LabArchives Supports NIH Data Management and Sharing Policy

The purpose of this document is to outline the key components of the NIH 2023 Data Management and Sharing (DMS) policy along with details on how LabArchives supports the requirements along with resources for institution’s to promote best practices to their researchers. 

The NIH 2023 Data Management and Sharing (DMS) policy now in effect has three high-level components:

1. Planning and budgeting for data management and sharing
2. Creation of a Data Management & Sharing (DMS) plan 
3. Implementation of the DMS plan 

LabArchives supports the key aspect of these sections of the requirement.

1. Planning and budgeting for data management and sharing

LabArchives ELN was designed for data management by all users, and limits public sharing to specific roles within the notebook. Researchers can utilize multiple notebooks to organize and plan the management of research data with templates and custom forms that can be used by all members of the research project. Scientific data that meets the NIH definition can be organized and presented in a notebook specifically designed for publication, to separate the research ELN from the notebook designated for public sharing.

Any budgeting tools used by the researcher can be stored in the notebook or a link can be added as a quick reference to the grant administration system in use.

 2. Creation of a Data Management & Sharing (DMS) Plan

The NIH Scientific Data Sharing site provides guidelines for the elements of a DMS plan that can be created and stored in the project ELN. Institutions with an Enterprise license to ELN have access to a customizable resource notebook, “Data Management & Sharing in LabArchives”, which includes a DMS plan template modeled after the NIH guidelines. Plans created using the template or other system can be stored in the notebook and updated if needed.  Just as with all ELN entries, every version of the plan is retained as part of the permanent record of the ELN.

3. Implementation of the DMS Plan 

The NIH 2023 DMS policy defines data management as “…the process of validating, organizing, protecting, maintaining, and processing scientific data to ensure the accessibility, reliability, and quality of the data for its users.” (NIH Data Management and Sharing Policy).  Enabling best practices for research data management and security have been the hallmarks and key values of LabArchives ELN long before the initiation of this new policy.  Both researchers and administrators will find features inherent to the ELN such as a complete audit history of every entry, the inability to delete any entry (or notebooks based on institution controls), custom format for organizing the notebook, pages, customize templates, rich access controls, and more support the implementation of the data management requirement of the policy.

The NIH 2023 DMS policy states that scientific data must be shared “…as soon as possible” with additional time frame recommendations.  Scientific data can be organized in a designated notebook, to separate it from the ELN and shared using one of the data publishing workflows available within the ELN.  Metadata can be added as an entry on the page containing the scientific data to be shared.  This may include methodology and procedures, protocols, data labels, definitions, or any other information that will aid in reproducing and understanding the data.  Further, when publishing data via the ELN with the creation of a DOI, additional metadata can be added to include authors, grant or funding IDs, and ORCID.  A DOI is created and assigned to the shared data as a permanent digital identifier that can be referenced elsewhere and provides a link back to the data.  Once published with the DOI, the scientific data is publicly available to anyone with access to the DOI.

In addition to the publishing option within the ELN, LabArchives will soon enable export to Figshare as another means for sharing scientific data.  Users will be able to leverage their institution’s license or their own personal Figshare account and make data publicly available.

Institution-level controls are available to enterprise sites to enable the public sharing option they prefer.  The option to publish via the ELN can be managed with a permission workflow if desired along with the ability to select Creative Commons licenses that align with the institution’s recommended best practices. 

LabArchives is taking an active role in facilitating information sharing among institutions, research administrators, research integrity officers, research librarians and others overseeing research data management and sharing.   Online resources are available at our Research Data & Security Center covering research security news, insights, and data security best practices.  In addition, we convene regular working group meetings covering NIH DMS policy and data security to share updates and information.  

Institutions with an enterprise license can take advantage of a special resource notebook, “Data Management & Sharing in LabArchives”, which can be customized and made available for all your users.  The notebook includes tips, templates, and other resources that researchers can leverage to meet the NIH requirement directly from the ELN along with reinforcing your institution’s policies.

Ensuring research data security and integrity are foundations of LabArchives service.  We align with multiple security standards, including 21CFR Part 11, SOC2 Type 2,  ISO 27001 and rigorously maintain security awareness and best practices across our entire team.  To further inform how we can provide support to the research community, we meet regularly with our Research Data Security Advisory Board, comprising thought leaders dedicated to development, integrity, and security of research practices.

The combination of tools to meet the NIH DMS policy and our overarching dedication to  research data security, privacy, integrity, and best practices provides one way for researchers and study teams to meet the NIH DMSP policy.  LabArchives will continue to adapt these tools so they will meet new federal funding policies as they arise.  

References

Lemke, Amy A., et al. “Broad data sharing in genetic research: views of institutional review board professionals.” Irb 33.3 (2011): 1.

Pasquetto, I. V., Randles, B. M., & Borgman, C. L. (2017). On the reuse of scientific data.

Rehm, H. L., Page, A. J., Smith, L., Adams, J. B., Alterovitz, G., Babb, L. J., & Rodarmer, K. W. (2021). GA4GH: International policies and standards for data sharing across genomic research and healthcare. Cell Genomics, 1(2).

Sim, I., Stebbins, M., Bierer, B. E., Butte, A. J., Drazen, J., Dzau, V., … & Li, R. (2020). Time for NIH to lead on data sharing. Science, 367(6484), 1308-1309.

NOT-OD-21-013: Final NIH Policy for Data Management and Sharing