Principles and Practices: The Implementation of Ethical Guidelines for Research on HIV

1. Principles and Practices: The Implementation of Ethical Guidelines for Research on HIV 2-3 June 2003 FCH/HIV/SRM World Health Organization Geneva WICRAM: Exploring Means to Adapt Research to Communities Alexander Morgan Capron Director, Ethics and Health, WHO Ethics and Health, Director-General’s Office, World Health Organization

2. WICRAM: WHO Inter-Cultural Research Assessment Materials • A project being developed by the Ethics and Health unit at WHO (DGO/ETH), principally by Nikola Biller-Andorno, M.D., Ph.D., and myself • Involves Tropical Disease Research programme, especially Dr. Johannes Sommerfeld (CDS/TDR/STR) • Principal contract now with Prof. Patricia Marshall Ethics and Health, Director-General’s Office, World Health Organization

3. Purpose Facilitate biomedical researchers’ planning of ethically sound and contextually appropriate studies, with particular attention to the preconditions for informed consent Ethics and Health, Director-General’s Office, World Health Organization

4. The Need for “Pre-Research” • Attention of ethicists has been directed toward the development of standards and debate over their rationales (and deficiencies) • For example, requirement of informed, voluntary consent has existed since Nuremberg, yet is often not met in practice--as every experience researcher knows • For example, Guideline 5 in latest version of CIOMS rules gives 26 topics that would constitute “full disclosure” • Particular problems when researchers and subjects view matters through different cultural “lenses” Ethics and Health, Director-General’s Office, World Health Organization

5. Issues that Need Illumination • What is the local understanding of “research” and the role of researchers • vis a vis standard or traditional medical practitioners? • vis a vis governmental programs (benign and coercive)? • What do potential subjects think about the disease being treated? • What do potential subjects think about “truth telling”? • What do potential subjects think about the “consent process” (who gives what permission for what to happen to whom--and why)? Ethics and Health, Director-General’s Office, World Health Organization

6. Three Phases of WICRAM Project 1-A. Prof. Marshall is conducting a comprehensive review of the theoretical and empirical explorations of ethical issues in research design and informed consent in resource-poor settings, which should illuminate the special factors that researchers should consider --will include “case vignettes” from culturally diverse settings B. She will develop an interview guide, which will be used with researchers experienced in countries such as Haiti, Brazil, China, Kenya, Mali, Thailand & Uganda Ethics and Health, Director-General’s Office, World Health Organization

7. CASE VIGNETTES • Examples of social/structural factors influencing research designs and application of consent in culturally diverse resource poor settings throughout the world. • Cases will include how investigators resolved issues and concerns. • Special attention will be given to TDR diseases. Ethics and Health, Director-General’s Office, World Health Organization

8. Three Phases of WICRAM Project C. The project will develop an Assessment Framework for Research Design and Informed Consent in Resource Poor Settings which will outline the relevant domains for investigators to consider in preparing study designs and planning effective strategies for obtaining informed consent D. Specific questions relevant to each dimension will be identified, in the form of a Assessment Guide (for example, for “focus groups” in the community) Ethics and Health, Director-General’s Office, World Health Organization

9. ASSESSMENT FRAMEWORK: DOMAINS Relevant domains to consider include: • Establishing collaborative partnerships • Community advisory board/data monitoring board • Review of research protocols by IRBs or ERCs • Historical factors relevant to exploitation. • Beliefs about autonomy, community consultation, decisional authority • Language and literacy • Applications of standard of care • Beliefs about disease etiology, implications for risk Ethics and Health, Director-General’s Office, World Health Organization

10. ASSESSMENT GUIDES • Assessment Guides: instruments that enable investigators to quickly assess the influence of specific issues related to study design and informed consent (e.g., beliefs about decisional authority). • Several interview guides will be developed for this report. If possible, pre-tested in limited settings. Ethics and Health, Director-General’s Office, World Health Organization

11. Three Phases of WICRAM Project 2. Based on this report, the next stage will be the full development and preliminary testing of the Assessment Framework and Assessment Guides -- Framework and Guides will be explored through workshops with researchers from developing countries 3. After further refinement, field testing will occur followed by revisions BIG ISSUE: will ONE guide suffice in all, diverse settings? Ethics and Health, Director-General’s Office, World Health Organization

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