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Institutional Biosafety Committee - Subcommittee for Clinical Gene Transfer (IBC-SCGT)

The Dartmouth College Institutional Biosafety Committee - Subcommittee for Clinical Gene Transfer (IBC-SCGT) 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. This sub-committee reports to the Dartmouth Institutional Biosafety Committee (IBC) and the Committee for Protection of Human Subjects (CPHS), the Institutional Review Board (IRB) at Dartmouth.  The IBC-SCGT 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 the sub-committee. 

The purview of the IBC-SCGT includes:

  1. review of the scientific principles and objectives of the clinical gene transfer protocol
  2. review of the protocol for concerns of the safety of clinical personnel, the community, and the environment
  3. determine whether all appropriate requirements as stated in the NIH Guidelines Appendix M have been fulfilled prior to initiation of the protocol
  4. review of the informed consent documents to make sure they comply with the NIH Guidelines (see the NIH Informed Consent Guidance for Human Gene Transfer Trials)

Standard Operating Procedure (SOP) for Protocol Submission:

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Purpose:

This SOP establishes the procedure for submitting a clinical gene transfer protocol to the IBC-SCGT for review. This SOP applies to all clinical trials involving the transfer of recombinant or synthetic nucleic acids into humans. Please refer to the NIH Guidelines, 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 for federal regulatory guidance.

Procedure:

1)    The Dartmouth College Biosafety Officer is the point of contact for IBC-SCGT submissions. Please contact Brenda Petrella, PhD, Biosafety Officer, at petrella@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:

     A.  Correspondence:

  1. Letter of approval from the National Institutes of Health Recombinant DNA Advisory Committee (RAC)
  2. Documentation of Investigational New Drug status (IND) of the test agent, referencing the holder of the IND and the protocol for review
  3. Letter of scientific review/merit if available (e.g., Department Approval Letter, CCRC Approval Letter)
  4. Letter of IRB approval or date of expected IRB review
  5. Letter of assurance from the investigational/site pharmacy of ability to receive, house, and dispense study agent

     B.  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/or 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-SCGT 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‑SCGT files. The IBC-SCGT correspondence with the PI and the approved Local Safety SOP are uploaded into Velos eResearch by the PI.

 

Refer to the NIH Guidelines for the regulations regarding protocol submission (Appendix M) to the Recombinant DNA Advisory Committee (RAC), as well as the responsibilities for all primary investigators.

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

 

Clinical Gene Transfer Subcommittee Members:

Lionel Lewis, BCH, MD, IBC-SCGT Chair/Medicine/Pharmacology & Toxicology

Deborah Hogan, PhD, IBC Chair/Microbiology and Immunology

Brenda Petrella, PhD, Biological Safety Officer, Environmental Health & Safety

Maureen O'Leary, PhD, MBA, CBSP, Director, Environmental Health and Safety

Dianne Ferris, Senior Human Research Analyst, CPHS

Kimberly Lyford, Senior Human Research Analyst, CPHS

Douglas Parr, Pharm.D, Investigational Pharmacy

Richard Powell, MD, Chief, Section of Vascular Surgery

Brent Berwin, PhD, IBC Member, Microbiology/Immunology

Sharon Segel, RN, BSN, Clinical Research Coordinator, Vascular Surgery

Nancy Rollings, RN, M.Ed., Administrative Director, Clinical Cancer Review Committee

 

Last Updated: 12/5/14