On November 30, 2021, the US National Institutes of Health (NIH) issued a “Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy.” The Association of Research Libraries (ARL) is pleased to offer the following comments in response to this request.
Comments of the Association of Research Libraries Regarding “Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy”
February 28, 2022
Thank you for the opportunity to comment on the “Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy.” I submit the following views on behalf of the Association of Research Libraries (ARL), a nonprofit collective of 126 leading research libraries and archives in Canada and the United States.
ARL applauds NIH’s leadership on data sharing, and its continuous engagement with policies that maximize openness within the frameworks of privacy and informed consent.
ARL offers the following comments on the proposed updates:
- Maximizing Data Sharing while Preserving Participant Privacy and Preferences
- ARL recommends that the NIH promote the CARE Principles for Indigenous Data Governance for the ethical and responsible collection and use of indigenous research data and work with tribal organizations to develop effective practices for informed community consent. ARL further recommends that the NIH work with groups such as the US Indigenous Data Sovereignty Network to develop effective practices for informed community consent—especially in regards to data collected about or in coordination with indigenous or other minoritized populations.
(Carroll, S.R., Garba, I., Figueroa-Rodríguez, O.L., Holbrook, J., Lovett, R., Materechera, S., Parsons, M., Raseroka, K., Rodriguez-Lonebear, D., Rowe, R., Sara, R., Walker, J.D., Anderson, J. and Hudson, M., 2020. The CARE Principles for Indigenous Data Governance. Data Science Journal, 19(1), p.43. DOI: http://doi.org/10.5334/dsj-2020-043); Tsosie, K.S., Yracheta, J.M. & Dickenson, D. Overvaluing individual consent ignores risks to tribal participants. Nat Rev Genet 20, 497–498 (2019). https://doi.org/10.1038/s41576-019-0161-z) - ARL recommends that the NIH provide tools and guidance to Institutional Review Boards to facilitate appropriate data management and sharing, while protecting personally identifiable information. The last few years of accelerated scientific advancements for COVID-related research have been made possible through rigorous and secure, yet open, research data. This type of research data sharing is critical for improving health outcomes and social conditions.
(Grant, S. and Bouskill, K.E., Why Institutional Review Boards Should Have a Role in the Open Science Movement. PNAS, 116 (43) (2019). https://doi.org/10.1073/pnas.1916420116) - ARL recommends the NIH adopt a core set of common data elements that will facilitate FAIR research data.
- ARL recommends that the NIH promote the CARE Principles for Indigenous Data Governance for the ethical and responsible collection and use of indigenous research data and work with tribal organizations to develop effective practices for informed community consent. ARL further recommends that the NIH work with groups such as the US Indigenous Data Sovereignty Network to develop effective practices for informed community consent—especially in regards to data collected about or in coordination with indigenous or other minoritized populations.
- Expectations for Alternative NIH-Supported Genomic Data Management and Sharing Resources that Store Human Genomic Data
- ARL commends the NIH’s efforts to develop a set of shared expectations to ensure that data protections are consistent for resources that store human genomic data.
- ARL appreciates the NIH’s adoption and use of the “Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research”.
- Policy Harmonization
- ARL appreciates NIH’s efforts to harmonize the NIH DMS and the GDS policies. Harmonization is critical for reducing burden for researchers on academic campuses and for institutions who are building and maintaining research data services.
- ARL offers the following additional recommendations:
- ARL recommends that the NIH be judicious about applying this policy retrospectively for ongoing longitudinal studies. Retrospective adoption of some requirements may put additional burden on researchers and institutions that could impact data veracity and reuse.
- ARL recommends that NIH strongly encourage machine-readable, or “active” Data Management Plans (DMPs) and appreciates the requirement to use core persistent identifiers.
(Chodacki, John, Cynthia Hudson-Vitale, Natalie Meyers, Jennifer Muilenburg, Maria Praetzellis, Kacy Redd, Judy Ruttenberg, Katie Steen, Joel Cutcher-Gershenfeld, and Maria Gould. Implementing Effective Data Practices: Stakeholder Recommendations for Collaborative Research Support. Washington, DC: Association of Research Libraries, September 2020. https://doi.org/10.29242/report.effectivedatapractices2020.) - ARL recommends that DMPs from funded awards be made available within the awardee’s institution, if not publicly.
- ARL recommends that NIH collect and share data on any cost adjustments for data management between submission and award, and over the course of the awards, so that the community can benefit from data on estimated and actual costs.
- ARL recommends that NIH work with research librarians, and medical and health sciences librarians to develop public guidance on good/exemplar data management and sharing plans.
- ARL recommends that NIH provide guidance and clear expectations on genomic data sharing deposits – including expectations for documentation and curation.
Thank you for your consideration of these comments.
Sincerely,
Mary Lee Kennedy
Executive Director
Association of Research Libraries
About the Association of Research Libraries
The Association of Research Libraries (ARL) is a nonprofit organization of 126 research libraries in Canada and the US whose mission is to advance research, learning, and scholarly communication. The Association fosters the open exchange of ideas and expertise; advances diversity, equity, and inclusion; and pursues advocacy and public policy efforts that reflect the values of the library, scholarly, and higher education communities. ARL forges partnerships and catalyzes the collective efforts of research libraries to enable knowledge creation and to achieve enduring and barrier-free access to information. ARL is on the web at ARL.org.
