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Member Research & Reports

Member Research & Reports

UC Irvine Retrospectively Examines Ethical Issues in a Clinical Trial

UC Irvine GHREAT faculty and students, along with the Director of the Research Ethics Training Institute (RETI) at Fordham University collaborate on a manuscript titled “Peruvian Female Sex Workers’ Ethical Perspectives on Their Participation in an HPV Vaccine Clinical Trial”. The article was recently accepted in Ethics and Behavior and is a continuation of work with the female sex worker (FSW) population which began in 2008.

Brandon Brown
[Photo: Dr. Brandon Brown]

Researchers examined FSW’s evaluation of social and health risks and benefits, informed consent, incentives, fair treatment, and post-trial care following their participation in an HPV vaccine phase IV clinical trial (Sunflower Study), in which all 200 participants received quadrivalent HPV vaccine and 92 percent completed all three vaccine doses.  Sixteen FSWs aged 23-29 years from Lima, Peru were administered semi-structured interviews to assess perceptions of study participation.

Broad themes emerging from content analysis included respect, concerns about privacy protections, absence of stigma, access to health care, and abandonment. Most participants reported that staff treated them with empathy, fairness, and dignity, participation provided protection from cancer and an opportunity to privately receive quality sexual health care, they were well prepared by consent procedures, participation was voluntary, and incentives were appropriate. Of note, one participant responded, “If nothing else, they always treated me as a human”. Some participants experienced feelings of desertion when the study ended.

Participants were generally content with all aspects of the study and emphasized its protective and non-coercive attributes. Balancing fear and trust was the most notable broad theme. Participants expressed gratitude for the professional treatment despite normalized stigma regarding their FSW status. Researchers may also need to develop navigation plans to properly transition participants out of research projects once studies have ended to reduce feelings of abandonment.  Additional research on perceptions of clinical trial participation is needed to ensure ethical treatment of research participants

Manuscript authors include Dr. Brandon Brown and Ms. Mariam Davtyan from the Global Health Research, Education, and Translation (GHREAT) Initiative at the UC Irvine Program in Public Health, and Dr. Celia Fisher from the Center for Ethics Education at Fordham University. Funded by R25DA031608-01.

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