What is required for ongoing/continuing review of a previously approved social/behavioral study, and how often must it occur?

What is required for ongoing/continuing review of a previously approved social/behavioral study, and how often must it occur?

• A. Review must occur every five years.
• B. Continuing review is required only if there is a change in personnel.
• C. IRB continuing review at least annually for non-exempt research; progress reports; prompt reporting of adverse events and protocol changes; approvals must be renewed.
• D. No continuing review is required after initial approval.

Answer: (C)

Ongoing oversight of a previously approved social/behavioral study is handled through continuing review by the IRB. For studies that are not exempt, this review must occur at least once a year. The process involves the researcher submitting progress reports, and the IRB reviewing ongoing conduct to ensure it still aligns with the approved protocol, consent documents, and risk/benefit considerations. Researchers must promptly report adverse events or unanticipated problems involving risks to participants and notify the IRB of any changes to the protocol or consent materials, and any such changes typically require IRB approval before they are implemented. In short, non-exempt research requires annual continuing review and renewed approvals, with ongoing monitoring through progress updates and timely reporting of safety issues and protocol modifications. (Exempt research generally does not require continuing review.)

Ongoing oversight of a previously approved social/behavioral study is handled through continuing review by the IRB. For studies that are not exempt, this review must occur at least once a year. The process involves the researcher submitting progress reports, and the IRB reviewing ongoing conduct to ensure it still aligns with the approved protocol, consent documents, and risk/benefit considerations. Researchers must promptly report adverse events or unanticipated problems involving risks to participants and notify the IRB of any changes to the protocol or consent materials, and any such changes typically require IRB approval before they are implemented. In short, non-exempt research requires annual continuing review and renewed approvals, with ongoing monitoring through progress updates and timely reporting of safety issues and protocol modifications. (Exempt research generally does not require continuing review.)