The IRB reviews study recruitment methods (including advertisements and payments) to evaluate whether they will affect the equitable selection of participants, and to ensure that the proposed methods adequately protect the rights and welfare of participants.

The protocol document or application must include a description of the following: (1) the source of subjects for all study groups (intervention/case and control); (2) when, where, how, and by whom these potential subjects will be recruited; (3) the methods employed to identify potential subjects; and (4) the materials used to recruit subjects, including the use of email and text messaging. If this is a multi-center study in which subjects are recruited by methods not under the control of the local site, e.g., call center or national advertisements, describe those methods.

The IRB must review and approve the content of all recruitment and advertisement materials, including oral communications, before implementation. For guidance on what to include in an advertisement, refer to the “Preparing Recruitment Materials” section as well as HRP 315-WORKSHEET-Advertisements.

These guidelines apply to all research studies that will identify and recruit participants. For guidelines specific to recruiting in a clinical health care setting, refer to the “Clinical Recruitment Guidelines” section.

• Advertising and recruiting procedures must protect potential participants’ confidentiality. In particular, names and contact information for potential participants must be collected and maintained in a confidential manner.
• When obtaining the names of potential participants from third parties, you 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.
• You 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 to professionals in exchange for referral of potential participants (“finder’s fees”) and payment tied to the rate or timing of enrollment (“bonus payments”) is prohibited.
• If a researcher plans to use snowball sampling to recruit participants, the participant population should be considered. For example, for certain populations, just providing a name or contact information to the researcher could present a risk to the potential participant. In these situations, the researcher could instead provide a business card to a participant with the directive “I am looking for others who may be willing to talk with me. If you know of anyone, please ask them to contact me, using this information.”
• You may not share names of previous research participants with other researchers without permission from the participants.
• The number of times a study team can attempt to contact participants is study dependent and the appropriateness of that number will be assessed by the IRB.
• Email and text messaging, while convenient methods for contacting subjects, are not considered secure methods for communicating sensitive or health related information. The email recruitment guidelines section outlines security measures for communicating with subjects via email. These same principles should also be used when communicating with subjects via text message. Both communication methods and the protections in place to minimize security risks must be described to the IRB as part of the review process.
  • When recruitment materials invite subjects to express interest in participation in a study involving sensitive or health related information via email, the following email disclosure language should be included on the research materials:
    • Email is generally not a secure way to communicate sensitive or health related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email. Email should also not be used to convey information of an urgent nature. If you need to talk to someone immediately or would prefer not to receive study communication by email, please contact [Name, Title, Phone Number].