Policy statement

Under UAB policy the IRB will determine that selection of subjects is equitable in order to approve research at initial review, continuing review, and review of proposed modifications to research. When making this determination the IRB will take into account the purposes of the research, the setting in which the research will be conducted, and whether potential subjects are vulnerable to coercion or undue influence (see PRO139 Procedure for Selection and Recruitment of Subjects in Research). The IRB will apply additional safeguards for the following designated populations with Subpart protections in accordance with federal regulations and UAB policy:

Pregnant women, infants, and fetuses (see POL032 policy on, PRO132 procedure for women, infants, and fetuses as research subjects);
Prisoners (see POL033 policy on, PRO133 procedure for prisoners as research subjects);
Children (see POL008 policy on, PRO108 procedure for children and minors as research subjects);
Decisionally Impaired Adults (see PRO125 Procedure for Review of Decisionally Impaired Adults Involved in Human Subjects Research);
U.S. Military Personnel (see GUI337);
Economically or educationally disadvantaged persons.

The Investigator will consider equitable selection of subjects in the research design and provide information on the targeted research population for the IRB to make its determinations. Such information will include population characteristics (e.g., age, sex, race, ethnicity), anticipated number of enrollees, inclusion/exclusion criteria, and additional information as requested by the IRB.

The IRB will evaluate enrollment procedures; recruitment processes, including any advertisements; and participation arrangements for clinical studies as each relates to:

Equitable selection of subjects;
Potential for undue influence and/or coercion.

All recruitment materials (e.g., flyers, or other printed materials, letters to potential subjects) will receive review and approval by the IRB prior to distribution. As part of sound study design, the Investigators should assess enrollment and recruitment practices for fairness and equitable selection. The Investigator will provide information to the IRB to make the above determinations.

Advertising intended to be seen or heard by prospective subjects to solicit enrollment into a study will receive IRB review and approval prior to dissemination. For advertisements, the IRB will review the information content and the mode of communication to determine that the procedures are not coercive. The IRB will review the final copy of printed advertisements to assess the relative size and type used and other visual effects. For audio and video advertisements, the IRB will review the final taped version. However, the IRB may approve the script of the advertisement prior to taping to preclude re-taping because of inappropriate wording. Subsequent approval of the final taped version may be approved via expedited review.

IRB review of advertisements should assure that advertisements do not:

State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the informed consent document and the protocol;
Make claims, either explicitly or implicitly, that the drug, biologic, or device is safe or effective for the purposes under investigation;
Make claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic, or device;
Use terms such as “new treatment,” “new medication,” or “new drug” without explaining that the test article is investigational;
Promise “free medical treatment” when the intent is only to say subjects will not be charged for taking part in the investigation;
Include any exculpatory language.

Advertisements to recruit subjects should be limited to information prospective enrollees need to determine their eligibility and interest. When appropriately stated, the following items may be included in advertisements:

The name and address of the Investigator or research facility;
The conditions under study and/or the purpose of the research;
In summary form, the criteria that will be used to determine eligibility;
A brief list of participation benefits (e.g., no-cost health examination);
The time or other commitment required of the subjects;
The location of the research and the person or office to contact for further information; and
A statement that the subjects may be paid, without emphasizing the payment or the amount by such means as larger or bolder type.

Listings of clinical trials on the internet will receive IRB review and approval before posting to a web site except when the system format limits the information provided to the following basic content:

Title of study;
Purpose of the study;
Protocol summary;
Eligibility criteria;
Study site locations;
How to contact the site for further information.

The IRB will review payment arrangements to participants. Both the method of payment and proposed method and timing of disbursement will be assessed to limit the risk of coercion, undue influence, or inequitable selection of subjects. Information concerning payments, including the amount and schedule of payments, will be set forth in the informed consent document. The IRB will determine that:

Credit for payment accrues as the study progresses and is not contingent upon the participant completing the entire study; and
Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they otherwise would have withdrawn.

The following payment arrangements will not be allowed:

The entire payment to be contingent upon completion of the entire study; and
Compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.