Featured Research

from universities, journals, and other organizations

NIH issues finalized policy on genomic data sharing

Date:
August 27, 2014
Source:
NIH/Office of the Director
Summary:
The National Institutes of Health has issued a final NIH Genomic Data Sharing 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 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 Aug. 26, 2014 and published in the NIH Guide for Grants and Contracts Aug. 27, 2014.

Related Articles


Starting with funding applications submitted for a Jan. 25, 2015, receipt date, the policy will apply to all NIH-funded, large-scale human and non-human projects that generate genomic data. This includes research conducted with the support of NIH grants and contracts and within the NIH Intramural Research Program. NIH officials finalized the policy after reviewing public comments on a draft released in September 2013.

The GDS policy can be traced to the Human Genome Project, completed in 2003, which required rapid and broad data release during its mapping and sequencing of the human genome. The GDS policy is an extension of and replaces the Genome-Wide Association Studies (GWAS) data sharing policy. Since 2007, the GWAS policy has governed biomedical researchers' submission and access to human data through the NIH database for Genotypes and Phenotypes (dbGaP). Its two-tiered data distribution system has made some information and data available to the public without restrictions. Access to other data has been controlled and made available only for research purposes consistent with the consent provided by participants in the original study.

Under the GWAS policy, more than 2,200 investigators from 41 different countries have received access to dbGaP data from 304 studies and produced more than 900 publications. A report on genomic data sharing through dbGaP under the GWAS policy appears in the Aug. 27, 2014, advance online issue of Nature Genetics. The report was written by members of the NIH Genomic Data Sharing policy team.

"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 and other types of genomic data," said 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 expects 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.

Other highlights of the GDS policy:

  • Investigators are encouraged to seek the broadest possible sharing permissions from participants for future research use of their data.
  • Timelines for data submission and access should promote timely and broad data sharing while being mindful of the significant effort by investigators to generate and prepare data for release, as well as to realize benefit from engaging research participants.
  • In general, investigators should make non-human genomic data publicly available no later than the date of initial publication. Non-human data can be deposited into widely used NIH-designated repositories other than dbGaP.
  • The NIH GDS policy explicitly encourages the broadest possible use of findings and development of products/technologies from the use of NIH-funded genomic data to promote maximum public benefit.
  • The scope is intentionally general enough to accommodate the evolving nature of genomic technologies, with more specific expectations provided through accompanying Supplemental Information to the NIH Genomic Data Sharing Policy.

Story Source:

The above story is based on materials provided by NIH/Office of the Director. Note: Materials may be edited for content and length.


Journal Reference:

  1. Dina N Paltoo, Laura Lyman Rodriguez, Michael Feolo, Elizabeth Gillanders, Erin M Ramos, Joni L Rutter, Stephen Sherry, Vivian Ota Wang, Alice Bailey, Rebecca Baker, Mark Caulder, Emily L Harris, Kristofor Langlais, Hilary Leeds, Erin Luetkemeier, Taunton Paine, Tamar Roomian, Kimberly Tryka, Amy Patterson, Eric D Green. Data use under the NIH GWAS Data Sharing Policy and future directions. Nature Genetics, 2014; 46 (9): 934 DOI: 10.1038/ng.3062

Cite This Page:

NIH/Office of the Director. "NIH issues finalized policy on genomic data sharing." ScienceDaily. ScienceDaily, 27 August 2014. <www.sciencedaily.com/releases/2014/08/140827131704.htm>.
NIH/Office of the Director. (2014, August 27). NIH issues finalized policy on genomic data sharing. ScienceDaily. Retrieved November 24, 2014 from www.sciencedaily.com/releases/2014/08/140827131704.htm
NIH/Office of the Director. "NIH issues finalized policy on genomic data sharing." ScienceDaily. www.sciencedaily.com/releases/2014/08/140827131704.htm (accessed November 24, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Monday, November 24, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Winter Can Cause Depression — Here's How To Combat It

Winter Can Cause Depression — Here's How To Combat It

Newsy (Nov. 23, 2014) Millions of American suffer from seasonal depression every year. It can lead to adverse health effects, but there are ways to ease symptoms. Video provided by Newsy
Powered by NewsLook.com
Ebola-Hit Sierra Leone's Late Cocoa Leaves Bitter Taste

Ebola-Hit Sierra Leone's Late Cocoa Leaves Bitter Taste

AFP (Nov. 23, 2014) The arable district of Kenema in Sierra Leone -- at the centre of the Ebola outbreak in May -- has been under quarantine for three months as the cocoa harvest comes in. Duration: 01:32 Video provided by AFP
Powered by NewsLook.com
Don't Fall For Flu Shot Myths

Don't Fall For Flu Shot Myths

Newsy (Nov. 23, 2014) Misconceptions abound when it comes to your annual flu shot. Medical experts say most people older than 6 months should get the shot. Video provided by Newsy
Powered by NewsLook.com
Indians Muck in for Cleaner Communities

Indians Muck in for Cleaner Communities

AFP (Nov. 22, 2014) India's government is urging all citizens to come together in a mass movement to clean the nation -- but will people heed the call? Duration: 02:39 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins