IRB Guidelines - Subject Recruitment and Advertising
Research projects often involve recruiting potential participants using a variety of methods. Some of the more commonly used recruitment methods include flyers, posters, brochures, media advertisements, recruitments letters and word-of-mouth recruiting.
Recruiting is part of the informed consent process; therefore the recruitment and advertising methods must be reviewed by the IRB prior to their use by an investigator. The review is done to ensure that the information is not misleading to subjects. The IRB is particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
It is also the responsibility of the IRB to determine that the procedure for recruitment is not coercive and that it accurately describes the likely risks and benefits of study participation. In addition, Federal Regulation states that selection of subjects must be equitable (45 CFR 46.111).
The following guidelines are intended to offer guidance to researchers in advertising and recruiting participants for their studies. These guidelines are consistent with requirements published by the U.S. Department of Health and Human Services.
- Advertising and recruiting procedures must protect potential participants' confidentiality.
- When obtaining the names of potential participants from third parties, the investigator must consider whether any breach of confidentiality or privacy laws has occurred. For example, doctors must contact their patients for written permission before releasing their names to a third party.
- Investigators are responsible for ensuring that approved procedures are followed by any third parties (e.g., therapists, teachers, or social-service providers) who may be aiding in the recruitment and/or advertising process.
- There are acceptable means of recruiting UMASS students or personnel via email (e.g., requesting permission from listserv masters to post a message to a group, obtaining permission from student organizations to send a message to their membership, obtaining permission from a department head or other authority to send a message to a select group of faculty or staff). The IRB does not generally support the use of wide-spread mass mailings to the campus community. All proposed methods of recruitment must be described in every protocol and approved by the IRB.
- Researchers may not share names of previous research participants with other researchers without permission from the participants.
- Advertisements must clearly state that volunteers are being recruited for research purposes.
- Advertisements must identify the study as a UMASS project and state the responsible contact person including phone number and/or email address. If research site has a web site address, include the web address.
- Advertisements must present the nature of the research and any potential benefits to the participants in ways that are not misleading or coercive.
- Advertisements recruiting children must explicitly state that parental consent is required for participation (unless the IRB has granted approval for a waiver of parental consent).
- Typically advertisements should include eligibility criteria.
- The IRB requires that a copy of the planned advertisement and the mode of its communication to ensure that advertisements do NOT:
- State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the informed consent form and the application/protocol.
- Make claims, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation.
- Use catchy words like “free” or “exciting.”
- Make claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic or device.
- Promise "free medical treatment" when the intent is only to say participants will not be charged for taking part in the investigation.
- Advertisements may state that participants will be paid, but should not emphasize the payment or the amount to be paid by such means as larger or bold type.
- The IRB must review and approve the final copy of printed advertisements in order to evaluate the relative size of type used and other visual effects.