NIH Data Management & Sharing Policy

As part of NIH’s long-standing commitment to promote the sharing of scientific data, NIH has issued the Data Management and Sharing (DMS) policy (effective 01/25/2023) to “promote the management and sharing of scientific data generated from NIH-funded or conducted research.” As part of this policy, NIH expects investigators and institutions to complete the following:

Plan and budget for the managing and sharing of data
Submit a DMS plan for review when applying for funding
Comply with the approved DMS plan

Information Session Recording

To prepare for the new 2023 NIH Data Management & Sharing Policy, the Office for Research and Innovation (ORI) hosted two information sessions on December 16, 2022 and January 12, 2023.

Resources

Frequently Asked Questions

To what types of NIH funded projects does the DMS policy apply?

DMS policy applies to all research generating scientific data, including but not limited to:

Research Projects (Rs)
Certain Career Development Awards (Ks)
Research Centers
Small Business SBIR/STTR

DMS policy does NOT apply to research projects not generating scientific data or non-research projects, including but not limited to:

Training (Ts)
Certain non-research Career Awards (e.g., KM1)
Fellowships (Fs)
Construction (C06)
Conference Grants (R13)
Resources (Gs)

What is the NIH-Data Sharing and Management Policy effective date?

Extramural

Competing applications submitted for January 25, 2023 and subsequent receipt dates
Non-competing awards will not immediately become subject to Policy

Contracts

Proposals submitted on or after January 25, 2023

Intramural

Projects conducted on or after January 25, 2023

Other funding agreements (e.g., Other Transactions)

Executed on or after January 25, 2023, unless otherwise stipulated by NIH

What if my application is prior to 01/25/2023 or it's already been awarded?

Application for receipt prior to 01/25/2023 are required to continue to follow the 2003 Data Sharing Policy.

Data Sharing Plans are only required for requests for funding, grants, intramural research, contracts or other agreements if they are $500,000 or more per year.
If you have a competing renewal (i.e., the projects is extended with additional funds) whichever policy was in effect at time of the competing renewal submission will apply.
If you have a non-competing renewal or no cost extension (i.e., the projects is extended without additional funds) whichever policy was in effect at time of the last submission that included funds will apply.

Should I use a NIH data repository, establish my own, or use one of the non-NIH sponsored repositories?

NIH, Institutes, Centers or Funding Opportunity Announcements (FOA) may identify or require specific repositories, and when identified should be used. Otherwise, the NIH has over 100 repositories available to researchers, and should always be used when possible.

Using NIH’s repositories provides a secure method, often at no cost to researchers to meet the policy requirements and promote data sharing. Establishing your own repository or utilization of a non-NIH data repository comes with significant additional burden to the researcher, and should only be utilized when necessary.

My project involves human subject’s research, do I need to submit a modification to the IRB for an existing study?

As NIH has not set required language, you do not need to submit a modification or amendment unless your subject to the NIH DMS Policy (effective 01/23/2023) and your plan has changed and is no longer accurate in your consent or IRB Protocol.

Please ensure in your modification/amendment description why participants either should be reconsented or not reconsented as part of the modification.
A modification/amendment is also required if you change and receive NIH approval to your DMS Plan and the Consent and IRB application is no longer accurate.

Are there repositories that the Office for Research and Innovation (ORI) recommend that I use?

NIH has continued to expand their list of data repositories: Repositories for Sharing Scientific Data, and ORI would recommend selecting an NIH support repository, if not already mandated by the award or funding institution, that is most appropriate for your data type and discipline. With the expansion of the repository listings, please note that some repositories are available at no-cost to researchers (e.g., NHLBI), while others come at a cost and will require budgeting. Please check with the selected repository before submitting your budget.

Will the Office of Research and Innovation help with monitoring compliance (Element 6)?

The Office of Research and Innovation at Drexel University will be conducting routine monitoring inspection of randomly selected studies that have indicated a Data and Sharing Management Plan and have received or been awarded funds through NIH and subject to the NIH Data Sharing Policy.

What do I need to include in the budget justification?

If a Data Management and Sharing Plan is required in the proposed application (see instructions for the “Other Plan(s)” attachment on the PHS 398 Research Plan Form and the PHS 398 Career Development Award Supplemental Form, as applicable), include a brief justification of the proposed activities that will incur costs. The Data Management and Sharing justification must be clearly labeled as “Data Management and Sharing Justification” within the budget justification attachment followed by the estimated dollar amount (total direct costs). Provide a brief summary of type and amount of scientific data to be preserved and shared and the name of the established repository(ies) where they will be preserved and shared. Indicate general cost categories such as curating data and developing supporting documentation, local data management activities, preserving and sharing data through established repositories, etc., including an amount for each category and a brief explanation. Specify in the justification if no costs will be incurred for Data Management and Sharing, if applicable. The recommended length of the justification should be no more than half a page.

What if I do not plan to incur any data management and sharing costs?

In the budget justification, note that no data management and sharing plans costs are anticipated.

Sarah Saxton