Medical Sequencing Program Data Access Policies
Controlled Data Access Overview
Although the guidelines for access to controlled data are similar for all Medical Sequencing and affiliated programs the specific process for some programs can differ and can require separate DARs. Processes to gain access to controlled data are detailed below.
Requesting Access to Medical Sequencing Program Data
A list of approved NHGRI medical sequencing projects is listed at Approved Medical Sequencing Projects.
Requesters should access the data via the dbGaP home page (dbGaP). Although dbGaP was primarily created for genome-wide association study data (phenotype and genotype), it is readily adaptable to handling phenotype and sequence data as well. In addition, several sample sets for which GWAS data sets are already available in dbGaP are also subjects of NHGRI MSP efforts.
Those requesting data via dbGaP will be asked to complete a Data Access Request (DAR), which will include a Data Use Certification (DUC) that the requester and institution, represented by an authorized Signing Official, will abide by any terms and restrictions associated with any data set. NHGRI will attempt to enable access to all NHGRI MSP datasets with a single DAR. However, some studies have use restrictions imposed by the original consent forms, and those may have to be requested individually.
To complete the web-based DAR, the requesting investigator and the authorized institution signing official (SO) must have an active NIH electronic Research Administration (eRA) User ID and password. NIH intramural investigators may utilize their NIH directory User ID and password. Visit era.nih.gov for information on creating an NIH eRA account.
Within two weeks of receiving the completed DAR submitted by the SO, the DAC will either 1) Approve, 2) Disapprove, or 3) Postpone data access for the requesting investigator. Requesters approved and authorized by the DAC are designated Approved Users. Approved Users certify that they will abide by the terms and conditions specified in the DUC, including the provision not to distribute MSP controlled-access data in any form to any third parties other than those of their own research staff who have agreed to the terms of the DUC. For collaborative projects, any independent collaborating investigator from a separate institution involved in the use of the MSP data is required to submit a separate DAR. All Approved Users and their institutions will be required to acknowledge responsibility for ensuring that all uses of the data are consistent with federal, state, and local laws and regulations and with any relevant institutional policies.
Approved Users will utilize their NIH eRA User ID and password to authenticate their identity and gain access to the controlled-access datasets. Access rights are granted for one year, subject to adherence to MSP policies. Annual renewal of approved access requires re-acknowledgement of the DUC and a modified Request Form that solicits the same information as a new request plus information about research accomplishments from utilization of MSP data and information about any violations of the terms and conditions for data use. The NHGRI DAC requests the latter information from Approved Users even in the absence of a renewal request.
Requesting Access to TCGA Program Data
The Cancer Genome Atlas (TCGA) operates a program-specific Data Access Committee that represents the joint management of the project by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI).
Please see the TCGA Data Portal for information on TCGA Data Access.
Last Updated: February 27, 2014