CO 015: ETHICAL CONSIDERATIONS IN DEVELOPING COUNTRIES IN HIV VACCINE TRIALS

J Pharm Pharmacogn Res 2(Suppl. 1): S8, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 015: ETHICAL CONSIDERATIONS IN DEVELOPING COUNTRIES IN HIV VACCINE TRIALS

Ellis G.

Strategies for Well-Being, LLC, Philadelphia, PA, USA. E-mail: glenn@glennellis.com

Abstract

Since no disease of global proportions has been eradicated or effectively controlled without a vaccine, implementing a successful AIDS vaccine program is critical. The effort poses not only scientific challenges, however, but also critical ethical issues.

At issue is the ethical principle of “beneficence,” the obligation to minimize possible harms and maximize possible benefits of medical intervention. Informed consent presents other ethical issues with trials in developing countries. In resource–poor areas, access to the medical care provided to trial participants can be seen as undue inducement to participate in a clinical trial.

Scientists may understandably also wish to minimize risk to study participants, and it has been shown that HIV can be prevented by reductions in high-risk behaviors. However, if this ethical imperative is followed and counseling and contraceptives provided, the study results could be jeopardized.

When a developed country enters a developing country to conduct a clinical trial, its actions are closely scrutinized because of the disparities that exist between the home nation of the researchers and the local trial population. If regulatory authorities and institutional review boards (IRBs) are not well developed in host countries, political and economic interests can influence which vaccines proceed in clinical trials.

This leads to the following question: if the ethical norms and standards of care differ between countries, whose rules prevail – those of the country which has developed the vaccine and is holding the clinical trial, or those of the host country?

This presentation will examine considerations to enhance and accelerate the development of an HIV vaccine in a manner sensitive to ethical concerns of subjects and their communities.