Continuing Review FAQ Updates

The IRB has added new guidance on the Continuing Review FAQ page: https://irb.upenn.edu/homepage/faqs/continuing-review-faqs.

The new guidance is entitled, “What constitutes long-term follow up?” Please utilize this guidance when answering Section III of the continuing review form.

This guidance is pulled from OHRP’s Continuing Review Guidance (2010), and clarifies how the IRB defines “long-term follow-up” in continuing review submissions.

 

Long-term follow-up excludes: “Research interventions* [i.e., procedures] that would not have been performed for clinical purposes (standard care), even if the research interventions involve no more than minimal risk.” If research specific procedures are being conducted, participants are not considered to be in long-term follow up, as defined by OHRP’s Continuing Review Guidance.

*An intervention, as described in 45 CFR 46.102(e)(2), is defined as:
• “Physical procedures by which information or biospecimens are gathered (e.g., venipuncture);
• Manipulations of the subject or the subject’s environment that are performed for research purposes.”

Long-term follow-up includes:
• “Research interactions [45 CFR 46.102(e)(3) Communication or interpersonal contact between investigator and subject] that involve no more than minimal risk to subjects (e.g., quality of life surveys); and
• Collection of follow-up data from procedures or interventions that would have been done as part of routine clinical practice to monitor a subject for disease progression or recurrence, regardless of whether the procedures or interventions are described in the research protocol.” (i.e., collection of follow-up data from the medical record such as survival follow-up)