Abstract
Purpose
To identify the specific motivations that drive healthy volunteers to consent for their participation in clinical studies. Additionally, the study aimed to document the socio-demographic determinants of participation in the trial related solely to the intention of securing financial gains.
Patients and methods
This cross-sectional study was conducted among subjects who participated as healthy volunteers in clinical trials conducted by Contract Research Organizations (CROs) of Delhi. Pre-tested, validated semi-structured questionnaires were used to collect baseline socio-demographic data, information about factors motivating participation in clinical trials, and pattern of utilisation of money received against participation in the trial. Logistic regression analysis was done to determine the factors that influenced participation in the trial related purely to the motive of securing financial gains.
Results
A total of 400 participants were selected. The majority of the volunteers (77.5%) reported that their sole reason for participating in clinical trials was for monetary gain. Around a tenth of the volunteers participated with the intent to advance scientific knowledge and another 4.5% participated due to benefits of free medical check-ups. Participants in the age group of 29–38 years, those that were married, those residing in an urban slum, male participants, those with a high number of dependent family members (ie, 5 to 8), and those earning less than 5000 INR (71 USD) a month had higher odds of participating in a clinical trial purely for the financial benefits. Those educated till intermediate and above had lower odds of participation in the trial due to monetary benefits.
Conclusion
Our study shows that healthy volunteers in Delhi consider participation in clinical trials mainly because of the prospect of financial reward. More research is needed to inform judgments around the ethics of providing financial rewards and enrollment of healthy research volunteers.
Ethical Approval
In accordance with the Committee on Publication Ethics (COPE) requirements, we acknowledge that human subjects research was approved by the Institutional Review Board (IRB) at Jamia Hamdard University, New Delhi (JM#1298/2024A).
Data Availability
Requests for data used in the preparation of the manuscript can be directed to the corresponding author.
Author Contributions
All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Disclosure
The authors report no conflicts of interest in this work.