NINDS Human Genetics Resource Center/NINDS Repository Goals, Access, Use Notice Number: NOT-NS-12-003 Update: following update relating this announcement been issued: 13, 2014 - Notice NOT-NS-14-032. NINDS Requirements Induced Pluripotent Stem Cell Development Resource Sharing. 8, 2014 - Notice NOT-NS-14-027. Notice Intent Publish Funding Opportunity Announcement Biomarker Discovery through Use Data Resources Developed the NINDS Parkinson's Disease Biomarker Program PDBP) U01). Key Dates Release Date: November 15, 2011 Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS committed reducing burden neurological disorders human lives. mission the NINDS Human Genetics Resource Center, also known the NINDS Repository, to accelerate discovery causes risk factors neurological disorders through broad sharing de-identified human samples clinical data across research community. purpose this notice to explain scope the Repository to provide guidelines submitting withdrawing samples data. NINDS Repository currently funded through contract the Coriell Institute Medical Research includes samples clinical data more 35,000 subjects, more 22,000 these samples available researchers academia industry. listing available samples information how obtain can found
http://ccr.coriell.org/Sections/Collections/NINDS/?SsId=10. present collection includes genomic DNA lymphoblastoid cell lines associated de-identified clinical data individuals dystonia, epilepsy, motor neuron disease including ALS), Parkinsons disease, stroke, Tourette syndrome, neurologically normal controls. addition supporting genetic discovery, NINDS Repository broadened scope recently launching resources sharing fibroblasts induced pluripotent stem cells iPSC) individuals Parkinsons disease, ALS, Huntingtons disease, a resource support biomarker discovery. core standardized de-identified HIPAA-compliant clinical data elements CDEs) available each sample. Repository CDEs, found
http://ccr.coriell.org/Sections/Collections/NINDS/ClinicalDataForms.asp…, broad enough discovery research, compact enough be streamlined, are harmonized the NINDS Common Data Elements:
http://www.commondataelements.ninds.nih.gov/. Repository also makes available number data dictionaries. Repository CDEs developed committee, including NINDS, Repository staff, experts the field. NINDS Repository CDEs modified phenotypic characterizations genetic knowledge evolve over time. Given practical limits the number samples can stored distributed, opportunity submit samples generally limited NINDS-funded investigators. Decisions which samples be accepted be by representatives the NINDS including Program Director most relevant the proposed submitters grant application NINDS Offices Programs
http://www.ninds.nih.gov/research/index.htm), Repository Contract Officer, the Repository Contract Officer's Technical Representative COTR). resource also available submissions, a case-by-case basis, other investigators samples collections may of value the wider research community. all instances, investigators are interested submitting samples should contact Repository COTR early possible the purpose planning, including budget considerations. Because the limits mentioned above, access submitting samples cannot assumed, may be granted, investigators should prepared make alternative plans. Requests add new disease collections and/or different sample types be considered an internal NINDS committee. samples accepted the NINDS Repository must collected under IRB-approved consent allows broad sharing de-identified samples clinical data use investigators academia industry discovery research relevant any medical disorder. Repository provides example consent criteria is available preview consents before are submitted IRBs;
http://ccr.coriell.org/Sections/Support/NINDS/Submissions.aspx. Samples received the NINDS Repository become property the NINDS, be shared the research community. Withdrawal samples the NINDS Repository available, a cost-offsetting fee, industry, not-for-profit organizations, to academic institutions. Withdrawers submit statement research intent via Repository. statement, may publicly posted, be reviewed NINDS staff. Prior distribution, appropriate signing official the requesting institution must sign Material Transfer Agreement MTA) assuring appropriate use:
http://ccr.coriell.org/Sections/Support/NINDS/assurance.aspx?PgId=307. MTAs not acceptable unless specifically indicated the Contract Officer COTR. Requests items are non-renewable therefore risk being depleted such genomic DNA whole blood, fibroblasts, samples biomarker discovery) reviewed the Repository NINDS staff a case-by-case basis. Acknowledgement the NINDS Repository required publications use samples clinical data the Repository. Model language acknowledging Repository provided the NINDS Repository website
http://ccr.coriell.org/Sections/Collections/NINDS/ackGuidelines.aspx?Pg…). Inquiries Please direct 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