1 Principles and Practices: The implementation of ethical guidelines for research on HIV Introduction and brief update on the evidence Carla Makhlouf Obermeyer June 2, 03

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

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

4 Goals of the workshop 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 4 related goals:

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

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

7 How do guidelines work in practice? A summary of the evidence 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 Recognize that contexts impinge on research and on ethics, and that scientific and ethical goals may conflict 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 3. Mutual misunderstandings

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

10 We know something about: We know less about How do guidelines work in practice? 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 In sum: The agenda of this workshop Principles, sources, formal requirements Review processes, IRBs Where field conditions influence implementation: comprehension, individual consent

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