Subject:  Compensation to Investigators & Health Care Workers for Enrolling Subjects

The use of special enrollment incentives in research involving human subjects creates an unacceptable potential for conflicts of interest. We are not referring to reasonable payments made to subjects for their participation in research or to the actual costs researchers incur when enrolling subjects. We are referring to the use of special incentives, bonuses or other similar forms of compensation provided to institutions or investigators as a mechanism for enrolling subjects in research, including clinical trials. Such incentives create conflicts of interest. They may have an adverse effect on human subjects because they may erode the informed consent process and increase the likelihood that ineligible persons are enrolled as subjects in the research.

It is the UAMS’ policy that it will not participate in any human subjects research involving use of enrollment incentives and that neither the University, its investigators, its collaborators, its intermediaries, nor its subcontractors shall accept enrollment incentives in connection with human subjects research.  

For purposes of this policy, the following definitions shall apply:

“Clinical trial” means human subjects research whose purpose is to assess the safety or efficacy of drugs, devices, diagnostics, treatments, or preventive measures.

“Enrollment incentive” means any form of direct or indirect inducement offered or received in exchange for enrolling subjects in human subjects research: (i) that is paid as reimbursement in excess of the reasonable cost of utilizing human subjects, or (ii) that is paid extra-contractually, including any bonus, reward, award, grant, gift, benefit, or other quid pro quo, or (iii) that creates a financial incentive that the University determines is contrary to the best interests of human subjects participating in the research.

“Human subjects research” means a systematic investigation designed to develop or contribute to generalizable knowledge that utilizes humans as research subjects and includes clinical trials.

The following is a non-exclusive list of examples that are not permitted in human subjects research under the foregoing policy:

1. Entering into a human subjects research agreement that contains an enrollment incentive provision.
2. Acceptance of or a request for an enrollment incentive by the University, its investigators, or subcontractors.
3. Fees that exceed the actual costs of recruiting human subjects.
4. Excessively high fees paid to subjects in exchange for participating in human subjects research. Bonuses, milestones, or similar forms of additional payments for timely, early, or over-enrollment of human subjects, for retention of human subjects, or for timely or early HRAC approval.
5. Use of per subject payment rates that vary based only upon the number of human subjects enrolled, including increased per subject rates paid for over-enrollment of subjects.
6. Extra-contractual benefits such as unrestricted research gifts, medical or office equipment, authorship rights, journal subscriptions, educational stipends, payment of conference fees, software, personal gifts, favors, or similar inducements provided in exchange for enrolling human subjects.
7. Payment of referral or finder’s fees in exchange for the referral by a professional of the professional’s patients or clients as potential subjects in human subjects research.
8. Obtaining human subjects through recruitment firms or persons whose practices are not consistent with this policy.