IBC Protocol Submission & Review

Before research begins, investigators must:

• Determine whether the research is subject to Section III-A, III-B, III-C, III-D, or III-E of the NIH Guidelines.
• Propose physical and biological containment levels in accordance with the NIH Guidelines when registering research with the IBC.
• Propose appropriate microbiological practices and laboratory techniques to be used for the research.
• Submit a research protocol to the IBC for review and approval.
• Seek NIH OSP’s determination regarding containment for experiments that require case-by-case review.
• Petition NIH OSP, with notice to the IBC, for proposed exemptions from the NIH Guidelines.
• Obtain IBC approval before initiating research subject to the NIH Guidelines.
• Seek NIH approval, in addition to IBC approval, to conduct experiments specified in Sections III-A and III-B of the NIH Guidelines.

1. Submit Required Documentation

A. Environmental Health and Safety (EHS) should be contacted for training requirements and further instruction. For research involving recombinant or synthetic nucleic acids, both of the following training courses must be completed by all personnel on the protocol.

• General Laboratory Safety Training
• Biosafety and Bloodborne Pathogens Training

B. Complete the appropriate protocol application available on Research Compliance System (RCS):

C. If the protocol is working with animals, an approved IACUC protocol is also required.

D. If the protocol involves use of human research subjects or identifiable human biospecimens, an approved IRB protocol is also required.

2. Protocol Draft Review

Pre-Review is conducted by an IBC Compliance Administrator, and a member of Environmental Health and Safety (EHS). The pre-review may involve requesting revisions, clarifications, and modifications to the protocol before review by the IBC Chair or IBC Committee. Required training will be verified for completion.

3. Committee Review

The IBC reviews projects by Full Committee Review (FCR).

4. Communicate Outcome

Utilizing the electronic protocol system, the IBC will notify investigators in writing of its decision to approve or withhold approval of protocols, or when modifications are required to secure IBC approval.

If you have any questions or concerns, please contact the IBC Compliance Administrator.