Ethics and Health, Director-General’s Office, World Health Organization

Principles and Practices: The ImplementationPrinciples and Practices: The Implementationof Ethical Guidelines for Research on HIVof Ethical Guidelines for Research on HIV2-3 June 20032-3 June 2003FCH/HIV/SRMFCH/HIV/SRMWorld Health OrganizationWorld Health OrganizationGenevaGeneva

WICRAM: Exploring Means toWICRAM: Exploring Means toAdapt Research to CommunitiesAdapt Research to Communities

Alexander Morgan CapronAlexander Morgan CapronDirector, Ethics and Health, WHODirector, Ethics and Health, WHO

Ethics and Health, Director-General’s Office, World Health Organization

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

Purpose

Facilitate biomedical researchers’ Facilitate biomedical researchers’ planning of ethically sound and planning of ethically sound and contextually appropriate studies, contextually appropriate studies, with particular attention to the with particular attention to the preconditions for informed preconditions for informed consentconsent

Ethics and Health, Director-General’s Office, World Health Organization

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

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

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

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

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

ASSESSMENT FRAMEWORK: DOMAINS

Relevant domains to consider include: Establishing collaborative partnershipsCommunity advisory board/data monitoring boardReview of research protocols by IRBs or ERCsHistorical factors relevant to exploitation.Beliefs about autonomy, community consultation,

decisional authorityLanguage and literacyApplications of standard of careBeliefs about disease etiology, implications for risk

Ethics and Health, Director-General’s Office, World Health Organization

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

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

Ethics and Health, Director-General’s Office, World Health Organization