|
Paying Participants Helps with Recruitment for Low-Risk but Not The High-Risk Clinical Trials
(Thursday, September 23, 2021) An old ethical question about should a sponsor pay or not pay subjects for participating in their clinical trials was investigated in two clinical trials, one with high risk to subjects and another with low risk to subjects. It was found that for the study where subjects would have low risk to participate, the financial incentive helped recruitment, and the study where subjects would be participating in a high-risk setting, paying them did not affect recruitment. In both cases, incentivizing subjects was deemed just and ethical. The first trial evaluated financial incentives for participation in a study evaluating smoking cessation interventions in people with major depressive disorder, and the second compared a gamification intervention with usual care to promote ambulation among hospitalized patients. It was found that recruitment to the smoking cessation study was helped with financial incentives up to $500, while those in the ambulation trial did not care whether they were paid up to $300. The study concluded that paying subjects for participating in clinical trials is just and ethical. Compensation to subjects participating in clinical trial is a common practice for all kinds of clinical trials. Such compensation is intended to cover reasonable expenses that the subjects may incur for participating in a given clinical trial such as travel to the clinical sites and meals. The amount of compensation to subjects is decided by the sites and need to be approved by the IRB prior to implementation. While it is hard to justify the ethics of patient payment with just two studies, but common sense dictates that patients participate in clinical trial for several reasons and not just to get paid. Clinical trials in high-risk setting likely involve patients with serious diseases looking for alternatives to standard of care, while low risk studies are conducted for products where the patients would have to be incentivized in additional ways as they may not see a direct benefit. Either way, to pay or not, and how much to pay would be a decision made on a trial-by-trial basis and should be evaluated by the IRB. Studies that involve generally healthy participants will likely require higher compensation than other studies. So, this study only confirms what is already firmly established. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
|
|
|
