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About the NGVB

Mission

The National Gene Vector Biorepository and Coordinating Center (NGVB), funded by the National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), is charged with enhancing the research and clinical environment for gene therapy investigators. In support of this mission, the goals of the NGVB are to provide the following: (1) maintain a database of pre-clinical pharmacology and toxicology studies (Pharm/Tox database) to support Investigational New Drug (IND) submissions to the Food and Drug Administration (FDA); (2) provide a reagent repository to support pre-clinical and clinical gene therapy studies; (3) provide biorepository and archiving services; (4) provide educational material about gene therapy; (5) provide IND-enabling testing services; and (6) conduct research related to gene therapy safety.

Background

The NGVB began in May 2008 and was 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 then transferred as a grant program of the National Heart, Lung and Blood Institute NHLBI). Moving forward, on December 2018 the NGVB was refunded for 5 years under US government contract 75N92019D00018.

Eligibility

To be eligible to receive NGVB reagents and archiving services, an investigator must: (1) qualify as a not-for-profit organization, small business, 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, (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.

For certain NGVB services, investigators must also have current or recent National Heart, Lung and Blood Institute (NHLBI) or National Cancer Institute (NCI) funding. Question regarding eligibility can be directed to the NGVB Coordinating Center Manager (NGVBCC.iu.edu).

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.

User Responsibility

Publication

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.

Post-distribution Monitoring

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.

Regulatory Compliance

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).

Additional Information

Investigators using the NGVB should consult the NGVB Manual of Policies and Procedures for additional information.

NGVB Manual of Policies and Procedures

Details regarding the structure, policies and procedure of the NGVB are contained within the NGVB Manual of Policies and Procedures.