This SOP describes the process a WVU investigator must follow when screening and recruiting participants in human subject research and when advertising for their research projects.
2.1. WVU IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the participant or the participant’s legally authorized representative if either of the following conditions are met:
Investigators must abide by the HIPAA Privacy Rule, when applicable. (See SOP 036: Research Data Protection / Data and Safety Monitoring.)
2.2. The IRB will evaluate recruitment processes (including advertisements) to ensure an equitable selection of participants. Additionally, the IRB considers advertising or soliciting for participants to be the start of the informed consent process. Therefore, the IRB reviews proposed recruitment processes and advertisements to ensure that they do not violate the regulatory requirements of consent. Advertisements should be included as part of the initial protocol application.
2.3. The investigator must obtain IRB approval before the use of all television, radio, print advertisements, e- mail solicitations, letters, websites, social media, and other recruitment methods and materials intended for the recruitment of prospective research participants.
2.4. When advertisements are to be taped for broadcast, the IRB must review the final audio or video advertisement before approval. The IRB may review and approve the script of an advertisement before taping to preclude re-taping because of inappropriate wording. The review of the final recorded message prepared from the IRB-approved script may be conducted via expedited procedures (for protocols that required initial approval from the convened IRB).
2.5. When advertisements or recruitment materials are to be delivered electronically, a link to the electronic materials and a printable file containing the final materials must be submitted with the protocol application for review. This includes websites, and text for social media, email messages, etc.
2.6. Recruitment and advertisements sent using email must follow the University Email policy and consider if the electronic method can lead to identification of a prospective participant and if identification is a risk to the prospective participant related to the research protocol.
2.7. The IRB reviews “direct advertising for research participants” which is defined as advertising that is intended to be seen or heard by prospective participants to solicit their participation in the research. This includes any sponsor-provided advertisements or Investigator-drafted advertisements.
2.8. Advertisements must be submitted to the IRB in their final form to receive IRB final approval for use.
3.1. Investigators should describe the plan for screening, recruiting, or determining eligibility in the initial research proposal.
3.2. Any advertising materials should be attached in the initial protocol application. Any advertising materials developed after IRB approval should be submitted as a modification to the approved protocol.
3.3. IRB review and approval for additional advertisements or changes in currently approved screening, recruiting, or advertising must be submitted in the form of an amendment to the IRB for approval prior to implementation (for expedited or full board studies only).
3.4. The IRB Chair or designee may review changes to approved screening, recruiting, or advertising by expedited means. However, the Chair or designee may refer the advertisement to the full, convened IRB if the IRB reviewer has doubts or other complicated issues are involved.
Federal Regulations:
21 CFR 50.20
21 CFR 56.111(a)(3)
21 CFR 56.111(b)
45 CFR 46.116(g)
AAHRPP:
Element II.3.C.1
