Informed consent for recruitment into partner studies of HIV transmission: A case study

Much attention has been devoted to ethical issues related to randomized controlled trials for HIV treatment and prevention. However, there has been little discussion of ethical issues surrounding families involved in observational studies of HIV transmission. This paper describes the process of ethical deliberation about how best to obtain informed consent of sex partners of injection drug users (IDUs) tested for HIV, within a recent HIV study in Eastern Europe. The study objectives were to assess the rate of HIV serodiscordance among IDUs and their sexual partners, identify barriers to harm reduction, and explore ways to optimize intervention programs. Including IDUs, either HIV-positive or at high risk for HIV, and their sexual partners would help to gain a more complete understanding of barriers to and opportunities for intervention. The central ethical dilemma was whether investigators should disclose the IDU's HIV status to partners. Disclosing risks to partners upholds the ethical value of respect for persons through informed consent. However, disclosure compromises the IDU's confidentiality, and undermines the scientific validity of the research as informing partners may result in a selection bias. Formal guidelines provide little ethical direction on this issue. In fact, in much of the world, including some US states, it is illegal to disclose the HIV status of study participants. We present ethical arguments in favor of disclosure, discuss how the cultural context shapes the ethical issues, and recommend refinement of guidance for couples research of communicable diseases to assist investigators encountering these ethical issues in the future.