We present an analysis of 34 initiatives sharing DNA-derived data based on public information. Cancer Moonshot℠ Public Access and Data Sharing Policy This policy requires researchers to plan prospectively for managing and sharing scientific data generated with NIH funds. Per the NIH GDS Policy, informed consent documents for prospective data collection after January 25, 2015 should state what data types will be shared (e.g., genomic, phenotype, health information, etc. The data should be deposited into dbGAP within six months of data generation or at … NIH Policy on Sharing of Model Organisms for Biomedical Research (2004) NIH Data Sharing Policy (2003) Examples of Projects That Fall Under GDS Policy. When does the policy go into effect? NIAID supports and complies with all NIH data sharing policies, including the NIH Genomic Data Sharing (GDS) Policy. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data. Transparency about data-sharing practices can cultivate trust among prospective and existing MIC participants. Get the latest public health information from CDC; Get the latest research information from NIH; Get the latest information and resources from NHLBI NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) NOT-OD-07-088. NIH is in the process of updating its general data-sharing policy from 2003. September 2020. The NIH’s mission is to improve the health of the public through support of biomedical research and the training of biomedical scientists. As a leader in genomics, including relevant policy development and implementation, the National Human Genome Research Institute (NHGRI) encourages data sharing practices that go beyond the NIH … The policy includes the NIH’s expectations and requirements for the broad sharing of genomic data. Genomic data are also particularly susceptible to re-identification – this fact has been recognized in the NIH Genomic Data Sharing Policy, which provides that such data are sufficiently sensitive to warrant obtaining from human participants informed consent explicitly discussing future research use and broad data sharing, even when the data are de-identified to the standard set forth in … The National Institutes of Health (NIH) Genomic Data Sharing Policy includes expectations for how researchers should obtain, share and access genomic data from human and non-human sources. NIH Genomic Data Sharing (GDS) Policy and NIH Applications. In the interim, it has developed separate policies on Genome Sharing and on Model Organism Sharing. NIH Genomic Data Sharing Policy Notice Number: NOT-OD-14-124 Key Dates Release Date: August 27, 2014 Related Announcements NOT-OD-17-110 NOT-HG-15-038 NOT-OD-15-086 NOT-OD-15-083 NOT-OD-15-027 NOT-OD-14-111 NOT-OD-13-119 NOT-OD-12-136 NOT-HG-10-006 NOT-OD-08-013 NOT-OD-07-088 NOT-OD-07-088 NOT-MH-19-033 NOT-HG-20-011 Issued National Institutes Health NIH) Purpose … The policy is expected to go into effect across NIH beginning January 25, 2023. Policymakers must respect that participants' assessment of the risks and benefits of data sharing and their privacy-utility determinations, which are associated with their final data release decisions, vary. To promote sharing of human and non-human genomic data and to provide appropriate protections for research involving human data, the National Institutes of Health (NIH) issued the Genomic Data Sharing (GDS) Policy on August 27, 2014, in the NIH Guide Grants and Contracts, and in the Federal Register on August 28, 2014. NIH To ensure the broad and responsible sharing of genomic research data generated from NIH-funded research. NIH: Genomic Data Sharing Policy: Expects that large-scale genomic research data from NIH-funded studies involving human specimens, as well as non-human and model organisms, will be shared through a publicly available data repository. Data are generated from human specimens collected before the effective date of the GDS policy and cannot be shared through NIH-designated data repositories. The NIH Genomic Data Sharing Policy ensures the broad and responsible sharing of genomic research data and applies to all NIH-funded research that generates or uses large-scale human or non-human genomic data as well as these data for subsequent research. This policy also establishes the baseline expectation that data sharing is a fundamental component of the research process, which is in line with NIH’s longstanding commitment to making the research it funds available to the public. By implementing the GDS policy, NIAID continues its long-standing tradition of timely genomic data release through broadly accessible open or controlled-access data repositories. Find definitions and examples of large-scale genomics projects at NIH GDS Policy Supplemental Information. What is the purpose of the policy? In order to advance the ethical conduct of genome research, proposed policy changes should c … 2. NIH Genomic Data Sharing Policy (GDS Policy) applies to all NIH-funded research that generates large-scale human or non-human genomic data, regardless of the funding level, as well as future use of the data. ), for what purposes (e.g., general research use, disease-specific research use, etc. January 25, 2015. Effective 1/25/15, the GDS Policy applies to the following: NIH-funded research that generates human or non-human genomic data (e.g. As for the NIH Genomic Data Sharing Policy, in certain instances NIA may expect submission of data from smaller scale research projects in the area of the genetics and genomics of Alzheimer’s disease based on the state of the science, the NIA’s programmatic priorities, and the utility of the data for the research community. NEWS: New NIH Policy on Data Management and Sharing (effective January 25, 2023). The NIH encourages broad use of NIH-funded genomic data that is consistent with a responsible approach to management of intellectual property derived from downstream discoveries, as outlined in the NIH Best Practices for the Licensing of Genomic Inventions 70 and Section 8.2.3, Sharing Research Resources, of the NIH Grants Policy Statement. To set forth expectations that ensure the broad and responsible sharing of genomic research data, NIH issued the Genomic Data Sharing (GDS) Policy. The Policy applies to contracts and all grant types, with […] NEW: Genomic Data Sharing (GDS) Policy Extension of the rationale for data sharing policies Accessibility of whole genome sequencing and other genomic technologies advancing rapidly Consistent approach for investigators, institutions secondary users, and participants Complexity of data and project types much greater . The policy applies to all NIH grantees and establishes the baseline expectation that data sharing is a fundamental component of the research process, which is in line with NIH’s longstanding commitment to making the research it funds available to the public. Genomic data from more than 100 genes in the genome will be generated from specimens previously collected from 700 study participants from a small population in Africa. What research is covered by the policy? REFERENCES The following links highlight NIH policy and related guidance on sharing of research data developed with NIH funding. W … 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. The policy applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research. *Please note that all studies conducting genomic research, regardless of cost, should refer to the NIH Genomic Data Sharing (GDS) Policy for additional requirements. The GDS Policy applies to all NIH-funded research (e.g., grants, contracts, and intramural research) that generates large-scale human or non-human genomic data, regardless of the funding level, as well as the use of these data for subsequent research. 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. Data generated from human genomic or human genome-wide association studies should be submitted as rapidly as possible to NIH dbGAP following the NIH Genomic Data Sharing Policy. To further advance and accelerate research to benefit the public health, data developed in the NIH Intramural Research Program (IRP) should be collected in a manner that permits and promotes the broadest sharing possible. 1. Making data broadly accessible is essential to creating a medical information commons (MIC). 3. NIH intramural projects generating genomic data on or after August 31, 2015; There is no minimum cost threshold provided the data are considered large-scale. SNP arrays, genome sequencing, RNA sequencing, transcriptomic, metagenomics, epigenomic and gene expression data, GWAS studies) from more than 100 individuals. Some documents, such as the data sharing management plans, must be submitted prior to the award of funding. [No authors listed] The NIH's new Genomic Data-Sharing policy, which goes into effect on January 25, 2015, outlines data sharing and informed consent expectations for researchers who generate large amounts of genomic data during NIH-funded studies. GDC policies for open and controlled data access adhere to the National Institutes of Health (NIH) Genomic Data Sharing Policy (GDS) Policy as well as the NCI GDS Policy.The GDC requires that users obtain authorization from the National Center for Biotechnology Information (NCBI) Database of Genotypes and Phenotypes (dbGaP) for accessing controlled data. OHSRP Education Series: The NIH Genomic Data Sharing Policy: applicability to IRP investigators; components; and required protocol and consent content NIH's new genomic data sharing (GDS) policy covers both human and model-organism genotypic and phenotypic data, and strives to balance rapid release of data with embargo periods to ensure that data producers have sufficient time to analyze their results. For NIH proposals generating non-human genomic data, U-M's response to the JIT request includes a more detailed genomic data sharing plan consistent with the GDS Policy and NIH's expectations for data sharing and timing of data release, as described in the Supplemental Information referenced above. 71 The NIH discourages the use of patents … Data sharing plans for NHGRI-funded or -supported projects to generate non-human genomic data proposed after January 25, 2016 should include pre-publication timelines for data submission and release consistent with NIH GDS Policy expectations for human genomic data (including a possible holding period before data release not to exceed six months). Investigators should work with their NCI Program Official regarding expectations. NIH broadens genomic data-sharing policy. 31 To share genomic data with NIH and NCI repositories, investigators will need to complete the following documentation. 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