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HUMANS

HUMAN GENE TRANSFER PROTOCOL

Penn's Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB) must conduct a preliminary review of all human gene transfer protocols prior to submission of the protocols to the NIH Office of Biotechnology Affairs (OBA) for consideration by the Recombinant DNA Advisory Committee (RAC) and/or the FDA.

Should OBA/RAC determine the protocol requires RAC review, the PI must address and respond to all RAC issues. Documentation of all such responses must be provided to the IBC before committee approval will be considered.

If the protocol does not require RAC review, the PI must provide the IBC written documentation indicating the protocol does not require RAC review, before full IBC approval will be considered.

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.

PROCEDURE

For Human Gene Transfer Protocols, submit twelve completed hard copies each of the following to EHRS for IBC approval.

  1. IRB Protocol Face Sheet
  2. Registration Document for Recombinant DNA Research
  3. Appendix M. Points to Consider NIH rDNA Guidelines, including the Informed Consent Document.
  4. Clinical Protocol, including the Informed Consent Document.
  5. Investigators Brochure (if available)

For Human Vaccine Trials, submit twelve completed hard copies each of the following to EHRS for IBC approval.

  1. IRB Protocol Face Sheet
  2. Registration Document for Recombinant DNA Research
  3. Clinical Protocol
  4. Investigators Brochure (if available)

Alternatively, PDF's of each of the above documents may be submitted via email to an EHRS Biosafety Officer.

Contact the Office of Regulatory Affairs at 215-898-2615 for information about submission of protocols for IRB review.

The Office of Human Research at the University of Pennsylvania School of Medicinesupports all human research activities.

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