The National Institutes of Health has issued a notice “seeking public comments on the draft Genomic Data Sharing (GDS) Policy that promotes sharing, for research purposes, of large-scale human and non-human genomic data generated from NIH-supported and NIH-conducted research.” Comments are due Nov. 20, 2013. Here’s more from the agency’s public notice:
Overview of the Policy
The draft GDS Policy describes the responsibilities of investigators and institutions for the submission of non-human and human genomic data to NIH (section IV) and the use of controlled-access data (section V). The Policy also provides expectations regarding intellectual property (section VI).
When data sharing involves human data, the protection of research participant privacy and confidentiality is paramount, and the Policy reflects NIH’s continued commitment to responsible data stewardship, which is essential to uphold the public trust in biomedical research. The draft GDS Policy, like the GWAS Policy, includes a number of provisions to protect research participant privacy (see section IV.C). For example, prior to data submission, traditional identifiers such as name, date of birth, street address, and social security number should be removed. The de-identified data are coded using a random, unique code to protect participant privacy.
NIH also maintains the expectation established under the GWAS Policy that the responsible Institutional Signing Official of the submitting institution should provide an Institutional Certification to the funding NIH Institute or Center prior to award. An Institutional Certification assures that the data have been or will be collected in a legal and ethically appropriate manner and have been de-identified. The draft GDS Policy clarifies the provisions of the Institutional Certification for datasets submitted to NIH-designated data repositories in Section IV.C.5.
NIH expects the Policy to be effective 60 days after the publication of the final Policy.
Request for Comments
As part of the process of developing the GDS Policy, NIH encourages the public to provide comments on any aspect of the draft GDS Policy.
To ensure that your comments will be considered, please submit your response to this Request for Information by 11:59 p.m. EST on November 20, 2013.
Submit comments by any of the following methods:
- Online: http://gds.nih.gov/survey.aspx
- Fax: 301-496-9839
- Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions) to: Genomic Data Sharing Policy Team, Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892.
Responding to this request for comments is voluntary. Submitted comments are considered public information; do not include any information that you wish to remain private and confidential. Comments in their entirety will be posted along with the submitter’s name and affiliation on the NIH GDS website after the public comment period closes. Commenters will receive a confirmation acknowledging receipt of comments but will not receive individual feedback on any suggestions. Please note that the Government will not pay for the use of any information contained in the response.
NIH intends to hold one or more public webinars on the draft Policy. Information about the webinars will be made available at http://gds.nih.gov.
Read the full notice for the draft genomic data sharing policy, including its purpose, scope, applicability, consent and data withdrawal.