WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR SOUTH-EAST ASIA 28 th Session of WHO South-East Asia Advisory Committee on Health Research 12-13 August 2003, Maldives SEA/ACHR/28/12 05 August 2003 Agenda Item 2.4 (b) GLOBAL ACHR DRAFT 41 st SESSION OF THE ADVISORY COMMITTEE ON HEALTH RESEARCH (ACHR) Geneva, June 10-12, 2003 Executive Summary The global Advisory Committee on Health Research (ACHR) held its 41st Session at WHO headquarters in Geneva, Switzerland from June 10-12, 2003. In addition to the members of ACHR, the meeting included chairs of regional ACHR's, WHO staff from regions and headquarters, invited observers, and representatives of partner organizations. The main item on the ACHR’s agenda was the World Health Report 2004 (WHR2004) on the theme of Health Research-Knowledge for Better Health. This Report, and its possible contents and structure, was discussed extensively by members and other participants. The Secretariat presented a progress report on its initiative on Health Research Systems Analysis (HRSA) which will serve to inform the WHR2004. The follow-up to the launch of the ACHR Report on Genomics & World Health, released on April 30, 2002, was also discussed in detail with a focus on discussions of the Report at the governing bodies of WHO and also the implementation of the Report’s recommendations. The ACHR was also informed of progress on its previous recommendations (e.g. database of WHO-supported research activities, peer-review of project proposals, ethics) and was briefed on the sentinel topic of Mental Health Research, one of the programme areas in the Noncomunicable Diseases & Mental Health (NMH) cluster. Highlights were also presented of research activities in WHO regions. As was done in 2002, the regional ACHR chairs and RPC counterparts in the regional offices held a separate session during the meeting to discuss closer cooperation between regional ACHR’s. The Committee was also briefed on the plans for a World Health Research Summit in Mexico in 2004, an event planned to coincide with the launch of WHR 2004. Briefings were also given on the activities of the Ethics in Health unit at WHO, the review process for scientific documents at the Institute of Medicine (USA) and the European Commission’s activities in research. In the annual meeting with the Director General, committee members had the opportunity to update her on the activities of the four sub-committees of ACHR dealing with the WHR 2004, ethics, peer review and the WHO research database. Dr. Brundtland expressed satisfaction at the good progress made in the preparations for the WHR 2004 and the advisory role that ACHR continues to play in its development. She informed members of the efforts of the Ethics in Health unit to provide leadership in ethics within the Organization. It was emphasized that WHO needs to work closely with Member 2 States in this important but sensitive area. The Director-General also agreed to the need for better data on research within WHO and that the WHR 2004 can act as a catalyst to get better information from technical units and regions, thus allowing better evaluation of the use of resources. The Report can also serve to broaden the definition of research and demystify the meaning of research to a broader audience. With regards to the Genomics & World Health Report, spirited discussion occurred at the Executive Board and Member States clearly needed more time to consider the many contentious issues, many of which were extending into broader, more philosophical areas beyond purely scientific issues (e.g. ethical and moral dilemmas). The secretariat was also asked to work more closely with other UN agencies in this area (e.g. UNESCO) and, after close consultations with Members States, requested to come back to the governing bodies with more concrete proposals on the various issues related to genomics and health. * * * 3 DRAFT 41st SESSION OF THE ADVISORY COMMITTEE ON HEALTH RESEARCH (ACHR) Geneva, June 10-12, 2003 Opening Session (Agenda Items 1-7) The meeting was opened with remarks from the Chair of ACHR, Professor Mahmoud Fathalla, who welcomed members. Professor Marian Jacobs was unable to attend and a special welcome was extended to Dr Vladimir Shkolnikov. The Chairman also welcomed members of the ACHR family from the regional offices of WHO, temporary advisors, representatives from the Institute of Medicine (USA), European Commission, IARC (International Agency for Research on Cancer), Alliance for Health Policy and Systems Research, CIOMS (Council for International Organizations of Medical Sciences), COHRED (Council for Health Research and Development), Global Forum, for Health Research, and RPC counterparts from the regional offices (see Annex 1, list of participants). Brief introductions were made by those present and it was mentioned that Professor Atta-ur Rahman was recently decorated with the Nishan-i- Imtiaz scientific award in Pakistan. The agenda for the meeting was adopted (Annex 2) and Professor Zulfiqar Bhutta appointed as Rapporteur. The Report of the 40 th session of the ACHR was formally approved (moved by Lars Walloe, seconded by Fumimaro Takaku). Dr Christopher J.L. Murray, Executive Director of the EIP cluster also welcomed members and participants and highlighted the continued guiding role ACHR provides in the development of research within WHO and he mentioned a possible future role for ACHR in ensuring the quality and validity of WHO’s scientific outputs. Follow up on ACHR Report on Genomics and World Health (Agenda Item 8) A presentation was made by Dr Tikki Pang on the follow up to the Genomics and World Health Report. 8.1 National and regional launches of The Report National launches of the Report were organized in Malaysia and India and regional launches in Brazil and Africa (conference of the Africa Human Genome Initiative in Cape Town, South Africa, March 2003). 4 8.2 The Report and WHO Governing Bodies The Report was an agenda item during the 112 th session of the Executive Board held in Geneva on May 29, 2003 (document EB112/4). Following another discussion of the Report at the 113 th session of the Executive Board (January, 2004) it is expected that the Report will be tabled at the 57 th World Health Assembly (WHA) in May, 2004. See separate document summarizing the EB discussion on this issue (Annex 3) 8.3 Future activities and follow-up In addition to follow-up items at the 113 th session of the Executive Board (January, 2004) and the 57 th WHA (May, 2004) (Annex 3) some proposed follow up activities in the field of bioinformatics was discussed (Annex 4) Comments from ACHR members on the above agenda items : • Some disappointment was expressed that the Report will be discussed only in the 2004 session of the WHA. • The planned information session at the 57 th WHA on genomics will be important for developing countries as there is much misunderstanding and misinformation, especially in southern Africa in relation to safety and ethical issues due to the recent controversy involving GM crops and famine relief. • North-South cooperation is important in ensuring that benefits from genomics accrue to the developing countries, especially with regards to material transfer, IPR issues, and embargoes on movements of biological materials. World Health Report 2004 (Agenda item 9) A presentation was made by Dr Tikki Pang on the progress towards the development of the WHR 2004. The presentation covered issues related to writing team composition, advisory group, objectives and key themes (Agenda Item 9.1), and also outlined the various options for a draft outline of the Report (Agenda Item 9.2). This was followed by a presentation from Dr Ritu Sadana in which she provided an update on the Health Research Systems Analysis (HRSA) initiative (Agenda Item 9.3). This presentation focused on the conceptual framework for national health research systems (goals-advancement of knowledge, health & health equity; functions-stewardship, financing, creating & sustaining resources, producing & using research), development of indicators (core indicators, descriptive variables, approaches and testing), and an overview on the nature of technical inputs to the WHR 2004 (e.g. projects on resource flows and research production). It was emphasized that the WHR 2004 was merely a milestone in a longer process and not an end in itself. 5 Four presentations were then given by members of the RPC HRSA Team on the second day of the meeting (June 11, 2003) which provided more detailed information on the initiative with regards to the following topics : 1. National health research systems-description and analysis, case studies and benchmarking towards evidence base for policy options (Ritu Sadana). 2. Estimating funding for health research in member states (Andrew Kennedy). 3. Estimating research output in health for the 192 member states of WHO ( Guillermo Paraje). 4. Gaps between knowledge and health gain-health research utilization assessment pilot project, overview and preliminary results (Emmanuel Guindon). The following is a summary of the discussion and comments from ACHR members and other participants over the two days during which the WHR 2004 was discussed (Agenda Item 9.4) : 1. Restoring public confidence in science : This remains an important issue despite apparent differences between the USA and Europe, where HIV/AIDS, mad cow disease and issues related to genetically-modified organisms (GMO’s) has led to a diminished public confidence in science and even opposition to it. There is also the reality that many scientists in the developed world now have links to industry-the public thus tends not to trust them as they are perceived to be not independent and receiving money from industry. In Japan, the lost of confidence in science and medicine among the public is a big issue as newspapers report cases of medical errors. The media needs to be educated as it sometimes fights against progress of science. 2. Key messages for WHR 2004 : It was important to identify what are the concrete, key messages for WHR 2004. One of these key messages should be that research should influence policy. The Report should be primarily for advocacy for research for health and should try to provide answers to some important questions such as : • What is the recent progress in public health resulting from research? • What progress can be expected in the future? • Why would I, as a government, put money into health research? • How would investing in research help to improve the health system with respect to equity and ethics? 3. Draft outline options for WHR 2004 : There were some expressions of support for option II of the draft outline which focuses on the health research system with mention of a possible hybrid option. It was also suggested that a composite section on ethics and equity could be added to option II. In option I, the section on national health research systems should not be a purely quantitative chapter but must provide vision for opportunities, not simply a “laundry list” or inventory. Some members also raised the issue of measurement and numbers and the views of the incoming DG-will 6 the Report be reoriented towards to measurable outcomes and the monitoring of outcomes of advances in research?. 4. Tight timeline : Some members expressed concern at the rather tight timeline and whether the planned analysis can be completed in time for the WHR 2004. The issue of how the analytical work will actually inform the WHR 2004 must also be addressed. How can the Report be structured without waiting for data?. What is doable in the timeframe available-is there a need to readjust/reorient the overall strategy? 5. Qualitative assessment of research quality : although this is an important issue, there appears to be no broad consensus on how research quality is evaluated in general and the Report needs to take this into account. 6. The need to highlight positive deviants and success stories : Several discussants emphasized the need for the Report to have a positive tone and that it should consider using good anecdotes and case studies to illustrate success stories on how research has made a difference. It has the potential to make a big impact. Consider qualitative approaches and case studies in addition to quantitative measurements-a qualitative, rather than a quantitative, focus should be driving the Report. 7. The need to check information with national sources and consult existing databases : Some analysis resulting from international databases (e.g. no IUD papers from India) needs to be verified with local databases as there may be publications in journals not covered by these databases. The same applies for data on number of researchers in a country and institutions involved in research, e.g. the National Research Council (NRC) in Chile has done a survey showing that 5 institutions contribute more than 80% of the research. The NRC did a study of research journals and funds only those who publish regularly and use peer review-this can be a source of non ISI data. In addition, much information on research in developed and developing countries exist and the Report should consult these whenever it is relevant, e.g. COMSTEC (a committee of 57 ministers from Islamic countries) has done a survey of research being done in these countries and have developed both an information and a publications database. In order to enlarge the coverage, it is also important that existing information sources and databases be consulted, e.g. web sites of health and medical research councils, regional and national bibliometric databases. 8. Disadvantages of bibliometric analysis using international databases : Although its use was justified for certain purposes, it was reiterated that analysis of research output based on international databases (e.g. ISI, MEDLINE) was fraught with difficulties and limitations. This issues was the subject of a lively and interesting discussion which is summarized below : 7 • It is primarily a measure of academic research and, as such, it may underestimate or omit other kinds of research, e.g. advocacy and evaluation research, health services research which is harder to publish and often appears in local journals. • It is still useful to have estimate of production of papers in major international journals, i.e. to know the balances and structures. However, this is only part of the whole picture. • Bibliometrics cannot be considered to represent the entire output of knowledge and some key areas, like research utilization, may require a more qualitative approach. It should also be supplemented with other information, e.g. number of patents (international & local), patents leading to developed products. • Citation indices are useful but the reality is that some local journals are read by policy makers (e.g. in Brazil) and this must be taken into account. Another way of expressing this is : how can one capture research disseminated in national settings which has an influence on policy, i.e. can benchmarks and other pathways be identified? • Highly risky research, which fails 99% of the time and is unpublished, but sometimes leads to important breakthroughs, is not usually captured in bibliometric analysis. • Bibliometric outputs should not be used to rank countries, i.e. don’t make countries look bad as they move in their own way. Although some common indicators may be shared, the social and cultural objectives may differ between countries. Research is a global endeavor and it seems counterintuitive to assign this to individual countries. Focus instead on developing an inventory on utilization of knowledge in countries • As access to the international scientific literature is often limited in developing countries, it is not unusual to that even important research proposals (e.g. in Tanzania), cited WHO publications and the “grey” literature from local scientists (e.g. local study on chloroquine resistance). Research networks which were already in place promoted the practice. • Impact factor of national journals are often low and some countries are trying to analyse this problem in order to improve the situation and eliminate low quality journals and better serve national health development. Based on the discussion, it was suggested that what is needed is to have a framework for different kinds of research and where they are likely to be published-this is critical for the WHR 2004. It is not sufficient that caveats and limitations are mentioned and then the assumption made that it is taken care of-the issue must be addressed or else the flawed analysis becomes the “truth” 5 years down the road. A key question is how do we enlarge the net to make this exercise more meaningful? 9. Are we measuring what we could instead of what we should? Are we looking at where the light is and not what the real problems are? 10. Target audience of WHR 2004 : The Report should acknowledge that science is understood differently by different sectors of society-the least important audience is the scientist and the Report should primarily target national politicians and the 8 press/media. It is also likely that the Report will find different uses by different people. 11. Emphasize the value of international collaboration : Equitable and effective scientific collaboration should be the next model for North-South collaboration, beyond just collection of specimens. Such collaboration is as an excellent way to raise the level of science in the developing world (e.g. the high impact factor of scientific papers from Chile is due to the fact that 67% of the research was done in collaboration with other countries) 12. The need to better analyse the 10/90 gap : Although much has been said about the fact that less than 10% of the funding for global R&D goes to studying more than 90% of the world’s health problems, what does this actually mean?. • Many governments in developing countries (e.g. Tanzania) do contribute significantly to health research but with collaborative external grants it is not known how much actually goes to the country. This figure may, in fact, be very low (around 10%) and this issue should be addressed in the Report. • R&D done by the private sector is another difficult area-there is a feeling that the current estimate of around $30 billion is too low and that the real figure may be closer to $60-70 billion annually. More emphasis and analysis is needed on the major, developed country sources of global health R&D. 13. Issues that should be covered in the Report : Discussants indicated areas and topics related to health research which should be covered and mentioned (not listed in order of priority) : • The universality of research and its role in development • Capacity building in health research • Current frontiers in medicine in different fields • Importance of research for public health-often not mentioned in developing countries • Limitations and risk of science • Barriers to doing research in developing countries : career structures for health researchers-inequity exists within countries, brain drain; the need for research managers and connectors to link knowledge to health gains • Factors in diffusion of innovations-why is it that some basic medical innovations which is part of normal life (e.g. insulin for diabetes, drugs to control high blood pressure, bypass surgery) is not available in many regions of the world? Could a map/illustration be developed to show this? • Gap between health research and health systems (e.g. implementation of DOTS for TB) • Avoid an overemphasis on communicable diseases as 60% of disease burden in the developing world in the near future will be due to non-communicable diseases. Research should not be restricted to Third World diseases only-common problems should be shared and science should form a continuous network to 9 provide public goods and the commonness of scientists, diseases and approaches should be shared by all. Others, however, felt that infectious diseases should still be a major priority and more investments are needed. • Some health research has economic gain (through development of products) as one of its objectives Dr Christopher Murray, Executive Director of the EIP cluster, responded to the various discussion points by stating that the emphasis on the health research system as a whole requires some efforts at identifying which systems produces more outputs than others and that numbers/quantities are important. The work related to the WHR 2004 must capture all the problems, especially the research to policy link. Despite its well- known limitations, the citation counts concept is attractive and the problems associated with its use can be overcome. There is a need to capture output and to tackle the limitations in trying to do so. Also, the failure to take up technology is not just the fault of the health research system and researchers but may be linked to other problems of access, human resources, financial incentives, etc. The Chair summed up the discussion and suggested that a decision be made soon on the options discussed for presentation of the Report. Was it to be largely quantitative or qualitative or perhaps a hybrid format?. He emphasized that the value of the Report was not so much in the form of information but in providing a tool for countries to use to assess their own health research systems. The test methodology must be explained and , examples shown where it has been rigorously tested and the information shared. Finally, he suggested that the ACHR Sub-Committee on WHR 2004 be consulted more closely as the Report takes shape. Update on World Health Research Summit (Agenda Item 10) An update was provided by Dr Tikki Pang on the Ministerial Summit for Health Research scheduled to take place in Mexico City from November 22-26, 2004 in conjunction with Forum 8 of the Global Forum for Health Research. A short background to the Summit was provided followed by an update on the planning process, a possible Summit Theme (Knowledge gaps in achieving Millennium Development Goals), programme outline and Summit objectives. A Summit Advisory Committee has been convened to assist in the organization of the Summit. Mental Health Research (Agenda Item 11) Dr Benedetto Saraceno (Director, MSD/NMH) provided some background information on the need to promote research in mental health and identify research gaps. Limited research on mental health is being conducted in developing counties, funding is limited and the subject of the research does not address population needs as it has been focused mainly on drug-related research. Research is needed to inform governments about policy and should be science-driven. A 10-year global action programme will place research as a vital component of mental health policy in developing countries. 10 Dr Shekhar Saxena (MSD/NMH) then gave a presentation on mental health research in low- and middle-income countries, describing the results of a review of published research in mental health through an analysis of databases (e.g.MEDLINE, EMBASE PSYCHIATRY) for the period 2000-2001. Research outputs from countries were analysed according to country of origin, income groups, type of articles, and primary research themes. The main results of the analysis are as follows : • Only 3% of all research is on low & middle-income countries • 20 low & middle income countries account for 3/4 of literature and 43 countries produce no publications • Most research on India, South Africa, Brazil, Russia & China • 72% research is from local researchers • 63% of publications describe original research • Common themes of research: assessment/questionnaires, mental disorders/conditions, and epidemiology • Services, intervention and policy research inadequate • Limitation- review limited to indexed journals Dr Saxena also described the Research for Change initiative which aims to identify the role of research in developing countries for reducing the burden of mental disorders, discuss the research needs of developing countries in mental health/substance abuse fields, establish a relevant priority agenda, and formulate strategies to facilitate implementation of priority agenda, including scientific/technical/financial support mechanisms. A Global Fellowship project has also been started for training purposes. A donors meeting in Geneva is planned for December, 2003 as well as a meeting of editors of leading international and national journals. The discussion following the presentation highlighted the following issues : • There is a need to create a demand for more research in mental health, with a focus on experiences for the community rather than medically-based treatment aspects • It would be helpful to analyse the role of collaborations between institutions in mental health research • Urban and rural mental health problems may be quite different and rural problems are often neglected • A road map for mental health research is needed to identify other problems, e.g. road rage, suicide-how do we tackle these new problems? • The analysis of publications should also be done through an equity lens, e.g. taking into consideration economic criteria, gender criteria, men/women, poorer/indigenous groups. • Social science research may not have been included in the analysis-research in poorer communities may be more in the social science sphere before it gets picked up by the mental health community. 11 • The analysis must look beyond available databases with all its well-known limitations, i.e. regional databases (e.g. Lilacs/SciELO in Latin America) should also be analysed.. Report from ACHR Sub-Committees (Agenda Item 12) 12.1 World Health Report 2004 This item was covered separately under agenda item 9 (see above) 12.2 WHO Research Database Sub-Committee Andrew Kennedy presented an update on the development of a WHO database of research activities. A survey of 24 technical departments in WHO was carried out and responses were received from all but 4 departments. This enabled an assessment of the number of projects commissioned by various departments, with TDR (Tropical Disease Research), RHR/HRP (Human Reproductive Health Research), and VAB (Vaccines & Biologicals) having the most number of research projects. However, the comparability of the information was limited as different methods of defining what is a “project” is used by different departments. Some smaller departments keep little data on projects. Larger departments like TDR and RHR/HRP have data management system. RPC’s proposal to set up a WHO-wide database has been strongly supported. A draft core data set has been proposed which covers approval, processes, funding, collaboration, research description and outputs. There was, however, some concern about duplication and the importation of data. Comments made during the discussion session : • Although some progress has been made, a comprehensive picture of research in WHO is still not available. This is paradoxical as the organization expects countries to provide data yet in-house data is often not available or not shared willingly. The provision of such data should be made mandatory. • A complete and comprehensive database on WHO’s research activity is important for informing the WHR 2004 on the importance of research. Is this still feasible given the time constraints?. Such a database will also be of value for peer review purposes, to ensure quality, and to assess the cost effectiveness of research supported by the organization. 12.3 Ethics Sub-Committee Dr Abha Saxena (RPC/EIP) gave a presentation on SCRIHS (Secretariat Committee on Research Involving Human Subjects) which was transferred to RPC recently. The function of the Committee is to assess the ethical aspects of research projects supported by WHO which involves human subjects. The topics covered included composition of the committee, role of the secretariat, number of proposals 12 received, types of review, standard operating procedures, databases and capacity building/educational activities. Comments made during the discussion session : • Members of ACHR were pleased at the progress made with SCRIHS in a short time and wished to reiterate their belief that WHO should take a leadership role in this area. It was a suggested that a World Health Assembly resolution be developed and tabled on the issue of research ethics. • Further development of concrete activities should be done in the context of ETH (Ethics in Health) unit activities and other guidelines used by WHO departments (e.g. TDR, HRP). • SCRIHS membership must include laypersons and representatives from civic society. • There is also an opportunity to create linkages between ethics review committees, e,g, for multi-centre projects. This will help to set up dialogue and bring common problems to the fore. In turn, it will lead to capacity development and enhance links to other international activities. • In the broader context of human subjects research being the focus of SRIHS, we need to take into consideration the needs of 3 major sectors : women, disadvantaged groups and disability groups. • There is also an opportunity to look at regional activities (e.g. FERCAP, PABIN), special issues such as stem cells, and to analyse how national bodies review the ethics of research proposals, Can a database be created for learning purposes. • Overall capacity development in countries in ethical review is also important. • A suggestion was made that the SCRIHS database of proposals can be linked to the WHO research database (see agenda item 12.2) 12.4 Peer Review Sub-Committee Valery Abramov (RPC/EIP) presented an update on peer-review within WHO. The process is well-established in EMRO, PAHO, SEARO and WPRO. In WHO HQ the situation is less clear. Although major research programmes like TDR and HRP have excellent peer-review processes in place, there is no official document defining what constitutes a peer review process. TDR and HRP identifies peer review as an underlying value and have established scientific committees and scientific review groups with independent, external members who must declare any conflict of interest. WHO Collaborating Centres are also used to assist in the process. The following points were made during the discussion : • There is a need to recognize the fundamental importance of peer review in the design, commissioning and funding of research, and in evaluation and refinement of research outputs. A general policy is needed for the whole organization. • All parts of WHO should commit to use peer review for research inputs and outputs. • The documents and procedures used by EMRO should be circulated to all WHO regions as an example of a good peer review process. 13 • A working group should be convened involving TDR and HRP as the major research programmes to come up with suggestions for peer-review procedures. • All research projects sponsored by WHO should be allocated a unique identifier in order to monitor adherence to peer and ethical review and to enable linkage to the planned WHO research database (see agenda item 12.2). Meeting with the Director General (ACHR members only) The following topics were discussed with the Director-General : 1. WHR2004 2. Ethics in health research 3. WHO research database 4. Peer review 5. Reactions to Genomics Report 6. Mental health research 7. Past and future role of the ACHR In a meeting prior to the dialogue with Dr Brundtland, the following points were raised ACHR members : 1. WHR 2004 : Although the preparations for the WHR 2004 appears to be progressing well, it is important that it be ratified by new Director-General. It must also be his Report and an effort must be made to see him, provide him with options, include items which may interest him, and ask for his advice, i.e. get him to become a stakeholder. The timelines planned for the Report should remain if at all possible and the ACHR should meet in March, 2004 in order to have another opportunity for further inputs. Some members also felt that the Report should have a positive tone, avoid negativity and comparisons, and use vignettes to highlight success stories and achievements. It should be an exciting, forward looking document and be an advocacy piece to policy makers; its impact is potentially great. 2. Ethics in health : There has been good progress in this area with the activities of SCRIHS being based in RPC and the active role played by the Ethics in Health Unit. Capacity building activities are particularly important and the ACHR should be proud that it had played a role in stimulating these developments. 3. WHO research database : Some progress has been made but this is insufficient. In- house information on research activities must be available in the form of a good database, and a cohesive picture needs to be developed. 4. Peer review : there has been little progress in this area although it is considered essential. Some parts of the organization (e.g. EMRO, TDR, HRP) have good peer– review mechanisms in place but, in overall terms, the system is fragmented and there is need for an organization-wide policy on the matter. 14 5. Genomics : The Genomics and World Health Report is a concrete product of ACHR and the Committee had some influence on its contents. The lead writer, Professor Sir David Weatherall has also been playing an important role in advocating for the Report and it is being disseminated at the highest levels in the scientific community. 6. Mental health research : what has been the impact of the World Health Report in 2001 on Mental Health in the various priority areas? 7. Past and future role of ACHR : It would be of interest to get Dr Brundtland’s reflections on the past contributions of ACHR and also her thoughts on how the committee can contribute in the future. In her response following the presentation of the above topics, the Director General made the following remarks : 1. On WHR 2004 and the planned Mexico Summit : She was pleased at the progress in preparing for the WHR 2004 and the Mexico Summit on health research. In this regard, she agreed that it was a good idea to choose an earlier date for the ACHR meeting in 2004. There was also some confusion on the definition of research and a need to broaden the definition, especially as it relates to WHO’s work-it needs to be more inclusive. The WHR 2004 is an opportunity to clarify matters. 2. On ethics : the Ethics in Health (ETH) unit was making good progress in its work and is focusing on internal activities related to ethics and bringing together the various interested parties through an Ethics Council. She felt that it was necessary for WHO to take a leadership role and draw on its own knowledge base, as well as working more closely with member states to see what can be done. She also mentioned that Spain had raised a question about the ethics of organ transplantation. WHO will host a meeting on this topic and a document will be prepared for the next meeting of the Executive Board. 3. On peer review : This has been discussed at Cabinet and, although it is used in some parts of WHO, other areas are not aware of the need. ACHR can make suggestions for policy on this issue. 4. On the Genomics & World Health Report : The Director General mentioned that the lack of extensive discussion during the Executive Board was probably related to the fact that the USA had stated that they were not ready to pass the resolution and wanted to amend the text. As a result, many countries held back their interventions. However, she expected vigorous discussion at the 113 th session of the EB in January, 2004. During the Lunch with the Director General (ACHR members only), three topics were discussed : 15 1. Public trust in science and medicine-different perspectives 2. WHO and the SARS epidemic 3. Reflections of the Director General on global health and the Organization. Matters referred to by Regional ACHR’s (Agenda Item 13) 13.1 AFRO No report was presented from AFRO 13.2 AMRO/PAHO (Presented by Professor Jorge Allende) The PAHO ACHR has not met in 2003 as the meeting has been postponed to November, 2003 due to the appointment of a new Regional Director. However, the Committee remains active with the launch of a joint initiative between PAHO and ICGEB in Trieste, Italy for funding research in the molecular biology of viral diseases. This area was identified by the PAHO ACHR as a follow up to the Genomics & World Health Report and emphasizes the formation of networks and granting of short-term training fellowships. ICGEB has expressed interest to initiate the same type of activities with other regions whose countries are members of ICGEB. 13.3. EMRO (Presented by Profesoor Atta-ur-Rahman) The EMRO ACHR met on 27-29 August, 2002 after 4 years of inactivity. Several activities have been carried out in the past year : regional office support for field research, human resource development, ethics in health research, development of research policy and advice, international collaboration & networking, and defining plans for 2003. Peer review was done on 271 research proposals, with 37 proposals approved (total of about $300,000) 13.4 EURO (Presented by Dr Yves Charpak) EURO is currently not involved in research as this was done at the national level by EC countries and former countries of the Soviet Union level. In addition, the Council of Europe deals with issues of ethics and WHO sits as an observer. ACHR exists in EURO with a mandate to focus on specific tasks linked to EURO priorities. It is hoped that the EURO ACHR will help define what kind of evidence is needed in public health and how to implement action plans and strategies. Some ideas are being developed on the type of evidence which is needed, expanding the definition of evidence and articulating the context of implementation. The ACHR is also working on other specific issues, e.g. language in evidence (translation problems, e.g. “stewardship”), format for evidence (English native speakers vs international English speakers), development of evidence for recommendations, identifying situations where evidence was used and had an impact, how it enters the process of decision making, and a review of the use of evidence by technical units in EURO. 16 13.5 SEARO (Presented by Professor Nirmal Ganguly) SEARO ACHR has reviewed the implementation of its research strategy and considered inputs from countries on their efforts to strengthen national capability in health research. SEARO has organized training course in health research management and has collaborated with other organizations such as INCLEN (International Clinical Epidemiology Network) and FERCAP (Forum for Ethical Review Committees in the Asia-Pacific). With the latter, an audit of problems in ethical issues related to health research is being carried out. Another important development is the formation of the Asia Pacific Health Research Forum, involving countries from both SEARO and WPRO. It was also mentioned that the distribution of WHO collaborating centres in SEARO is uneven and this needs to be corrected, e.g. Bangladesh has only two centres, Indonesia has three and Sri Lanka only one. Good progress has been made in several areas of research including cardiovascular diseases, thallasaemia, nutrition, arsenic contamination of water, health impact and environmental health risk assessment. Several SEARO countries have also been active in research : 1. Bangladesh : Bangladesh Medical Research Council has funded projects and students. 2. Bhutan : mental health, EPI, and reproductive health surveys. 3. DPR Korea : postgraduate medical education. 4. India : databases for health research system, e.g. cancer registry, ethics documents on specific issues and disease burden estimate for major diseases. 5. Indonesia : economic analysis, policy analysis, health system performance, ethics. 6. Myanmar : iodine intake among schoolchildren. 7. Nepal : TRIPS and IPR issues, ethics guidelines, journal, book on research methodology. 8. Sri Lanka : Study with the Alliance for Health Policy and Systems research on shifts in health sector policies. 13.6 WPRO (Presented by Professor Terry Dwyer) WPRO currently has no resources allocated for supporting research projects. However, the WPRO ACHR has developed a regional framework for health research focusing on basic principles. In particular, the framework emphasizes that training should be done in developing countries. The objective of the framework is to help developing countries in the region through WHO Country Representatives who will be asked to recommend to countries to establish national health research committees. The New Zealand Health Research Council and the Pacific Health Research Council will assist selected islands in the Pacific to establish national committees. Cambodia will also be establishing a national health research council. Closer interactions between WHO collaborating centres involved in research will also be encouraged and promoted. WPRO ACHR is prepared to help in the preparation of the WHR 2004 with regards to data collection. 17 13.7 Report from Regional ACHR’s and Counterparts meeting (Dr Adik Wibowo) Dr Wibowo presented a report from the meeting between regional ACHR Chairs and RPC counterparts held on June 11, 2003 and chaired by Professor Atta-ur Rahman. The following issues were discussed at the meeting : 1. Mechanisms for inter-regional collaboration. 2. Access and exchange of databases. 3. Establishing networks. 4. Assessment on quality of research. 5. Recommendations to global ACHR. The meeting was also informed that an EMRO-SEARO Bi-regional meeting will be held in the Maldives from Aug 12-14, 2003, 2003. Programme of work in the coming year (Agenda itema 14 and 16) 14.1 Reviewing WHO’s scientific outputs-a role for ACHR? Dr David Challoner (Foreign Secretary, Institute of Medicine, USA) gave a presentation on the process for review of reports at the US National Academy of Sciences (NAS). He addressed the following topics : purpose of report review, unique feature of the NAS process, facts about the review process, approximate costs, primary criteria for review, number of reports reviewed, and notable recent publications. He posed four questions for ACHR to consider : 1. who is asking the question?: 2. who owns the report and who signs off?; 3. who can speak unpleasant truths to power?; 4. how is the study committee chosen?; 5. how would reviewers be chosen and would they be anonymous?. Dr Tessa Tan-Torres (GPE/EIP) briefed the meeting on the process for guiding the development of guidelines within WHO. This has been completed and implemented but there was variable compliance in-house to adhering to these guidelines. The challenge is how to get people to follow the process. Also, these guidelines do not cover other documents, e.g. Expert Committee and Study Group reports, which should perhaps be subjected to the same standards. In the ensuing discussion on this issue, the following points were made : 1. There is a definite need for independent review and to institutionalise assurance of the quality of scientific documents produced by the organization as industry and governments are paying more and more attention to WHO’s recommendations. The guidelines on guidelines is a voluntary process but it there is no requirement to adhere-should a more active process be adopted and can ACHR play a role?. 18 2. Concomitantly, there is also a need to develop a better, more transparent process for choosing members of expert advisory panels from which expert committees are drawn. The same applies to selecting members of scientific groups, study groups and other “expert” groups. Clear criteria for selection should be developed and posted for all to see. In the past, members have been selected who are not in the mainstream of science. Can the ACHR play a role in ensuring scientific quality of WHO documents?. It was generally felt that this was a complex and difficult area and, for practical reasons, the ACHR can not play this role as it has a mostly advisory function. It was felt that this was mostly a Secretariat function and that ACHR’s role would be to comment/advise on possible mechanisms for review and on the balance between scientific robustness and need for expediency. As the committee met only once a year, direct involvement in a routine manner would be impractical. 14.2 Ethics and Health Unit Alex Capron (Director, ETH) provided background information on the Ethics and Health Unit which began functioning in October, 2002. The following were highlighted : 1. Ethics activities are already ongoing in different parts of WHO, including that of SCRIHS (Secretariat Committee for Research Involving Human Subjects which is based in RPC (see agenda item 12.3) and in technical units such as TDR, HRP and VAB. 2. Regular monthly meetings (Ethics Council) are held of interested persons to discuss topics of interest , to reach out, to coordinate, to draw on expertise, and for others to raise issues and discuss topics of general interest. 3. Close cooperation with the Strategy Unit on issues related to globalization and human rights. 4. Ethics focal points have been identified in regional offices and they are currently cataloguing activities in the area of research ethics. 5. ETH acts as the secretariat for the Global Bioethics Commission and links regularly with other UN organizations, e.g. UNESCO, UN Interagency Committee on Bioethics 6. Major areas of interest for ETH : . 1. Ethical aspects of equity in health systems; 2. Genomics and world health-ethical aspects; 3. Biotechnology and other general topics, e.g. organ and tissue transplantation; 4. Implications of stem cell research for health systems and health care; 5. Human subjects research-support for SCRIHS, educational seminars for WHO staff, capacity building activities in countries; 6. Development of intercultural issues, e.g. issues arising when researchers do not come from the same community (design of surveys and research ethics may need adjustment). 7. A longer term aim is for WHO to develop guidelines for research with member state participation and perhaps play an accreditation role for national ethical review committees. 19 The following issues were raised during the discussion : 1. Thought should be given to a more normative role of WHO, i.e. development of universal guidelines for health research and an ombudsman function 2. A network should be created between developing countries and WHO ethics support units-how can ACHR help? 3. There is a need to recognize what is already is going on, especially in capacity strengthening efforts where there are many activities which do not necessarily involve WHO regional office focal points. European Commission and Health Research (Agenda Item 15) Dr Kevin McCarthy (European Commission, Brussels) gave a presentation on the EC’s Sixth Framework Programme (2002-2006). He highlighted the ERA (European Research Area) and the objectives of the Sixth Framework Programme and the place of health within this programme. Priority areas included life sciences, genomics and biotechnology for health and policy-oriented research in various areas of health. He also mentioned the recently launched European & Developing Countries Clinical Trials Partnership (EDCTP) whuch focuses on HIV/AIDS, TB and malaria. Date & place of next meeting (Agenda item 17) It was suggested that the 42 nd session of the ACHR be held earlier in 2004 due to the World Health Report. The suggested dates were the last week of March, or the first two weeks of April, 2004 in Geneva. ANNEXES TO BE ADDED Annex 1 List of participants Annex 2 Agenda of meeting Annex 3 EB discussion on Genomics & World Health Report Annex 4 Bioinformatics proposal from Professor Gordon Dougan 20
WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR SOUTH-EAST ASIA 28 th Session of WHO South-East Asia Advisory Committee on Health Research 12-13 August 2003, Maldives SEA/ACHR/28/12 05 August 2003 Agenda Item 2.4 (b) GLOBAL ACHR DRAFT 41 st SESSION OF THE ADVISORY COMMITTEE ON HEALTH RESEARCH (ACHR) Geneva, June 10-12, 2003 Executive Summary The global Advisory Committee on Health Research (ACHR) held its 41st Session at WHO headquarters in Geneva, Switzerland from June 10-12, 2003. In addition to the members of ACHR, the meeting included chairs of regional ACHR's, WHO staff from regions and headquarters, invited observers, and representatives of partner organizations. The main item on the ACHR’s agenda was the World Health Report 2004 (WHR2004) on the theme of Health Research-Knowledge for Better Health. This Report, and its possible contents and structure, was discussed extensively by members and other participants. The Secretariat presented a progress report on its initiative on Health Research Systems Analysis (HRSA) which will serve to inform the WHR2004. The follow-up to the launch of the ACHR Report on Genomics & World Health, released on April 30, 2002, was also discussed in detail with a focus on discussions of the Report at the governing bodies of WHO and also the implementation of the Report’s recommendations. The ACHR was also informed of progress on its previous recommendations (e.g. database of WHO-supported research activities, peer-review of project proposals, ethics) and was briefed on the sentinel topic of Mental Health Research, one of the programme areas in the Noncomunicable Diseases & Mental Health (NMH) cluster. Highlights were also presented of research activities in WHO regions. As was done in 2002, the regional ACHR chairs and RPC counterparts in the regional offices held a separate session during the meeting to discuss closer cooperation between regional ACHR’s. The Committee was also briefed on the plans for a World Health Research Summit in Mexico in 2004, an event planned to coincide with the launch of WHR 2004. Briefings were also given on the activities of the Ethics in Health unit at WHO, the review process for scientific documents at the Institute of Medicine (USA) and the European Commission’s activities in research. In the annual meeting with the Director General, committee members had the opportunity to update her on the activities of the four sub-committees of ACHR dealing with the WHR 2004, ethics, peer review and the WHO research database. Dr. Brundtland expressed satisfaction at the good progress made in the preparations for the WHR 2004 and the advisory role that ACHR continues to play in its development. She informed members of the efforts of the Ethics in Health unit to provide leadership in ethics within the Organization. It was emphasized that WHO needs to work closely with Member 2 States in this important but sensitive area. The Director-General also agreed to the need for better data on research within WHO and that the WHR 2004 can act as a catalyst to get better information from technical units and regions, thus allowing better evaluation of the use of resources. The Report can also serve to broaden the definition of research and demystify the meaning of research to a broader audience. With regards to the Genomics & World Health Report, spirited discussion occurred at the Executive Board and Member States clearly needed more time to consider the many contentious issues, many of which were extending into broader, more philosophical areas beyond purely scientific issues (e.g. ethical and moral dilemmas). The secretariat was also asked to work more closely with other UN agencies in this area (e.g. UNESCO) and, after close consultations with Members States, requested to come back to the governing bodies with more concrete proposals on the various issues related to genomics and health. * * * 3 DRAFT 41st SESSION OF THE ADVISORY COMMITTEE ON HEALTH RESEARCH (ACHR) Geneva, June 10-12, 2003 Opening Session (Agenda Items 1-7) The meeting was opened with remarks from the Chair of ACHR, Professor Mahmoud Fathalla, who welcomed members. Professor Marian Jacobs was unable to attend and a special welcome was extended to Dr Vladimir Shkolnikov. The Chairman also welcomed members of the ACHR family from the regional offices of WHO, temporary advisors, representatives from the Institute of Medicine (USA), European Commission, IARC (International Agency for Research on Cancer), Alliance for Health Policy and Systems Research, CIOMS (Council for International Organizations of Medical Sciences), COHRED (Council for Health Research and Development), Global Forum, for Health Research, and RPC counterparts from the regional offices (see Annex 1, list of participants). Brief introductions were made by those present and it was mentioned that Professor Atta-ur Rahman was recently decorated with the Nishan-i- Imtiaz scientific award in Pakistan. The agenda for the meeting was adopted (Annex 2) and Professor Zulfiqar Bhutta appointed as Rapporteur. The Report of the 40 th session of the ACHR was formally approved (moved by Lars Walloe, seconded by Fumimaro Takaku). Dr Christopher J.L. Murray, Executive Director of the EIP cluster also welcomed members and participants and highlighted the continued guiding role ACHR provides in the development of research within WHO and he mentioned a possible future role for ACHR in ensuring the quality and validity of WHO’s scientific outputs. Follow up on ACHR Report on Genomics and World Health (Agenda Item 8) A presentation was made by Dr Tikki Pang on the follow up to the Genomics and World Health Report. 8.1 National and regional launches of The Report National launches of the Report were organized in Malaysia and India and regional launches in Brazil and Africa (conference of the Africa Human Genome Initiative in Cape Town, South Africa, March 2003). 4 8.2 The Report and WHO Governing Bodies The Report was an agenda item during the 112 th session of the Executive Board held in Geneva on May 29, 2003 (document EB112/4). Following another discussion of the Report at the 113 th session of the Executive Board (January, 2004) it is expected that the Report will be tabled at the 57 th World Health Assembly (WHA) in May, 2004. See separate document summarizing the EB discussion on this issue (Annex 3) 8.3 Future activities and follow-up In addition to follow-up items at the 113 th session of the Executive Board (January, 2004) and the 57 th WHA (May, 2004) (Annex 3) some proposed follow up activities in the field of bioinformatics was discussed (Annex 4) Comments from ACHR members on the above agenda items : • Some disappointment was expressed that the Report will be discussed only in the 2004 session of the WHA. • The planned information session at the 57 th WHA on genomics will be important for developing countries as there is much misunderstanding and misinformation, especially in southern Africa in relation to safety and ethical issues due to the recent controversy involving GM crops and famine relief. • North-South cooperation is important in ensuring that benefits from genomics accrue to the developing countries, especially with regards to material transfer, IPR issues, and embargoes on movements of biological materials. World Health Report 2004 (Agenda item 9) A presentation was made by Dr Tikki Pang on the progress towards the development of the WHR 2004. The presentation covered issues related to writing team composition, advisory group, objectives and key themes (Agenda Item 9.1), and also outlined the various options for a draft outline of the Report (Agenda Item 9.2). This was followed by a presentation from Dr Ritu Sadana in which she provided an update on the Health Research Systems Analysis (HRSA) initiative (Agenda Item 9.3). This presentation focused on the conceptual framework for national health research systems (goals-advancement of knowledge, health & health equity; functions-stewardship, financing, creating & sustaining resources, producing & using research), development of indicators (core indicators, descriptive variables, approaches and testing), and an overview on the nature of technical inputs to the WHR 2004 (e.g. projects on resource flows and research production). It was emphasized that the WHR 2004 was merely a milestone in a longer process and not an end in itself. 5 Four presentations were then given by members of the RPC HRSA Team on the second day of the meeting (June 11, 2003) which provided more detailed information on the initiative with regards to the following topics : 1. National health research systems-description and analysis, case studies and benchmarking towards evidence base for policy options (Ritu Sadana). 2. Estimating funding for health research in member states (Andrew Kennedy). 3. Estimating research output in health for the 192 member states of WHO ( Guillermo Paraje). 4. Gaps between knowledge and health gain-health research utilization assessment pilot project, overview and preliminary results (Emmanuel Guindon). The following is a summary of the discussion and comments from ACHR members and other participants over the two days during which the WHR 2004 was discussed (Agenda Item 9.4) : 1. Restoring public confidence in science : This remains an important issue despite apparent differences between the USA and Europe, where HIV/AIDS, mad cow disease and issues related to genetically-modified organisms (GMO’s) has led to a diminished public confidence in science and even opposition to it. There is also the reality that many scientists in the developed world now have links to industry-the public thus tends not to trust them as they are perceived to be not independent and receiving money from industry. In Japan, the lost of confidence in science and medicine among the public is a big issue as newspapers report cases of medical errors. The media needs to be educated as it sometimes fights against progress of science. 2. Key messages for WHR 2004 : It was important to identify what are the concrete, key messages for WHR 2004. One of these key messages should be that research should influence policy. The Report should be primarily for advocacy for research for health and should try to provide answers to some important questions such as : • What is the recent progress in public health resulting from research? • What progress can be expected in the future? • Why would I, as a government, put money into health research? • How would investing in research help to improve the health system with respect to equity and ethics? 3. Draft outline options for WHR 2004 : There were some expressions of support for option II of the draft outline which focuses on the health research system with mention of a possible hybrid option. It was also suggested that a composite section on ethics and equity could be added to option II. In option I, the section on national health research systems should not be a purely quantitative chapter but must provide vision for opportunities, not simply a “laundry list” or inventory. Some members also raised the issue of measurement and numbers and the views of the incoming DG-will 6 the Report be reoriented towards to measurable outcomes and the monitoring of outcomes of advances in research?. 4. Tight timeline : Some members expressed concern at the rather tight timeline and whether the planned analysis can be completed in time for the WHR 2004. The issue of how the analytical work will actually inform the WHR 2004 must also be addressed. How can the Report be structured without waiting for data?. What is doable in the timeframe available-is there a need to readjust/reorient the overall strategy? 5. Qualitative assessment of research quality : although this is an important issue, there appears to be no broad consensus on how research quality is evaluated in general and the Report needs to take this into account. 6. The need to highlight positive deviants and success stories : Several discussants emphasized the need for the Report to have a positive tone and that it should consider using good anecdotes and case studies to illustrate success stories on how research has made a difference. It has the potential to make a big impact. Consider qualitative approaches and case studies in addition to quantitative measurements-a qualitative, rather than a quantitative, focus should be driving the Report. 7. The need to check information with national sources and consult existing databases : Some analysis resulting from international databases (e.g. no IUD papers from India) needs to be verified with local databases as there may be publications in journals not covered by these databases. The same applies for data on number of researchers in a country and institutions involved in research, e.g. the National Research Council (NRC) in Chile has done a survey showing that 5 institutions contribute more than 80% of the research. The NRC did a study of research journals and funds only those who publish regularly and use peer review-this can be a source of non ISI data. In addition, much information on research in developed and developing countries exist and the Report should consult these whenever it is relevant, e.g. COMSTEC (a committee of 57 ministers from Islamic countries) has done a survey of research being done in these countries and have developed both an information and a publications database. In order to enlarge the coverage, it is also important that existing information sources and databases be consulted, e.g. web sites of health and medical research councils, regional and national bibliometric databases. 8. Disadvantages of bibliometric analysis using international databases : Although its use was justified for certain purposes, it was reiterated that analysis of research output based on international databases (e.g. ISI, MEDLINE) was fraught with difficulties and limitations. This issues was the subject of a lively and interesting discussion which is summarized below : 7 • It is primarily a measure of academic research and, as such, it may underestimate or omit other kinds of research, e.g. advocacy and evaluation research, health services research which is harder to publish and often appears in local journals. • It is still useful to have estimate of production of papers in major international journals, i.e. to know the balances and structures. However, this is only part of the whole picture. • Bibliometrics cannot be considered to represent the entire output of knowledge and some key areas, like research utilization, may require a more qualitative approach. It should also be supplemented with other information, e.g. number of patents (international & local), patents leading to developed products. • Citation indices are useful but the reality is that some local journals are read by policy makers (e.g. in Brazil) and this must be taken into account. Another way of expressing this is : how can one capture research disseminated in national settings which has an influence on policy, i.e. can benchmarks and other pathways be identified? • Highly risky research, which fails 99% of the time and is unpublished, but sometimes leads to important breakthroughs, is not usually captured in bibliometric analysis. • Bibliometric outputs should not be used to rank countries, i.e. don’t make countries look bad as they move in their own way. Although some common indicators may be shared, the social and cultural objectives may differ between countries. Research is a global endeavor and it seems counterintuitive to assign this to individual countries. Focus instead on developing an inventory on utilization of knowledge in countries • As access to the international scientific literature is often limited in developing countries, it is not unusual to that even important research proposals (e.g. in Tanzania), cited WHO publications and the “grey” literature from local scientists (e.g. local study on chloroquine resistance). Research networks which were already in place promoted the practice. • Impact factor of national journals are often low and some countries are trying to analyse this problem in order to improve the situation and eliminate low quality journals and better serve national health development. Based on the discussion, it was suggested that what is needed is to have a framework for different kinds of research and where they are likely to be published-this is critical for the WHR 2004. It is not sufficient that caveats and limitations are mentioned and then the assumption made that it is taken care of-the issue must be addressed or else the flawed analysis becomes the “truth” 5 years down the road. A key question is how do we enlarge the net to make this exercise more meaningful? 9. Are we measuring what we could instead of what we should? Are we looking at where the light is and not what the real problems are? 10. Target audience of WHR 2004 : The Report should acknowledge that science is understood differently by different sectors of society-the least important audience is the scientist and the Report should primarily target national politicians and the 8 press/media. It is also likely that the Report will find different uses by different people. 11. Emphasize the value of international collaboration : Equitable and effective scientific collaboration should be the next model for North-South collaboration, beyond just collection of specimens. Such collaboration is as an excellent way to raise the level of science in the developing world (e.g. the high impact factor of scientific papers from Chile is due to the fact that 67% of the research was done in collaboration with other countries) 12. The need to better analyse the 10/90 gap : Although much has been said about the fact that less than 10% of the funding for global R&D goes to studying more than 90% of the world’s health problems, what does this actually mean?. • Many governments in developing countries (e.g. Tanzania) do contribute significantly to health research but with collaborative external grants it is not known how much actually goes to the country. This figure may, in fact, be very low (around 10%) and this issue should be addressed in the Report. • R&D done by the private sector is another difficult area-there is a feeling that the current estimate of around $30 billion is too low and that the real figure may be closer to $60-70 billion annually. More emphasis and analysis is needed on the major, developed country sources of global health R&D. 13. Issues that should be covered in the Report : Discussants indicated areas and topics related to health research which should be covered and mentioned (not listed in order of priority) : • The universality of research and its role in development • Capacity building in health research • Current frontiers in medicine in different fields • Importance of research for public health-often not mentioned in developing countries • Limitations and risk of science • Barriers to doing research in developing countries : career structures for health researchers-inequity exists within countries, brain drain; the need for research managers and connectors to link knowledge to health gains • Factors in diffusion of innovations-why is it that some basic medical innovations which is part of normal life (e.g. insulin for diabetes, drugs to control high blood pressure, bypass surgery) is not available in many regions of the world? Could a map/illustration be developed to show this? • Gap between health research and health systems (e.g. implementation of DOTS for TB) • Avoid an overemphasis on communicable diseases as 60% of disease burden in the developing world in the near future will be due to non-communicable diseases. Research should not be restricted to Third World diseases only-common problems should be shared and science should form a continuous network to 9 provide public goods and the commonness of scientists, diseases and approaches should be shared by all. Others, however, felt that infectious diseases should still be a major priority and more investments are needed. • Some health research has economic gain (through development of products) as one of its objectives Dr Christopher Murray, Executive Director of the EIP cluster, responded to the various discussion points by stating that the emphasis on the health research system as a whole requires some efforts at identifying which systems produces more outputs than others and that numbers/quantities are important. The work related to the WHR 2004 must capture all the problems, especially the research to policy link. Despite its well- known limitations, the citation counts concept is attractive and the problems associated with its use can be overcome. There is a need to capture output and to tackle the limitations in trying to do so. Also, the failure to take up technology is not just the fault of the health research system and researchers but may be linked to other problems of access, human resources, financial incentives, etc. The Chair summed up the discussion and suggested that a decision be made soon on the options discussed for presentation of the Report. Was it to be largely quantitative or qualitative or perhaps a hybrid format?. He emphasized that the value of the Report was not so much in the form of information but in providing a tool for countries to use to assess their own health research systems. The test methodology must be explained and , examples shown where it has been rigorously tested and the information shared. Finally, he suggested that the ACHR Sub-Committee on WHR 2004 be consulted more closely as the Report takes shape. Update on World Health Research Summit (Agenda Item 10) An update was provided by Dr Tikki Pang on the Ministerial Summit for Health Research scheduled to take place in Mexico City from November 22-26, 2004 in conjunction with Forum 8 of the Global Forum for Health Research. A short background to the Summit was provided followed by an update on the planning process, a possible Summit Theme (Knowledge gaps in achieving Millennium Development Goals), programme outline and Summit objectives. A Summit Advisory Committee has been convened to assist in the organization of the Summit. Mental Health Research (Agenda Item 11) Dr Benedetto Saraceno (Director, MSD/NMH) provided some background information on the need to promote research in mental health and identify research gaps. Limited research on mental health is being conducted in developing counties, funding is limited and the subject of the research does not address population needs as it has been focused mainly on drug-related research. Research is needed to inform governments about policy and should be science-driven. A 10-year global action programme will place research as a vital component of mental health policy in developing countries. 10 Dr Shekhar Saxena (MSD/NMH) then gave a presentation on mental health research in low- and middle-income countries, describing the results of a review of published research in mental health through an analysis of databases (e.g.MEDLINE, EMBASE PSYCHIATRY) for the period 2000-2001. Research outputs from countries were analysed according to country of origin, income groups, type of articles, and primary research themes. The main results of the analysis are as follows : • Only 3% of all research is on low & middle-income countries • 20 low & middle income countries account for 3/4 of literature and 43 countries produce no publications • Most research on India, South Africa, Brazil, Russia & China • 72% research is from local researchers • 63% of publications describe original research • Common themes of research: assessment/questionnaires, mental disorders/conditions, and epidemiology • Services, intervention and policy research inadequate • Limitation- review limited to indexed journals Dr Saxena also described the Research for Change initiative which aims to identify the role of research in developing countries for reducing the burden of mental disorders, discuss the research needs of developing countries in mental health/substance abuse fields, establish a relevant priority agenda, and formulate strategies to facilitate implementation of priority agenda, including scientific/technical/financial support mechanisms. A Global Fellowship project has also been started for training purposes. A donors meeting in Geneva is planned for December, 2003 as well as a meeting of editors of leading international and national journals. The discussion following the presentation highlighted the following issues : • There is a need to create a demand for more research in mental health, with a focus on experiences for the community rather than medically-based treatment aspects • It would be helpful to analyse the role of collaborations between institutions in mental health research • Urban and rural mental health problems may be quite different and rural problems are often neglected • A road map for mental health research is needed to identify other problems, e.g. road rage, suicide-how do we tackle these new problems? • The analysis of publications should also be done through an equity lens, e.g. taking into consideration economic criteria, gender criteria, men/women, poorer/indigenous groups. • Social science research may not have been included in the analysis-research in poorer communities may be more in the social science sphere before it gets picked up by the mental health community. 11 • The analysis must look beyond available databases with all its well-known limitations, i.e. regional databases (e.g. Lilacs/SciELO in Latin America) should also be analysed.. Report from ACHR Sub-Committees (Agenda Item 12) 12.1 World Health Report 2004 This item was covered separately under agenda item 9 (see above) 12.2 WHO Research Database Sub-Committee Andrew Kennedy presented an update on the development of a WHO database of research activities. A survey of 24 technical departments in WHO was carried out and responses were received from all but 4 departments. This enabled an assessment of the number of projects commissioned by various departments, with TDR (Tropical Disease Research), RHR/HRP (Human Reproductive Health Research), and VAB (Vaccines & Biologicals) having the most number of research projects. However, the comparability of the information was limited as different methods of defining what is a “project” is used by different departments. Some smaller departments keep little data on projects. Larger departments like TDR and RHR/HRP have data management system. RPC’s proposal to set up a WHO-wide database has been strongly supported. A draft core data set has been proposed which covers approval, processes, funding, collaboration, research description and outputs. There was, however, some concern about duplication and the importation of data. Comments made during the discussion session : • Although some progress has been made, a comprehensive picture of research in WHO is still not available. This is paradoxical as the organization expects countries to provide data yet in-house data is often not available or not shared willingly. The provision of such data should be made mandatory. • A complete and comprehensive database on WHO’s research activity is important for informing the WHR 2004 on the importance of research. Is this still feasible given the time constraints?. Such a database will also be of value for peer review purposes, to ensure quality, and to assess the cost effectiveness of research supported by the organization. 12.3 Ethics Sub-Committee Dr Abha Saxena (RPC/EIP) gave a presentation on SCRIHS (Secretariat Committee on Research Involving Human Subjects) which was transferred to RPC recently. The function of the Committee is to assess the ethical aspects of research projects supported by WHO which involves human subjects. The topics covered included composition of the committee, role of the secretariat, number of proposals 12 received, types of review, standard operating procedures, databases and capacity building/educational activities. Comments made during the discussion session : • Members of ACHR were pleased at the progress made with SCRIHS in a short time and wished to reiterate their belief that WHO should take a leadership role in this area. It was a suggested that a World Health Assembly resolution be developed and tabled on the issue of research ethics. • Further development of concrete activities should be done in the context of ETH (Ethics in Health) unit activities and other guidelines used by WHO departments (e.g. TDR, HRP). • SCRIHS membership must include laypersons and representatives from civic society. • There is also an opportunity to create linkages between ethics review committees, e,g, for multi-centre projects. This will help to set up dialogue and bring common problems to the fore. In turn, it will lead to capacity development and enhance links to other international activities. • In the broader context of human subjects research being the focus of SRIHS, we need to take into consideration the needs of 3 major sectors : women, disadvantaged groups and disability groups. • There is also an opportunity to look at regional activities (e.g. FERCAP, PABIN), special issues such as stem cells, and to analyse how national bodies review the ethics of research proposals, Can a database be created for learning purposes. • Overall capacity development in countries in ethical review is also important. • A suggestion was made that the SCRIHS database of proposals can be linked to the WHO research database (see agenda item 12.2) 12.4 Peer Review Sub-Committee Valery Abramov (RPC/EIP) presented an update on peer-review within WHO. The process is well-established in EMRO, PAHO, SEARO and WPRO. In WHO HQ the situation is less clear. Although major research programmes like TDR and HRP have excellent peer-review processes in place, there is no official document defining what constitutes a peer review process. TDR and HRP identifies peer review as an underlying value and have established scientific committees and scientific review groups with independent, external members who must declare any conflict of interest. WHO Collaborating Centres are also used to assist in the process. The following points were made during the discussion : • There is a need to recognize the fundamental importance of peer review in the design, commissioning and funding of research, and in evaluation and refinement of research outputs. A general policy is needed for the whole organization. • All parts of WHO should commit to use peer review for research inputs and outputs. • The documents and procedures used by EMRO should be circulated to all WHO regions as an example of a good peer review process. 13 • A working group should be convened involving TDR and HRP as the major research programmes to come up with suggestions for peer-review procedures. • All research projects sponsored by WHO should be allocated a unique identifier in order to monitor adherence to peer and ethical review and to enable linkage to the planned WHO research database (see agenda item 12.2). Meeting with the Director General (ACHR members only) The following topics were discussed with the Director-General : 1. WHR2004 2. Ethics in health research 3. WHO research database 4. Peer review 5. Reactions to Genomics Report 6. Mental health research 7. Past and future role of the ACHR In a meeting prior to the dialogue with Dr Brundtland, the following points were raised ACHR members : 1. WHR 2004 : Although the preparations for the WHR 2004 appears to be progressing well, it is important that it be ratified by new Director-General. It must also be his Report and an effort must be made to see him, provide him with options, include items which may interest him, and ask for his advice, i.e. get him to become a stakeholder. The timelines planned for the Report should remain if at all possible and the ACHR should meet in March, 2004 in order to have another opportunity for further inputs. Some members also felt that the Report should have a positive tone, avoid negativity and comparisons, and use vignettes to highlight success stories and achievements. It should be an exciting, forward looking document and be an advocacy piece to policy makers; its impact is potentially great. 2. Ethics in health : There has been good progress in this area with the activities of SCRIHS being based in RPC and the active role played by the Ethics in Health Unit. Capacity building activities are particularly important and the ACHR should be proud that it had played a role in stimulating these developments. 3. WHO research database : Some progress has been made but this is insufficient. In- house information on research activities must be available in the form of a good database, and a cohesive picture needs to be developed. 4. Peer review : there has been little progress in this area although it is considered essential. Some parts of the organization (e.g. EMRO, TDR, HRP) have good peer– review mechanisms in place but, in overall terms, the system is fragmented and there is need for an organization-wide policy on the matter. 14 5. Genomics : The Genomics and World Health Report is a concrete product of ACHR and the Committee had some influence on its contents. The lead writer, Professor Sir David Weatherall has also been playing an important role in advocating for the Report and it is being disseminated at the highest levels in the scientific community. 6. Mental health research : what has been the impact of the World Health Report in 2001 on Mental Health in the various priority areas? 7. Past and future role of ACHR : It would be of interest to get Dr Brundtland’s reflections on the past contributions of ACHR and also her thoughts on how the committee can contribute in the future. In her response following the presentation of the above topics, the Director General made the following remarks : 1. On WHR 2004 and the planned Mexico Summit : She was pleased at the progress in preparing for the WHR 2004 and the Mexico Summit on health research. In this regard, she agreed that it was a good idea to choose an earlier date for the ACHR meeting in 2004. There was also some confusion on the definition of research and a need to broaden the definition, especially as it relates to WHO’s work-it needs to be more inclusive. The WHR 2004 is an opportunity to clarify matters. 2. On ethics : the Ethics in Health (ETH) unit was making good progress in its work and is focusing on internal activities related to ethics and bringing together the various interested parties through an Ethics Council. She felt that it was necessary for WHO to take a leadership role and draw on its own knowledge base, as well as working more closely with member states to see what can be done. She also mentioned that Spain had raised a question about the ethics of organ transplantation. WHO will host a meeting on this topic and a document will be prepared for the next meeting of the Executive Board. 3. On peer review : This has been discussed at Cabinet and, although it is used in some parts of WHO, other areas are not aware of the need. ACHR can make suggestions for policy on this issue. 4. On the Genomics & World Health Report : The Director General mentioned that the lack of extensive discussion during the Executive Board was probably related to the fact that the USA had stated that they were not ready to pass the resolution and wanted to amend the text. As a result, many countries held back their interventions. However, she expected vigorous discussion at the 113 th session of the EB in January, 2004. During the Lunch with the Director General (ACHR members only), three topics were discussed : 15 1. Public trust in science and medicine-different perspectives 2. WHO and the SARS epidemic 3. Reflections of the Director General on global health and the Organization. Matters referred to by Regional ACHR’s (Agenda Item 13) 13.1 AFRO No report was presented from AFRO 13.2 AMRO/PAHO (Presented by Professor Jorge Allende) The PAHO ACHR has not met in 2003 as the meeting has been postponed to November, 2003 due to the appointment of a new Regional Director. However, the Committee remains active with the launch of a joint initiative between PAHO and ICGEB in Trieste, Italy for funding research in the molecular biology of viral diseases. This area was identified by the PAHO ACHR as a follow up to the Genomics & World Health Report and emphasizes the formation of networks and granting of short-term training fellowships. ICGEB has expressed interest to initiate the same type of activities with other regions whose countries are members of ICGEB. 13.3. EMRO (Presented by Profesoor Atta-ur-Rahman) The EMRO ACHR met on 27-29 August, 2002 after 4 years of inactivity. Several activities have been carried out in the past year : regional office support for field research, human resource development, ethics in health research, development of research policy and advice, international collaboration & networking, and defining plans for 2003. Peer review was done on 271 research proposals, with 37 proposals approved (total of about $300,000) 13.4 EURO (Presented by Dr Yves Charpak) EURO is currently not involved in research as this was done at the national level by EC countries and former countries of the Soviet Union level. In addition, the Council of Europe deals with issues of ethics and WHO sits as an observer. ACHR exists in EURO with a mandate to focus on specific tasks linked to EURO priorities. It is hoped that the EURO ACHR will help define what kind of evidence is needed in public health and how to implement action plans and strategies. Some ideas are being developed on the type of evidence which is needed, expanding the definition of evidence and articulating the context of implementation. The ACHR is also working on other specific issues, e.g. language in evidence (translation problems, e.g. “stewardship”), format for evidence (English native speakers vs international English speakers), development of evidence for recommendations, identifying situations where evidence was used and had an impact, how it enters the process of decision making, and a review of the use of evidence by technical units in EURO. 16 13.5 SEARO (Presented by Professor Nirmal Ganguly) SEARO ACHR has reviewed the implementation of its research strategy and considered inputs from countries on their efforts to strengthen national capability in health research. SEARO has organized training course in health research management and has collaborated with other organizations such as INCLEN (International Clinical Epidemiology Network) and FERCAP (Forum for Ethical Review Committees in the Asia-Pacific). With the latter, an audit of problems in ethical issues related to health research is being carried out. Another important development is the formation of the Asia Pacific Health Research Forum, involving countries from both SEARO and WPRO. It was also mentioned that the distribution of WHO collaborating centres in SEARO is uneven and this needs to be corrected, e.g. Bangladesh has only two centres, Indonesia has three and Sri Lanka only one. Good progress has been made in several areas of research including cardiovascular diseases, thallasaemia, nutrition, arsenic contamination of water, health impact and environmental health risk assessment. Several SEARO countries have also been active in research : 1. Bangladesh : Bangladesh Medical Research Council has funded projects and students. 2. Bhutan : mental health, EPI, and reproductive health surveys. 3. DPR Korea : postgraduate medical education. 4. India : databases for health research system, e.g. cancer registry, ethics documents on specific issues and disease burden estimate for major diseases. 5. Indonesia : economic analysis, policy analysis, health system performance, ethics. 6. Myanmar : iodine intake among schoolchildren. 7. Nepal : TRIPS and IPR issues, ethics guidelines, journal, book on research methodology. 8. Sri Lanka : Study with the Alliance for Health Policy and Systems research on shifts in health sector policies. 13.6 WPRO (Presented by Professor Terry Dwyer) WPRO currently has no resources allocated for supporting research projects. However, the WPRO ACHR has developed a regional framework for health research focusing on basic principles. In particular, the framework emphasizes that training should be done in developing countries. The objective of the framework is to help developing countries in the region through WHO Country Representatives who will be asked to recommend to countries to establish national health research committees. The New Zealand Health Research Council and the Pacific Health Research Council will assist selected islands in the Pacific to establish national committees. Cambodia will also be establishing a national health research council. Closer interactions between WHO collaborating centres involved in research will also be encouraged and promoted. WPRO ACHR is prepared to help in the preparation of the WHR 2004 with regards to data collection. 17 13.7 Report from Regional ACHR’s and Counterparts meeting (Dr Adik Wibowo) Dr Wibowo presented a report from the meeting between regional ACHR Chairs and RPC counterparts held on June 11, 2003 and chaired by Professor Atta-ur Rahman. The following issues were discussed at the meeting : 1. Mechanisms for inter-regional collaboration. 2. Access and exchange of databases. 3. Establishing networks. 4. Assessment on quality of research. 5. Recommendations to global ACHR. The meeting was also informed that an EMRO-SEARO Bi-regional meeting will be held in the Maldives from Aug 12-14, 2003, 2003. Programme of work in the coming year (Agenda itema 14 and 16) 14.1 Reviewing WHO’s scientific outputs-a role for ACHR? Dr David Challoner (Foreign Secretary, Institute of Medicine, USA) gave a presentation on the process for review of reports at the US National Academy of Sciences (NAS). He addressed the following topics : purpose of report review, unique feature of the NAS process, facts about the review process, approximate costs, primary criteria for review, number of reports reviewed, and notable recent publications. He posed four questions for ACHR to consider : 1. who is asking the question?: 2. who owns the report and who signs off?; 3. who can speak unpleasant truths to power?; 4. how is the study committee chosen?; 5. how would reviewers be chosen and would they be anonymous?. Dr Tessa Tan-Torres (GPE/EIP) briefed the meeting on the process for guiding the development of guidelines within WHO. This has been completed and implemented but there was variable compliance in-house to adhering to these guidelines. The challenge is how to get people to follow the process. Also, these guidelines do not cover other documents, e.g. Expert Committee and Study Group reports, which should perhaps be subjected to the same standards. In the ensuing discussion on this issue, the following points were made : 1. There is a definite need for independent review and to institutionalise assurance of the quality of scientific documents produced by the organization as industry and governments are paying more and more attention to WHO’s recommendations. The guidelines on guidelines is a voluntary process but it there is no requirement to adhere-should a more active process be adopted and can ACHR play a role?. 18 2. Concomitantly, there is also a need to develop a better, more transparent process for choosing members of expert advisory panels from which expert committees are drawn. The same applies to selecting members of scientific groups, study groups and other “expert” groups. Clear criteria for selection should be developed and posted for all to see. In the past, members have been selected who are not in the mainstream of science. Can the ACHR play a role in ensuring scientific quality of WHO documents?. It was generally felt that this was a complex and difficult area and, for practical reasons, the ACHR can not play this role as it has a mostly advisory function. It was felt that this was mostly a Secretariat function and that ACHR’s role would be to comment/advise on possible mechanisms for review and on the balance between scientific robustness and need for expediency. As the committee met only once a year, direct involvement in a routine manner would be impractical. 14.2 Ethics and Health Unit Alex Capron (Director, ETH) provided background information on the Ethics and Health Unit which began functioning in October, 2002. The following were highlighted : 1. Ethics activities are already ongoing in different parts of WHO, including that of SCRIHS (Secretariat Committee for Research Involving Human Subjects which is based in RPC (see agenda item 12.3) and in technical units such as TDR, HRP and VAB. 2. Regular monthly meetings (Ethics Council) are held of interested persons to discuss topics of interest , to reach out, to coordinate, to draw on expertise, and for others to raise issues and discuss topics of general interest. 3. Close cooperation with the Strategy Unit on issues related to globalization and human rights. 4. Ethics focal points have been identified in regional offices and they are currently cataloguing activities in the area of research ethics. 5. ETH acts as the secretariat for the Global Bioethics Commission and links regularly with other UN organizations, e.g. UNESCO, UN Interagency Committee on Bioethics 6. Major areas of interest for ETH : . 1. Ethical aspects of equity in health systems; 2. Genomics and world health-ethical aspects; 3. Biotechnology and other general topics, e.g. organ and tissue transplantation; 4. Implications of stem cell research for health systems and health care; 5. Human subjects research-support for SCRIHS, educational seminars for WHO staff, capacity building activities in countries; 6. Development of intercultural issues, e.g. issues arising when researchers do not come from the same community (design of surveys and research ethics may need adjustment). 7. A longer term aim is for WHO to develop guidelines for research with member state participation and perhaps play an accreditation role for national ethical review committees. 19 The following issues were raised during the discussion : 1. Thought should be given to a more normative role of WHO, i.e. development of universal guidelines for health research and an ombudsman function 2. A network should be created between developing countries and WHO ethics support units-how can ACHR help? 3. There is a need to recognize what is already is going on, especially in capacity strengthening efforts where there are many activities which do not necessarily involve WHO regional office focal points. European Commission and Health Research (Agenda Item 15) Dr Kevin McCarthy (European Commission, Brussels) gave a presentation on the EC’s Sixth Framework Programme (2002-2006). He highlighted the ERA (European Research Area) and the objectives of the Sixth Framework Programme and the place of health within this programme. Priority areas included life sciences, genomics and biotechnology for health and policy-oriented research in various areas of health. He also mentioned the recently launched European & Developing Countries Clinical Trials Partnership (EDCTP) whuch focuses on HIV/AIDS, TB and malaria. Date & place of next meeting (Agenda item 17) It was suggested that the 42 nd session of the ACHR be held earlier in 2004 due to the World Health Report. The suggested dates were the last week of March, or the first two weeks of April, 2004 in Geneva. ANNEXES TO BE ADDED Annex 1 List of participants Annex 2 Agenda of meeting Annex 3 EB discussion on Genomics & World Health Report Annex 4 Bioinformatics proposal from Professor Gordon Dougan 20