A compilation of information, announcements, & updates for UK Institutional Review Board (IRB) members, research investigators, & others involved with human subject research.
Revised Common Rule: Efficiencies Experienced
Two provisions of the Revised Common Rule Regulation are just now being experienced by Researchers and IRB Members.
Annual Administrative Review – Protocols approved under the January 21, 2019 revised common rule are just now coming up for annual review; instead of regular continuing review submission, non-FDA Expedited studies qualify for an abbreviated annual review dubbed Annual Administrative Review (AAR). AAR consists of only four questions and keeps communication open regarding study and enrollment status, while limiting information to what is adequate for minimal risk research. See Sample AAR forms.
Closure criteria –if accrual is finished, all data collection is complete, and the only remaining activity is data analysis, non-FDA regulated studies approved after January 21, 2019 are eligible for closure even if the data has identifiers. The identifiable data should be secured (e.g., encryption), to prevent a breach of confidentiality during analysis. Contact your department or campus information security for guidance. For additional information see Study Closure on the IRB Survival Handbook.
Road to Re-accreditation
The next step in the re-accreditation process has been confirmed. Representatives of the Association for Accreditation of Human Research Protection Programs (AAHRPP) will conduct a site visit at the University of Kentucky on February 25-26, 2020.
AAHRPP will randomly select and interview researchers, staff, IRB members, and others involved in human subject research. Individuals selected for interviews will be notified as soon as AAHRPP finalizes their agenda. See the ORI AAHRPP Website for Questions of the Week, Training Materials, and Updated Policies.