Annual Review

For non-exempt studies, the IRB was required to conduct substantive and meaningful continuing review of research no less than once per year. 45 CFR 46.109(e)(pre-2018)/45 CFR 46.109(e)(1/19/2017); 21 CFR 56.109(f); 21 CFR 56.108(a)(1); ICH 3.1.4.

The Revised Common Rule changes this requirement. Unless otherwise determined by the IRB, continuing review will no longer be required for expedited studies.

Despite no longer having to conduct a continuing review, other investigator responsibilities still remain.

To assist investigators with compliance, the TAMU-CC IRB will implement a short “annual check-in” process to assist the investigators with ensuring ongoing responsibilities.

Studies Required to Undergo Continuing Review:

• Full Board Studies

Studies Required to Undergo Annual Check-in:

• Expedited Studies (after January 21, 2019)

Studies where no annual review is required:

• Exempt Studies

Click to learn more about submitting an annual check-in

Click to learn more about submitting a continuing review