In January of next year, the NIH’s Data Management & Sharing (DMS) Policy goes into effect. About a month ago, the NIH blog Under the Poliscope provided an update on DMS Policy implementation. What is it and how will it affect your research?
As stated in the NIH blog and elsewhere, the DMS Policy aims to promote a “culture change” that both enables reproducibility of research results and enhances the public’s trust in research. Data sharing should be prospectively planned for during the grant application process; it should be the default practice for all NIH-funded research; and it should be implemented responsibly, establishing safeguards to protect participants’ privacy and rights.
In a Nutshell
Here’s what you need to know. The DMS Policy:
- Replaces the 2003 NIH data sharing policy but does not replace other guidelines, such as the Genomic Data Sharing (GDS) Policy
- Applies to any NIH grant applications (new or competing), contracts, or cooperative agreements submitted on or after January 25, 2023, that support projects generating scientific data
- Expects all grant applications to describe a data management and sharing plan
- Expects data sharing to commence no later than publication or, for unpublished data, the end of the award period
- Establishes that failure to comply with a DMS plan will be factored into future grant decisions
- Encourages grantees to submit data to established, NIH-supported data repositories
What does this mean for IRB submissions?
While ORRP staff can’t help you write your NIH grant proposal, we have had enough experience with existing data sharing initiatives—such as the GDS Policy—to know it’s essential that researchers plan ahead and ensure data sharing plans are clearly articulated in IRB protocols and consent documents.
Some Ohio State researchers are already familiar with data sharing practices. For example, investigators conducting activities subject to the GDS Policy have been required to submit research data to the Database of Genotypes and Phenotypes (dbGaP) or similar repository at the conclusion of their projects. (You can find ORRP’s investigator guidance on dbGaP here.) In the last few years, we’ve also seen requests to submit data to other national databases, such as the National Institute of Mental Health Data Archive and Rapid Acceleration of Diagnostics (RADx) initiative.
What’s next?
The NIH recently sought public comment on guidance related to the DMS policy. The public comment periods closed at the end of February, and we expect to see some harmonized guidance later this year.
As we learn more, we’ll share it with you through Controverted Issues and education sessions, as applicable. We’ll also share Ohio State resources for researchers developing data management and sharing plans, even though drafting plans is out of the scope of our office.
Future blog posts will cover the data submission process—and why you need to understand it before you begin your research, informed consent considerations for data sharing, and the institutional certification process. Stay tuned!
Resources
Gearing Up for 2023: Implementing the NIH Data Management and Sharing Policy – NIH Extramural Nexus
NOT-OD-21-013: Final NIH Policy for Data Management and Sharing
FAQs for the NIH Policy for Data Management and Sharing (DMS Policy) – Office of Science Policy
Update on Implementation of New NIH Data Management and Sharing Policy – YouTube