The Challenges of Ensuring Participant Consent in Internet-based Sex Studies: A Case Study of the Men's INTernet Sex (MINTS-I and II) Studies

摘要

This study documents our experience in designing, testing, and refining human subjects’nconsent protocol in 3 of the first NIH-funded online studies of HIV/STI sexual risk behaviornin the USA. We considered 4 challenges primary: a) designing recruitment and enrollmentnprocedures to ensure adequate attention to subject considerations; b) obtaining andndocumenting subjects’ consent; c) establishing investigator credibility through investigator-nparticipant interactions; d) enhancing confidentiality during all aspects of the study.Humannconsent in online studies appears more relative, continuous, inherent, tenuous, and diversenthan in offline studies. Reasons for declining consent appear related to pragmatic concernsnnot human subjects’ risks. Reordering the consent process, and short, chunked, stepwise,ntailored consent procedures may enhance communicating information and documentingnconsent.