WHO operational handbook on tuberculosis Module 1: Prevention Tuberculosis preventive treatment Second edition Web Annex B. Conflict of interest assessment for experts contributing to the handbook content W H O com p anion hand b ook on tub erculosis M od ule 1: Prevention
WHO operational handbook on tuberculosis Module 1: Prevention Tuberculosis preventive treatment Second edition Web Annex B. Conflict of interest assessment for experts contributing to the handbook content © World Health Organization 2024. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence. Suggested citation. Web Annex B. Conflict of interest assessment for experts contributing to the handbook content. In: WHO operational handbook on tuberculosis. Module 1: prevention – tuberculosis preventive treatment, second edition. Geneva: World Health Organization; 2024. https://doi.org/10.2471/B09117 This publication forms part of the WHO document entitled WHO operational handbook on tuberculosis. Module 1: prevention – tuberculosis preventive treatment, second edition. It is being made publicly available for transparency purposes and information. WHO consolidated guidelines on tuberculosis. 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Conflict of interest assessment for experts contributing to the handbook content The Declaration of Interest forms submitted by the experts contributing to different sections of this handbook, as well as its review, were examined by WHO staff members Dennis Falzon and Avinash Kanchar. The reviews sought to assess whether there were, or might be, actual or perceived conflicts of interest, considering the different roles of the experts involved. This evaluation then made a decision on whether a management plan was required, following the guidelines for declaration of interests for WHO experts (2014) and the WHO handbook for guideline development (2nd edition) (1). Both financial and non-financial interests were considered. A “significant” conflict of interest would include: • “intellectual bias”, where an individual may have repeatedly and publicly taken a position on an issue under review, which may affect the individual’s objectivity and independence in the global policy development process; • involvement in research or publication of materials related to issues under review; and • a financial interest above US$ 5000. All experts contributed in their individual capacity and none were representing their agencies. (See the list of contributors, affiliations and countries in the Acknowledgments section of the second edition of the WHO operational handbook on tuberculosis. Module 1: prevention - tuberculosis preventive treatment.) The outcome of the review of potential conflict is summarized in Table WB.1. 2 WHO operational handbook on tuberculosis: tuberculosis preventive treatment, second edition Web Annex B. Conflict of interest assessment for experts contributing to the handbook content Table WB.1. Declarations of interests and conclusions Expert Interest declared Decision Peter Kerndt None declared No conflict of interest Sevim Ahmedov None declared No conflict of interest Anthony D. Harries None declared No conflict of interest Fernanda Dockhorn Costa None declared No conflict of interest Ethel Leonor Noia Maciel None declared No conflict of interest Tiemi Arakawa None declared No conflict of interest Luiz Henrique Arroyo None declared No conflict of interest Nicole Menezes de Souza None declared No conflict of interest Maria do Socorro Nantua Evangelista None declared No conflict of interest Daniele Gomes dell Orti None declared No conflict of interest Luiza Ohana Harada None declared No conflict of interest Gavin Churchyard Research support from Sanofi to his employer, Aurum Institute, as donated rifapentine and isoniazid for the WHIP3TB trial (valued at about US$ 350 000). He declared participation in a Sanofi advisory board on rifapentine for TPT, without travel support or payment. In addition, he reported a grant from USAID via KNCV/Challenge TB grant for the WHIP3TB trial (about US$ 14.2 million). He further reported a donation of rifapentine from Lupin Ltd to IMPAACT4TB studies (valued at US$ 300 000) and an honorarium from Janssen Pharmaceuticals for participating in an advisory board for developing long-acting injectable for bedaquiline (US$ 1100). Contribution was limited to a discussion on aspects of the handbook which did not conflict with the declared interests Anurag Bhargava None declared No conflict of interest Razia Fatima None declared No conflict of interest Daniele Maria Pelissari None declared No conflict of interest Ryo Miyakawa None declared No conflict of interest Web Annex B. Conflict of interest assessment for experts contributing to the handbook content 3 Expert Interest declared Decision Rada Savic Declared research funding from the AIDS Clinical Trial Group, Gates Foundation, Critical Path Institute, Global Alliance for TB Drug, Johns Hopkins University, NIH, NIAID, Otsuka, Rutgers University, SMART4TB, Stanford University, Stellenbosch University, UNITAID, UNITE4TB-Innovative Medicines initiative, USAID, CRDF, Emory University and WHO totalling over US$ 29 million in support of various TB research projects from 2019 up to 2028 No conflict with role of researcher contributing data Maureen Shin None declared No conflict of interest Belén Perez Solans None declared No conflict of interest Anneke C. Hesseling Support totalling about US$6 million over 7 years from US CDC, UNITAID, Wellcome, SA MRC, BMRC and DFID for two TB preventive treatment trials – TBTC Study 35 and TB CHAMP. Both of these trials contributed to the updates in the second edition of the WHO guidelines and operational handbook in 2024 No conflict with role of researcher contributing data Louvina van der Laan Sub-investigator on TBTC Study 35 and principal investigator on the PERFORM study (PK and acceptability of dispersible levofloxacin). Received support from US CDC and CDC Foundation, and UNITAID, for these studies. Member of the Technical Advisory Group on dosing of TB medicines No conflict with role of researcher contributing data Paolo Denti WHO support (ca. EUR 40,000) to employer – University of Cape Town – for work on weight-band harmonization. Other support from NIH, Wellcome and EDTCP for salary and student scholarships for other research on optimization of dosing of TB/HIV guidance No conflict with role of researcher contributing data Lufina Tsirizani Galileya None declared No conflict of interest Roeland Wasmann WHO support (ca. EUR 40,000) to employer – University of Cape Town – for work on weight-band harmonization. No conflict with role of researcher contributing data Rosanna Boyd Employment at US CDC No conflict of interest Makaita Gombe UNITAID support to her employer – Aurum Institute – for projects related to rifapentine-based TPT No conflict of interest 4 WHO operational handbook on tuberculosis: tuberculosis preventive treatment, second edition Web Annex B. Conflict of interest assessment for experts contributing to the handbook content Reference 1. WHO handbook for guideline development. Second edition. Geneva: World Health Organization; 2014. (https://www.who.int/publications/i/item/9789241548960).
Module 1: Prevention W H O op erational hand b ook on tub erculosis M od ule 1: Prevention For further information, please contact: Global Tuberculosis Programme World Health Organization 20, Avenue Appia CH-1211 Geneva 27 Switzerland Web site: www.who.int/tb