Information to Be Submitted to NIH OBA

Information to Be Submitted by the PI to NIH OBA

The PI shall:

  • Submit information to NIH/OBA for certification of new host-vector systems.
  • Petition NIH/OBA, with notice to the Institutional Biosafety Committee, for proposed exemptions to the NIH Guidelines.
  • Petition NIH/OBA, with concurrence of the Institutional Biosafety Committee, for approval to conduct experiments specified in Sections III-A-1, Major Actions Under the NIH Guidelines, and III-B, Experiments that Require NIH/OBA and Institutional Biosafety Committee Approval Before Initiation.
  • Petition NIH/OBA for determination of containment for experiments requiring case-by-case review.
  • Petition NIH/OBA for determination of containment for experiments not covered by the NIH Guidelines.
  • Ensure that all aspects of Appendix M have been appropriately addressed prior to submission of a human gene transfer experiment to NIH OBA, and provide a letter signed by the Principal Investigator(s) on institutional letterhead acknowledging that the documentation being submitted to NIH OBA complies with the requirements set forth in Appendix M. No research participant shall be enrolled (see definition of enrollment in Section I-E-7) in a human gene transfer experiment until the RAC review process has been completed (see Appendix M-I-B, RAC Review Requirements); IBC approval (from the clinical trial site) has been obtained; Institutional Review Board (IRB) approval has been obtained; and all applicable regulatory authorization(s) have been obtained.
  • For a clinical trial site that is added after the RAC review process, no research participant shall be enrolled (see definition of enrollment in Section I-E-7) at the clinical trial site until the following documentation has been submitted to NIH OBA: (1) IBC approval (from the clinical trial site); (2) IRB approval; (3) IRB-approved informed consent document; (4) curriculum vitae of the principal investigator(s) (no more than two pages in biographical sketch format); and (5) NIH grant number(s) if applicable.
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