NIH Data Sharing Requirements

The NIH endorses the sharing of final research data. The NIH Data Management & Sharing (DMS) Policy, effective January 25, 2023, applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. This includes all NIH-supported research regardless of funding level, including: extramural grants, extramural contracts, intramural research projects, and other funding agreements.

Benefits of Sharing Data

Sharing scientific data accelerates biomedical research discovery, enhances research rigor and reproducibility, provides accessibility to high-value datasets, and promotes data reuse for future research studies. Ultimately, the sharing of scientific data expedites the translation of research results into knowledge, products, and procedures to improve human health.

Definition of Scientific Data

Scientific Data is defined as data 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.

1. Scientific data includes any data needed to validate and replicate research findings.
2. Scientific data does 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.

What do you include in your data management plan?

Your plan should address the following recommended elements, in two pages or less in length. Essential information includes:

1. Data Type
2. Related Tools, Software or Code
3. Standards
4. Data Preservation, Access, and Associated Timelines
5. Access, Distribution, or Reuse Considerations
6. Oversight of Data Management and Sharing

Visit NIH's Writing a Data Management & Sharing Plan page to see how to write a data sharing plan, examples and how to submit the data management sharing plan.
Important: Do not include hypertext (e.g., hyperlinks and URLs) in the DMS Plan attachment.

Which data do you need to share?

You need to share your final research data, not your summary statistics and tables, but the actual data on which your summary statistics and tables are needed to be validated and could be replicated your research findings. You don’t need to share laboratory notebooks, partial datasets, preliminary analyses, drafts of scientific papers, plans for future research, peer review reports, communications with colleagues, or physical objects, such as gels or laboratory specimens.

How do you share?

The NIH does not specify data content, formatting, presentation, or transport mode. There are no standards or best practices. The method you choose may depend on several factors, including the sensitivity of your data, its size and complexity, and the volume of requests anticipated.

There are three methods for sharing data:

• The PI may store the data where he likes and share it in any manner he chooses. For example, you can share your data on a website or in a journal.
• Data Archive (open access database): for data that will get a high number of requests, possible frivolous requests, and data that needs technical assistance for researchers to use. Most of them charge a fee which you can include in your grant. You can find data archives at:
  1. NIH Data Sharing Repositories
  2. Registry of Research Data Repositories
  3. DigitalCommons@TMC (An online repository sponsored by The TMC Library and dedicated to serving as a scholarly resource for member institutions of the Texas Medical Center, visit Get Start Guide on how you can submit research to DigitalCommons@TMC)
• Data Enclave (restricted access database): for data that cannot be distributed to the general public due to confidentiality concerns, third-party licensing agreements, or national security considerations. One example is the CDC’s National Center for Health Statistics’ Research Data Center

Regardless of the method used to share data, datasets will require documentation which gives information about the methodology and procedures used to collect the data, details about codes, definitions of variables, variable field locations, frequencies, etc. For more information see Data Standards and Common Data Elements Resource Guide.

Data would need to be shared when your work is published, or before your performance period ends, whichever comes first.

In general, you should make your data accessible as soon as possible. You can also use relevant requirements and expectations such as data repository policies, award record retention requirements, or journal policies, to decide when to share your data sets.

Implementing Data Management Sharing Plans

You are expected to carry out data management and sharing as outlined in approved plans and as a term and condition of award.

1. Manage and share data as described in the approved DMS Plan.
2. Provide updates on data management and sharing activities in annual progress reports.
3. If plans change over the course of the project, work proactively with NIH Program Officer to obtain review and approval of modifications.

Exceptions

NIH understands that some scientific data generated with NIH funds may be proprietary. Under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive, effective May 2, 2019, SBIR and STTR awardees may withhold applicable data for 20 years after the award date, as stipulated in the specific SBIR/STTR funding agreement and consistent with achieving program goals. SBIR and STTR awardees are expected to submit a Data Management & Sharing Plan per DMS Policy requirements.

More Information

NIH Data Management and Sharing Policies
2023 Data Management & Sharing Policy (FAQs)
NIH Data Management and Sharing (LibGuide)
DMP Tool
Budgeting for Data Management and Sharing