Please define “digital” in the context of expedited review category 6.  Does “digital” include the voluntary collection prospective subjects’ identifiable data via a secure webpage platform when the only purpose of the platform is to inform interested potential research participants about available research studies?
– Director, state university IRB


If the screening activities you describe are solely for the purposes of creating a database of individuals who may be interested in future research opportunities and not created to facilitate recruitment for a specific clinical trial, then it may be reasonable to determine that the activity is not an investigation and therefore not research in and of itself as defined by HHS.  In that case, no prospective IRB review would be required under the HHS regulations. Because there is no test article, no prospective IRB review is required under FDA regulations. There may be local institutional policies that govern the creation of such systems, and this may include obtaining IRB approval.

If the database is being established for a specific clinical trial, then it may be considered part of the research and therefore require prospective approval by the IRB.  If the nature of the information being collected is minimal risk, then providing information for the purpose of consent could be incorporated into the website and the IRB could waive documentation.

Expedited review category six allows for the collection of data from voice, video, digital, or image recordings made for research purposes.  The regulations do not define “digital” in this context, but we can consider what would have been the intent of including digital in the same category as voice, video and image recordings, taking into consideration that this list was last revised in the 1990s. It would be reasonable to conclude that in this context that “digital” was intended to cover digital recordings as an alternative to recordings captured on audio or video tape.  The screening activities you describe do not appear to fall under expedited category 6.


Our experts answer your research ethics and oversight questions, and share the (anonymized) answers as a resource for our industry.