IBC Protocol Submissions and Review

Protocol Pre-Review, the IBC Administrator, serves as a conduit between the reviewers and committee before and after the IBC review. Pre-Review focuses on the required training of personnel, enrollment in the OHP (BSL3/ABSL3 workers), grammatical and typographical errors, and compliance with institutional IBC policies and guidelines. If applicable pre-review comments and/or suggestions are emailed to the Principal Investigator before committee review.

Full Committee Review is the standard process for new IBC submissions that fall under specific NIH guidelines and must be reviewed by the IBC at a convened meeting. Suppose the protocol falls under NIH guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. In that case, a majority (quorum) of IBC committee members conduct an in-person meeting. The protocol is shared with all committee members for review and discussion. Following protocol review, the primary reviewer motions to the committee for one of the following actions: Approve, Require Modifications (to secure approval) or Withhold Approval.

Online Full Committee Review is a protocol that does not make use of recombinant DNA materials. A majority (quorum) of IBC committee members conducts a Full Committee review online through IRBNet.

Chair Review the IBC chair reviews Biosafety Level 1 or exempt rDNA research. The Chair will notify the Investigator in writing of the determination of their review. If the research is not significantly modified, no additional action is required of the Investigator or the IBC. *Note: If a new Investigator is conducting exempt BSL-1 research, a new laboratory inspection is not necessary.

IBC and work with other committees if there is a need for review by other compliance committees, such as IRB and IACUC, the IBC will work with the other committees to ensure those approvals are in place. IBC approval does not supersede or waive the requirement for independent review by other research compliance committees. To help expedite the review and approval process, reviews between committees are recommended in parallel. *Note: Any work begun before receiving IACUC or IRB approval violates federal law and jeopardizes all research.

Approved once a project is approved by a majority vote (a quorum), the PI is notified by electronic letter that their project is approved, and research activities may begin.

Modifications Required (to secure approval) a detailed memorandum is sent to the PI describing the required changes. The PI must address all comments and revise the protocol accordingly. The subsequently modified protocol is reviewed using the Designated Member Review (DMR) process. However, if during the DMR process, a member requests FCR of the revised protocol, the modified protocol will be reviewed at the next convened meeting.

Withhold approval if a majority vote (a quorum) of members withholds approval, a detailed memorandum is sent to the PI that describes the changes required before approval can be granted. The PI can address the necessary changes and resubmit the protocol as a new submission. The protocol will be reviewed at the next convened meeting.

Three Year IBC Renewal Investigators, who wish to continue their work beyond the third year of the protocol, must submit a renewal form. At 30, 60, and 90 days, the Investigator will receive an IRBNet email message about project expiration status. Three-year renewals are done through IRBNet. Renewal forms are located under Forms and Templates in IRBNet.

Amendments such as personnel changes, adding cell lines, protocol title, changes to approved protocol sections and change of PI, etc. require an amendment. Once amendments are submitted, the IBC administrator will determine if the amendment falls under administrative review or full committee review.

Protocol Closures normally the IBC Administrator reaches out to the Investigator before the protocol expires and inquires if the protocol should be closed or if the work will continue. The Investigator also has the option of letting the protocol expire naturally or request closure of the protocol by contacting the IBC Administrator.