EGRP News Flash - November 16, 2009

NIH Announces Development of Data Sharing Policy for Sequence and Related Genomic Data

The National Institutes of Health (NIH) published a notice in the NIH Guide for Grants and Contracts, NOT-HG-10-006, to inform the research community of plans to:

  • Update data sharing policies for NIH supported research, including extramural and intramural projects, involving sequence and related genomic data obtained with advanced sequencing technology (e.g., medical resequencing data, sequence data from non-human species, as well as data needed for interpretation, including associated clinical and other phenotype and metadata, such as supporting study documents and methodologies);
  • Encourage investigators and Institutional Review Boards to consider the potential for broad sharing of sequence and related genomic data in developing informed consent processes and documents for such studies involving human sequence data; and
  • Communicate the agency’s intent and current underlying considerations related to developing a policy pertaining to the deposition of these large datasets into centralized databases, such as the GenBank Short Read Archive (SRA) or the Database of Genotypes and Phenotypes (dbGaP), so that they are available as broadly and rapidly as possible to a wide range of scientific investigators.

NIH is currently considering several issues relating to the deposition and release of sequence and related data through central database resources, such as the following:

  • The characteristics and rationale for determining whether a project might be subject to any new sequence and other genomic data-release policy, such as:
    • Broad utility of the dataset (either alone or in combination with other available data) to the wider community, e.g., for performing new analyses, critical validations, and additional studies not considered by the original data producer;
    • Uniqueness of the dataset, as indicated in part by the size and cost to NIH of the dataset to be produced, including the extent of the genomic region(s) to be analyzed, the number of samples to be analyzed, and the target amount of data to be produced;
    • Quality and extent of the available associated non-sequence data, such as phenotype and exposure data in the study population(s), if relevant to the study design, and
    • Consideration of issues related to the protection of participant interests, e.g., privacy, confidentiality, and the consistency of the informed consent process with broad data sharing in projects involving human data.
  • The specific types of primary and processed data that should be released, the types of accompanying metadata and other annotation (e.g., phenotype, epigenetic mark) that may be critical for data interpretation, and the technical capabilities and requirements for broad sequence data sharing, including standard data formats.
  • Timing of broad data release, including the potential for pre-publication data release.
  • Mechanisms and policies for making data available to third parties and terms of access including the possibility of a period of exclusivity for publication by the Principal Investigator and collaborators, and consideration of any limitations on future data use within the informed consent agreement.
  • Costs of implementing policies to investigators, institutions, and NIH.

This Notice serves as a reminder for investigators to consider the issues listed above carefully in designing any study seeking NIH support that includes the use of large-scale advanced sequencing technologies, and within any applications submitted to the NIH, as applicable. Some NIH Institutes/Centers may begin considering these issues prior to release of a final policy; applicants are encouraged to contact their program official for specific issues related to an application or project. The NIH anticipates that this policy development process will occur over the next several months. At an appropriate time before the policy is implemented, the NIH will publish additional details on the policy plans.

To share comments or for further information regarding policy development, please contact the representative listed below.

Laura Lyman Rodriguez, Ph.D.
National Human Genome Research Institute
National Institutes of Health
31 Center Drive, Room 4B09
Bethesda, Maryland 20892
Phone: 301-496-0844

  • Access the NIH Guide for Grants and Contracts for details: NOT-HG-10-006External Web Site Policy.

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