Per the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013), starting on January 25th, 2023, all grant applications submitted to the National Institutes of Health (NIH) are required to include and follow a Data Management and Sharing Plan (DMSP). The new policy intends to promote transparency and accountability in research by setting a minimum set of expectations for data management and sharing.
The Cornell University IRB is in the process of putting together a guidance document regarding the impact of the policy on our process and procedures. For now, when you are submitting protocols to the IRB for review that involve (or potentially involve) NIH funding, you should plan to include your Data Sharing and Management Plan in the protocol. In your RASS-IRB application, you can upload this in the Additional Documents section, under Other Documents.
Below, we have provided resources to read more about this policy change, and learn how it impacts you and your research.
- The NIH’s central resource for this new policy is at their NIH Scientific Data Sharing website. If you would like to read the full text of the policy, you can read the NIH’s Final Policy notice. This notice includes definitions related to the policy as well as all information required to be compliant. Additionally, the NIH has provided multiple supplemental documents with guidance particularly relevant when crafting IRB protocols.
- Protecting Privacy When Sharing Human Research Participant Data – We specifically suggest reviewing the sections titled ‘Operational Principles for Protecting Participant Privacy When Sharing Scientific Data’ and ‘Best Practices for Protecting Participant Privacy When Sharing Scientific Data.’
- Responsible Management and Sharing American Indian/Alaska Native Participant Data – If you are focusing your research on these indigenous populations, we highly recommend reviewing this guidance document, especially the sections titled ‘Considerations for Researchers Working with Tribal Nations’ and ‘Best Practices for Researchers.’
- Cornell University has also developed resources to assist with this policy change. The Research Data Management Service Group (RDMSG) is offering free and confidential feedback on draft Plans, as well as guidance for creating and implementing Plans. For a broader view of the NIH data policy, the RDMSG has a page of frequently asked questions on their website.
- Cornell’s Office of Sponsored Programs (OSP) hosted a November 2022 roundtable focused on this NIH data policy change – the Zoom recording and PowerPoint slides have been saved for general perusal.
- For questions about how this policy might impact your current NIH funding or upcoming proposal submission, contact your OSP Grant & Contract Officer.
- For help drafting a DMS Plan, contact RDMSG at email@example.com.
- For questions about how this policy might impact your human participant research, contact the IRB office at firstname.lastname@example.org.