Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research Ethics in clinical research: challenges linked to the combination HIV prevention research agenda Raffaella Ravinetto, ITM Antwerp

Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research “In medical research, the well-being of the human subject takes precedence over the interests of science and society” The caregiver and the researcher are often the same person … Abuses have been often reported ….

Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research

Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research Borderline situations and ethical dilemmas are constantly faced in medical research…. Ethics: a group of moral principles, or a set of reasonable general values, that help direct us to the right (ethical) choice.

Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research Nuremberg Code, 1947 WMA Declaration of Helsinki, 1964 (last 2008) The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979) International Ethical Guidelines for Biomedical Research Involving Human Subjects of CIOMS (2002) Good Clinical Practices, Word Health Organization, 1995 Good Clinical Practices, International Conference of Harmonization, 1996

Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research - UNAIDS Guidance Document, Ethical considerations in HIV preventive vaccine research - UNAIDS Good participatory practices guidelines for biomedical HIV prevention trials - UNAIDS UNAIDS Good participatory practices guidelines for biomedical HIV prevention trials - Kenyan National Guidelines for research and development of HIV-AIDS Guidelines, 2005

Ethical challenges and dilemmas in HIV prevention Research

HIV prevalence and risk are often high in populations and/or in groups which are vulnerable: –to exploitation… –to stigmatization…. –to criminalization … Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research

An example of challenge in vulnerable individuals/groups: the informed consent –Alternative and lack of access to care? –Written consent and confidentiality? –Consent from couples? –Consent from communities? – Consent in undocumented migrants? Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research

What do Guidelines say? –“Research with disadvantaged or vulnerable groups is justified if responsive to their health needs, and if there is a reasonable likelihood that they will benefit from results” –“Interventions must be tested vs. the best current proven intervention, unless it does not exist or if placebo is necessary to determine the efficacy or safety of an intervention and there is not any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option” Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research

The scenario of HIV prevention research: –Multiple settings and countries –North-South gap in resources / access to care –Power inequalities research teams /communities –Quality of care in the study > general population –Post-trial access to subjects and community? – Fairness: where is the research carried out? Who benefit from the research itself? And from its results? Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research

The scenario of HIV prevention research: –Package of care/comparator –Best standard vs. best available standard –Who decides on “best available standard”? –Who decides on “best proven intervention”? – Fairness: where and how is the research carried out? Who benefit from its results? Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research

Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research Vulnerability Power unbalance How does this influence the way we design and conduct the research, and the way we use the results? Standard of care North-South gap Study participants General population Post-trial access North-South gap Informed consent Access to health care