The goal of the National Gene Vector Biorepository (NGVB) is to provide gene therapy investigators with a variety of services that can enhance their research.
The NGVB began in May of 2008 and is made possible by a grant from the National Institutes of Health (NIH) to the Department of Medical and Molecular Genetics, Indiana University School of Medicine. The program was initially funded by the National Center for Research Resources (NCRR) and now is a grant program of the National Heart, Lung and Blood Institute.
To be eligible to receive NGVB reagents and archiving services, an investigator must: (1) qualify as a not-for-profit organization, or government agency eligible to receive NIH funding and also have the capability to perform scientific studies; (2) submit a request for NGVB services following directions listed on the NGVB website, (3) agree to post-distribution monitoring as defined in Section 6.0 of the NGVB Policy and Procedure manual (see below), (4) follow the guidelines of the NIH, FDA, and the local Institutional Biosafety Committee (IBC) and Institutional Review Board (IRB), (5) agree to assurance and certification requirements as described in the Application for a Public Health Service Grant (PHS 398 Section III.G, http://grants.nih.gov/grants/funding/phs398/phs398.pdf), and (6) disclose other forms of grant support for all research projects using NGVB services or reagents.
The NGVB Pharm/Tox database and educational resources are provided on the NGVB website (www.NGVBCC.org) are open to all researchers, commercial entities, and other interested parties.
Investigators will be required to acknowledge the NGVB in all publications, in the same manner that funding support is acknowledged.
Sharing Pharmacology/Toxicology Data
To receive NGVB support for archiving Pharm/Tox samples, the investigator must agree to submit a summary of the Pharm/Tox data to the NGVB Coordinating Center for inclusion in the NGVB pharmacology/toxicology database.
The NGVB will monitor use of NGVB services to allow reporting of activities to the NIH. When requested by the NGVB Coordinating Center, investigators agree to supply: (1) the name, grant number, and time period of federal or other grants that utilize NGVB services; (2) publications that acknowledge NGVB resources; and (3) the number of IND or other regulatory submissions that utilize the Pharm/Tox database.
Material Transfer Agreements
Investigators requesting reagents from the reagent repository will be required to complete a Material Transfer Agreement (MTA) with the owner of the reagent as well as an MTA with the NGVB. Draft MTA(s) will be provided by the NGVB Coordinating Center. Once all MTAs are completed the reagent can be shipped.
An additional MTA between the Donor Institute and the NGVB will be executed for material submitted into the NGVB Repository.
Reagents must be used in compliance with current regulatory guidelines and approved by the appropriate Boards prior to use (ex. Institutional Review Board, Institutional Biosafety Committee, US Food and Drug Administration, or other applicable agencies).
Investigators using the NGVB should consult the NGVB Policy and Procedure Manual for additional information.
NGVB POLICY AND PROCEDURE MANUAL
Details regarding the structure, policies and procedure of the NGVB are contained within the NGVB Policy and Procedure Manual.