Good Clinical Practice Q&A: Focus on Referral Fees

While much has been written and said about the controversial recruitment practice of referral fees offered and paid to physicians who refer patients to clinical studies, what about referral fees offered to existing participants in an ongoing trial? Would a sponsor/site be permitted to offer current study participants referral fees for referring other prospective subjects to the clinical study in which they are enrolled? Is it fair to assume that this would require IRB review and approval and that such fees, if paid, should be disclosed to prospective subjects in the informed consent document?

In a February 2009 response to this question, the FDA’s Good Clinical Practice program noted that “there is nothing in FDA regulations or guidance that would prohibit this. That does not, of course, indicate that it is a prudent method of recruiting potential study subjects. As you note, the reviewing IRB would need to review this, and they are the ones who will decide whether or not it is appropriate for the particular study and, if so, if the proposed compensation is appropriate. It would definitely require IRB approval, and it is most likely they would require a full discussion of it in the informed consent document so everyone participating in the study is aware of it.

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” Source “Good Clinical Practice: A Question & Answer Reference Guide”, Barnett International. The Guide is available at http://www.barnettinternational.com in electronic and paper form.