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700-16-Screening Recruiting and Advertising for Research

Title: Screening, Recruiting, and Advertising in Research
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: information through oral or written communication with the prospective subject.The USU IRB may approve a research proposal in which an investigator will obtain information for screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the subject if the investigator obtains

Investigators must abide by the HIPAA Privacy Rule, when applicable (see 700-19: Privacy and Confidentiality).

The IRB will evaluate recruitment processes (including advertisements) to ensure an equitable selection of participants (and therefore, these materials must be included with the IRB submission). Additionally, the IRB considers advertising or soliciting for study 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.

The investigator must obtain IRB approval prior to the use of all television, radio, print advertisements, email solicitations, letters, websites, social media postings, instant messaging content, and other recruitment methods and materials intended for the recruitment of prospective research participants. This includes any sponsor-provided advertisements or investigator-drafted advertisements. Advertisements must be submitted to the IRB in their final form in order to receive IRB final approval for use.

The IRB adheres to the advertising guidelines included in the IRB Handbooks.

Purpose: The purpose of this policy is to detail requirements related to screening, recruiting, and advertising for research enrollment.

Procedures:

  1. Investigators must describe the plan for screening, recruiting (including any advertising materials), or determining eligibility in the initial submission to the IRB.
  2. If the posting of the materials will require approval from another entity (e.g., owner of a LinkedIn group, principal of a school), this approval must be included with the submission.
  3. Investigators must include any advertising materials in the initial submission to the IRB. Any advertising materials developed after IRB approval must be submitted via an Amendment Form.
  4. Changes in currently approved procedures for screening, recruiting (including any advertising materials), or determining eligibility must be submitted via Amendment Form to the IRB for approval prior to implementation.
  5. The IRB Chair or designee may review changes to approved procedures for screening, recruiting, or determining eligibility via expedited review (see 700-22: Expedited Review). Changes to advertising materials may also be reviewed via expedited review.

Scope: This policy applies to all research being reviewed by the USU IRB.

Documents and Forms: 

IRB Handbook - Doctoral Student Edition 

IRB Handbook - Faculty & Staff 

Amendment Form