December 9, 2016 This symposium brought together a variety of experts to discuss key ethical and legal questions regarding offers of payment to research participants. Panels covered: - Why payment is offered to research participants - Regulatory parameters governing payment - Whether payment to research participants should be considered exceptional, compared to payment in other contexts - How offers of payment affect participants - How to define coercion and undue influence with regard to paying research participants - Which factors should be considered when evaluating proposed payments - The problem of low payment This event was free and open to the public. This event was part of the collaboration between the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School. Cosponsored by the MRCT Center of Brigham and Women's Hospital and Harvard. Learn more on our website: http://petrieflom.law.harvard.edu/events/details/paying-research-participants

1. Paying Research Participants:
Regulatory Perspective
December 9, 2016
Julie Kaneshiro
HHS Office for Human Research Protections

2. What’s to be covered
1. The regulations
2. OHRP guidance
3. OHRP compliance

3. Regulations
“An investigator shall seek such consent
only under circumstances that provide the
prospective subject or the representative
sufficient opportunity to consider whether
or not to participate and that minimize the
possibility of coercion or undue
influence.” [45 CFR 46.116]

4. Regulations
“A statement that…the subject may
discontinue participation at any time
without penalty or loss of benefits to
which the subject is otherwise entitled.”
[45 CFR 46.116(a)(8)]

5. OHRP Guidance
FAQ: When does compensating subjects
undermine informed consent or parental
permission?
Compromises evaluation or voluntariness

6. OHRP Guidance
Excerpt from Answer:
“Paying research subjects in exchange for their
participation is a common and, in general,
acceptable practice…IRBs must be sensitive to
whether any aspect of the proposed remuneration
will be an undue influence, thus interfering with the
potential subjects’ ability to give voluntary
informed consent.”

7. OHRP Guidance
Excerpt from Answer:
“Both researchers and IRBs need to be familiar with
the study population and the context of the research
in order to make reasonable judgments about how
compensation might affect participation… IRBs should
be cautious that payments are not so high that they
create an ‘undue influence’ or offer undue
inducement that could compromise a prospective
subject’s examination and evaluation of the risks or
affect the voluntariness of his or her choices.”

8. OHRP Guidance
Excerpt from Answer:
“Finally, in studies of considerable duration or that
involve multiple interactions or interventions, OHRP
recommends that payment be prorated for the time
of participation in the study rather than delayed until
study completion because the latter could unduly
influence a subject’s decision to exercise his or her
right to withdraw at any time.”

9. OHRP Guidance
What the guidance no longer says:
“The level of remuneration should not be so high as
to cause a prospective subject to accept risks that he
or she would not accept in the absence of the
remuneration.”
Stated reason for deletion:
“…to clarify that remuneration to subject may include
compensation for risks associated with their
participation in research and that compensation may
be an acceptable motive for agreeing to participate in
research.”

10. OHRP Guidance
What the guidance no longer says:
“The level of remuneration should not be so high as
to cause a prospective subject to accept risks that he
or she would not accept in the absence of the
remuneration.”
Stated reason for deletion:
“…to clarify that remuneration to subject may include
compensation for risks associated with their
participation in research and that compensation may
be an acceptable motive for agreeing to participate in
research.”

11. OHRP Compliance
 Very few allegations of noncompliance related to
payment.
 OHRP has made no determinations of noncompliance
about payment to subjects being so high as to create
undue influence

12. OHRP Compliance
 OHRP determinations of noncompliance related to
payment have focused on inappropriate
“withholding” of payment:
Not prorating payment for participation prior to
withdrawal
Significantly reducing payment if subjects
withdrew without medical approval
* Related to coercion and the right to withdraw without
penalty or loss of benefits to which the subject is otherwise
entitled

13. 13

14. OHRP Guidance and
Compliance Letters
Informed consent FAQs:
http://www.hhs.gov/ohrp/regulations-and-
policy/guidance/faq/informed-consent/index.html
Student subject pools, penalties for nonattendance:
http://www.hhs.gov/ohrp/regulations-and-
policy/guidance/january-08-2010-correspondence-student-
subject-pools-and-use-of-penalties/index.html
Compliance letters:
http://www.hhs.gov/ohrp/compliance-and-
reporting/determination-letters/index.html