Institutional Biosafety Committee for Clinical Gene Transfer (IBC-CGT)
The Dartmouth College Institutional Biosafety Committee for Clinical Gene Transfer (IBC-CGT) is a multidisciplinary committee charged with the review of clinical protocols involving gene transfer as defined in the NIH Guidelines For Research Involving Recombinant Or Synthetic Nucleic Acid Molecules, March 2013. The IBC-CGT has the authority to approve, require modifications, or disapprove all research activities that fall within its jurisdiction. All new clinical gene transfer protocols and amendments to existing protocols are subject to review by this committee.
The purview of the IBC-CGT includes:
review of the scientific principles and objectives of the clinical gene transfer protocol
review of the protocol for concerns of the safety of clinical personnel, the community, and the environment
determine whether all appropriate requirements as stated in the NIH Guidelines Appendix M have been fulfilled prior to initiation of the protocol
Standard Operating Procedure (SOP) for Protocol Submission:
1) The Dartmouth College Biosafety Officer is the point of contact for IBC-CGT submissions. Please contact Maureen O'Leary, PhD, MBA, CBSP, Biological Safety Officer, Director, Environmental Health & Safety, at Maureen.O'Leary@dartmouth.edu 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:
Letter of approval from the National Institutes of Health Recombinant DNA Advisory Committee (RAC)
Documentation of Investigational New Drug status (IND) of the test agent, referencing the holder of the IND and the protocol for review
Letter of scientific review/merit if available (e.g., Department Approval Letter, CCRC Approval Letter)
Letter of IRB approval or date of expected IRB review
Letter of assurance from the investigational/site pharmacy of ability to receive, house, and dispense study agent
Signed Investigator Protocol Signature Page
Investigator’s Brochure (IB)
Pharmacy and Laboratory Manual for study agent
C. Consent Forms (please see the NIH Informed Consent Guidance for Human Gene Transfer Trials on how to include lay language about recombinant nucleic acid technology in Informed Consent forms)
D. 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 Velos eResearch by the PI.
Refer to Appendix M of the NIH Guidelines and the IBC-CGT Reporting SOP for the regulations regarding reporting adverse events and annual reports to NIH/OBA and to the IBC-CGT.
Refer to the IBC-CGT Charter to learn more about the subcommittee review and oversight process and the scope of the committee's oversight.
Clinical Gene Transfer Subcommittee Members:
Brent Berwin, PhD, IBC Member, Associate Professor, Microbiology/Immunology
Dianne Ferris, Research and Compliance Officer, Office of Clinical Research, NCCC
Caitlyn Hauke, PhD, Research Safety Officer, Environmental Health & Safety
Yina Huang, PhD, Assistant Professor, Microbiology/Immunology
Lionel Lewis, BCH, MD, IBC-CGT Chair, Professor of Medicine, Pharmacology & Toxicology
Kimberly Lyford, Senior Human Research Analyst, CPHS
Alix Manny, Community Representative
Maureen O'Leary, PhD, MBA, CBSP, Biological Safety Officer, Director, Environmental Health and Safety
Douglas Parr, Pharm.D, Investigational Pharmacy
Richard Powell, MD, Chief, Section of Vascular Surgery
Sharon Segel, RN, BSN, Clinical Research Coordinator, Vascular Surgery
Terryl Stacy, Community Representative
Neal Wilson, Clinical Research Administrator and Laboratory Specialist, Office of Clinical Research