September 2005

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [authors of the Belmont Report] identify the equitable selection of subjects as one of the major ethical principals. Federal regulations (45 CFR 46.111) also state that the selection of subjects must be equitable. Recruitment of study participants is considered the beginning of the research process. For this reason, the Institutional Review Board (IRB) must consider all recruitment materials and methods used for recruitment purposes before they are implemented.

Some commonly used materials for recruitment include flyers, posters, brochures, press releases, or advertisements. Distribution of materials may occur via bulletin boards, newspaper, TV, radio, or websites. Recruitment letters and announcements or presentations made at various meetings are still another form of advertising.

The Food and Drug Administration (FDA) Information Sheet: Recruiting Study Subjects presents the following guidelines for study advertisements:

• Name and address of the Principal Investigator;
• Purpose of the research
• Inclusion/exclusion criteria
• A brief list of study procedures
• Time or other commitment required (e.g., number of study visits)
• Compensation or reimbursement
• Location of the research
• Contact person for further information

In other words the information must be adequate, accurate and balanced so that potential participants can make an informed decision about possible participation.

The method must also be taken into account and receive IRB approval prior to implementation. For example, recruitment materials such as flyers or posters are often placed in strategic locations or distributed in order to target a specific population. Where recruitment materials are placed and how materials are distributed are just as important as the material itself.

Another issue related to method of recruitment is the ‘who’ of recruitment. In certain situations, the Investigator may not be the best individual to recruit, as s/he may unduly influence an individual to participate (e.g., teachers recruiting students, employers recruiting employees) particularly if the Investigator has direct supervisory oversight over these individuals.

The next issue to consider is the ‘when’ of recruitment. The time at which an individual is approached should be convenient and not increase an individual’s anxiety level. Presenting research studies in advance and allowing potential participants time to review the consent and recruitment material is paramount to good recruitment practices.

The Principal Investigator is key to the development of recruitment materials that are appropriate and adequately describe the study. Institutional Review Board approval must be obtained for both recruitment materials and procedures prior to implementation. Questions to ask oneself include: ‘what’ materials will be used, ‘how’ will recruitment procedures be performed, ‘who’ will perform the recruiting procedure, ‘when’ will recruitment occur, and ‘where’ will the activity take place.

*Homer, R. Krebs, R. & Medwar, L. (2002). Advertisements for Research. In R. J. Amdur and E. A. Bankert (Eds.), Institutional Review Board Management and Function (pp. 179-184). Sudbury , MA : Jones and Bartlett.