Sharing Data and Specimens
When you share research data broadly with other investigators, it may lead to discoveries that improve the understanding of health risks, diseases and treatment options. Equitable sharing balances accessibility with the rights of research subjects who allow their data and biospecimens to be used and reused for future research.
When you share research data broadly with other investigators, it may lead to discoveries that improve the understanding of health risks, diseases and treatment options. Equitable sharing balances accessibility with the rights of research subjects who allow their data and biospecimens to be used and reused for future research.
Sharing excess biospecimens collected during research is crucial for advancing scientific knowledge and ensuring responsible use of valuable resources. As an NIH IRP investigator, you are expected to share data for secondary research, consistent with laws, regulations, and NIH policy. However, the sharing of data and biospecimens may be limited by agreements with outside collaborators, like Cooperative Research and Development Agreements (CRADAs) or Clinical Trial Agreements.
Equitable sharing balances accessibility with the rights of research subjects who allow their data and biospecimens to be used and reused for future research. To advance and accelerate scientific discovery, data and biospecimens collected in the NIH Intramural Research Program (IRP) should include consent for broad sharing.
Guidance
If you plan to share or receive data and biospecimens, you must consider what the consent form says about sharing and future research. The planned sharing and research should not conflict with the language in the signed consent form. Also, consider whether the receiving investigators will have access to identifiers. If they do, the research is considered human subjects research and requires IRB approval. If you receive results back from collaborators that you can link to identifiable, living subjects, you are engaged in human subjects research and need IRB review and approval for the research.
If your study involves generating a large amount of genetic or genomic data, contact your Institute and Center (IC) Genomic Program Administrator (GPA) to see if you need to comply with the NIH Genomic Data Sharing Policy (GDS). If you plan to share genomic data in a repository (e.g., to meet journal expectations), even when you are not required to per policy, you should ensure the consent language does not conflict with your plan. All studies must also comply with the 2023 NIH Data Management and Sharing Policy and the Intramural Research Program Human Data Sharing Policy.
When using Material Transfer Agreements (MTAs), Data Transfer Agreements (DTAs), Data Use Agreements (DUAs), or Research Collaboration Agreements (RCAs) to share or receive biospecimens or data, you must complete the Investigator Attestation and share it with your Tech Transfer contact. You do not need to revise the protocol to reference specific MTAs or name collaborators or their institutions unless they will have access to identifiers as part of the study.
Related Resources
When IRB Approval is Necessary and How to Complete the New Investigator Attestation for Tech Transfer Agreements
Presented by Julie Eiserman
Best Practices for the Approval and Conduct of Secondary Research, including Repositories
Presented by Julie Eiserman and Jonathan Green
Using and Sharing Existing Specimens and Data for Secondary Research: Expectations for Consent and IRB Approval
Presented by Julie Eiserman
The NIH Genomic Data Sharing Policy: Applicability to the Intramural Research Program
Presented by Kathleen Calzone
Implementing the NIH Data Management and Sharing Policy within the NIH IRP
Presented by Taunton Paine and Chuck Dearolf
Implementing the NIH Genomic Data Sharing Policy: What Intramural Investigators Need to Know
Presented by Cheryl Jacobs, PhD and Julia Slutsman, PhD