Www.ias2011.org Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research Ethics in clinical research: challenges linked

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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

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• “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 ….

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• 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.

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• 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

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- UNAIDS Guidance Document, 2000. Ethical considerations in HIV preventive vaccine research

- UNAIDS 2007. Good participatory practices guidelines for biomedical HIV prevention trials

- UNAIDS 2011. UNAIDS 2007. Good participatory practices guidelines for biomedical HIV prevention trials

- Kenyan National Guidelines for research and development of HIV-AIDS Guidelines, 2005

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Ethical challenges and dilemmas in HIV

prevention Research

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• HIV prevalence and risk are often high in populations and/or in groups which are vulnerable:

– to exploitation…

– to stigmatization….

– to criminalization …


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• 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?


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• 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”


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• 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?


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• 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?


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• 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

Documents

Www.ias2011.org Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research Ethics in clinical research: challenges linked