The final NIH Policy for Data Management and Sharing (DMS Policy), together with a statement by NIH Director Francis Collins, M.D., Ph.D., was released in late October. The DMS Policy requires all NIH-funded researchers to submit a plan, at the time of application, for how the data they generate will be managed and shared. It will replace the 2003 NIH Data Sharing Policy once it goes into effect on January 25, 2023.
In November 2019, NIH released a draft DMS Policy and sought public comments. AAI submitted comments to NIH agreeing with the principle of and need for data sharing, preservation, and management, but offering numerous suggestions and raising important questions for NIH to consider before moving forward with a final policy. The AAI comments stressed the importance of providing clear definitions of “scientific data,” “preliminary analyses,” “negative data,” and “unpublished data.” Other issues raised by AAI include the need to ensure that the policy is not a new unfunded mandate, to establish how it will be monitored and enforced, and to determine what metrics will be used to evaluate its efficacy.
The final policy does define some key terms, including “scientific data,” which importantly also describes what the term does not include. The definition reads as follows: “[t]he recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens.”
The DMS Policy also includes a section that describes the ways in which compliance will be monitored and enforced during and after the funding period. NIH Institutes, Centers, and Offices (ICOs) will be given the discretion to monitor plans as they see fit, including potentially at the time that progress reports are submitted. After the funding period is over, “non-compliance with the NIH ICO-approved Plan may be taken into account by NIH for future funding decisions for the recipient institution.”
On the issue of cost, NIH does include some clarifications, including that personnel costs for activities related to complying with the policy will be allowable in budget requests, as will costs for long-term data preservation and sharing. Meanwhile, metrics to measure the success of this new requirement are not included in the DMS Policy.
Dr. Collins’ statement notes that NIH will continue to seek input from the biomedical research community as the policy moves toward implementation. AAI looks forward to continuing to work with NIH on this important effort.