|Footnotes for this article are available at the end of this page.
Recruiting a sufficient number of trial participants is a common difficulty for clinical trial sponsors. To obtain such numbers, sponsors may offer financial incentives to investigators or study sites or site personnel to identify and recruit participants. Such arrangements are not expressly precluded by the U.S. Food and Drug Administration (FDA), though it does have certain disclosure requirements that could be applicable.1 But drug and medical device manufacturers that sponsor clinical trials should be cognizant of potential regulatory risks inherent in such recruitment arrangements. Also, various organizations have called for more governmental regulation of recruitment incentives in clinical trials,2 so it is possible that we may see increased governmental enforcement in this area going forward.
Areas of Concern
Compensation for recruitment of participants in clinical trials should conform to existing governmental and industry guidance. For example, according to the trade association, Pharmaceutical Research and Manufacturers of America (PhRMA), “[p]ayment to clinical investigators or their institutions should be reasonable and based on work performed by the investigator and the investigator’s staff, not on any other consideration.”3 Further, PhRMA guidance includes the following: “[w]hen enrollment is particularly challenging, reasonable additional payments may be made to compensate the clinical investigator or institution for time and effort spent on extra recruiting efforts to enroll appropriate research participants.”4 This is in contrast, however, to so-called “finder’s fees,” which are payments solely for referrals of study participants, as opposed to payment for services provided at fair market value, such as time and effort in screening prospective participants for suitability as candidates for the study.
Various professional organizations, including the American College of Physicians and the American Medical Association (AMA), have stated that the use of finder’s fees is unethical.5 This is also an issue for institutional review boards (IRBs).6 Some IRBs may require disclosure of recruitment incentives to the potential participants. Other IRBs prohibit “finder’s fees” or other bonus compensation that they view as having potential to compromise study integrity.
Also, recruitment arrangements, such as use of finder’s fees, could implicate the federal anti-kickback Statute. Accordingly, manufacturers should ensure that their recruitment arrangements fit within the anti-kickback “personal services” safe harbor whenever possible.7 Among other things, this requires the compensation to be at fair market value for commercially reasonable services.
Based on the foregoing considerations, study sponsors should attend to the following in establishing recruitment incentive programs:
- Ensure that the value of the compensation reflects fair market value for the work being compensated. Further, the compensation should not have any relationship with the participant’s completion or the outcome of the trial;
- The arrangement should be set forth in a written agreement (also a safe harbor requirement) among the investigator and/or study site and the study sponsor, which could be in the form of an amendment to an existing clinical trial agreement; and
- Obtain IRB approval, as necessary.
- Also, manufacturers should determine whether the compensation is reportable under the Sunshine Act, which will likely be the case for any site that is a teaching hospital or where the recipient of the compensation is another provider covered under this Act. As of January 1, 2021, this list now includes physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives.
For more information, please contact Neil W. Hoffman or Laura S. Dona.
 21 C.F.R. Part 54.
 See, e.g., Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight. A White Paper by The Center for Health & Pharmaceutical Law & Policy, Seton Hall University of Law (Nov. 2009).
 PhRMA Principles on Conduct of Clinical Trials; Communication of Clinical Trial Results.
 Conflicts of Interest in Clinical Trial Recruitment: A Call for Increased Oversight.
 See Office of Inspector Gen., U.S. Dep’t of Health and Human Servs., Recruiting Human Subjects Pressures in Industry-Sponsored Clinical Research. OEI-01-97-00195 at *4 (June 2000); Office of Inspector Gen., U.S. Dep’t of Health and Human Servs., Recruiting Human Subjects Sample Guidelines for Practice. OEI-01-97-00196 at *6 (June 2000).
 See Office of Inspector Gen., U.S. Dep’t of Health and Human Servs., OIG Compliance Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. 23731, 23736 (May 5, 2003).