10.1    Equitable Selection

Section revised: 6/1/13  

The IRB has and follows written policies and procedures to evaluate the equitable selection of participants.  (AAHRPP Element II.3.C)

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:

Š      Recruitment [GUI-33]

Š      Advertisements: Appropriate Language for Recruitment Material [GUI-16]

Š      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, and 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). In determining if the selection and recruitment of participants is equitable, the IRB takes into account the purpose of the research, the setting in which the research will be conducted, whether prospective participants will be vulnerable to coercion or undue influence, the selection (inclusion/exclusion) criteria, participant recruitment and enrollment procedures, and the influence of payments to participants.  The IRB also evaluates whether the study imposes fair and equitable burdens and benefits - such that one group of persons does not disproportionately receive 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 not 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 these populations. While pregnant women are considered vulnerable participants, women of reproductive age should not be arbitrarily excluded from participation in research.  If women are to be excluded, such exclusion must be fully justified by the PD based on scientific rationale.  The IRB adheres to Research Policy Handbook RPH 5.3 Women as Subjects in Research when considering women as participants. 

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) and 21 CFR 50.27(b)(2). 

10.2    Review of Recruitment Methods, Advertising Materials and Payment

Section revised: 12/07/2015    

The IRB has and follows written policies and procedures to review proposed participant recruitment methods, advertising materials, and payment arrangements and determines whether such arrangements are fair, accurate, and appropriate. (AAHRPP Element II.3.C.1)

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 one’s own patients, seeking referrals from colleagues (via word of mouth or referral letters sent to colleagues) and advertisements. 

 

Advertisements

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. If recruitment will be by advertisement, the mode of advertisement (flyers, radio, newspaper, or internet) and information contained in the advertisement must be approved by the IRB.

Š      Audio and video tape: The IRB may review and approve the wording prior to taping in order to preclude re-taping due to inappropriate wording. The IRB reviews the final version of the advertisement.

Š      Printed advertisement: The IRB reviews the final copy. 

See:

Š      Recruitment [GUI-33]

Š      Advertisements: Appropriate Language for Recruitment Material

Š      Recruiting Study Subjects [FDA]

 

Telephone Screening

For protocols involving telephone screening of participants in response to an advertisement, the IRB generally requires investigators to review all the required 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:

Š      Payment from research participants

Š      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.

Š      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.

 

Payment Practices – Additional Requirements

Other Federally-Funded Research:

Additional requirements might apply, (such as payment and compensation limits, minimizing undue influence, etc.), depending on the source of support/funding (e.g., Department of Defense, Department of the Navy, Department of Justice): see Other Federal Agencies - Additional Requirements [GUI-42].