Over the past two decades, the Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI), as part of the National Institutes of Health (NIH) Intramural Research Program, has been required to share data from studies shortly after their publication under the Freedom of Information Act. In addition, DCEG also makes available a variety of research tools and resources, including datasets, software to calculate power and sample size for epidemiologic studies, questionnaire modules, interactive cancer atlas maps, and other assessment tools on its internet website http://dceg.cancer.gov/tools.
General Policy
- Data sharing policy must be implemented uniformly across the Division.
- Data, as defined by the NIH Data Sharing Policy and Implementation Guidance, are "recorded factual material commonly accepted in the scientific community as necessary to document, support, and validate research findings".
- One manner in which data can be shared is in the context of a formal collaboration between DCEG investigators and investigators outside of DCEG. In such circumstances, interested parties should contact the Principal Investigator (PI) of the study. The data to be shared and the manner of sharing should be established by mutual consent of all the collaborators.
The policies outlined below refer to sharing outside of such formal collaboration.
Published Data
- Data from completed studies with published research findings should be made freely available.
- Data must be stripped of all personal identifiers and any variables that permit deductive identification of individual subjects to ensure confidentiality.
Unpublished Data
- Studies where data collection is ongoing are exempt from data sharing.
- Data under active analysis are exempt from data sharing until publication of the results of the analysis, or until a decision is made not to publish results.
Review Considerations
- Data sharing plans must be included in all protocols submitted for the Committee for the Technical Evaluation of Protocols (TEP) Committee review.
- There must be a written justification in the study protocol if the data set is not appropriate for data sharing, e.g., the study will include samples drawn from small geographic areas, rare populations, or linked datasets that could allow deductive identification of individual subjects.
Requests for Data
- All requests to access data that do not involve a collaboration with a DCEG PI must be submitted as a Freedom of Information Act (FOIA) request to the NCI FOIA Coordinator, Building 31 Room 10A34, 9000 Rockville Pike, Bethesda, MD 20892. Information on how to file a FOIA request may be found at http://legislative.cancer.gov/foia.
