a crucial step in the process of integrating the use of research for decision-making in the health system of a country [4]. Strengthened capacity in research ethics is needed in both developed and developing countries, although the need is particularly acute in developing countries. The crucial step, yet to be taken, is to strengthen ethics centres and training programmes in developing countries [5]. Capacity-strengthening in research eth- ics can be done through networking and it is applicable to institutions and also to individuals. Strengthening existing institu- tions through networking and setting up new institutions according to the needs of the country, and even the region, are es- sential. The establishment of the Center of Biomedical Ethics and Culture (CBEC) at the Sindh Institute of Urology and Trans- plantation in Karachi, Pakistan is a very positive development for strengthening research ethics review systems. Training and continuing education, inter- action at the regional and international level through organization of conferences, semi- nars and meetings are ways to strengthen ethics review systems. To maintain ethical standards in the countries of the region, the following actions are important: interaction between the regional ethics review com- mittees, collaboration in review of ethical issues of research proposals and sharing of views in difficult situations. Formation of national ethical guidelines by the countries of the region and also enactment of these guidelines are crucial for further strengthen- ing ethics review system in the countries of the region. References 1. Rashid HA. Research bioethics training in Bangladesh. Bangladesh Medical Re- search Council Bulletin, 2003, 29(3):78– 85. 2. Bangladesh Medical Research Council (BMRC). Organizational structure and functions of BMRC. Dhaka, Bangladesh Medical Research Council, 2003:8. 3. DeCenzo DA, Robbins SP. Personnel – human resource management, 3rd ed. New Delhi, Prentice–Hall of India Private Limited, 1999:637. 4. Rashid HA. Promoting road traffic injuries research in South Asia: capacity strength- ening in health research. Journal of the College of Physicians and Surgeons-- Pakistan, 2004, 14(12):736–8. 5. Singer PA. Beyond Helsinki: a vision for global health ethics. Improving ethi- cal behaviour depends on strengthening capacity. British medical journal, 2001, 322:747–8. Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S73 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما Bioethics in Sri Lanka Athula Sumathipala1 1Director, Forum for Research and Development, Columbo, Sri Lanka (Correspondence to: Athula Sumathipala@iop.kcl.ac.uk). SUMMARY Bioethics took off slowly in Sri Lanka, but now there are ethics review committees in many medical schools and national organizations. All medical schools teach some medical ethics but there are not enough trained teachers. There are no national guidelines on research ethics. The Forum for Research and Development was formed with the aim of building a new ethical research culture. The bioethics initiative includes: awareness-raising; education activities and capacity building; advocacy; and the development of policy guidelines. We aim to raise awareness in the scientific community and the general public on ethical, legal and social principles guiding the responsible conduct of research. Perspectives régionales sur l’éthique de la recherche : rapport du Sri Lanka RÉSUMÉ L’essor de la bioéthique a été lent au Sri Lanka, mais il existe maintenant des comités d’exa- men éthique dans de nombreuses écoles de médecine et organisations nationales. Toutes les écoles de médecine enseignent l’éthique médicale sous une forme ou une autre mais il n’y a pas suffisam- ment d’enseignants formés. Il n’y a pas de lignes directrices nationales sur l’éthique de la recherche. Le Forum pour la Recherche et le Développement a été créé dans le but de développer une nouvelle culture de la recherche éthique. L’initiative de bioéthique inclut les éléments suivants : sensibilisation ; activités d’éducation et renforcement des capacités ; plaidoyer ; et élaboration de lignes directrices. Notre objectif est de sensibiliser la communauté scientifique et le grand public aux principes éthiques, juridiques et sociaux qui guident la conduite responsable de la recherche. ʻɷ®Ceǟ¿ºÀºPÇVF¶=L>É®Ø]?6>³¾ØÈfiÀºfÈf¯I >I>E>JɺÇi×ÇMA  „=Í[qØ6ÍÉ®Ø]Ù=L>£Q=f»·¶Á>‚ÁÛ=µ>¿ÂÁ>²ÁCÆ(>³¾ØÈfi›ÍÒÉìEÎì~ÍÉQǶÇÉF¶=L>É®Ø]Ù=jI ÍÉ¿{Ƕ=L>»Ÿ¿™=ÆGì¶=L>É·²ÀºbÈb£¶=›*ebJEGì¶=L>É·²¤É–½Ç¯IÆÁCÆ(ÍÉFì¶=L>É®Ø]Ù=x£EkÈ Eçeb™=ieb™=Àº­>²ab¢fª=ÇJÈ*L>[É®Ø]@EÍ[É¿£™=Í[É¿{Ƕ=ÍÈa>[meÝ=¸Ñ×b¶=›eÇr®Ë?bQÇÈ×Æ PÇVF¶=*Í[É®Ø]Ù=PÇ[VF·¶Ìb[ÈbQÍ[ª>¯MÐ>¿EíÍßÉá§àEfÈÇìJ¶=ÆPÇVF¶=ÏbJ¿º¸É³nIb®Æ*Ìea>[Fº¸»Jn[IÆ QǶÇÉF¶=L>É®Ø]Ù=Ê[·È>[ºÎ[·¢Åd[ÂÍ[É6Ð>[¿EÆÍ[ɻɷ£J¶=Íìn[¾Ù=Æ7Í[ÉQǶÇÉF¶=L>[É®Ø]Ù=Í[É»Â@EÍ[É¢ÇJ¶= L>i>Éj·¶ÍÈa>meÝ=¸Ñ×b¶=a=b¢CÆ7½Çë™==dÃEnFJ¶=Æ7L=eb¯¶=*Í[É¢ÇI‘CÏb[J¿™=Î[·¢ÁÇ»Ñ>¯¶=­bÃÈÆ »JQ×=ÆÍɾǾ>¯¶=Æ(ÍÉ®Ø]Ù=Ôa>F™>Eð>ºÇ»¢eÇû‚=Æ(Ê»·£¶=¤»J=¹ÆÖj™=ÊNVF¶=µÇ·j¶=ÄQÇI¶=ÍÉ¢>*  ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S74 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 Introduction In terms of measurable health indices, Sri Lanka is very much comparable with the industrialized countries. Our public health system is very good: during the tsunami of December 2004, for example, we did not have a single disease outbreak because the system worked so well. There is, however, no overarching re- search culture, although we have some very eminent, internationally renowned researchers. Therefore our actual research output is low, less than that of India, Paki- stan and Bangladesh, and just marginally above that of Nepal. With this background, it is not surpris- ing that bioethics has not taken off rapidly in Sri Lanka. Bob Simpson, who did some work in the country, came to the conclusion that bioethics was in a very early stage of development: there were no formal teaching or training or advanced training courses en- tirely dedicated to research ethics or clinical medical ethics [1]. Now the situation has totally changed. There are ethics review committees in 5 medical schools and in the Sri Lanka Medi- cal Association. The association also has an ethics committee. Interest in medical ethics is, however, more or less confined to universities. The National Science Founda- tion has a national committee for bioethics, although it is not universally considered “national”, and it is certainly not truly mul- tidisciplinary. The Sri Lanka Association for the Advancement of Science has an ethics committee, but it is not a review com- mittee. The Medical Research Institution has an ethics review committee but it is not clear whether it is functioning. The National Institute of Health Science also has an eth- ics review committee. Teaching and training on ethics Although all the medical schools in Sri Lanka teach some aspects of medical ethics to undergraduate students, the contents of the curricula vary. Most medical schools teach medico-legal aspects of ethics in the forensic medicine department. The Univer- sity of Peradeniya has been teaching medi- cal ethics in the Department of Forensic Medicine. The course deals with medical issues relating to resource allocation and health policy but not very much on clinical ethics or research ethics as such. However, at Colombo Medical School, the Depart- ment of Psychological Medicine has started a formal teaching programme. They have a very innovative behavioural medicine pro- gramme running across 5 years, in which ethics is included. However, they have only 60 hours of contact time—6 lectures, seminars and small group discussions and assessment of 2 structured essays in the examination. There is one dedicated senior lecturer and they appointed another lecturer recently. The course content includes his- tory of medical ethics, principles of medical ethics and informed consent. Other faculties, e.g. the Faculty of Medi- cine in Ruhuna, which is in the south of the country, have a limited amount of input. Two other universities around Colombo also give some input on ethics, although it cannot be considered adequate. Ethical review and ethical review bodies in Sri Lanka When it comes to research ethics, there are no national guidelines: there are limited guidelines covering in vitro fertilization but Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S75 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما nationally accepted, widely discussed guide- lines do not exist. The Faculty of Medicine at Colombo Medical School was probably the first institution to start formal ethical review in Sri Lanka. That was in the 1970s, and they review about 35–40 submissions annually using international guidelines. Peradeniya University started their ethics committee in 1984. However, most of the members are not formally trained in ethics committees. There are a number of shortcomings and problems associated with the teaching of medical ethics. Specific problems include lack of a research culture, lack of trained medical teachers to teach medical ethics, lack of adequate time on the curriculum, lack of teacher motivation to emphasize ethical aspects during teaching, and lack of interest from the students. Forum for Research and Development Against this background of no research culture and no adequate ethics, the Forum for Research and Development was formed 4 years ago, with the main aim of help- ing build the nation through research. The Forum is trying to integrate indigenous knowledge and scientific development for national development. We are working to achieve a paradigm shift in the thinking and actions of the scientific and academic community to create a new strategic alli- ance among scholars, professionals, and especially the public: work at grass-roots level is crucial. We aim to build a new ethical research culture in Sri Lanka. In doing this, our mis- sion is to bring Sri Lankan scholars—there are about 2 million Sri Lankans all over the world—from diverse disciplines, not only medicine, living anywhere in the world to create a research culture in Sri Lanka and to foster evidence-based, informed decision- making for national development. Although the Sri Lankan academic community dis- plays a degree of intellectual richness and variety, structure and form is inadequate, even though there are many organizations contributing positively. Lack of a research culture is reflected in the scientific research output per capita in Sri Lanka in terms of measurable indicators. Unfortunately, only around 0.2% of our gross domestic prod- uct is spent on research and development. There was a plan for it to be increased to 1% during the current budget. It is expected to come through in the next budget. The Forum for Research and Develop- ment has a different focus and emphasis in terms of research and ethics. We will, however, collaborate and network with all the institutions and individuals involved in research and development in Sri Lanka to address this challenging task. Our organiza- tion does not work for ownership, it works for partnership. We have expatriate forums, local professional forums and student fo- rums. We also work to promote network- ing for strategic partnerships; development of an ethical framework; development of leadership qualities, commitment and dedi- cation; awareness raising; and collaboration with the public and with the media. We believe researchers have a duty to bring together different stakeholders. We do not believe that researchers are only researchers, and we do not see research and ethics as opposing disciplines or as rivals. We very much believe that ethics is an integral part of research, a friend of research rather than an enemy. We have capabili- ties, expertise and dedication to ethics but we do a lot of research as well: we hold 9 Wellcome grants for different projects. Cur- rent activities include setting up a genetics ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S76 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 laboratory and training people in statistics and writing skills. A holistic approach is used—trying to create scientists as opposed to separate ethicists and separate research- ers. We believe in converting research into policy and practice. That is the sum of our mission and agenda. In the local professional forum, one of the main arms is the bioethics initiative, and a multidisciplinary group is involved in educational activities and research. We have actually converted philosophy into action. Our bioethics initiative covers 4 areas: awareness-raising; education activi- ties and capacity building; advocacy; and the development of policy guidelines from a developing world perspective. Education When the word “exploitation” was first used, it was considered a political word, but even so, it is used because exploitation happens in research as well. The foremost objective in our educational activities is awareness- raising, within the scientific community as well as the general public, particularly on ethical, legal and social principles guiding the responsible conduct of research in Sri Lanka. So our strategy is to train a critical mass of mid-career faculty members to take a leading role in cultivating interest among the wider scientific community. To bring this about, we ran our first workshop in 2003 over 7 days. We adver- tised 30 places, and did not expect to fill them as this is considered an uninteresting subject by some people, so we did not expect there would be many applicants. In the event, it was a very popular course. We ended up having 150 applicants and had to increase the intake to 50. Representation came from all universities, but again mainly mid-career academics—some of the senior people did not want to know about it. We had representation not only from medical faculties but many other faculties. It was a very successful initiative. Another of our activities is promoting bioethics among schoolchildren because we think they are still unspoiled: it is better to catch them early and plant the seeds early. Our initiative attracts people from different universities, from the medical community, education, nursing, veterinary science, law—a very mixed group. We do not review research projects, we work on capacity-building in ethics to elevate the level of review. Advocacy and policy We have drafted a set of guidelines, “Re- search ethics from a developing world per- spective”. Rather than the end product, the document itself, the most important thing was the process involved in drawing it up. We circulated the proposal as widely as possible among the scientific commu- nity nationally and internationally, allow- ing people to discuss and develop the local guidelines. We have also contributed to internation- al guidelines, including documents from the Nuffield Council of Bioethics. When it comes to ethics, we believe that we have to research ethics as well. It should also be evidence-based, otherwise it would be based only on philosophy or personal preju- dice, and this would not be the best way. We did a study on the informed consent process, a qualitative study carried out with participants from many parts of the world. Basically, it elaborated on issues which are part of the informed consent process. A theme repeatedly appearing during this survey was conflict of interest during in- ternal collaboration. It was published in the American journal of bioethics [2]. We have also contributed to the ethical issue of the global divide in other publications. Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S77 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما We are also carrying out a project on informed consent, mapping current prac- tices and producing a leaflet on quality of information, consent forms and understand- ing the process. All these have implications for the ethics we practice in our part of the world. We believe in public engagement and consultation and there is discussion about what should happen after finishing a research project. We have put forward the slogan to the international community “What should hap- pen before you start research?” Consulting the public and other researchers is impor- tant. So we do public engagement work. Our informed consent project was presented to the scientific community in Sri Lanka, where it was discussed and the protocol altered. We also organized a qualitative work- shop to be used in research in ethics, which we organized not only for medical scientists but also for sociologists and anthropologists. We have established a successful network with most parts of the world, and we formed the Asia Pacific Bioethics Network We do not believe that ethics is merely a fashion; and ethics is definitely not just for intellectual debate—a self-gratifying exercise behind closed doors. Ethics is a mission. It has to come into the open and the public has to be involved. Certainly it needs to be removed from the hands of the medical profession and taken to the wider community. We took the 2004 tsunami as an opportu- nity for policy development and sustainable capacity-building, e.g. we used the slogan “Prevent retraumatization of the trauma- tized” because we foresaw this as one of the serious issues that would come up. So we used the media quite heavily. We also launched a campaign for a national ethics framework for disaster-related research. We managed to establish an ethics committee at the National Institute of Education. This was important because at that time a lot of children were approached by groups from different parts of the world to be exploited for easy, cheap research. It was also proposed that a central ethics committee be established at the Ministry of Health but it did not come about. There are initiatives from the World Health Organiza- tion to have ethics committees throughout the country. We do not, however, believe in the mushrooming of ethics committees: it becomes counterproductive and these com- mittees become heads not brains. So there has to be a balance between the need and the forming of ethics committees—it is not advisable to have an ethics committee under every tree. In any case, there should be accreditation of training. However, we felt that a central ethics committee at the Min- istry of Health was important, particularly one dedicated to post-disaster research. We have also worked with politicians, the top-down approach, not only bottom-up. We gave evidence to the parliamentary se- lect committee to propose steps to minimize the damage from the disaster and highlight- ed ethical issues in addition to other work, including identification of the dead and the role of genetics. We used all these openings to try to convince people (top-down and bottom-up) to make this a national issue: it also needs to be a regional issue. Networking is extremely important and we took things even further. We appealed to the international ethics community, journal editors in particular, to be vigilant about ex- ploitative research, particularly after disas- ters, and urged them to insist upon ethical clearance. There is still some debate on how to do this and what to do, but we wanted to highlight the issue. If researchers allow their findings to be put in a library without trying to convert research into policy and practice, that is an ethical issue. Not every ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما S78 La Revue de Santé de la Méditerranée orientale, Vol. 12 (Supplément No 1), 2006 researcher can do this, but there is a social responsibility to try. Again, we have used the tsunami as a reason to convert into policy and practice research done over the past 15 years on medically unexplained symptoms, which are very common after disasters. We have done clinical trials using psychological in- tervention, which was efficacious not only when the therapy was done by a physiatrist, but also when the primary care physician carried out the intervention. Through a World Health Organization grant we have produced a poster on the use of psychological intervention which will be distributed throughout Sri Lanka. There has been a request from Pakistan to send it to the disaster areas there because they have found people are using psychotropic drugs for medically unexplained symptoms. In Sri Lanka we found people doing computerized tomography scans and magnetic resonance imaging when people present with medi- cally unexplained symptoms. This is an example of how it is the ethical responsibil- ity of a researcher to convert research into policy and practice. We have also produced a manual, which will be distributed free of charge to local researchers as well as to the international community. We hold training workshops nationally, funded by the World Health Organization, and are happy to do them internationally. Non-use of ethics in research We say research is important but how can we ensure that research happens in an ethi- cal framework? There are 2 main types of reasons why ethical obligations are not ca- tered to, intentional and unintentional. Unintentional reasons result from lack of awareness of ethical issues and lack of sensitivity to specific ethical issues. The researchers simply do not consider ethical issues an essential component of research. By creating awareness among the research community this ignorance can be defeated. This can be done by guiding researchers to do quality research because they believe in the ethical framework: you should pro- mote ethics because ethics produces good research and you should become an ethical researcher because you believe in it and not because somebody has started to police you. Intentional reasons include conflict of interest, exploitation and lack of respect for survivors and for their dignity. This is more difficult to deal with. You have to draw on protective mechanisms such as guidelines and legislation, networking (in particular), public awareness, exposing those who do not comply with ethical obligations (a very important method), imposing sanctions on publications and exposing research fraud when it occurs. One example serves to highlight this. After the tsunami, a foreign group collected blood samples in the southern district for a proteomic study on neurobiological markers of stress. One of the local medical officers confiscated the blood and reported it to the Ministry of Health and Centre for National Operation where we were dealing with psychological issues related to the tsunami. It was judged unethical and was stopped. Then a young researcher was recruited to become the applicant. He applied for autho- rization from the ethics committee, where his father headed the organization. Fast- track approval was given. The documents attached to those from the foreign group saying that they had ethical clearance were for a completely different project, however, one which had been given ethical clearance in 2003. We considered it definite collusion. The matter has been taken very seriously. The people involved should be held respon- sible and all measures taken to expose them, Eastern Mediterranean Health Journal, Vol. 12 (Supplement 1), 2006 S79 ٢٠٠٦ ،١ مقر رشع نياثلا دلجلما قحلم ،ةيلماعلا ةحصلا ةمظنم ،طسوتلما قرشل ةيحصلا ةلجلما in addition to taking all professional steps to try to rectify the situation and safeguard the dignity of the ethics committee. Finally, I would like to quote Abra- ham Lincoln, “To sin by silence when they should protest makes cowards of men.” References 1. Simpson B. Ethical regulation and the new reproductive technologies in Sri Lanka: perspectives of ethics committee members. Ceylon medical journal, 2001, 46(2):54–7. 2. Sumathipala A, Siribaddana S. Revisiting “freely given informed consent” in relation to the developing world: role of an om- budsman. American journal of bioethics, 2004, 4(3):W1. Health and human rights Every country in the world is now party to at least one human rights treaty that addresses health-related rights, including the right to health and a number of rights related to conditions necessary for health. WHO is actively strengthening its role in providing technical, intellec- tual and political leadership in the field of health and human rights. The main objectives are to: • Strengthen WHO’s capacity to integrate a human rights-based ap- proach in its work • Support governments to integrate a human rights-based approach in health development • Advance the right to health in international law and international development processes/ Further information about WHO’s work in this importantant area can be found at: http://who.int/hhr/en