Informed recruitment in partner studies of HIV transmission: an ethical issue in couples research

BACKGROUND: Much attention has been devoted to ethical issues related to randomized controlled trials for HIV treatment and prevention. However, there has been less 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 from sex partners of injection drug users (IDUs) tested for HIV, within a recent HIV study in Eastern Europe. The study aimed to assess the amount 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. DISCUSSION: This paper focuses on the ethical dilemma regarding informed recruitment: whether researchers should disclose to sexual partners of IDUs that they were recruited because their partner injects drugs (i.e., their heightened risk for HIV). Disclosing risks to partners upholds the ethical value of respect for persons through informed consent. However, disclosure compromises the IDU's confidentiality, and potentially, the scientific validity of the research. Following a brief literature review, we summarize the researchers' systematic evaluation of this issue from ethical, scientific, and logistical perspectives. While the cultural context may be somewhat unique to Eastern Europe and Central Asia, the issues raised and solutions proposed here inform epidemiological research designs and their underlying ethical tensions. SUMMARY: We present ethical arguments in favor of disclosure, discuss how 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.