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    I. Human Gene Transfer Protocols

    Penn's Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB) must review and approve all human gene transfer protocols prior to initiation of enrollment.

    RAC Review procedures were revised by the NIH Office of Science Policy and the changes are effective April 27, 2016.

    Determination whether a protocol requires RAC review will be made by the IBC.

    New Penn-specific guidance is available: Penn New HGT Protocol Submissions (pdf)

    Please refer all questions to Dr. Andrew Maksymowych, Institutional Biosafety Officer.

    Registration Forms:

    PDFs of each of the following documents may be submitted via email to Dr. Andrew Maksymowych for IBC review.  

    1. Registration Document for r∙s∙NA Research, signed by PI

    2. IRB Protocol Face Sheet

    3. Appendix M. Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant or Synthetic Nucleic Acid Molecules Into One or More Human Research Participants (Section M-I-A.  Requirements for Protocol Submission)

    4. Penn-specific Informed Consent Document(s)

    5. Clinical Protocol

    6. Investigator's Brochure (if available)

    II. Human Vaccine Trials

      When recombinant vaccine trials are conducted at or sponsored by Penn, they must be reviewed and approved by the IBC before research participants can be enrolled.

      Registration Forms: 

      PDFs of each of the following documents may be submitted via email to Dr. Andrew Maksymowych for IBC review. 

      1. Registration Document  for r∙s∙NA Research, signed by PI

      2. IRB Protocol Face Sheet

      3. Clinical Protocol

      4. Investigator's Brochure (if available)

      5. Penn-specific Informed Consent document(s)

      III. Resources
          1. NIH Office of Science Policy (OSP) 
          2. NIH Guidelines for Research Involving Recombinant & Synthetic Nucleic Acids
          3. Institutional Biosafety Committee (IBC)
          4. IBC Meeting Schedule and Submission Deadlines
          5. Contact the Institutional Review Board (IRB) regarding submission of protocols for IRB review
          6. The Office of Clinical Research at the Perelman School of Medicine, University of Pennsylvania supports all human research activities