Sneak Preview: NIH Seeking Input on Privacy When Research Data Is Shared

(The following was excerpted from a recent Thompson Grants Compliance Expert article.) The National Institutes of Health (NIH) is requesting public comment on how best to protect the privacy of participants when federally funded research data is shared. NIH is seeking input on draft supplemental information to the NIH Data Management and Sharing (DMS) policy to address privacy.

This “supplemental information” is not intended as “a guide for compliance with regulatory requirements, but is rather a set of principles, best practices and points to consider for creating a robust framework for protecting the privacy of research participants when sharing data under the NIH Policy for Data Management and Sharing,” according to NIH notice NOT-OD-22-131. Lyric Jorgenson, acting associate director for science policy and acting director of the NIH Office of Science Policy, in a recent blog post, asked commenters to prepare their input with the understanding that “the main purpose” of the document is to provide researchers with information on:

• operational principles for protecting participant privacy when sharing scientific data;
• best practices for protecting participant privacy when sharing scientific data; and
• points to consider for designating scientific data for controlled access.

Comments on the draft are due by June 27, and should be submitted using NIH’s online comment form. After considering public comments on this draft supplemental information, NIH intends to issue final supplemental information later this year.

In NOT-OD-22-131, NIH said that “respect for and protection of participant privacy is the foundation of the biomedical and behavioral research enterprise,” and the agency outlined certain “paramount” principles that researchers should “uphold … in their [DSM] plans and throughout the research project.”

NIH’s new DMS policy goes into effect on Jan. 25, 2023, and replaces data sharing guidelines now in effect. NIH’s goal in updating its plan “is to lead a cultural shift that makes data sharing the norm,” Jorgenson said (see “NIH Revamps Policy on Data Sharing Plans, Effective for Applications Submitted in 2023”). The policy lays out NIH expectations for grant applicants to submit a DMS plan with an application, and, if funded, comply with their plan. Peer reviewers will evaluate plans to ensure the proposed budget adequately supports DMS, according to Jorgenson, and NIH program staff will assess the adequacy of the plans to meet scientific requirements as identified in the policy.

During the January 2022 meeting of the National Institute of Allergy and Infectious Diseases Advisory Council meeting, Jorgenson said that the new DMS policy furthers four main policy goals: (1) increase scientific transparency and public trust; (2) improve reliability/reproducibility; (3) enable reuse of valuable data; and (4) accelerate discoveries. She also clarified that all scientific data should be managed, though not necessarily shared. The term “scientific data” includes not only data underlining publications, but also null results. Data should be shared no later than at the time of research publication or, for unpublished data, at the end of the grant award, she said.

(The full version of this story has now been made available to all for a limited time here.)

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