NINDS Human Genetics Resource Center/NINDS Repository Goals, Access, and Use


Notice Number:  NOT-NS-12-003

Key Dates

Release Date:  November 15, 2011  

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The NINDS is committed to reducing the burden of neurological disorders on human lives. The mission of the NINDS Human Genetics Resource Center, also known as the NINDS Repository, is to accelerate the discovery of causes and risk factors for neurological disorders through broad sharing of de-identified human samples and clinical data across the research community. The purpose of this notice is to explain the scope of the Repository and to provide guidelines for submitting and withdrawing samples and data.

The NINDS Repository is currently funded through a contract to the Coriell Institute for Medical Research and includes samples and clinical data from more than 35,000 subjects, with more than 22,000 of these samples available to researchers in academia and industry. A listing of available samples and information about how to obtain them can be found at http://ccr.coriell.org/Sections/Collections/NINDS/?SsId=10. At present the collection includes genomic DNA and lymphoblastoid cell lines with associated de-identified clinical data from individuals with dystonia, epilepsy, motor neuron disease (including ALS), Parkinson’s disease, stroke, Tourette syndrome, and neurologically normal controls. In addition to supporting genetic discovery, the NINDS Repository broadened its scope recently by launching resources for sharing fibroblasts and induced pluripotent stem cells (iPSC) from individuals with Parkinson’s disease, ALS, and Huntington’s disease, and a resource to support biomarker discovery.

A core of standardized de-identified HIPAA-compliant clinical data elements (CDEs) is available for each sample. Repository CDEs, found at http://ccr.coriell.org/Sections/Collections/NINDS/ClinicalDataForms.aspx?PgId=148&coll=ND, are broad enough for discovery research, compact enough to be streamlined, and are harmonized with the NINDS Common Data Elements: http://www.commondataelements.ninds.nih.gov/. The Repository also makes available a number of data dictionaries. Repository CDEs are developed by committee, including the NINDS, Repository staff, and experts in the field. NINDS Repository CDEs are modified as phenotypic characterizations and genetic knowledge evolve over time.

Given the practical limits on the number of samples that can be stored and distributed, the opportunity to submit samples will generally be limited to NINDS-funded investigators. Decisions about which samples can be accepted will be made by representatives of the NINDS including the Program Director most relevant for the proposed submitter’s grant application (see NINDS Offices and Programs at http://www.ninds.nih.gov/research/index.htm), the Repository Contract Officer, and the Repository Contract Officer's Technical Representative (COTR). The resource is also available for submissions, on a case-by-case basis, from other investigators with samples or collections that may be of value to the wider research community. In all instances, investigators who are interested in submitting samples should contact the Repository COTR as early as possible for the purpose of planning, including budget considerations. Because of the limits mentioned above, access for submitting samples cannot be assumed, and may not be granted, so investigators should be prepared to make alternative plans. Requests to add new disease collections and/or different sample types will be considered by an internal NINDS committee. All samples accepted by the NINDS Repository must be collected under an IRB-approved consent that allows broad sharing of de-identified samples and clinical data for use by investigators from academia and industry for discovery research relevant to any medical disorder. The Repository provides example consent criteria and is available to preview consents before they are submitted to IRBs; see http://ccr.coriell.org/Sections/Support/NINDS/Submissions.aspx. Samples received by the NINDS Repository become the property of the NINDS, to be shared with the research community.

Withdrawal of samples from the NINDS Repository is available, for a cost-offsetting fee, to industry, to not-for-profit organizations, and to academic institutions. Withdrawers submit a statement of research intent via the Repository. This statement, which may be publicly posted, will be reviewed by NINDS staff.  Prior to distribution, the appropriate signing official at the requesting institution must sign a Material Transfer Agreement (MTA) assuring appropriate use: http://ccr.coriell.org/Sections/Support/NINDS/assurance.aspx?PgId=307. Other MTAs are not acceptable unless specifically indicated by the Contract Officer and COTR. Requests for items that are non-renewable and therefore at risk of being depleted (such as genomic DNA from whole blood, fibroblasts, and samples for biomarker discovery) are reviewed by the Repository and NINDS staff on a case-by-case basis. Acknowledgement of the NINDS Repository is required in publications that use samples or clinical data from the Repository. Model language for acknowledging the Repository is provided on the NINDS Repository website (http://ccr.coriell.org/Sections/Collections/NINDS/ackGuidelines.aspx?PgId=349&coll=ND).

Inquiries

Please direct all inquiries to:

Roderick A. Corriveau, Ph.D.
Program Director, Neurodegeneration & COTR, NINDS Repository
NIH/NINDS
6001 Executive Blvd., Room 2153
Bethesda, MD  20892-9531
(FedEx/courier use:  Rockville, MD  20852)
Phone:  301-496-5680
roderick.corriveau@nih.gov


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