Last month, the National Institutes of Health (NIH) released its Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance (Draft NIH Policy), making it available for public comment. Comments are due by January 10, 2020. Because everyone’s voice matters, I’m calling on the Musings audience to review the draft and offer your perspectives on this policy now!
The Draft NIH Policy arises from NIH’s deep commitment to fostering a culture of scientific data stewardship.
Data stewardship is a research responsibility that includes systematically acquiring data, carefully documenting data, securely storing data, and, where possible, making data available for use by other scientists and society as a whole. This last activity, often referred to as “data sharing,” is essential for accelerating the translation of science into knowledge and ensuring that the full value of the data collected becomes the substrate for future discoveries.
NIH’s Long-Standing Commitment to Make Research Results Available
In 2003, NIH released its original data sharing policy, which established the expectation that research data from large NIH-supported awards will be shared to the extent allowed by scientific protocol and human subjects considerations. Since 2008, the NIH Public Access Policy has ensured that the public has free access to the published results of NIH-funded research. NLM’s PubMed Central, a free, full-text archive of peer-reviewed biomedical and life sciences journal literature, serves as the repository for these articles.
In 2014, NIH updated its Genome-Wide Association Studies Policy with an expanded NIH Genomic Data Sharing Policy to ensure the broad and responsible sharing of genomic research data. And in 2016, the NIH published the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, which established expectations for registering and submitting the results of all NIH-funded clinical trials on ClinicalTrials.gov. Individual Institutes, Centers, and programs have also established expectations for managing and sharing data resulting from their funded research.
Data Sharing Principles
NIH recognizes that all scientific data need to be managed according to sound principles. The Draft NIH Policy would require researchers to develop explicit data management and sharing plans that describe their approaches for preserving and sharing data. Reasonable, allowable costs for data curation and preservation would be permitted as direct expenses for the project. Proposed guidance about allowable costs of data management and sharing, and the elements of a good data management and sharing plan was released along with the draft policy and can be found on the NIH Data Management and Sharing Activities Related to Public Access and Open Science web page.
While promoting broad sharing of data, the Draft NIH Policy is deliberately designed to be flexible and allow researchers to propose approaches that address legal, ethical, and other practical considerations that may limit data sharing. The policy proposes that data management and sharing plans be submitted “just in time” and evaluated by NIH program staff. Agreed plans will be incorporated into Terms and Conditions of the Award, and NIH staff will monitor compliance with the plans at regular reporting intervals.
Data Sharing Benefits the Scientific Community and the Public
For the scientific community, data sharing enables the validation of scientific results by both the originator of the data and other scientists, increasing transparency and accountability. Data sharing also strengthens collaborations, which allows for richer analyses. Strong data-sharing practices facilitate the reuse of hard-to-generate data, such as those acquired during complex experiments or once-in-a-lifetime events like natural disasters. And, finally, data sharing promotes scientific progress and accelerates future research.
For the public, sound data-sharing practices demonstrate good stewardship of taxpayer funds. Clear, well-written data-sharing and management plans promote transparency and accountability to society. And for research involving human subjects, data sharing honors participants’ efforts by maximizing the contribution of the data acquired through their participation.
Tell Us What You Think!
NIH acknowledges that this draft policy offers new opportunities for advancing science while also creating new expectations and responsibilities for librarians, scientists, trainees and graduate students, and institutional research management offices. And I’ve highlighted some of the benefits of data sharing to the scientific community and the public.
As I emphasized earlier in this post, everyone’s voice matters — so we’d like to hear from all of you about the approach NIH is proposing. You can share your comments on the purpose of the policy, its key definitions, the scope and requirements for the plans, and the effective dates until Friday, January 10, 2020.
Want to Learn More?
NIH is hosting an informational webinar on the Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance on Monday, December 16, 2019, from 12:30 p.m. to 2:00 p.m. EST. The purpose of the webinar is to provide information on the draft policy and answer any questions about the public comment process.
Please note that public comments will not be accepted during the webinar; they must be submitted here.
Accessing the Webinar
If you would like to attend the December 16 webinar, please see the instructions below:
- To view the webinar presentation, click here.
- To join the webinar by phone:
- U.S. and Canadian participants can dial 866-844-9416 and enter passcode 4009108.
- International participants should refer to the table of toll-free numbers.
Please note that while you will be able to view the webinar through Webex, you must use one of the specified phone lines to connect to the audio. You will not be able to dial in to the webinar via your computer.
You may also send questions in advance of the webinar to SciencePolicy@od.nih.gov.