The National Institutes of Health (NIH)’s Policy for Data Management and Sharing and accompanying supplemental guidances on Allowable Costs and Elements of a Data Management and Sharing Plan detail NIH’s proposed requirements for how researchers at NIH or receiving NIH funding who are aiming to produce scientific data must plan for the management and sharing of those data. Prior to performing any research but after funds have been awarded, a researcher must submit a data management and sharing plan to NIH for their approval. These plan creation requirements would apply to all NIH-funded data, regardless of the size of the project or of the grant award. If finalized, this proposed policy would replace NIH’s 2003 Data Sharing Policy, which applied only to projects receiving more than $500,000 annually in NIH funding.
Researchers’ plans, which NIH specifies should not exceed two written pages, must detail both how the researchers will manage and share scientific data. The policy defines data management as any steps necessary to validate, maintain, and process scientific data for long-term preservation; it defines data sharing as any actions necessary to make scientific data available for others’ use, including other researchers and the public. And the policy defines scientific data as any factual material necessary for other researchers to validate and replicate research findings, even if those findings were not published in academic journals; scientific data does not include material like lab notebooks, draft scientific papers, or physical specimens. In creating these plans, NIH does provide flexibility for managing and sharing potentially sensitive data, especially data derived from human research subjects or from Native American nations, so that researchers can take necessary steps to protect the privacy and rights of human participants.
In addition to the creation of these data management and sharing plans, NIH expects researchers to comply with the plans as they perform the research. NIH will allow researchers to periodically update their plans as necessary; should researchers fail to follow their plan, NIH will bring appropriate enforcement mechanisms against researchers, such as by terminating funding or potentially referencing non-compliance to inform future funding decisions. NIH will continue this enforcement after the funding period for the specific research project ends; however, NIH does clarify that shared data need only be made available for “as long as it is deemed useful to the research community or the public.”
In the supplemental guidance titled Elements of a NIH Data Management and Sharing Plan, NIH specifies that these plans must include:
- Data Type: providing descriptions of what type and amount of data the project will generate, and explanations of which of those data will be maintained and shared. When applicable, this item will include descriptions of protections for data from human participants.
- Related Tools, Software, and/or Code: identifying whether the research requires any specialized tools or software in order to replicated, and if so, how readily those tools and software can be accessed.
- Standards: identifying whether any pre-existing data standards would be applied to any scientific data generated in the research.
- Data Preservation, Access, and Associated Timelines: identifying for the long term where data will be stored, how it will be findable and accessed, what degree of public accessibility will exist for certain types of data, and how long scientific data will be accessible.
- Data Sharing Agreements, Licenses, and Other Use Limitations: if applicable, identifying whether any sort of legal restrictions would apply to accessing the scientific data.
- Oversight of Data Management: identifying who will be responsible for executing the various components of the data management and sharing plan.
In the supplemental guidance titled Allowable Costs for Data Management and Sharing, NIH permits researchers to request “reasonable, allowable” costs of the research budget to be dedicated to meeting the provisions of the data management and sharing plan, particularly costs associated with curating data, developing supporting information such as metadata, preserving data in established repositories, and providing necessary local information infrastructure.
NIH is accepting public comments on this draft policy and draft supplemental guidances until January 10, 2020, and aims to finalize the documents in 2020. Shortly after NIH released these draft documents, as reported by Bloomberg Law, some stakeholders praised the flexibility provided by NIH; others offered critiques about requiring submission of these plans after projects have been approved rather than before, and about whether NIH could or would actually enforce any plans.