Relative Versus Absolute Standards for Everyday Risk in Adolescent HIV Prevention Trials: Expanding the Debate

Abstract

The concept of minimal risk has been used to regulate and limit participation by adolescents in clinical trials. It can be understood as setting an absolute standard of what risks are considered minimal or it can be interpreted as relative to the actual risks faced by members of the host community for the trial. While commentators have almost universally opposed a relative interpretation of the environmental risks faced by potential adolescent trial participants, we argue that the ethical concerns against the relative standard may not be as convincing as these commentators believe. Our aim is to present the case for a relative standard of environmental risk in order to open a debate on this subject. We conclude by discussing how a relative standard of environmental risk could be defended in the specific case of an HIV vaccine trial among adolescents in South Africa.

Keywords:

• ethics committees
• human subjects research
• international/global health
• institutional review board (IRB)
• research ethics

Acknowledgments

The authors thank Stephanie Gatto for her research help in preparing this article.

Notes

As defined by the Canadian Paediatric Society (2003).

This ambiguity is present in other national research guidelines. The Canadian federal guidelines define minimal risks as “no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research” (Tri-Council 2005, 1.5).

Though, conceivably, a researcher could use considerations of cost to choose among two or more communities in which the research meets standards of scientific necessity and all other relevant ethical standards.

Adapted from proposed relative standard for multinational research in adults (Wendler, Emanuel, and Lie 2004).