Funding Source: HIV Center Pilot Studies Program; 2009-2010

Principal Investigator:
Robert L. Klitzman, M.D.

Co-Investigator:

Lisa Chin, J.D., Ed.D.

Project Overview
(from abstract):

Obtaining informed consent prior to research participation is the cornerstone of ethical conduct in human subject research. Participants' failure to understand informed consent information and/or properly apprise risks and benefits associated with research participation are threats to ethically valid informed consent. There has been little research examining the understanding of informed consent information among US-based HIV/AIDS vaccine trial participants and the extent trial participants experience therapeutic misconception associated with trial participation, and if trial participants' motivations for participation impact their level of therapeutic misconception.

The purpose of this proposed study is to examine a group of US-based HIV/AIDS vaccine trial participants' understanding of the informed consent information, therapeutic misconception of trial participation, and their motivations for participating in an HIV
vaccine trial. The study sample will be participants of HIV/AIDS vaccine trials sponsored by the HIV Vaccine Trials Network and conducted at Columbia University Medical Center and New York Blood Center.

We are conducting 40 qualitative interviews with vaccine trial participants. This data will be used to refine a quantitative instrument we will use to survey vaccine trials participants' understanding of informed consent information, therapeutic
rnisconception, a nd their motivation for research participation. This work may identify problems with the informed consent process conceming HIV vaccine trial participation that need to be addressed.