To ensure equitable selection of research subjects and to prevent coercion in recruiting participants for research that is conducted under the purview of the CHS IRB.
Institutional Review Boards (IRBs) are responsible for ensuring equitable selection of research subjects. As part of this responsibility, the IRB reviews all advertisements and recruitment methods.
- The Institutional Review Board views participant recruitment as an extension of the informed consent and subject selection process; as a result, all methods of recruitment must be reviewed and approved prior to use or publication.
- IRB review is necessary to ensure that the information is not misleading to subjects, especially when a study will involve vulnerable populations, such as those with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged.
Material used to recruit subjects, such as advertisements, must be submitted to the IRB for review and approval before being used.
If submitted at the time of initial review, the material will be evaluated by the IRB as part of the initial approval process. If the study requires Full Board review, the subject recruitment material will be reviewed by the Full Board. Subsequent requests for review of subject recruitment materials may be reviewed and approved through an expedited process by the IRB Chairperson, pursuant to FDA guidance concerning subject recruitment (Recruiting Study Subjects, FDA Information Sheets, Updated 9/98: www.fda.fob/oc/oha/irb/toc4/html). Advertisement requests must be related to an established approved protocol
The IRB submission should contain the following:
- IRB cover page.
- A memo listing the specific potential sources for the recruitment (e.g. radio, TV, newspaper, direct mail to physicians, direct mail to patients, meetings and seminars - and their announcements, etc.)
- One copy of the proposed ad copy, presentation outline (i.e. powerpoint), script, or audio/video recording.
The following information should be included in an advertisement:
- The name and address of the Principal Investigator and/or the research facility.
- The purpose of the research and, in summary form, the eligibility criteria that will be used to admit the subjects into the study.
- A straightforward and truthful description of the incentives to the subject for participation in the study (e.g., payment or free treatment).
- The location of the research and the name of the person or the telephone number to contact for further information.
- Studies involving experimental drugs or devices must clearly state that they are "experimental."
- If the study is to be presented at a public seminar, meeting and/or classroom situation where potential enrollees are in the group, all of the above disclosure criteria must be presented. The IRB will review the written outline of the study's presentation as it will be discussed at the meeting.
Note: Do not use terms such as a "new" drug or device since the word new can imply "improved" or "approved" and not investigational. Avoid using the word "free" in reference to treatment procedures.
In medical studies no claims should be made, either explicitly or implicitly, that any experimental drug or device is safe or effective, or equivalent or superior to any other drug or device. Such representation would not only be misleading to subjects, but would violate FDA regulations concerning promotion of investigational drugs (21 CFR 312.7a) and investigational devices (21 CFR 812.7d).
If payment is to be made to subjects, the IRB reviews 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.
Recruiting Methods Requiring IRB Approval:
- Brochures, protocol summary cards
- Flyers, mailers, letters
- Printed ads in newspapers, magazines, journals
- News releases
- Radio and television announcements / interviews
- Web site / internet advertising / postings
- Classes, lectures, presentations
- Telephone Scripts
- And any other avenue in which potential subjects are exposed to information about the investigation.
The first contact prospective study subjects make is often with an individual who follows a script to determine basic eligibility for the specific study. This duty is frequently carried out by a study coordinator/clinical research coordinator.
If personal or sensitive information is gathered about the individual, the IRB should have assurance that the information will be appropriately handled. A simple statement such as "confidentiality will be maintained" does not adequately inform the IRB of the procedures that will be used. The actual methods used to maintain confidentiality should be clearly outlined. As previously noted, a copy of the script should be included in the request for IRB review. The acceptability of the procedures would depend on the sensitivity of the data gathered, including personal, medical, and financial information. All procedures and data gathering must conform with the HIPAA Privacy Rule (see IRB policy 8012.11 for more information regarding Protected Health Information).