WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
It is the responsibility of the DOH IRB to review and approve all forms of advertising for recruitment purposes. IRB review is necessary to ensure the information is not misleading or coercive to potential participants.
INVESTIGATOR HELP:
Because advertisements and recruitment procedures are considered to be the initiation of the informed consent process, the IRB must review and approve all documents and procedures. Federal guidelines specify the information that should/should not be contained in an advertisement for research and these guidelines must be followed for an IRB to approve an advertisement. Advertisements that must be approved include those for television, radio, videotaped or written advertisements, email solicitations, internet websites, etc. An IRB must review/approve final copies of all audio/videotapes prior to use.
IRB POLICIES AND PROCEDURES:
IRB Policy 4.12 - Recruitment/Advertising
It is the policy of the DOH IRB to review and approve all recruitment materials for participants in research conducted under its jurisdiction.
FEDERAL REGULATIONS/GUIDANCE:
OHRP IRB Guidebook
Advertising for Subjects. One method of recruiting subjects is through advertisements (e.g., posted notices and newspaper or magazine ads). Advertising for research subjects is not, in and of itself, an objectionable practice. When advertising is to be used, however, the FDA requests that IRBs review the information contained in the advertisement, as well as the mode of its communication, to determine whether the procedure for recruiting subjects affords adequate protection. IRB review is necessary to ensure that the information is not misleading to subjects, especially when a study will involve persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged.
The FDA believes that any advertisement to recruit subjects should be limited to: (1) the name and address of the clinical investigator; (2) the purpose of the research, and, in summary form, the eligibility criteria that will be used to admit subjects into the study; (3) a straightforward and truthful description of the incentives to the subject for participation in the study (e.g., payments or free treatment); and (4) the location of the research and the person to contact for further information [FDA IRB Information Sheet: "Advertising For Study Subjects" (1989)].
If a study involves investigational drugs or devices, no claims should be made, either explicitly or implicitly, that the drug or device is safe or effective for the purposes under investigation, or that the drug or device is in any way equivalent or superior to any other drug or device. Such representation would not only be misleading to subjects, but would also violate FDA regulations concerning the promotion of investigational drugs [21 CFR 312.7(a)] and investigational devices [21 CFR 812.7(d)].
Paying Subjects to Participate. Another method of recruiting research subjects is to pay them for their participation. It is not uncommon for subjects to be paid for their participation in research, especially in the early phases of investigational drug or device development. In such cases, the IRB should review both the amount of payment and the proposed method of disbursement to assure that neither entails problems of coercion or undue influence. Such problems might occur, for example, if the entire payment were to be contingent upon completion of the study or if the payment were unusually large. Payments should reflect the degree of risk, inconvenience, or discomfort associated with participation. See Guidebook Chapter 3, Section G, "Incentives for Participation."