Extended Approval for Minimal Risk Research
Overview
UCSC’s Federalwide Assurance (FWA) allows some flexibility in applying federal regulations for human subjects research to non-federally supported human subjects research studies. As such, the UCSC Office of Research Compliance Administration (ORCA) and the UCSC Institutional Review Board (IRB) have implemented a procedure for utilizing yearly administrative check-in rather than setting expiration dates for human subjects research studies that:
- involve no more than minimal risk to subjects (as defined by 45 CFR 46.102), and
- are not subject to federal oversight.
ORCA reserves the right to make exceptions; inclusion/exclusion of any research project under this procedure will be at ORCA’s discretion.
Post-Approval Submission Requirements
Studies that are assigned an administrative check-in date will continue to have the same post IRB approval/exempt determination requirements. Principal Investigators (PIs) continue to be responsible for submitting:
- modifications to the study, which must receive IRB/ORCA approval before being implemented;
- reports of adverse events/protocol deviations/unanticipated problems/subject complaints, and other safety information meeting UCSC IRB reporting criteria; and
- a Renewal Submission 30-45 days prior to the study’s administrative check-in date;
- a Closure Submission when all activities involving human subjects described in the IRB-approved/exempt certified study are completed. This includes research-related interaction/intervention with subjects and analysis of identifiable private information (data).
Important: If new federal funding is secured during the approval period, the PI is responsible for promptly submitting a Modification Submission to ORCA.
If the study requires an expiration date because of new federal funding or other changes, the modification approval letter will include the expiration date.
Research That Will Receive Expiration Dates
Research Subject to Federal Oversight
Projects that receive federal support, that are implemented at the direction of federal agencies, or otherwise subject to federal oversight. Examples of federal oversight include:
- Federal sponsorship, directly or indirectly, including federal training and program project grants
- Research directed or overseen by a federal agency that has signed on to the Common Rule, including every agency within Department of Health and Human Services
- Student studies when the faculty advisor (PI) uses federal funding for the student’s project
- Federal no-cost extensions
- Studies subject to FDA regulatory oversight
- Studies involving Certificates of Confidentiality (CoC) issued by the National Institute for Health (NIH) or other federal funding agency
Studies That Involve Greater than Minimal Risk
- Studies with contractual obligations or restrictions that preclude eligibility in this policy, e.g., the nonfederal sponsor or funder of the research requires an annual review such as the American Cancer Society
- Studies in which UCSC is serving as IRB of record for an institution not mentioned above that requires annual review
- Studies involving prisoners or parolees as subjects
- Studies funded by the California Institute for Regenerative Medicine (CIRM)
