Client Alert: NIH Proposes Agency-Wide Policy for Data Management & Sharing
National Institutes of Health (NIH) joins rank with its peers via its Data Management and Sharing Policy. This proposed policy will apply to all research that is funded or conducted in whole or in part by NIH. Importantly, NIH also seeks input on the types of costs that could be considered for inclusion in an application to support data management and sharing.
The Office of Science and Technology Policy (OSTP) has led policy discussion about data access and management. Beginning in 2011, the National Science Foundation began requiring applicants to include a supplementary Data Management Plan. In 2013, OSTP issued a memorandum that required other grant agencies to develop a plan to make the results of federally funded research available to the public at no cost within twelve months after their original publication.
NIH’s policy addresses autonomy and privacy of research participants as well as the protection of confidential data. Under the proposed provisions, grantees would be required to (a) submit a data management and sharing plan at the “Just-In-Time” phase and (b) describe specific strategies for sensitive scientific data, such as human participants. The draft policy encourages “shared scientific data to be made available as long as it is deemed useful to the research community or public.” Grantees are expected to have privacy protections in place for the life of the data.
Upon reviewing an application, NIH would then potentially approve the plan, its related budgeted costs, and require the grantee to adhere to it. Many Institutes at NIH already require applicants to provide specific data management plans in applications. (See Table 1) The proposed NIH-wide policy outlines “minimum expectations.”
A Data Plan Must Answer:
- What data will be shared?
- Who will have access to the data?
- Where will the data to be shared be located?
- When will the data be shared? and
- How will researchers locate and access the data?
What can happen if the policy is violated? Answer: The Plan will become a Term and Condition of the grant that will be incorporated in the notice of award. An enforcement action could result if researchers fail to comply with the Terms and Conditions of the Notice of Award. Failure to comply could also be considered for pending or future funding decisions so effective planning and adherence to the plan will be vital moving forward.
NIH joins peers; The Departments of Energy, Defense, Transportation and National Science Foundation all have similar requirements.
Comment on the Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance before January 10, 2020 online at: https://osp.od.nih.gov/draft-data-sharing-and-management.
If you have any questions about this update or other matters, please contact Ted Waters (Managing Partner), or call (202) 466-8960.
|Table 1: Related NIH Data Policies for Specific Research|
|ENCODE Consortia Data Release, Data Use, and Publication Policies|
|NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies|
|Alzheimer’s Disease Genetics Sharing Plan|
|Alzheimer’s Disease Neuroimaging Initiative (ADNI) Data Sharing and Publication Policy|
|NIAID/DMID Data Sharing and Release Guidelines|
|Data Sharing Guiding Principles for the NIAID/DMID Systems Biology Program|
|Human Immunology Project Consortium (HIPC) Data Sharing Plan|
|Revised Resource Sharing Plan Instructions for Genetic Screens to Enhance Zebrafish Research and Enhancing Zebrafish Research with Research Tools and Techniques (PAR-08-138 and PAR-08-139)|
|NIDA Data Sharing Policy|
|Clinical Trials Network Data Share Policy|
|The Environmental Determinants of Diabetes in the Young (TEDDY)|
|NIH Policy on Deposit of Atomic Coordinates into Structural Databases|
|Genomic Data Sharing Policy|
|National Database of Autism Grantees Data Sharing Policy|
|Sharing Data via the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System|
|The Collaboration, Education, and Test Translation (CETT) Program’s Guidelines for Data Collection and Sharing|
- NIH Public Access Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research (02/2015) (PDF – 474 KB)
- NSF Public Access Plan: Today’s Data, Tomorrow’s Discoveries
- NSF- Dissemination and Sharing of Research Results
- NSF Frequently asked questions about DMPs
- NSF Grant proposal guide on contents of the DMP
- USAID’s Open Data Policy
- DOE Public Access Plan
- DOT Public Access Plan: Increasing Access to Federally Funded Research Results
- NASA Plan for Increasing Access to the Results of Scientific Research
- DOD Plan to Establish Public Access to the Results of Federally Funded Research
- AHRQ Public Access to Federally Funded Research
- ASPR Public Access to Federally Funded Research: Publications and Data
- CDC Plan for Increasing Access to Scientific Publications and Digital Scientific Data Generated with CDC Funding
- Plan to Increase Access to Results of FDA-Funded Scientific Research