The proposed project will investigate healthy volunteers'patterns of participation in Phase I clinical trials, attending to differences based on their racial and ethnic backgrounds. It focuses on the relationship over time between healthy volunteers'perceptions of the risks and benefits of trial participation and their decision-making and behaviors surrounding enrollment in those studies. The majority of healthy volunteers in clinical trials are serial participants, meaning that they enroll repeatedly in studies, so a longitudinal study design is needed to understand their patterns of participation in clinical trial. The project is designed with four primary aims: 1. Assess how participants'perceptions of the risks and benefits of Phase I participation change over time; 2. Examine how participants make decisions regarding their participation in clinical trials - including continuing serial participaion - and assess the consistency of their choices over time; 3. Document how participants'self-reported behaviors (a) affect the validity of clinical trials and (b) increase and/or mitigate har that could come from serial participation, including behaviors that have health benefits;and 4. Compare participants'perceptions, decisions, and behaviors across racial and ethnic groups. This 5-year project is a prospective, longitudinal, qualitative study and includes 200 healthy volunteers (50 1st-times Phase I participants, 50 2nd-time participants, 50 3rd-5th-time participants, and 50 6th+-time participants) who will be followed for 3 years. They will participat in 5 semi-structured interviews (total of 880): at enrollment, 6 months, 1 year, 2 years, and 3 years. Participants will also maintain """"""""clinical trial diaries"""""""" documenting their activities in Phae I studies between interviews. In each group, 10 participants will serve as controls and be interviewed only at enrollment and at three years. The control group will be used to evaluate whether the interviews and diaries have an unintended interventional effect on volunteers over the course of the study.

Public Health Relevance

It is critical to understand the patterns of healthy volunteers'participation in Phase I clinical trials, including differences in the participation of minority grups in these early-phase studies. Through this knowledge, efforts can be made to better protect the health of participants as well as to improve their understanding of the risks of serial participatin in clinical trials. In addition, this project can help identify factors associated with serial participation that could affect the validity of clinical trials and potentially threaten the publics health.

National Institute of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Research Project (R01)
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Study Section
Special Emphasis Panel (SEIR)
Program Officer
Krasnewich, Donna M
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University of North Carolina Chapel Hill
Other Health Professions
Schools of Medicine
Chapel Hill
United States
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Walker, Rebecca L; Fisher, Jill A (2018) Companion Animal Studies: Slipping Through a Research Oversight Gap. Am J Bioeth 18:62-63
McManus, Lisa; Fisher, Jill A (2018) To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials. AJOB Empir Bioeth 9:82-90
Walker, Rebecca L; Cottingham, Marci D; Fisher, Jill A (2018) Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research. J Med Philos 43:83-114
Williams, Quintin; Fisher, Jill A (2018) Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions. Sociol Inq 88:724-748
Fisher, Jill A; McManus, Lisa; Wood, Megan M et al. (2018) Healthy Volunteers' Perceptions of the Benefits of Their Participation in Phase I Clinical Trials. J Empir Res Hum Res Ethics 13:494-510
Cottingham, Marci D; Fisher, Jill A (2017) From fantasy to reality: managing biomedical risk emotions in and through fictional media. Health Risk Soc 19:284-300
Cottingham, Marci D; Fisher, Jill A (2016) Risk and Emotion Among Healthy Volunteers in Clinical Trials. Soc Psychol Q 79:222-242
Edelblute, Heather B; Fisher, Jill A (2015) Using ""clinical trial diaries"" to track patterns of participation for serial healthy volunteers in U.S. phase I studies. J Empir Res Hum Res Ethics 10:65-75
Monahan, Torin; Fisher, Jill A (2015) 'I'm still a hustler': entrepreneurial responses to precarity by participants in phase I clinical trials. Econ Soc 44:545-566