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Principles and Practices:The implementation of ethical guidelinesfor research on HIV

Introductionand brief update on the evidence

Carla Makhlouf ObermeyerJune 2, 03

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Background to the workshop

A brief summary of the evidence

Review of the agenda

Outline of presentation

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Controversies surrounding researchUniversalists vs relativistsConcern 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 OthersCritiques of Western bioethics; charge of“ethical imperialism”

Two observations:

Need to bridge the gap

Need for perspectives from different settings

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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:

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Diffusion and feedbackReinterpretation 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 principlesInstitutions and communitiesLocal views

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How do guidelines work in practice? A summary of the evidence -1

1. Inadequate comprehension

Take care of translation--and more

Basic information does not get acrossLanguage, readability, complexityDifficulties of finding local equivalents:“positive” results, “passing the test,” random assignment, double blind, confidentiality

Examining real situations shows:

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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

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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

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Autonomous, free agent vs. socially embedded actor, constraintsAbstract principles vs personal values

The individual

The community

How do guidelines work in practice?

Study populations, “communities” and nationsThe community is not homogenous

Some notions to critically examine

Clarify assumptions, correct expectationsWork on two levels: build consensus and build capacity

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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

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General issues: adaptation of principlesTheme 1 informed consentTheme 2 standards of careThe experience of institutions in different settingsWorking groupsReport

Agenda of workshop