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Submissions to the IBC
What to expect when you submit a protocol for biosafety review
All research and teaching activities at Indiana University involving recombinant DNA (rDNA) or synthetic nucleic acid molecules or any non-recombinant Biosafety Level 2 or higher biological materials must be reviewed by the Institutional Biosafety Committee (IBC) prior to beginning the work and reviewed annually after the work begins.
The committee reviews ensure that:
- you are conducting your work using the appropriate microbiological practices and laboratory techniques.
- you are conducting work in an appropriate location with adequate containment and personal protective equipment.
- biological materials are being stored and handled in accordance with relevant regulatory standards and with utmost safety in mind.
- you meet the requirements to act as a principal investigator (PI) on an IBC Protocol. Read the PI policy.
- all lab staff have sufficient knowledge and are sufficiently trained to safely perform the responsibilities for which they have been assigned.
The review process
All Institutional Biosafety Committee protocols will undergo administrative pre-review by IBC office staff for completeness and clarity. If the IBC office finds significant issues with your submission, you will have the chance to resolve those issues before your protocol is assigned to a reviewer.
Based on the information in your protocol, the IBC office will determine which type of review your protocol will receive, full committee review or expedited review.
Full committee review
Full committee review is required for all non-exempt research. Non-exempt research is any research that falls under sections III-A through III-E of the NIH Guidelines. When you submit a protocol that involves non-exempt research, the IBC office will add it to the agenda of an IBC meeting and assign reviewers. Protocols must be received two weeks prior to an IBC meeting to be considered for review that month.See upcoming meetings and deadlines
Full committee review process
- Primary and secondary IBC reviewers
Assignment of primary and secondary reviewers is based on the nature of the research described in your protocol and the expertise of the IBC members.
- Biological Safety reviewer
All protocols are also assigned to a member of the IU Environmental Health and Safety - Biological Safety for review.
- Primary and secondary IBC reviewers
After reviewing your protocol, each reviewer will prepare a sheet with requested revisions or questions for the PI. At the IBC meeting, the reviewers will present a summary of the protocol submission to the committee along with any requested revisions they would like made and their recommendations for approval status. The IBC will vote on your new protocol based on the reviewer recommendations.
- Approved: Your new protocol submission satisfactorily addressed all issues and the submission is fully approved. No modification is necessary on your part.
- Provisionally Approved: Your new protocol submission has minor issues that must be addressed. Your revised submission is reviewed and may be approved outside of full IBC.
- Tabled: Your new protocol submission has significant issues that require full IBC review following your response to the requested revisions.
- Rejected: Your protocol submission is not approved and has not been recommended for further consideration by the IBC.
After the IBC meeting the IBC office will compile and forward all requested revisions to you. You will have one week to make the necessary revisions. When you complete all requested revisions and return your revised protocol to the IBC office, it will be forwarded to the reviewers for review and approval. The reviewers have one week to re-review. If the reviewers find that additional revision is required, they will submit an updated revisions sheet, which will be forwarded to you by the IBC office. This process will continue until all necessary revisions have been made.
Once all reviewers agree that your protocol is ready for approval, the Biological Safety reviewer will contact you to schedule a lab inspection, if necessary. After the lab inspection, the Biological Safety reviewer will sign off on your protocol and return it to the IBC office. It will then be signed by the primary reviewer. Once all reviewers have signed your protocol, the IBC office will perform a final check for training completion. If all training is complete, the IBC office will grant final approval and notify you that your work may begin.
Expedited review is required for all exempt research or teaching activity. Exempt research includes research that falls under section III-F of the NIH Guidelines, any research or teaching activities that involve Biosafety Level 2 or higher biological materials, or teaching activities that involve rDNA or synthetic nucleic acid molecules regardless of biosafety level. When you submit a protocol that involves exempt research or teaching activities, the IBC office and the Environmental Health and Safety - Biological Safety Program will review the work.
Expedited review process
All exempt research or teaching protocols are assigned to a Biological Safety reviewer. If that reviewer determines the protocol is not truly exempt or has concerns about the work, the reviewer may request that the protocol be given full committee review. There is no deadline for expedited review; exempt protocols are reviewed as they are received.
The Biological Safety reviewer has one week to perform the review. The reviewer will prepare a requested revisions sheet, which will be forwarded to you by the IBC office. You will have one week to make the necessary revisions. When you complete all requested revisions and return your revised protocol to the IBC office, it will be forwarded to the reviewer for review and approval. The reviewer has one week to re-review. If additional revision is required, the reviewer will submit an updated revisions sheet, which will be forwarded to you by the IBC office. This process will continue until all necessary revisions have been made.
Once the reviewer determines that your protocol is ready for approval, the reviewer will contact you to schedule a lab inspection, if necessary. After the lab inspection, the reviewer will sign off on your protocol and return it to the IBC office. The IBC office will perform a final check for training completion. If all training is complete, the IBC office will grant final approval and notify you that your work may begin.
Managing your protocol
Avoid protocol noncompliance
Be sure to follow the terms and conditions of your approved protocol. Noncompliance can lead to temporary or permanent suspension of the activity, more frequent laboratory inspections or monitoring, additional training of personnel, removal of personnel or animals from the protocol, or suspension of funding.
Examples of noncompliance include, but are not limited to:
- beginning research projects without IBC approval
- unlisted personnel involved in a protocol
- failure to complete required training
- use of unapproved biological materials
- conducting unapproved procedures
- working in an unapproved research location
- improperly disposing of biological materials
Protocol deviations, noncompliance, and other situations that may impact subject safety, confidentiality, information security, privacy, etc., are known as reportable events.Learn more about reportable events