Ethical and regulatory considerations in HIV prevention studies employing respondent-driven sampling☆☆☆

Abstract 

Objective

To review the scientific, ethical, and regulatory literature because no official guidance exists on remuneration for participant-driven recruitment or on investigators’ responsibilities for informing participants of their discordant partnerships.

Methods

We reviewed the studies that used RDS to recruit injection-drug users (IDUs), 1995–2006, and the relevant scientific, ethical, and regulatory literature that shed light on arguments for and against practices that can be used in studies employing RDS.

Results

Concerns that payments can be used to buy drugs or can subvert altruistic motivations for study participation are not supported by the literature. Concerns about peers’ coercion to barter coupons or surrender payments are offset by safeguards used in RDS. Remuneration shows respect for participants’ time and effort in recruitment and judgment to use remuneration for personal needs. Tension between ensuring participants’ confidentiality and protecting the health of network members highlights difference in roles between investigators and health care providers. Investigators can choose to rely on public health agencies for partner notification services, ask participants if and how they would like to be informed of their discordant partnerships, and offer training on how to disclose HIV status and adopt risk-reduction and harm-reduction behaviours.

Conclusion

Clarifying ethical and regulatory considerations is important for research sponsors, institutional review boards (IRBs), ethics review committees (ERCs), investigators, and participants. We provide a checklist of ethics and regulatory variables to be included as feasible in future studies to enhance development of evidence-based ethics.

Keywords: Respondent-driven sampling, Injection-drug user, Ethics, HIV disclosure, Incentives, Sexual risk, Hidden populations, Men who have sex with men