Announcement - MUST READ - Memo from IO to PIs Regarding Expired Studies
The University of Maryland, Baltimore’s Human Research Protection Program (HRPP) underwent its Association for Accreditation of Human Research Protection Programs (AAAHRP re-accreditation review this week. Thank you to those that participated in the virtual site visit.
During AAAHRP’s review of UMB’s HRPP, UMB was found to have expired approvals for Human Subjects Research requiring approval and/or continuing review by the Institutional Review Board (IRB). Maintaining IRB approval for any human subjects research study is the sole responsibility of the Principal Investigator. (See the Principal Investigator Manual (pages 17-18) and HRPP Plan).
As a reminder, conducting research activities on an expired protocol is against federal regulations.
DHHS regulations at 45 CFR 46.109(e) and FDA regulations at 21 CFR 56.109(f) require that an IRB conduct continuing review of research at a frequency determined by the IRB to ensure the continued protection of the rights and welfare of research subjects. The expiration date is the first date that the protocol is no longer approved.
All research activities must cease upon expiration of approval and may not resume until and unless the IRB approves the study.
For all expired studies:
- Research activities, including enrollment, study interventions, data collection, and data analysis must cease; and
- Report any research activity that occurred after expiration to the IRB.
If the cessation of all or any research activities could reasonably jeopardize the health or safety of a participant, the PI must:
- Consult with the IRB Chair to determine if continuing an intervention is in the best interests of currently enrolled participants;
- Obtain approval by the IRB Chair to perform specific interventions or interactions that are in the best interest of currently enrolled participants; and
- Submit a CR through CICERO for the expired study within five (5) calendar days.
All expired human subjects research studies must be rectified immediately. The Human Research Protections Office is available to assist and can be reached at 410-706-5037.
Thank you for your ongoing commitment to the welfare of the individuals that participate in UMB research.
Sincerely
Dr. Susan C. Buskirk, DM, MS, CCEP
Vice President
Chief Accountability Officer
Institutional Official