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APHA Scientific Session and Event Listing

Recorded presentation

Patricia A. Marshall, Ph D¹, Lauretta E. Grau, Ph D², Merrill Singer, Ph D³, Greg Scott, Ph D⁴, and Robert Heimer, Ph D². (1) Center for Biomedical Ethics, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH 44106-4976, 216-368-2502, pam20@po.cwru.edu, (2) Department of Epidemiology and Public Health, Yale University, PO Box 208034, 60 College St., New Haven, CT 06520, (3) Hispanic Health Council, 175 Main St., Hartford, CT 06106, (4) Sociology Department, DePaul University, 990 W. Fullerton Ave., Rm. 1118, Chicago, IL 60614

BACKGROUND: A secondary study aim was to conduct a systematic investigation of the informed consent process.

METHODS: Approximately two weeks post-consent, 397 IDUs who were eligible for vaccination were asked about their understanding of the purpose of the study, potential risks and benefits of participation, the voluntary nature of participation, and motivations for participating in the study. Item content was independently coded by two researchers, and consensus on code assignments was achieved at periodic team meetings.

RESULTS: Most participants had positive attitudes about participating in the study. They reported being highly motivated to participate in studies that potentially benefit their health regardless of whether or not they received financial incentives for participation. The majority of participants also had excellent comprehension of study procedures, risks and benefits as outlined during the informed consent discussion at the screening visit. Most participants accurately reported that they were told participation in the study is voluntary. By contrast, understanding of the study purpose and the scientific questions to be addressed in the study were less well understood.

CONCLUSIONS: While the majority of participants were aware of study procedures, risks, and benefits, our findings raise questions about the level of comprehension necessary for participants to make informed choices regarding study participation. There is an urgent need for empirical research on informed consent in research with vulnerable populations such as IDUs. Simplified consent forms and educational interventions to improve comprehension of consent for studies with IDUs should be tested and evaluated.

Learning Objectives:

• Injection drugs users' perceptions about the informed consent discussion and attitudes concerning participation in public health research will be identified. Implications for improving the informed consent process will be discussed.

Keywords: Research Ethics, Injection Drug Users

Presenting author's disclosure statement:

Any relevant financial relationships? No

Recorded presentation