Human Research Protection Program: Policy
Recruitment of Research Participants
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: January 22, 2009
Purpose: This document describes how the UW-Madison IRBs
evaluate whether participant recruitment methods, advertising materials, and
participant payment arrangements are fair, honest, and appropriate.
Policy
I. To approve research submitted for
initial review, continuing review, or review of modifications, UW-Madison IRBs
must evaluate the methods and material that
investigators propose to use to recruit subjects and any incentives offered for
research participation to assure that the procedures followed adequately
protect the rights and welfare of the prospective participants. Belmont Report; 45
CFR §46.111(a)(3); 21 CFR §56.111(a)(3).
Procedure
II. Investigators are asked to describe
the recruitment methods, advertisements and any participant incentives in the
Application for Initial Review. Investigators should submit copies of the
actual recruitment materials that will be used in their research with their
protocol application.
A. Health Sciences IRB and Health Sciences Minimal Risk IRB: HS IRB and MR
IRB Application for Initial Review.
B. Social and Behavioral Sciences IRB and Education Research IRB: SBS IRB
and ED IRB Application for Initial Review.
III. When reviewing research submitted for
initial review, continuing review, or review of modifications, UW-Madison IRBs
systematically evaluate:
A. The methods, materials, procedures and tools used to recruit
participants to assure that they are not coercive or unduly influential and
that they accurately reflect the likely risks and benefits of participation
because the IRBs view recruitment procedures to be part of the informed consent
process.
B. Whether recruitment processes, including advertisements affect the
equitable selection of participants.
C. Any proposed incentives offered for participation in the research to
assure that the incentives are not coercive and do not constitute undue inducement
to consent to participate in the research.
D. Whether payment arrangements among sponsors, organizations,
investigators, and those referring research participants may place participants
at risk of coercion or undue influence or cause inequitable selection.
E. In clinical research, whether the research personnel who will identify
potential participants and the method of identification are appropriate in
terms of whether there is valid access to participants’ clinical information.
IV. In most cases, UW-Madison IRBs do not
allow direct recruitment of participants by someone in a status relationship
with those individuals (e.g., supervisor/employee, faculty member/student).
See, Recruitment of Participants in Status Relationships (Relatives, Employees
and Students) Guidance on the Human Research Protection Program website: (http://www.grad.wisc.edu/research/hrpp/submissioninstructions.html).
V. In reviewing participant recruitment
methods, UW-Madison health sciences IRBs apply the principles set out in the FDA
Information Sheets: Recruiting Study Subjects, Payment to Research Subjects and
Screening Tests Prior to Study Enrollment (http://www.fda.gov/oc/ohrt/irbs/default.htm).
VI. Recruitment Incentives or Payments to
Participants
A. Financial incentives for participation in research may be allowed in
low risk, nontherapeutic studies as long as the amount is not coercive.
However, financial incentives are not allowed for participation in therapeutic
research studies, although IRBs allow reimbursement to participants in all
research studies for research-related expenses such as the cost of
transportation and parking and loss of wages. Compensation should not be
excessive relative to the nature of the project.
B. If participants will be paid for their time/effort, it is recommended
that the wording "Compensation Available" be used in recruitment
materials, rather than specifying a specific amount. Statements of payment
should not be in larger type than the rest of the ad.
C. The UW-Madison IRBs recommend that compensation not be withheld
contingent on the participant's completion of the study. In most cases involving
continued participation, compensation should be given on a reasonable prorated
basis to avoid the impression that the investigator is coercing the participant
to continue in a study or is punishing the participant for non-compliance.
D. All information concerning payment, including the amount and schedule
of payments, must be set forth in the consent document.
E. Information regarding how to process payment for research participants
is posted on UW-Madison’s website: How to Pay Human Subjects.
VII. Payments to participants in Veterans
Affairs Medical Center (VAMC) research:
A. The Department of Veterans Affairs (VA) prohibits payments to research
participants when the research is integrated with a patient's medical care and
makes no special demands on the patient beyond those of usual medical care.
B. The VA permits payments to research participants when:
1. The research is not directly intended to enhance the diagnosis or
treatment of the medical condition for which the participant is being treated,
and when the standard of practice in affiliated non-VA institutions is to pay
participants in this situation.
2. The research is a multi-institutional study and participants at
collaborating non-VA institutions are paid for the same participation in the
same study at the same rate proposed.
3. In the opinion of the reviewing IRB payment of participants would be
appropriate in other comparable situations.
4.
The participant will incur transportation expenses that would not be
incurred in the normal course of receiving treatment and were not reimbursed by
another mechanism.
VIII. Payment arrangements among sponsors,
organizations, investigators, and those referring research participants.
A. UW-Madison policy prohibits payments from the University or a research
sponsor to an investigator if such payments are conditioned upon the rate or
timing of participant recruitment, a particular research result or are linked
to successful research outcomes.
B. Payments for subject enrollment or for the referral of patients to
clinical studies are only permitted when such payments:
1. Are reasonably related to costs incurred, as specified in research
agreements between the sponsor and the University
2. Reflect the fair market value of services performed, and
3. Are commensurate with the efforts of the individual(s) performing the
research.
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