1. review of all human gene transfer experiments for compliance with the NIH Guidelines as specified in Section III-C: Experiments Covered by the NIH Guidelines, and approving those research projects that are found to conform with the NIH Guidelines
2. assessment of the facilities, procedures, practices, and training and expertise of personnel involved in HGT research to determine appropriate biocontainment levels required by the NIH Guidelines for the proposed research
3. notifying the Principal Investigator of the results of the IBC-CGT's review and approval
4. reporting any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH OSP within thirty days. Reports shall be sent to the Office of Science Policy, National Institutes of Health, preferably by email. Additional contact information is also available here and on the OSP website.

Purpose

This SOP establishes the procedure for submitting a clinical gene transfer protocol to the IBC-CGT for review. This SOP applies to all clinical trials involving the transfer of recombinant or synthetic nucleic acids into humans.

Procedure

1. The Dartmouth College Biosafety Officer is the point of contact for IBC-CGT submissions. Please contact Erik Pietrowicz to submit a protocol or with any inquiries regarding the submission process.
2. The following materials must be included in the protocol submission. Please email the following materials to the Biosafety Officer:
   1. Correspondence
      1. Letter of scientific review/merit (e.g., Department Approval Letter, CCRC Approval Letter)
      2. Letter of IRB approval or date of expected IRB review
      3. Letter of assurance from the investigational/site pharmacy of ability to receive, house, and dispense study agent
   2. Protocols/Procedures/Manuals
      1. Completed Local Safety Standard Operating Procedure (SOP) (please complete this Local Safety SOP template)
      2. Clinical Protocol
      3. Signed Investigator Protocol Signature Page
      4. Investigator’s Brochure (IB)
      5. Pharmacy and Laboratory Manual for study agent
   3. Documentation of completion of appropriate training requirements (e.g. BSL2, blood borne pathogen training) for all study personnel and pharmacy personnel who will come into contact with study agent
3. The Biosafety Officer and IBC-CGT Chair will perform a pre-review and inform the PI if any additional information is needed. Then, the protocol materials will be sent to the full committee for review.
4. A meeting will be scheduled within a reasonable amount of time. The PI may attend to answer questions posed by the committee.
5. The committee will privately discuss and vote on the protocol. The protocol may be “approved”, “conditionally approved”, or “not approved”. A letter cosigned by the Chair and Biosafety Officer will be sent to the PI stating the committee’s decision. If further information is necessary for the committee to reach a decision this will be requested. A copy of this letter kept on file with Environmental Health & Safety.
6. A copy of each protocol and all information pertaining to that protocol is filed in the EHS office IBC‑CGT files. The IBC-CGT correspondence with the PI and the approved Local Safety SOP are uploaded into the Clinical Trials Management System (CTMS) by the PI.

Refer to the IBC-CGT Charter to learn more about the subcommittee review and oversight process and the scope of the committee's oversight.

Section III-C of the NIH Guidelines describes experiments involving human gene transfer.

FAQs regarding human gene transfer protocol registration and review process.

Additional FAQs on the April 2019 NIH Guidelines Amendment and changes to human gene transfer protocol review requirements.

• Lionel Lewis, BCH, MD, IBC-CGT Chair, Professor of Medicine, Pharmacology & Toxicology
• Lliam Harrison, MA, JD, CIP, CIM, IRB Manager, DHMC
• Raymond Hicks, MD, MPH, Occupational and Environmental Medicine, DHMC
• Kristofer Knauss, Pharm.D, Investigational Pharmacy
• Kimberly Lyford, BA, CIP, Senior Human Research Analyst, CPHS
• Erin Lynch, BS, CCRP, Regulatory & Compliance Officer, Office of Clinical Research
• Douglas Parr, Pharm.D, Investigational Pharmacy (Alternate)
• Diwakar Pattabiraman, PhD, Assistant Professor of Molecular and Systems Biology
• Erik Pietrowicz, MS, Interim Biological Safety Officer, Environmental Health & Safety
• Richard Powell, MD, Chief, Section of Vascular Surgery
• R. Brooks Robey, MD, VA Representative (Alternate)
• Michael Salamy, MS, VA Representative
• Sharon Segel, RN, BSN, Community Representative

• Terryl Stacy, PhD, Community Representative