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Institutional Biosafety Committee

New Study

Review Process:
Full Committee Review

  1. Primary/Secondary IBC reviewers

    A primary (IBC member) and secondary (BSO representative) reviewer will be assigned to each new protocol submission by the IBC administrator approximately two weeks prior to the regularly scheduled IBC meeting. (See the Deadlines & Meeting Dates page for exact dates.) This assignment is based upon the nature of the research described in the protocol and the expertise of the IBC member(s).

  2. Revisions presented to and voted upon by the IBC

    The primary and secondary reviewers will verbally summarize the new protocol submission to the IBC, request revisions (if deemed necessary), give recommendation for approval status (i.e. provisional approval), and then the full IBC will vote to approve the new protocol based upon reviewer recommendations.

    • Possible Outcomes:
    • Approved –

      The new protocol submission satisfactorily addresses all issues and the submission is fully approved, no modification is necessary on the part of the principal investigator.

    • Provisionally Approved –

      Minor issues remain that must be addressed by the principal investigator prior to approval. The revised protocol submission is reviewed by the primary reviewer and may be approved outside of the full IBC if changes are deemed satisfactory. Multiple revisions are allowed and may be necessary in some cases.

    • Tabled –

      Significant issues remain requiring full IBC review upon the principal investigator’s response to the requested revisions.

    • Rejected –

      The protocol submission is not approved and has not been recommended for further consideration by the IBC.

  3. Requested Revisions completed and approved by primary IBC reviewer

    All requested revisions from the primary and secondary reviewers will be forwarded to the principal investigator by the IBC administrator. Once all requested revisions have been implemented, the IBC administrator will then forward the revised version of the protocol to the primary reviewer for revision approval.

  4. Biosafety Office (BSO) review

    Upon the primary reviewer’s approval of the new protocol, the submission will then be forwarded to the Biosafety Office (BSO) to conduct a lab inspection (if necessary).

  5. Final approval notification

    Once the BSO has signed the protocol submission form and submitted a final lab inspection (if necessary) notice, the IBC administrator will check the status of each researcher’s required training (i.e. NIH Guidelines, Bloodborne Pathogens, Biological Safety, etc.) record. If training is complete, the IBC administrator will forward final approval to the principal investigator and that research may commence.

Review Process:
Exempt Research Review

  1. Biosafety Office (BSO) review Upon receiving the completed protocol submission form, the IBC administrator will forward it to the BSO for review to ensure that the proposed research falls under Sec. III-F of the NIH Guidelines. The Biosafety Office (BSO) will conduct a lab inspection (if necessary).
  2. Final approval notification Once the BSO has signed the protocol submission form, the IBC administrator will check the status of each researcher’s required training (i.e. NIH Guidelines, Bloodborne Pathogens, Biological Safety, etc.) record. If training is complete, the IBC administrator will forward final approval to the principal investigator and that exempt work may commence.
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