Video & Audio Recruitment Guidelines

The IRB is required to ensure that appropriate safeguards exist to protect the rights and welfare of humans participating in research.

Regulatory bodies consider direct advertising for study participants to be the start of the informed consent and participant selection process. USC requires all direct recruitment tools intended to be seen or heard by prospective participants to be approved by the IRB prior to use for non-exempt (expedited and full board) applications. Decisions on whether taped audio/video recruitment materials will require review by the IRB.

Prior to distributing video or audio recruitment materials USC’s Media Relations should be consulted. A Media Release may be required to be executed. The contact information for USC’s Media Relations office is at the end of this document.

If Protected Health Information (PHI) is accessed/utilized for participant testimonials, compliance with the Health Insurance Portability and Accountability Act (HIPAA) may be required. Office of Culture, Ethics and Compliance (OCE&C) for guidance. The contact information for OCE&C is at the end of this document.

Recruitment of participants to give testimonials and recruitment of potential participants must be equitable and include racial, ethnic, educational, socioeconomic, and gender identity diversity appropriate to the condition that is studied. All recruitment methods must respect rights to privacy and confidentiality of all prospective participants.

NOTE: Regardless of the risk determination or approval type all recruitment guidelines should be adhered to.

The radio/television/video recruitment script must be informative, explanatory, and contain useful information about the study. The language in the recruitment tool should reflect the language in the approved protocol and Informed Consent Form or Information Sheet and may include the following:

• Name and contact information of the investigator and facility
  • Including university affiliation and/or department
  • USC email address must be utilized
• Accurate description of the research purpose
• A statement that participation in the study is voluntary
• Condition under study and/or purpose of the research
• Eligibility criteria
• Basic overview of study procedures, including the time commitments required
• Location of the research
• Compensation (should not stand out from the surrounding text)

The following information should NOT be used in recruitment materials:

• Coercive, persuasive, or exculpatory language
• Claims that a device, drug and/or intervention is safe and/or effective
• Statements or implications assuring favorable outcome(s) or other benefits beyond what is outlined in the consent document and protocol
• The words “new treatment,” “new therapy,” “new medication,” “new intervention,” or “new drug” if the research is investigational
• The use of the word “free,” including promises of “free medical treatment “or “free treatment”
• Claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic, device, therapy, or intervention
• Non-USC email addresses (Google, Yahoo, etc.)

Researchers should be aware that there is a power dynamic that exists between the researcher and participant. Researchers should recognize that when they ask participants to act as recruiters, they may feel obligated to do so because of their study participation and feeling that they owe something to the researcher.

The recruitment section of the study protocol document must clearly describe the testimonial including:

• Description of attestants (participants, actors, etc.) 
  • Criteria for identifying potential attestants
  • If research participant, instructions for withdrawal of testimony
  • When the invitation to attestants will be presented to them
• Instructions for attestant(s), including language restrictions
• Anticipated length of testimony
• Whether/which research data will be shared with event holders
• Website address where the testimonial will be placed, if applicable
• Description of the event/organizer, if applicable

The consent document(s) must:

• Fully describe the use of testimonies, including 
  • A description of event/organizer/platform
  • The anticipated length of testimony
• Indicate whether research data will be shared with event holders
• Include a statement that participation in testimonies is voluntary and participation in the study is not contingent on providing testimonials
• Include a statement that participants can change their mind at any time
• Include instructions of what can and cannot be said
• Include instructions for withdrawing testimony
• Include two checkboxes in the signature section
  • I agree to participate in the testimony
  • I do not agree to participate in the testimony

Media Relations Contact

Emily Gersema, Executive Director
Media Relations
Email: gersema@usc.edu
Phone: 213 712 3168

Office of Culture, Ethics and Compliance Contact

Email: compliance@usc.edu
Phone: 213 740 8258

Credits

• University of Kentucky
• University of Virginia
• FDA
• OHRP
• https://hrpp.usc.edu/wp-content/uploads/sites/3/2022/06/Guidance-and-Requirements-for-Recruitment-Letters-and-Emails-for-Potential-Human-Subjects-Identified-from-Electronic-Health-Records.pdf