The National Institutes of Health has issued a final NIH Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products, and procedures that improve health while protecting the privacy of research participants. The final policy was posted in the Federal Register August 26, 2014, and published in the NIH Guide for Grants and Contracts August 27, 2014.
Starting with funding applications submitted for a January 25, 2015, receipt date, the policy will apply to all NIH-funded large-scale human and nonhuman projects that generate genomic data, including research conducted with the support of NIH grants and contracts and within the NIH Intramural Research Program.
A report on genomic data sharing through the NIH database for Genotypes and Phenotypes (dbGaP) appears in the August 27, 2014, advance online issue of Nature Genetics.
“Everyone is eager to see the incredible deluge of molecular discoveries about disease translated into prevention, diagnostics, and therapeutics for patients,” said Kathy Hudson, Ph.D., NIH deputy director for science, outreach, and policy. “The collective knowledge achieved through data sharing benefits researchers and patients alike, but it must be done carefully. 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.”
Along with statistics about the use of dbGaP data, the Nature Genetics report outlines the challenges facing the field, such as the increased volume and complexity of genomic data.
“Advances in DNA sequencing technologies have enabled NIH to conduct and fund research that generates ever-greater volumes of GWAS [genome wide association studies] and other types of genomic data,” noted Eric Green, M.D., Ph.D., NHGRI director, report co-author and a co-chair of the trans-NIH committee that developed the GDS policy. “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.”
A key tenet of 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. NIH also has 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.
NIH officials say they expect any institution submitting data to certify that the data were collected in a legal and ethically appropriate manner and that personal identifiers, such as name or address, have been removed. The NIH GDS policy also expects investigators and their institutions to provide basic plans for following the GDS policy as part of funding proposals and applications.
The NIH GDS governance structure, described at http://gds.nih.gov/04po2.html, will be responsible for oversight of the GDS policy, including policy needs and issues related to data submission and access. The NIH advises investigators seeking funding to contact relevant extramural program directors or an NIH institute or center Genomic Program Administrator (GPA) as early as possible to discuss data sharing expectations and timelines that would apply to their proposed studies. For a list of GPAs, visit http://gds.nih.gov/04po2_2GPA.html.