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Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed Methods, Community-Engaged
Jerome T Galea1,2,3, Karah Y Greene1, Brandon Nguyen4
1School of Social Work, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States.
JMIR Research Protocols
|November 24, 2021
Summary
This study addresses the lack of guidance on research incentives by engaging stakeholders to develop evidence-based recommendations for HIV research. The findings will help researchers and IRBs ethically recruit participants.
Area of Science:
- Biomedical research ethics
- Clinical trial management
Background:
- Limited empirical data exists on how researchers select incentives for studies.
- There is a need for evidence-informed guidance for investigators and Institutional Review Boards (IRBs) on determining participant incentives.
- Monetary incentives influence decisions to enroll in research studies, alongside other factors like risk and benefit.
Purpose of the Study:
- To understand stakeholder perspectives on incentives in biomedical HIV research.
- To achieve consensus on factors influencing incentive selection and their relative importance.
- To pilot-test developed guidance using hypothetical research study vignettes.
Main Methods:
- A 2-year study involving a stakeholder advisory board, a nationwide survey (N=300) of people living with HIV, focus groups (n=60), and key informant interviews (n=36).
- Conjoint analysis to determine the importance of study attributes on participation.
- Development of 25 vignettes describing hypothetical HIV research studies for incentive selection by stakeholders.
Main Results:
- The stakeholder advisory board commenced monthly meetings in March 2021.
- All study aims are projected for completion by December 2022.
Conclusions:
- This research will establish a decision-making framework for selecting incentives in HIV research.
- The developed paradigm aims to facilitate ethical recruitment of clinical research participants.
- The findings may eventually extend to other research areas beyond HIV studies.
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