Ethical and regulatory considerations in HIV prevention studies employing respondent-driven sampling☆☆☆
Received 29 June 2007; received in revised form 28 November 2007; accepted 5 December 2007. published online 13 February 2008.
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.
☆ An earlier version of this paper was presented at the XV International AIDS conference, Bangkok, Thailand, 15 July 2004 and at the U.S. National HIV Prevention Conference, Atlanta, GA, 4 December 2007.
☆☆ The findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.
ABSTRACT