IRB Guideline III - Subject Recruitment and Advertising
Many research projects involve recruiting potential participants by advertising in newspapers, on bulletin boards, or through other media. Participant recruitment may also involve contacting individuals listed on rosters provided by organizations. Such advertising and recruiting is part of the research procedure, and investigators should keep in mind that these procedures are subject to approval by the IRB and should not proceed until approval is granted.
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. In particular, names and contact information for potential participants are to be collected and maintained in a confidential manner.
- 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. Payment in exchange for referral of potential participants and payment tied to the rate or timing of enrollment ("bonus payments") is prohibited.
- Investigators are advised that Penn State Policies AD20 ("Computer Network and Security" particularly item "f" under "System Users") and AD56 ("Use of Group Communication Tools to Communicate University Business to Employees and Students") prohibit unsolicited group e-mailings to faculty, staff, and students. Recruitment of research participants by unsolicited group e-mailings ("spam") is against University policy. Exceptions to these policies may be considered on a case-by-case basis by the Center for Academic Computing.
- There are acceptable means of recruiting Penn State 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).
- 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 Penn State project. They should also identify a responsible contact person and a means of contacting this person (phone number and/or email 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.
- If applicable, advertisements should include eligibility criteria.
- When advertisements are to be taped for broadcast, the IRB needs to review the final audio/video tape. The IRB can review and approve the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording. The review of the final taped message prepared from IRB-approved text may be accomplished through the expedited procedure.
The IRB requires that a copy of the planned advertisement and the mode of its communication be submitted with all applications for review and approval to determine that the procedure for recruiting participants is not coercive and to assure that advertisements do not:
- a. State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the informed consent form and the application/protocol.
- b. Make claims, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation.
- c. Make claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic or device.
- d. Use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational.
- e. Promise "free medical treatment" when the intent is only to say participants will not be charged for taking part in the investigation.
- f. 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.
Approved: Social Science IRB: February 15, 2007; Biomedical IRB: February 15, 2007
- Last Approved: Feb 15, 2007