Enrollment Incentives (Prohibition
of)
Policy Prohibiting Use of Enrollment
Incentives in Human Subjects
Research
Office of Research
March 6, 2002
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. Some
enrollment incentives may also be contrary to Washingtonās Ethics in Public
Service Act, RCW Chapter 42.52.
It is the University of Washingtonās 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 trials
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:
- Entering into a human subjects research
agreement that contains an
enrollment incentive provision.
- Acceptance of or a request for an enrollment
incentive by the University,
its investigators, or subcontractors.
- Fees that exceed the actual costs of
recruiting human subjects.
- 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 IRB approval.
- 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.
- 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.
- Payment of referral or finderās fees
in exchange for the referral
by a professional of the professionalās
patients or clients as potential
subjects in human subjects
research.
- Obtaining human subjects through recruitment firms or persons whose
practices are not consistent with this policy.
February 19, 2002
To: (Health Sciences Deans, Assoc. Deans
Research)
(Arts & Sciences Dean, Assoc.
Deans)
(Education Dean, Assoc. Dean)
Fr: Alvin L. Kwiram
Vice Provost for Research
Re: Policy Prohibiting Use of Enrollment Incentives in Human Subjects
Research
The use of enrollment incentives in research involving human subjects in general
and in clinical trials in particular has become increasingly problematic in
recent years. We are not referring to reasonable payments made to subjects
for their participation in research or to the actual costs researchers incur
in enrolling subjects. The concern is with practices in which sponsors provide
payments, gifts, or other benefits that go beyond the actual costs of enrolling
subjects to the researchers themselves. These often take the form of extra-contractual
payments made directly to researchers and their staff.
Enrollment incentives were first banned in clinical trials in the University
of Washington School of Medicine. After consultation with the Human Subjects
Division, the UW Conflict of Financial Interest Advisory Committee and other
groups, we are now promulgating the attached policy for use with human subjects
research of all types at the University of Washington.
cc: Lee Huntsman
Helen McGough
Carol Zuiches
Malcolm Parks
Patricia Kuszler
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