Human Research Protection Program (HRPP)
DOMAIN II: RESEARCH COMPLIANCE OFFICE, INCLUDING
IRBs
Chapter
10: Participant Recruitment and
Selection
The STANFORD* IRBs
and their staff systematically evaluate recruitment and participant selection
practices. (AAHRPP Standard II-5)
The IRB
evaluates equitable selection of participants from various populations and
sub-populations, when applicable, and consider whether inclusion and exclusion
criteria impose fair and equitable burdens and benefits. (AAHRPP Element II.5.A)
Guidance and information is made available to Protocol Directors (PDs)
to assist and guide them in creating recruitment and participant selection
methods that are fair and equitable.
See - Recruitment
- Advertisements: Appropriate Language for Recruitment Material
-
Chapter
14.4.
PDs are directed
to enter detailed information on how participants will be identified and
recruited in response to questions in the Protocol
Application. PDs are required to
identify the target populations (including age range, gender, ethnic
background), the inclusion and exclusion criteria and whether payments will be
made for participation. In addition, PDs are required to justify the inclusion
of targeted persons (e.g., healthy participants, employees, students or
participants with certain medical conditions). The IRB evaluates this
information in determining if the selection and recruitment of participants is
equitable and that the study imposes fair and equitable burdens and benefits - such that one group of persons does not
disproportionately received the benefits compared to another group assuming only
the risks.
IRB
staff and members review this information and confirm the recruitment and
selection strategies are fair, equitable, and non-misleading. If recruitment strategies fail to meet these
requirements, the protocol will not be approved as written and the PD will be
asked to modify the recruitment plan accordingly as a condition of approval.
Vulnerable Subjects
Investigators must provide a rationale for involvement of vulnerable
subjects, such as children, prisoners, pregnant women, economically and
educationally disadvantaged, decisionally impaired, and homeless people. The PD
must substantiate his/her decision to involve a vulnerable population and further
provide a rationale why a less vulnerable population would not serve the
purpose of the research. When vulnerable populations will be targeted for
enrollment, the IRB assesses the additional safeguards proposed by the PD to minimize
the possible risks and the chance of harm to potentially vulnerable
participants. While pregnant women are considered vulnerable participants,
women of reproductive age should not be arbitrarily excluded from participation
in research. If women will be excluded,
such exclusion must be fully justified by the PD based on scientific rationale. The IRBs adhere to the following policy when
considering women as participants – “Women as Subjects in Research,” Research
Policy Handbook, RPH 7.2.
Non-English Speaking Participants
Non-English speaking participants should not be systematically excluded
because of language barriers. The IRB
encourages the inclusion of non-English speaking participants and permits such
persons to be enrolled via the short form consent process consistent with 45
CFR 46.117(b)(2).
10.2
Review of Recruitment Methods, Advertising Materials and Payment
The IRB reviews proposed participant recruitment methods, advertising
materials, and participation payment arrangements, and permits them when fair,
honest, and appropriate. (AAHRPP Element
II.5.B)
Recruitment
Methods
PDs
are required to provide details on all methods of recruitment proposed on a
project, including how participants will be identified for recruitment. Guidance on recruitment is available, as well as sample
phone screens when screening will be conducted over the phone to determine
study eligibility. Some common
recruitment methods include recruiting from own clinic patients, seeking
referrals from colleagues (via word of mouth or referral letters sent to
colleagues) and advertisements.
Advertisements
If recruitment
will be by advertisement, the mode of advertisement (flyers, radio, newspaper,
internet) and information contained in the advertisement must be approved by
the IRB. The IRB considers that advertisements begin the informed consent
process and thus, consistent with the consent process, coercion and undue
influence are prohibited during recruitment.
The IRB reviews advertising
to ensure that advertisements do not imply a certainty of favorable outcome or
other benefits beyond what is outlined in the consent document and the
protocol. See guidance Advertisements:
Appropriate Language for Recruitment Material.
Telephone Screening
For
protocols involving telephone screening of participants in response to an
advertisement, the IRB generally requires investigators to review all the
elements of informed consent orally with prospective participants. However, investigators may request a waiver
of documentation of consent limited to the screening portion (only) of the
protocol if they demonstrate that the screening procedure meets regulatory
criteria in 45 CFR 46.117(c)(2) or 21 CFR 56.109(c)(1).
Payment
PDs must disclose any
proposed payments to participants in the protocol application form, including
the method, type and timing of the payments. Payments to research participants
may not be of such an amount as to result in coercion or undue influence on the
research participant’s decision to participate.
If a study has multiple paid visits, payment should be prorated throughout
the duration of the study to provide partial payment to persons who withdraw
before completing the study. See
guidance Payment
– Ethical Considerations.
Prohibited Recruitment and Payment Practices
The following activities are examined carefully and are generally not
allowed:
·
Payment
from research participants
·
Compensation
for participation in the form of a coupon for a discount on the test article to
be used after the product has been approved for marketing.
·
“Cold-calling” of potential research participants
(i.e., unrelated party initiating telephone contact based on
knowledge of confidential information), unless the following preferred methods
are unavailable and good reason exists:
- Patients
of a particular clinic, physician or other caregiver only after the patient’s
physician or caregiver has previously notified the potential research
participant (or parent or legal representative) and obtained approval for such
contact.
-
Members of a program based in the community, workplace, school, trade or
union only after a program representative has previously notified the potential
research participant (or parent or legal representative) and obtained approval
for such contact.
·
Exculpatory
language through which the participant or participant’s LAR is made to waive or
appear to waive any of the participant’s legal rights, or releases or appears
to release the investigator , the sponsor, the institution or its agents from
liability for negligence.
Payment Arrangement Among
Sponsors/Organizations, Investigators and Others
Payment in exchange for referrals of
potential participants (finder’s fees) and payments designed to accelerate
recruitment tied to the rate or timing of enrollment (bonus payment) are
generally unacceptable.
In some special circumstances Stanford
contracts with organizations for a fee who have volunteer participants who have
previously agreed to be study participants in survey studies.
Additionally for VA research - Payment
Practices
The VA
prohibits paying participants for participation in research 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.
The VA permits paying
participants when:
i.
The research is not directly intended to enhance
the diagnosis or treatment of the medical condition for which the participant
was being treated, and when the standard of practice in affiliated non-VA
institutions is to pay participants in this situation.
ii.
The research is a multi-institutional study and
participants at collaborating non-VA institutions were paid for the same
participation in the same study at the same rate proposed.
iii.
In the opinion of the IRB, payment of participants
is appropriate in other comparable situations.
iv.
The participant will incur transportation expenses
that would not be incurred in the normal course of receiving treatment and will
not be reimbursed by another mechanism.