Institutional Review Board (IRB)
- Types of Review
- Applications and Forms
- Continuing Review/Annual Renewal
- Final Reports
- BSU Human Subject Policy
- IRB Program Guide
- Definitions
- Guidelines for Researchers
- Training & Education - CITI Program
- IRB Contact Information
Continuing Review / Annual Renewal
Federal regulations (45 CFR 46.109 (e)) require the IRB to conduct a continuing review of research at intervals appropriate to the degree of risk, but not less than once per year. Therefore, the principal investigator is required to submit an annual renewal for IRB review and approval if the research will continue past the approved protocol’s expiration date. (The expiration date may be less than one year from the protocol’s approval date if the IRB determines an early review is appropriate to the degree of risk.)
The IRB cannot accept a renewal form after a protocol expires. There can be no “grace period” for a renewal after the expiration date of the protocol. The BSU IRB and Federal Regulations do not permit extensions of human subjects research projects beyond the IRB approval date.
The Office of Research Compliance will send out renewal reminders 60 and 30 days before the expiration of protocols applications, but it is the Principal Investigator’s responsibility to submit a renewal in a timely fashion. If the renewal form is not received by the expiration date, the protocol will be closed and a new protocol application must be submitted to continue research with human subjects.
Determining if Renewal is Required
If you are unsure if your protocol needs to be renewed, consider the following questions:
- Will future research activities involve obtaining data through intervention or interaction with human subjects?
- Will future research activities involve obtaining identifiable private information about living individuals? Information is identifiable if subjects can be identified directly or through identifiers linked to subjects. This includes any lists of participations that have not yet been destroyed.
- Will future research activities include analyzing identifiable private information about living individuals?
If you answered YES to any of these 3 questions, an Renewal Form must be submitted.
If you answered NO to all of the above questions, a Renewal Form is not required and a Final Report Form may be submitted.
