Annual Review

The IRB is 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.

Forms

Sixty days before your expiration date, you will receive a notice that your Annual Check-in or Continuing Review is due. At the end of the notice you will find a link to your annual check-in or continuing review submission form. Click this link or copy the link into your internet browser to complete the annual check-in or continuing review form.

How to fill out Redcap Annual Check-in Form
Annual Review Frequently Asked Questions

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 not requiring continuing review include:

  • Studies determined to not be human subjects research
  • Studies determined to be exempt
  • Studies approved by limited IRB review
  • Expedited studies approved after January 21, 2019 and the IRB has not otherwise determined continuing review is required or
  • Expedited studies approved prior to January 21, 2019 that have been converted to 2018 Requirements
  • Full Board studies that have progressed to the point of one of the following:
    • Data analysis, including analysis of identifiable private information or identifiable biospecimens
    • Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care

Prior to the study’s annual anniversary, the Office of Research Compliance will send out an annual check-in form.

Investigators should take the time to review the form.

If the study remains current, then the annual check-in form is emailed back to the IRB and filed with the research record. No further action is required.

If the annual check-in indicates further action is needed, the investigator is required to complete that action. For example, if changes are needed to update study personnel, then the investigator must submit an amendment to make a personnel change (i.e., add or remove researchers).