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.

**Announcement: Starting in February 2025, IBC protocols will be managed in SciShield. You can access the User's Guide here. To schedule a system walkthrough, feel free to contact Nat, an IBC Administrator at ibc@rice.edu.**

Follow this link to log into the SciShield system: https://rice.scishield.com/

1. Submit Required Documents

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 in SciShield (Biological Profile)

• Starting in February 2025, we will begin using SciShield for submitting and reviewing IBC protocols.
• Follow this link to log into the SciShield system: https://rice.scishield.com/
• Click here to open the full PDF: User's Guide for Managing and Submitting IBC Protocols in SciShield.

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.

*IBC Review Information

Click here to access the Standard Operating Procedure (SOP) for IBC Protocol Review for the protocol review process, including information required for review, how risks are assessed, mitigation strategies, training, the potential outcomes of review, how the review outcome is communicated to the protocol's PI, and the process for appealing an IBC decision.

If you have any questions or concerns, please contact the IBC Administrator at ibc@rice.edu or call (713)348-4844.