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NHGRI to require explicit consent for data sharing in genomics research

News December 30, 2019

The National Institutes of Health (NIH) Genomic Data Sharing Policy includes expectations for how researchers should obtain, share and access genomic data from human and non-human sources. As a leader in genomics, including relevant policy development and implementation, the National Human Genome Research Institute (NHGRI) encourages data sharing practices that go beyond the NIH expectations.

Overview

In early 2020, NHGRI will require explicit consent for future research use and broad data sharing of all genomic data derived from human sources, such as specimens and cell lines. The policy applies to NHGRI-funded research that will generate genomic data and share it with other researchers through genomic data repositories. This expectation is intended to ensure that participants whose data are shared via a genomic data repository gave explicit permission for that data to be shared.

NHGRI announced the update in a Guide Notice and FAQs posted today.

Why NHGRI is doing this

NHGRI is committed to the promotion of forward-thinking genomic data-sharing processes, with a clear understanding of the ethical, legal and social implications of such sharing. This new policy will increase transparency with researchers and participants and promote consistent data sharing across genomic studies. While NHGRI encourages the broadest sharing possible, this update does not change the fact that participants might choose to limit how and with whom their data are shared.

Who this policy affects

The policy will first go into effect in early 2020 for relevant funding opportunity announcements to provide NHGRI an opportunity to learn from the experience of implementing this new policy with a small set of grant applications before expanding to all grant applications.  Researchers applying for investigator-initiated grants from NHGRI as well as investigators in the NHGRI Intramural Research Program will be expected to follow the policy starting in 2021. 

Researchers who need to use human samples that lack explicit consent may submit an exception request with a brief scientific justification for using such human data sources (see NHGRI’s FAQs for information about how to request an exception).  These requests will be reviewed on a case-by-case basis. 

Data from existing studies are likely to already be present in genomic data repositories, such as dbGAP and AnVIL; this policy expectation does not affect the sharing or use of these data. 

Definitions

Explicit consent: Explicit consent is a clear, affirmative response -- usually given orally or in writing -- for a particular choice. In the research context, explicit consent for broad data sharing is typically obtained by a research team, wherein a participant affirms if they are willing to share their de-identified data in a data repository.  

Broad data sharing: Broad data sharing indicates that data can be shared with others, often through data repositories. Data repositories can either be unrestricted or controlled-access. Consent for broad data sharing does not prevent the participant’s ability to limit the future use of their data (e.g., data can only be used for cancer research). Consent for broad data sharing is different from “broad consent.”

Genomic data repositories: Genomic data repositories (or genomic databases) store and distribute genomic data. They are useful because the data may then be used for purposes beyond those that the data were collected for. Such use is called “secondary research use” and helps maximize the scientific utility of the data and promotes its potential to benefit the public.

Funding Opportunity Announcement: A Funding Opportunity Announcement (FOA) contains all the official information about opportunities to receive grant funding from the NIH. It is a publicly available document published in the NIH Guide for Grants and Contracts. There are various types of FOAs, including program announcements (PA), programs announcements with special receipt dates (PAR), and Request for Applications (RFA).

Contacts

Media Contact
NHGRI Press Office
nhgripressoffice@mail.nih.gov

Policy Contact
NHGRI GDS Team
nhgrigds@nih.gov

Last updated: December 30, 2019