Sharing Data and Specimens

When research findings are shared broadly with investigators in the research community, it leads to discoveries that deepen the understanding of disease and improve treatment options for patients. Equitable data sharing balances data accessibility with the rights of the patients who allow their data to be used and reused to catalyze discovery.

To further advance and accelerate research to benefit the public health, data developed in the NIH Intramural Research Program (IRP) (NIH-owned or jointly-owned) should be collected in a manner that permits and promotes the broadest sharing possible. NIH IRP investigators are expected to broadly share data for secondary research purposes consistent with applicable laws, regulations, and policies. Data sharing may be limited, in certain cases, by agreements with outside collaborators, e.g., Cooperative Research and Development Agreements (CRADAs), Clinical Trial Agreements, or other agreements.

The key points that investigators must consider when planning to share or receive data and specimens include the following:

1) What the signed consent form said about sharing and future research with data and specimens (The planned sharing and research should not conflict with the language in the signed consent.)

2) Will the receiving investigators have access to identifiers?  If so, the research is considered human subjects research, and they must have IRB approval for their planned research.

3) Will the "sharing" investigators receive results back from the collaborators that they are able to link to identifiable, living subjects?  If so, the "sharing" investigators would be considered engaged in human subjects research, and they must have IRB review and approval for the research that will take place as part of the collaboration. 

4) It is not necessary to revise your protocol to reference specific MTAs or name collaborators or their institutions, unless they will have access to identifiers as part of the study.

5) When MTAs, DTAs/DUAs (Data Transfer Agreements/Data Use Agreements), or RCAs are used to share or receive specimens or data, the NIH investigator must complete the Attestation (see below) and share it with their Tech Transfer contact.

6) If your study involves generating large array genetic or genomic data, you must contact your GCP to determine if the study requires compliance with the NIH Genomic Data Sharing Policy.

7) If your study is not required to share genomic data in a repository as part of the protocol, but you intend to share it anyway, e.g. in order to meet the expectations of a journal, the same rules in the GDS Policy regarding informed consent will apply; and all studies must comply with the 2023 NIH Data Management and Sharing Policy.

NIH Policy

• NIH Genomic Data Sharing Policy (1/25/2015)
• Intramural Research Program Human Data Sharing Policy (7/31/2015)

• NIH Data Management and Sharing Policy (1/25/2023)

• Intramural Specific Information about the NIH Data Management and Sharing Policy (2/17/2023)

OHSRP Forms

• Attestation For MTAs_DTAs_RCAs.pdf PDF, 175 kB (11/21/2021)

OHRP Guidance

• Engagement of Institutions in Human Subjects Research (10/16/2008)

• Coded Private Information or Biospecimens Used in Research, Guidance (1/19/2018)

OHSRP Guidelines