Recruitment of homeless adults for HIV research: Ethical considerations encountered with the informed consent process

Ethical concerns exist around the informed consent process to recruit homeless individuals into social research, as this population is more likely to suffer from cognitive limitations when compared to the general population. To recruit homeless and transitionally housed adults for an assessment of HIV outreach services in Memphis, Tennessee, various methods of informed consent were explored. This paper reports the challenges encountered using a capacity-to-consent screener in the pilot study and describes the final informed consent protocol.

A three-item screening tool previously used to measure decisional capacity was adapted to assess participants' understanding of the purpose, risks and benefits of the study. Interviewers administered the screening tool with eight participants and scored responses using standardized probes (when necessary) to maximize scoring. Participants also were allowed to refer back to the informed consent documents for correct answers. The frequency of probes provided and referrals to consent forms were recorded. No signatures were required on the consent documents to protect participant anonymity.

The capacity-to-consent tool was highly complex for this population, as all eight participants had to either use a probe or refer back to the informed consent document to produce a score high enough to participate in the study. The consent forms were modified and modeled after examples of adolescent assent forms to simplify the consent process. Following modification of the consent process, 106 individuals consented to participate in the research project. Interviewers noted using the modified consent process not only decreased participation time but also lessened participants' frustrations.