July 9, 2021
Office of The Director, National Institutes of Health (OD)
NIH is requesting input on strategies for harmonizing, simplifying, and streamlining mechanisms for accessing data in NIH-supported controlled-access data repositories that continue to uphold robust data privacy and security protections. In particular, NIH would like to understand better researchers’ experiences in finding and accessing controlled access data housed in NIH-supported repositories and the extent to which existing NIH policies address aggregation and linkage of controlled access data.
This Notice is part of several NIH activities to engage stakeholders on this topic. Interested parties may find additional information at: https://datascience.nih.gov/streamlining-access-to-controlled-data.
NIH stores and facilitates access to many datasets, both open and controlled, with the goal of accelerating new discoveries, thereby maximizing taxpayer return on investment in the collection of these datasets. Data derived from humans that are shared through controlled-access mechanisms in particular, reflect NIH’s commitment to protect sensitive data from and honor the informed consent provided by research participants in NIH-supported studies.
NIH has supported multiple controlled-access data repositories that uphold appropriate data protections (for both human data and other sensitive data) while meeting the needs of various researcher communities. However, as data access requests increase, new repositories are established, and new mechanisms of providing access to data are developed, it is apparent that opportunities remain to improve efficiency and harmonization among repositories to make NIH-supported controlled-access data more Findable, Accessible, Interoperable, and Reusable (FAIR) and to ensure appropriate oversight when data from different resources are combined. While these trends are enabling datasets and datatypes to be combined in new ways that advance the science, datasets and datatypes that may or may not be controlled may, when combined, create inadvertent re-identification risks.
Request for Information
NIH is requesting input on issues that are relevant to users of NIH-supported controlled-access data repositories (hereinafter “repositories”). NIH notes that the scope of this RFI is intended to cover strategies generalizable to all NIH-supported controlled-access data repositories, and all data types featured therein and is not specific to particular data repositories. This RFI is not intended to identify specific repository access challenges, but rather to help NIH understand users’ experiences and potentially workable solutions to streamlining access to controlled data. Prior RFIs sought community input on opportunities and challenges associated with particular repositories, (for example with dbGaP in 2017).
While elements of this RFI touch on informed consent in the sense of ensuring a common understanding and vocabulary to describe how data may or may not be used, NIH has released another RFI on sample informed consent language for data and biospecimen sharing. Respondents interested in consent for data and biospecimen sharing may wish to review and comment in response to that RFI.
The NIH seeks comments on any or all of, but not limited to, the following topics:
General opportunities for streamlining access to controlled data
Making controlled-access data readily findable and accessible
Addressing oversight, governance, and privacy issues in linking controlled access data from different resources
How to Submit a Response
All comments must be submitted electronically on the Web Portal at: https://datascience.nih.gov/streamlining-access-to-controlled-data-rfi-submission.
Responses must be received by 11:59:59 pm (ET) on 08/09/21.
Responses to this RFI are voluntary and may be submitted anonymously. You may voluntarily include your name and contact information with your response. If you choose to provide NIH with this information, NIH will not share your name and contact information outside of NIH unless required by law.
Other than your name and contact information, please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion. Other than your name and contact information,the Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.
We look forward to your input and hope that you will share this RFI opportunity with your colleagues.
 Data that provide additional information intended to make scientific data interpretable and reusable (e.g., date, independent sample and variable construction and description, methodology, data provenance, data transformations, any intermediate or descriptive observational variables). See NIH Policy for Data Management and Sharing at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html.
Vivian OTA WANG PhD
Office of Data Science Strategy
Division of Program Coordination, Planning, and Strategic Initiatives
Office of the Director