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1. Application Submission and IBC Approval Process
2. Items Subject to IBC Review
3. Order of Review and Submission
4. IBC Membership at the University of Minnesota
1. Application Submission and IBC Approval Process
Q:Where should I send my completed IBC application form?
A:Submissions to the IBC should be sent electronically to ibc@umn.edu from the Principal Investigator’s University of Minnesota e-mail account.
Q: Do I need to send a hard copy of my submission with original signatures, as well as my electronic submission?
A: No, the IBC office is prepared to receive all documents electronically and in most cases, requires that correspondence is sent in an electronic format. Submissions must be transmitted directly from the Principal Investigator’s University of Minnesota e-mail account, as this is considered their electronic signature.
Q: Do I need to submit the Decontamination and Spill Clean-up Plan Template and the Biological Waste Disposal Template with my IBC application?
A: The IBC strongly recommends that you use the Decontamination and Spill Clean-up Plan Template and the Biological Waste Disposal Template when creating Standard Operating Procedures (SOPs) for management of accidental spills/exposure and waste disposal. Customization and submission of the templates will help to ensure that the committee receives sufficient information for review. The templates may be located at: http://www.dehs.umn.edu/Docs/WasteTemplate.doc and http://www.dehs.umn.edu/Docs/DecontaminationTemplate.doc
Q: When can I expect to hear from the IBC about the status my application?
A: You will receive an e-mail from the IBC within 48 hours of when your application is received. The e-mail will inform you of the IBC Code Number assigned to your application and that your application will be scheduled for the next available meeting.
Approximately 7-10 business days after your application is reviewed by the committee, you will receive additional electronic correspondence from the IBC outlining the results of the review.
Q: How long will the IBC approval process take?
A: If an application is received on or before a submission deadline, it will be reviewed at the next IBC meeting, which falls approximately two weeks after the deadline. The Principal Investigator will receive notice of the meeting results approximately 7-10 business days after the meeting. Projects that are assigned stipulations will take an additional amount of time, depending on how quickly the stipulations are met and when they can be reviewed, either by the Biosafety Officer or by the full committee.
Q: How should I respond to stipulations from the IBC?
A: Responses to IBC stipulations should be submitted electronically to ibc@umn.edu. Please submit your response in the form of a letter, addressing each point in the order in which they are presented in the stipulations letter from the IBC. Responses to stipulations should be attached as a Microsoft Word document or PDF and sent directly from the Principal Investigator’s University of Minnesota e-mail account.
Q: Should I submit a revised IBC Application with my response to stipulations letter?
A: The IBC prefers that you do not submit a revised application with your response to stipulations unless a revised application is explicitly requested in the stipulations.
Q: Does the IBC have a template I can use to write Standard Operating Procedures (SOPs) for my laboratory?
A: Department of Environmental Health and Safety (DEHS) offers guidance for writing SOPs on the Bio Basics Fact Sheet entitled, “Writing Standard Operating Procedures.”
2. Items Subject to IBC Review
Q: Does research that is exempt from the NIH Guidelines for Research Involving Recombinant DNA Molecules require IBC review?
A: Yes, the University of Minnesota Board of Regents Policy requires that University faculty, staff and students using any potentially hazardous biological agents (rDNA, infectious agents and/or biologically-derived toxins) in research or teaching activities apply to the IBC. Even if rDNA activities are exempt according to Section III-F of the NIH Guidelines, the activities must be reviewed by the IBC.
3. Order of Review and Submission
Q: In what order should I submit my IACUC and IBC applications?
A: There is no prescribed requirement for the order in which IACUC and IBC application are submitted; however, IACUC final approval will not be granted until IBC approval has been received. It is advisable to submit your IBC proposal either before or at the same time as when you submit your IACUC proposal to avoid delays.
Q: Can I submit a single application to be reviewed by the IBC and the IACUC?
A: No, separate applications must be submitted to the IBC and the IACUC in order to be reviewed. Although both the IBC and IACUC are housed in the RSPP, we are unable to accept a single application for multiple compliance committees at this time. RSPP is exploring options to move toward new types of forms in the future; however, we do not have the capability to accept a single form at this time.
Q: What is the RAC?
A: The RAC is the Recombinant DNA Advisory Committee, which issues recommendations to the NIH Director regarding recombinant DNA activities. The recommendations are conveyed through the NIH Office of Biotechnology Activities (OBA), which is responsible for the NIH oversight system of recombinant DNA research.
The RAC is also responsible for reviewing human gene transfer research on behalf of the NIH. Human gene transfer trials conducted at, or sponsored by, institutions receiving NIH funding for recombinant DNA research must be registered with NIH-OBA and be reviewed by the RAC. If a protocol raises novel or especially important scientific, safety or ethical considerations, it will be discussed by the RAC at one of its quarterly public meetings.
More information about the RAC may be located at:
Q: What are the requirements for human gene transfer review by the IBC?
A: The NIH Guidelines (Appendix M-I-B-1) require that no research participants be enrolled in a human gene transfer project until:
- The RAC review process has been completed**
- Institutional Biosafety Committee (IBC) approval has been obtained from the clinical trial site
- Institutional Review Board (IRB) approval has been obtained from the clinical trial site
- All applicable regulatory authorization(s) have been obtained.
** The RAC review process must be completed BEFORE the University of Minnesota IBC will review a human gene transfer project. Principal Investigators must submit the following materials to the IBC for review of a human gene transfer project:
- Completed Recombinant DNA and Artificial Gene Transfer Application Form
- A copy of the completed NIH Appendix M
- A copy of the NIH RAC review letter and comments
- A copy of the human subjects consent form
- Any additional items, as required by the Recombinant DNA and Artificial Gene Transfer Application Form
4. IBC Membership at the University of Minnesota
Q: How can I find out about becoming an IBC member?
A: If you are interested in becoming an IBC member, please contact the IBC office at (612)-626-5654 or ibc@umn.edu to be directed to the
appropriate person.
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