Does the IRB need to approve doctor-to-doctor letters?
– Site Activation Lead, CRO
We address this question in our WCG IRB Guide for Researchers. The guidebook can be downloaded here, under “Most Popular IRB Downloads” on page 43.
Essentially, in our Guide for Researchers, we advise that doctor-to-doctor materials follow the FDA Information Sheet. This states that: “Direct advertising includes, but is not necessarily limited to: newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects. Not included are: (1) communications intended to be seen or heard by health professionals, such as “dear doctor” letters and doctor-to-doctor letters (even when soliciting for study subjects), (2) news stories and (3) publicity intended for other audiences, such as financial page advertisements directed toward prospective investors.”
Based on this guidance, WCG IRB does not require prior IRB review of doctor-to-doctor letters, press releases, or interviews with the media and there is no need to provide WCG IRB with copies of these materials. However, if you like to have IRB review for such materials we will provide a review upon submission. Please note WCG IRB Policy on submitted press releases: WCG IRB reviews submitted press releases as advertising.