Notice Number: NOT-HG-07-024
Key Dates
Release date: June 14, 2007
Issued by
National Human Genome Research Institute (NHGRI) (http://www.genome.gov)
Purpose
Researchers may now request controlled-access datasets from cancer sequencing projects being conducted as part of the NHGRI Medical Sequencing Program (MSP). Two data categories have been designated: open (available to anyone with no restrictions), and controlled (requiring pre-authorization). The controlled-access category provides for downloads of individual-level genotype and assembled DNA sequence data that can be unique to an individual subject. Limited clinical information is available in the open database. However, no personal identifiers such as name are contained in the database and all links to such personal information have been irreversibly removed. For a full description of the projects and the data types, see http://www.genome.gov/cancersequencing. Most data are in the open category and located at the NCI Center for Bioinformatics. DNA sequences are located in the National Center for Biotechnology Information (NCBI) Trace Archive. Controlled-access data include the genotype data from the Tumor Sequencing Project examination of copy number variation in lung adenocarcinoma using genotyping microarrays and the sequence trace linking tables for the Tumor Sequencing Project and for the J. Craig Venter Institute investigations of glioblastoma.
In addition to the cancer sequencing projects described above, NHGRI has partnered with the National Cancer Institute on a comprehensive cancer genome characterization effort, The Cancer Genome Atlas (http://cancergenome.nih.gov). Procedures to access individual-level data for that program will be announced separately. Furthermore, the NHGRI Medical Sequencing Program is supporting investigations of diseases other than cancer (see MSP web page). Those data will be accessed through the NCBI database of Genotype and Phenotype, dbGaP, as they become available.
How to Apply for Access to Cancer Sequencing Project Controlled-Access Data
To request access to the individual-level datasets in the controlled access category, the Principal Investigator (PI) and the Signing Official (SO) at the investigator’s institution will need to submit an electronic request for data access to be reviewed by an NHGRI Data Access Committee. Submission of a request constitutes agreement to the terms and conditions for data use specified in a Data Use Certification (DUC). To initiate a request, which utilizes the SF 424 (R&R) form more commonly used for grant applications, both will need to have accounts with the NIH eRA Commons. These are the same accounts used to apply for grants, and PIs and SOs who already have such accounts do not need to do anything further. For investigators and organizations unfamiliar with NIH grants systems, information on applying for an eRA Commons account can be found at https://commons.era.nih.gov/commons/.
The DUC statements outline policies and procedures for using the data, such as not distributing the data beyond those permitted to handle it; not attempting to identify or contact study participants from whom phenotype data and DNA were collected; and other provisions designed to protect the confidentiality of study participants and to foster scientific advance.
More information on NHGRI Medical Sequencing Policies including Participant Protections Policies can be viewed at http://www.genome.gov/20019650.
Inquiries
Bradley A. Ozenberger, PhD
Program Director
National Human Genome Research Institute
5635 Fishers Lane
Bethesda, MD 20892-9305
Voice: (301) 496-7531
Fax: (301) 480-2770
http://genome.gov
nhgridac@mail.nih.gov
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