Human Data Sharing

The NIH’s mission is to improve the health of the public through support of biomedical research and the training of biomedical scientists. To further advance and accelerate research to benefit the public health, data developed in the NIH Intramural Research Program (IRP) should be collected in a manner that permits and promotes the broadest sharing possible. Data sharing may be complicated or limited, in certain cases, by agreements with outside collaborators, e.g., Clinical Research and Development Agreements (CRADAs) or Clinical Trial Agreements, by Institutional Review Board (IRB) rules or by other constraints. NIH IRP investigators should share data broadly for secondary research purposes, in all cases consistent with applicable laws, regulations and policies.

• Intramural Research Program Human Data Sharing (HDS) Policy

Key Points of Policy

1. This Policy applies to all human data in the NIH IRP, including the NIH Clinical Center as well as NIH Institutes and Centers.
2. A Data Sharing Plan must be developed for any research involving human data.
3. Data Sharing Plans will be included in the institute scientific review process for research involving human data.
4. The Institute Scientific Director (SD) or their designee is responsible for approving all Data Sharing Plans.
5. All IRP-supported clinical investigators are expected to develop protocols and consent processes/forms to enable broad data sharing for secondary research consistent with this Policy.
6. Sharing data for secondary research purposes shall comply with human subjects research regulations and procedures, if applicable.
7. All IRP investigators are encouraged to deposit data in publicly accessible research repositories for sharing to the extent feasible and appropriate.
8. This Policy is effective as of October 1, 2015. Any intramural research involving human data undergoing scientific review after October 1, 2015 must have a data sharing plan.

Data Repositories

Available research repositories include:

• NIH-Supported Data Sharing Repositories
• Biomedical Translational Research Information System (BTRIS)

Additional Resources

• NIH Genomic Data Sharing Policy Memo
• Sample Data Sharing Plan
• NIH Catalyst Article: Data Sharing: Greater Than the Sum of All Parts
• IRP Blog Post: A New Life for Lifesaving Data