Section XVII:

Special Requirements and Guidance for Investigators

WPP #: XVII-3

Title 3:

Research Involving Genomic Data Sharing

Effective Date:

8-15-16

Revision History:

Policy Statement

Research studies involving genomic data sharing require IRB approval and Institutional Certification if federally funded. Investigators should strive to obtain informed consent that grants permission for future research and broad sharing of data.

Background

To promote robust sharing of human and non-human data from a wide range of genomic research and to provide appropriate protections for research involving human data, the National Institutes of Health (NIH) issued the NIH Genomic Data Sharing Policy (GDS Policy) on August 27, 2014. The policy took effect for grant applications submitted January 25, 2015 or later.

The GDS Policy applies to all NIH-funded research (e.g., grants, contracts, 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. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. Supplemental Information to the GDS Policy provides examples of genomic research projects that are subject to the Policy.

Investigators must include a Genomic Data Sharing Plan in the grant proposal. Resources necessary to carry out the Data Sharing Plan should be included in the proposal budget.

Guidance

Steps Involved in Starting Research with a Genomic Data Sharing Plan or Adding a Data Sharing Plan to an Existing Study

  1. If the grant receives a fundable score, prepare a new IRB application or amendment to an existing study as soon as possible.
    1. Describe the data sharing plan in the IRB application. It should match what is contained in the grant proposal.
    2. Prepare / update informed consent document(s) that address broad data sharing (see below for specific consent guidance).
  2. Submit the IRB application including the following important documents:
    1. Grant proposal containing the data sharing plan
    2. New or revised informed consent document(s) addressing data sharing
    3. For existing studies, all prior versions of informed consent documents
    4. Any institutional certification form(s) provided by the funding agency requiring an authorized institutional signature
  3. The IRB will review the submission to determine that the following are true:
    1. The data sharing plan described in the grant and the IRB application match
    2. The informed consent document(s) adequately address data sharing according to what is described in the plan
    3. The study is/remains approvable according to the regulations
  4. If required by the funding source, the IRB will make Institutional Certification determinations as part of its review of the IRB application. The Institutional Certification should indicate whether the data will be submitted to an unrestricted- or controlled-access database. The IRB must determine and document in the certification the following:
    1. The data submission is consistent, as appropriate, with applicable national, tribal, and state laws and regulations as well as relevant institutional policies;
      • Any limitations on the research use of the data, as expressed in the informed consent documents, are delineated. NIH recognizes that in some circumstances broad sharing may not be consistent with the informed consent of the research participants whose data are included in the dataset. In such circumstances, institutions planning to submit aggregate or individual-level data to NIH for controlled access should note any data use limitations in the data sharing plan submitted as part of the funding request. These data use limitations should be specified in the Institutional Certification submitted to NIH prior to award. [NIH Genomic Data Sharing Policy Section IV.C.4.];
    2. The identities of research participants will not be disclosed to NIH-designated data repositories; and
    3. An IRB, privacy board, and/or equivalent body, as applicable, has reviewed the investigator’s proposal for data submission and assures that:
      1. The protocol for the collection of genomic and phenotypic data is consistent with 45 CFR Part 46;
      2. Data submission and subsequent data sharing for research purposes are consistent with the informed consent of study participants for whom the data were obtained;
      3. Consideration was given to risks to individual participants and their families associated with data submitted to NIH-designated data repositories and subsequent sharing;
      4. To the extent relevant and possible, consideration was given to risks to groups or populations associated with submitting data to NIH-designated data repositories and subsequent sharing; and
      5. The investigator’s plan for de-identifying datasets is consistent with the standards outlined in the NIH Genomic Data Sharing Policy (section IV.C.1.), which states: “Investigators should submit large-scale human genomic data as well as relevant associated data (e.g., phenotype and exposure data) to an NIH-designated data repository in a timely manner. Investigators should also submit any information necessary to interpret the submitted genomic data, such as study protocols, data instruments, and survey tools.”
  5. Upon completion of the review, the IRB will approve the submission and issue the Institutional Certification, which the PI should provide to the Office of Sponsored Programs and the funding agency. The Institutional Certification is signed by the Institutional Official or delegate.

Informed Consent Considerations for Research Involving Genomic Data Sharing

  • After the January 25, 2015 implementation date, NIH expects that consent be obtained for future use and broad sharing, even if the data or specimens are de-identified.
    • NIH expects investigators to obtain participants’ consent for their genomic and phenotypic data to be used for future research purposes and to be shared broadly. The consent should include an explanation about whether participants’ individual-level data will be shared through unrestricted- or controlled-access repositories. [NIH Genomic Data Sharing Policy Section IV.C.4.]
    • For studies proposing to use genomic data from cell lines or clinical specimens that were created or collected after the effective date of the Policy, NIH expects that informed consent for future research use and broad data sharing will have been obtained even if the cell lines or clinical specimens are de-identified. [NIH Genomic Data Sharing Policy Section IV.C.4.]
  • Data or specimens collected prior to the implementation date:
    • There may be considerable variation in the extent to which future genomic research and broad sharing were addressed in the informed consent materials for the primary research. In these cases, an assessment by an IRB, privacy board, or equivalent body is needed to ensure that data submission is not inconsistent with the informed consent provided by the research participant. NIH will accept data derived from de-identified cell lines or clinical specimens lacking consent for research use that were created or collected before the effective date of this Policy. [NIH Genomic Data Sharing Policy Section IV.C.4.]
  • NIH encourages the use of informed consent forms that include permission for unspecified future research and broad data sharing. The NIH provides a useful resource discussing informed consent and other ethical considerations for genetic research: https://www.genome.gov/27559024/.
  • Sample consent language for broad sharing:
    Your samples, genomic data and health information will be stored and shared with other researchers. The samples and information will be available for any research question, such as research to understand what causes certain diseases (for example heart disease, cancer, or psychiatric disorders), development of new scientific methods, or the study of where different groups of people may have come from.

Resources

NIH Genomic Data Sharing Policy

Supplemental Information to the GDS Policy

NIH Guidance: Informed Consent for Genomics Research

NIH GDS Points to Consider for Institutions and IRBs