Carla Makhlouf Obermeyer June 2, 03

1. Principles and Practices:The implementation of ethical guidelinesfor research on HIVIntroductionand brief update on the evidence Carla Makhlouf ObermeyerJune 2, 03

2. Outline of presentation Background to the workshop A brief summary of the evidence Review of the agenda

3. Background to the workshop Two observations: Controversies surrounding research Universalists vs relativists Concern over the future of research Polarization of the debates Need to bridge the gap Should ethics be left to ethicists? Oversimplification of Others Critiques of Western bioethics; charge of“ethical imperialism” Debates insufficiently informed by field evidence Need for perspectives from different settings

4. Goals of the workshop 4 related goals: 1. Bring views and experiences from diverse settings 2. Find a middle ground between extreme ethical positions 3. Show concrete examples of how ethical dilemmas are addressed in real situations 4. Explore avenues for further work

5. The implementation of guidelines Getting perspectives from the field Diffusion and feedback Reinterpretation and change Global/local connections Getting insights from those involved in the process: how do guidelines work in practice? Listening to voices from the field “User perspectives” A multi-layered approach: The adaptation of principles Institutions and communities Local views

6. Basic information does not get across Language, readability, complexity Difficulties of finding local equivalents: “positive” results, “passing the test,” random assignment, double blind, confidentiality How do guidelines work in practice? A summary of the evidence -1 Examining real situations shows: 1. Inadequate comprehension Take care of translation--and more

7. How do guidelines work in practice? A summary of the evidence - 2 2. Lack of correspondence The meaning of taking blood Seropositivity: “I don’t have the virus though it lives inside of me,” soul vs. flesh Disclosure not a yes/no event: concealment, hinting, retracting, admitting, believing Reasons for taking a test; the different meanings of testing Acknowledge limitations of categories

8. How do guidelines work in practice? A summary of the evidence - 3 3. Mutual misunderstandings Confidentiality: the influence of class and gender; secrecy and isolation Local competition for incentives Rumors and expectations Benefits from research, imagined an real Does counselling help? Testing, disclosure, and risks: The power of trust Recognize that contexts impinge on research and on ethics, and that scientific and ethical goals may conflict

9. How do guidelines work in practice? Some notions to critically examine The individual Autonomous, free agent vs. socially embedded actor, constraints Abstract principles vs personal values The community Study populations, “communities” and nations The community is not homogenous Clarify assumptions, correct expectations Work on two levels: build consensus and build capacity

10. How do guidelines work in practice? In sum: Principles, sources, formal requirements Review processes, IRBs Where field conditions influence implementation: comprehension, individual consent We know something about: We know less about • How principles are adapted in different settings • How guidelines on consent and care are actually developed and applied • Working with communities: who are representatives, how they are selected, how the process operates; the role of governments/ other political entities • Improving communication, facilitating implementation: what works and does not work The agenda of this workshop

11. Agenda of workshop General issues: adaptation of principles Theme 1 informed consent Theme 2 standards of care The experience of institutions in different settings Working groups Report