NIH issues genomic data sharing rules

August 28, 2014 in Medical Technology

The National Institutes of Health has issued a final policy it hopes will promote genomic data sharing as a way to improve health while still protecting the privacy of research participants.

[See also: Genomics come to HIE]

The NIH Genomic Data Sharing policy traces back to the Human Genome Project, which necessitated rapid and broad data release during its mapping and sequencing of the human genome, officials say.

The new GDS policy extends and replaces the Genome-Wide Association Studies data sharing policy, which, since 2007, has governed biomedical researchers’ submission and access to human data through the NIH database for Genotypes and Phenotypes, or dbGaP.?

[See also: Genomics pose 'daunting' test for EHRs]

Posted in the Federal Register Aug. 26, it will apply to all NIH-funded, large-scale human and non-human projects that generate genomic data.

“Advances in DNA sequencing technologies have enabled NIH to conduct and fund research that generates ever-greater volumes of GWAS and other types of genomic data,” said Eric Green, MD, director of the National Human Genome Research Institute and co-chair of the committee that developed the GDS policy, in a press statement.

“Access to these data through dbGaP and according to the data management practices laid out in the policy allows researchers to accelerate research by combining and comparing large and information-rich datasets.”

Key to the GDS policy is the expectation that researchers obtain the informed consent of study participants for the potential future use of their de-identified data for research and for broad sharing, say NIH officials, with similar expectations for studies that involve the use of de-identified cell lines or clinical specimens.

The two-tiered system for providing access to human data is based on data sensitivity and privacy concerns developed under the GWAS policy will continue. For controlled-access data, investigators will be expected to use data only for the approved research, protect data confidentiality (including not sharing the data with unauthorized people), and acknowledge data-submitting investigators in presentations and publications.?

“Everyone is eager to see the incredible deluge of molecular discoveries about disease translated into prevention, diagnostics, and therapeutics for patients,” said Kathy Hudson, NIH deputy director for science, outreach and policy, in a statement.?

“The collective knowledge achieved through data sharing benefits researchers and patients alike, but it must be done carefully,” she added. “The GDS policy outlines the responsibilities of investigators and institutions that are using the data and also encourages researchers to get consent from participants for future unspecified use of their genomic data.”

Learn more here.

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