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Submissions to the IBC
What to expect when you submit a protocol for IBC review
All research and teaching activities at Indiana University involving recombinant DNA (rDNA) or synthetic nucleic acid molecules or any non-recombinant biological material that requires biosafety level 2 or higher containment 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 (Accessible 09/20/21)
- 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 it to 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 Office's Biological Safety Program for review.
Based on the date your submission was received, it will be added to an upcoming IBC meeting agenda. At the meeting, the committee will review your protocol and hear any reviewer comments and decide if any revisions are necessary. The committee will then vote on the protocol. Click here to see upcoming meetings and deadlines.
- 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.
- Disapproved: Your protocol submission is not approved and has not been recommended for further consideration by the IBC.
After the IBC meeting you will receive a notification from Kuali Protocols informing you of the committee’s vote and any necessary requested revisions. You will have one week to make the necessary revisions. Once you complete all requested revisions you will resubmit your submission through Kuali Protocols for further review. Reviewers have one week to re-review. If the reviewers find that additional revisions are required, they will submit their comments to 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. If your lab inspection meets all safety and containment requirements, your submission will be ready for final approval and the IBC Office will perform a final check for training completion. If all training is complete, the IBC Office will grant final approval and your work may begin.
Expedited review is required for all exempt research or teaching activities. Exempt research includes research that falls under section III-F of the NIH Guidelines, any research or teaching activities that involve biological materials that require biosafety level 2 or higher containment, 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 IU Environmental Health and Safety Office's 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. After their review is complete, you will receive a notification from Kuali Protocols informing you of that the submission is ready for your attention. You will have one week to make the necessary revisions. Once you complete all requested revisions you will resubmit your submission through Kuali Protocols for further review. The reviewer has one week to re-review. If additional revision is required, the reviewer will submit their comments to 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. If your lab inspection meets all safety and containment requirements, your submission will be ready for final approval. The IBC Office will perform a final check for training completion. If all training is complete, the IBC Office will grant final approval and 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