IRB Application: Other Required Committee Review/Approvals

Section 7
FORM EE.   Institutional Biosafety Committee (IBC)

If your research involves recombinant DNA, infectious agents, and/or human gene transfer/therapy products, the Institutional BioSafety Committee (IBC) will need to review and provide provisional approval for your research prior to submission of your IRB application to the IRB (Please note, SOME vaccine trials also require IBC review and approval. You may contact the Biological Safety Officer to help you make that determination, 859-257-1049).

In the space provided on the General Information Sheet [Section 1, Form A] provide the IBC # given to you, and indicate the date of IBC approval.

If your research requires IBC review, you will need to submit with your IRB application an IBC packet consisting of:

1. the IBC provisional approval letter;
2. Part 3 "Additional Site Specific Information" from the IBC application; and,
3. only the following completed sections from NIH's Appendix M:
   • M-II-A-1 (purposes);
   • M-II-B-3 (procedures and monitoring);
   • M-II-B-4 (public health considerations);
   • M-II-C (subject selection);
   • M-III (informed consent);
   • M-IV (privacy);
   • M-V (special issues).

If any of these materials are missing from your submission, your IRB application will be returned to you.

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