Is IRB review required when linking to clinicaltrials.gov postings on patient advocacy websites and newsletters?

Question:

Is IRB review required when providing a link to clinicaltrials.gov postings on patient advocacy group websites, and newsletters? Is IRB approval required before they can be posted? If so, is central IRB review enough or if an institution uses local IRB, must they also approve?

Response:

Recruitment materials such as websites, newsletters, advertisements, brochures intended to be used to recruit subjects into the study are considered part of the informed consent process and require review by the IRB. Based on FDA guidance, if you are providing just a link to the CT.gov listing, reposting or providing a paper copy of the original CT.gov listing, then IRB review is not required.

If you are using a central IRB and the generic recruitment materials have been approved by the central IRB but are being adjusted with the site-specific details (names, contact information, etc.), the study specific materials used at each site require IRB review. If the site is relying on the central IRB for the oversight of the study at their site, the submission can be added via an expedited review by the IRB as soon as the site is approved by the IRB.

If a central IRB has reviewed and approved recruitment materials for some sites but a specific site is being overseen by a local IRB, then that local IRB must also approve the materials for that site; that is, the IRB responsible for that site must review and approve the materials. The central IRB approval can’t be applied to all sites.