Federal regulatory agencies view media relations material as a form of participant recruitment and an element of the informed consent process. Media relations material includes press releases, scripted broadcasts, non-scripted interviews, or information distributed on the Internet.
If a current participant in an ongoing study will participate in a non-scripted interview, the Principal Investigator (PI) must submit their completed Media Relations Permissions Form (HRP-516) with their completed Media Relations Form (HRP-216) within an eIRB+ submission for IRB review and approval.
- HRP-216 - Media Relations
- Step-by-step instructions, including which offices to contact and what materials the PI must submit to the IRB for approval, are within HRP-216.
- HRP-516 - Media Relations Permission Form
- The participant should sign the IRB-approved version of HRP-516 before their interview.
When to submit the Media Relations Form and accompanying materials to the IRB
- When the material pertains to a study that is currently approved by the Northwestern IRB, this may be when Northwestern University is a site, or its affiliates, or a site where Northwestern is serving as the IRB of record;
- When the activity involves a non-scripted interview of a study participant who is currently enrolled and actively participating in the research study. The Media Relations Permissions Form (HRP-516) must be submitted with the Media Relations Form (HRP-216) for IRB review within an eIRB+ submission. Once the submission receives IRB approval, the participant should sign the IRB-approved Media Relations Permissions Form.
The PI should inform the study participant that the study data is still being collected or analyzed and avoid making statements claiming the efficacy of the investigational product or referring to it as a treatment.
The Northwestern University Media Relations contact will provide the participant with a Multimedia Release Form to sign, granting Northwestern University and its agents the right to record the participant’s appearance and participation on videotape, audiotape, film, photograph, or any other medium. Please refer to the Multimedia Release Form for additional information.
When the Media Relations Form and accompanying materials do NOT need to be submitted to the IRB
- When the material is unrelated to a media relations activity. All materials aimed at recruiting participants into a research study require IRB approval but may be submitted to the IRB without this form.
- The material pertains to a study whose closure has been approved by the Northwestern University IRB.