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-SCBT 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:
Refer to the IBC-SCGT ByLaws to learn more about the subcommittee review and oversight process and the scope of the committee's oversight.
This SOP establishes the standard procedure for submitting a clinical gene transfer protocol to the IBC-SCGT for review.
1. The principal investigator (PI) submits an email to Environmental Health & Safety (EHS) stating his/her intent to open the protocol at Dartmouth. firstname.lastname@example.org
2. The PI submits a copy of the following to EHS via email:
a. Clinical Protocol with fully signed signature page
b. Letter of approval from the National Institutes of Health Recombinant DNA Advisory Committee (RAC)
c. Completed Local Standard Operating Procedure (SOP) for conducting a clinical gene transfer research protocol. This is a required document by the IBC-SCGT to analyze the risks associated with the potential study hazards.
d. Documentation of Investigational New Drug status (IND) of the test agent, referencing the holder of the IND and the protocol for review
e. Investigator’s Brochure (IB) for the agent to be studied
f. Documentation of scientific review/merit if available
g. Documentation by the investigational/site pharmacy of ability to receive, house, and dispense study agent
h. Pharmacy and Laboratory manual for study agent
i. Documentation of completion of appropriate training requirements for all study personnel and pharmacy personnel who will come into contact with study agent
3. EHS will send a copy of the protocol and associated documents to each of the subcommittee members 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 then privately discuss and vote on the protocol. The protocol may be "approved", "conditionally approved" or "not approved". The Chair will send a letter 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 is sent to EHS for the files.
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 SOP are uploaded into Velos eResearch.
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.
Deborah A. Hogan, Ph.D., IBC Chair/Microbiology and Immunology
Lionel Lewis, BCH, MD, IBC-SCGT Chair/Medicine/Pharmacology & Toxicology
Brenda L. Petrella, Ph.D., Biological Safety Officer, Environmental Health & Safety
Maureen O'Leary, Ph.D., MBA, CBSP, Director, Environmental Health and Safety
Elizabeth Bankert, MA, Assistant Provost/Human Subjects Protection Official
Rebecca Rogers, NCCC, Office of Clinical Research
Dianne Ferris, Human Research Analyst, CPHS
Douglas D. Parr, Pharm.D, Investigational Pharmacy
Richard J. Powell, MD, Chief, Section of Vascular Surgery
Brent Berwin, Ph.D., IBC Member, Microbiology/Immunology
Last Updated: 7/30/14