Good Clinical Practice: A Question & Answer Reference Guide - May 2016 - 464

GCP: A Question & Answer Reference Guide
provide sufficient information and training on the protocol so that they can fulfill their duties as a sub-investigator
appropriately."
12.36 Q. 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?
A. 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."
12.37 Q. In practice, to what degree is there active IRB oversight of various subject recruitment practices?
A. Not much, at least according to a government study several years ago. A 2000 HHS Office of the Inspector
General report titled, "Recruiting Human Subjects: Pressures in Industry-Sponsored Research," for example,
concluded that the "oversight of the recruitment of subjects is minimal," and worse, that "IRBs are not reviewing
many of the recruitment practices that they and others find most troubling." The study looked at what HHS identified
as the "four main strategies" that sponsors and investigators use to recruit human subjects and encourage timely
recruitment: (1) sponsor-offered financial and other incentives to investigators to boost enrollment; (2) investigators
"target" their own patients as potential subjects; (3) investigators seek additional subjects from other sources, such
as physician referrals and disease registries; and (4) sponsors and investigators advertise and promote their studies.
"Although financial incentives given to investigators by sponsors to boost enrollment are among the recruitment
practices that IRBs are most concerned about, 75 percent of IRBs that responded to our survey do not review
any financial arrangements between sponsors and investigators," the study states. "When IRBs do review subject
recruitment practices, they primarily review advertisements and incentives paid to subjects, not practices involving
sponsor-investigator interactions.
"In addition, 25 percent of IRB survey respondents do not ask investigators to explain recruiting practices in
their application for review. The finding that a significant percentage of IRBs do not gather basic information about
recruitment practices on their application for review raises the possibility that some IRBs may not be reviewing
recruitment practices at all. In addition, of the 23 applications provided by our surveyed IRBs, 13 ask only general
questions about recruitment such as 'How will subjects be recruited for the study?' Few inquire about specific
recruitment practices in their application for review."
At the same time, the 2000 HHS report did find some positive trends, including the fact that IRBs reported
devoting increasing attention to recruitment-related issues. In addition, 61 percent of the surveyed IRBs reported
that they had requested changes in the recruitment practices called for by a protocol during the previous three years,
and many said that they were requesting more recruitment-related changes than they had three years earlier.
12.38 Q. Suppose a clinical research center develops a generic preliminary screening log that is not study
specific, and will be used to collect general information on prospective subjects, such as name, age,
gender, address, telephone number, medical history, current symptoms and where the person heard about
the study/research center. Since the screening log is not study specific, would it require IRB review and
approval?
A. In a response to this question, the FDA noted that, "the Institutional Review Board (IRB) has the authority
and should review the method and material(s) that investigators propose to use to recruit subjects. The telephone
screening is a form of recruitment for subjects that should be viewed as the start of the informed consent and subject
selection process. As such, it is subject to IRB review either as part of its initial review of the specific research

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Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2016
