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. 

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 : https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-data/repositories-for-sharing-scientific-data. 

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.

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.

a. Please ensure in your modification/amendment description why participants either should be reconsented or not reconsented as part of the modification.
b. 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.

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.

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.

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.

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