Data Sharing Policies
When research findings are shared broadly with investigators in the research community, it leads to discoveries that deepen the understanding of cancer 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 ensure broad and responsible data sharing for the research and participant (patient and advocate) communities, NCI’s research and data adhere to all NCI and NIH data sharing policies including, but not limited to the excerpt listed below. For additional policies that affect NIH data sharing, visit the NIH Grants and Funding page.
NIH Data Sharing Policy
All data, particularly those generated through public funds, should be considered for data sharing. Furthermore, when the data is shared, it should be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.
To facilitate data sharing for investigators, the NIH Data Sharing Policy applies to:
- Sharing of final research data for research purposes, especially unique data that cannot be readily replicated.
- Basic research, clinical studies, surveys, and other types of research supported by NIH.
- Research that involves human subjects and laboratory research that does not involve human subjects.
- Applicants seeking $500,000 or more in direct costs in any year of the proposed project period through grants, cooperative agreements, or contracts.
- Research applications submitted beginning October 1, 2003.
Review the NIH Data Sharing Policy for more information on expectations for investigators.
NIH Genomic Data Sharing (GDS) Policy
The Genomic Data Sharing (GDS) policy sets expectations for sharing NIH funded data broadly and equitably through a supported NIH repository. NCI’s data submission processes are consistent with the NIH GDS policy guidelines and requirements.
The GDS policy applies to research that:
- Is funded by any NIH funding mechanism (extramural competing grant applications, contract proposals, or intramural projects).
- Generates large-scale human and non-human genomic data. For examples of large-scale genomic data, view the Expectations for Data Submissions and Release Based on Processing Level Table in the Supplemental Information for the NIH Genomic Data Sharing Policy.
- Generates small-scale genomic data that NCI determines should be shared because of the state of the science, programmatic priorities, utility, and/or value of the data for the research community. Examples of the data include but are not limited to mitochondrial DNA sequencing, projects focusing on under-studied populations, or projects examining rare cancers and their subtypes and outcomes.
Extramural research initiated prior to January 25, 2015, and intramural research prior to August 31, 2015, will continue to operate under the terms of the policies that were in effect when the research began. This includes:
- NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (2008)
- NIH Policy on Sharing of Model Organisms for Biomedical Research (2004)
- NIH Data Sharing Policy (2003)
Review the NIH GDS policy for expectations and supplemental instructions.
Cancer Moonshot Public Access and Data Sharing Policy
The primary goal of NCI’s Cancer Moonshot℠ is to significantly accelerate cancer research discovery and meaningful implementation. The Cancer Moonshot Public Access and Data Sharing Policy addresses the recommendation of the Blue Ribbon Panel’s Enhanced Data Sharing working group to the National Cancer Advisory Board that researchers, clinicians, and patients should collaborate in sharing their collective data and knowledge about cancer to accelerate progress towards improving cancer outcomes. Under this policy, applicants for Cancer Moonshot Research Projects are required to submit a “Public Access and Data Sharing Plan” that describes their proposed process for making, to the extent possible, resulting Publications and the Underlying Primary Data immediately and broadly available to the public. Investigators applying for Cancer Moonshot funds must provide a justification to NCI if such sharing is not possible.
The policy applies to:
- Competing grant and cooperative agreement applications that are submitted to NCI in response to a Cancer Moonshot Research Project Funding Opportunity Announcement on or after October 1, 2017.
- Proposals for contracts for Cancer Moonshot Research Projects that are submitted on or after October 1, 2017.
- NCI intramural Cancer Moonshot Research Projects generating Publications and Underlying Primary Data on or after October 1, 2017.
Review the Cancer Moonshot Public Access and Data Sharing Policy for expectations of the policy.
Intramural Research Program (IRP) Human Data Sharing (HDS) Policy
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 policy applies to all NIH IRP human data (including the NIH Clinical Center as well as NIH Institutes and Centers.
Review the IRP HDS policy for expectations of investigators supported by the IRP program.