Human Gene Transfer Research

Date: February 1, 2021
Policy ID: 2.100
Status: Final

Contact Office:
Assistant Dean for Research
University of Virginia School of Medicine PO Box 800793
Phone: 434-243-7088

Oversight Executive:
Senior Associate Dean for Research University of Virginia School of Medicine PO Box 800793
Phone: 434-243-7088

Applies to: Any faculty member who wishes to conduct research involving the deliberate transfer into human research participants of either recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or synthetic nucleic acid molecules at the University of Virginia.

Reason for Policy: This policy will ensure that any research involving the deliberate transfer into human research participants of either recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or synthetic nucleic acid molecules is carried out in accordance with University and Federal policies.

Policy
Human Gene Transfer (HGT) research conducted at the University of Virginia must comply with the NIH Guidelines for Research Involving Recombinant DNA and Synthetic Nucleic Acid Molecules (III-C; III-C-1.)

The Principal Investigator (PI) is responsible for obtaining all appropriate institutional approvals before initiation of research and complying with all post-monitoring requirements of the University and the NIH. Final approval of all HGT research at the University of Virginia is the responsibility of the Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB) of Record. Procedures to obtain approval for HGT research at UVA may be found in the document “Procedures for submitting HGT experiments at UVA”.

Additional approvals may be required from the Food & Drug Administration, NIH Novel and Exceptional Technology Research Advisory Committee (formerly known as the RAC),  the UVA School of Medicine Clinical Research Office and/ or a Scientific Review Committee.

Responsibilities

Institutional Biosafety Committee (IBC)

The IBC reviews and approves HGT experiments in compliance with the NIH Guidelines and will:

• Review and approve HGT experiments in accordance with the NIH guidelines for Research Involving Recombinant DNA and Synthetic Nucleic Acid Molecules
• Notify the School of Medicine Dean about the proposed work and request, if necessary, additional expertise to review the protocol
• Assess the containment levels and safety practices for the proposed work.
• Inspect laboratory and/or clinical facilities and equipment where work is performed as necessary
• Ensure compliance with all UVA biosafety training requirements
• Ensure reporting of biosafety accidents and incidents to the NIH Office of Science Policy (OSP)

Institutional Review Board (IRB) of Record

The IRB will review and approve all HGT experiments to ensure compliance with federal regulations related to human subject research and will:

• Ensure the safety and welfare of human subjects
• Verify that approval from all other required review committees or bodies have been obtained
• Confirm that all modifications requested by other review committees are incorporated into all final documents

Gene Transfer Oversight Committee

A group made up of at least one person each from IRB-HSR, IBC, SOM Clinical Research Office, SOM Research Office, and the Cancer Center Protocol Review Committee will meet, as required, to review this policy and related compliance issues.

Policy History: Implemented January 1, 2002. Revised 3/20/08; 12/10/11; 12/19/11, 07/6/17; 2/1/21

Approved 2/1/21 by:
David S. Wilkes, MD
Dean