Following regulations issued by OHRP 45 CFR 46.110 and FDA 21 CFR 56.110, IRBMED commonly uses 'expedited review' procedures for initial and continuing review, and review of proposed changes, for research described by one or more categories on the 1998 list of Expedited Categories published at 63 FR 60364.
Category (8) applies to Continuing review of research previously approved by the convened IRB as follows:
- where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
63 FR 60364 also clarifies that Category eight (8) identifies three situations in which research that is greater than minimal risk and has been initially reviewed by the convened IRB, could undergo subsequent continuing review by the expedited review procedure.
OHRP Guidance on Continuing Review 2010 (section E.2) states, Under expedited review category (8)(a), OHRP interprets “long-term follow-up” to include:
- Research interactions 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
OHRP Guidance on Continuing Review 2010 (section E.2) also states, Under expedited review category 8(c), an IRB may use an expedited review procedure to conduct continuing review when the only remaining human subjects research activity is the analysis of data that includes identifiable private information and the IRB chairperson (or another experienced IRB member designated by the chairperson) determines that this activity involves no more than minimal risk.
FDA Guidance on Continuing Review 2012 (section D.1) does not suggest a stricter interpretation of 8(c).