About the Genomic Data Sharing (GDS) Policy

When the Policy Applies

Because the GDS policy applies to a broad range of research, a wide array of data repositories will be used. Genomic data should be shared via a supported NIH repository. See the NIH Genomic Data Sharing Repository list.

The GDS policy is in effect for:

• Competing grant applications submitted for the January 25, 2015 receipt date
• Contract proposals submitted to NIH on or after January 25, 2015
• Intramural projects generating data on or after August 31, 2015

Research that was initiated prior to the effective date of the GDS policy will continue to operate under the terms of the policies that were in effect when the research began. This includes:

• the 2008 NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (the GWAS Policy),
• the 2004 NIH Policy on Sharing of Model Organisms for Biomedical Research, or
• the 2003 NIH Data Sharing Policy

The NIH, however, strongly encourages investigators to comply with the expectations outlined in the policy. For studies initiated before the policy's effective date that involved human specimens and did not use consents that meet the expectations of the GDS policy, investigators should plan to transition to a consent for future research uses and broad sharing, if possible.

Examples of Projects That Fall Under GDS Policy

The GDS Policy applies to all NCI-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research. Additionally, NCI may choose on a case-by-case basis to apply the Policy to projects generating data on a smaller scale depending on the state of the science, the needs of the research community, and the programmatic priorities of the institute. Therefore investigators should consult with appropriate NCI Program Officers or your intramural Scientific Director as early as possible.

Thresholds for Large Scale Projects

Examples of projects for which the NCI anticipates data sharing (regardless of study design) include, but are not limited to:

Research that does not meet the above criteria and involves instrument calibration exercises and/or statistical or technical methods development is outside the scope of the GDS policy.

Smaller Scale Research Projects

While the GDS policy pertains to large-scale genomic data, submission of data from smaller scale research projects may be expected depending on:

• the state of the science
• the programmatic priorities of NCI
• the utility of the data for the research community

Examples of smaller-scale projects that NCI would likely mandate data sharing for include, but are not limited to:

• projects examining rare cancers, rare-cancer-related outcomes, or rare cancer subtypes
• projects focusing on under-studied populations
• mitochondrial DNA sequencing

Definition of a rare disease:

• FDA: A disease or condition affecting less than 200,000 persons in the United States (Orphan Drug Act Pub L 97-414, as amended 1984)
• Rare Disease Act 2002: Rare diseases and disorders are those, which affect small patient populations, typically populations smaller than 200,000 individuals in the United States
• Genetic and Rare Diseases (GARD) list of rare cancers

Investigators should consult with appropriate program directors or their Intramural Scientific Director (SD) as early as possible.

Exceptions to the GDS Policy

The Institute recognizes that data sharing is not always appropriate. In such rare cases, NCI will consider requests for an exception to usual data sharing expectations. Exceptions will be considered on a case-by-case basis. Factors that may preclude data sharing include:

• international laws
• limitations in the original informed consents
• concerns about harms to individuals or groups
• other cases where expectations for data submission cannot be met

In cases where data sharing is not appropriate, investigators should provide a justification for the exception and an alternative data sharing plan in the funding application or proposal. The request will first be reviewed by NCI divisions and the Trans-NCI Data Sharing Working Group before going to the NCI Scientific Program Leaders (SPL). If the SPL reaches a consensus, the request will be sent to the NCI Director for signature. Intramural investigators must also have their request signed by the NIH Deputy Director for Intramural Research.

NCI takes the following into account when assessing data sharing exception requests:

• impact of data sharing compliance on scientific merit
• unique or high-value resource
• regulatory considerations
• ethical considerations
• NIH data sharing exception precedents
• having an acceptable alternative data sharing plan (ADSP)
• impact of ADSP on data re-use and discoverability
• burden and feasibility

If an exception is granted, and an alternative data sharing plan is determined to be appropriate, a basic summary of the study and study data, as well as information on how to request access to the data, will be listed in the database of Genotypes and Phenotypes (dbGaP).

Informed Consent

NIH-designated data repositories will not accept data generated from samples or cells lines acquired or created after the effective date of the GDS Policy unless informed consent has been provided for future research use and broad data sharing.

In some circumstances, broad sharing may not be consistent with the consent of the research participants whose data are including in the dataset. For more information, the NIH has provided Guidance on Consent for Future Research Use and Broad Sharing of Human Genomic and Phenotypic Data Subject to the GDS Policy.

Research that was initiated prior to the effective date of the GDS policy will continue to operate under the terms of the policies that were in effect when the research began; however, NIH strongly encourages investigators to comply with the expectations outlined in the policy.

Consent forms should be tailored to each individual study. The National Human Genome Research Institute (NHGRI) has made approved consent forms available. These have been used in various NIH-funded research projects and should be used as references, not templates. Visit NHGRI’s website to view sample consent forms.