Understanding the NIH Genomic Data Sharing (GDS) Policy
Version Date: 11/18/2019
BackgroundThe NIH GDS policy requires the submission of large-scale genomic data, as well as relevant associated data, to an NIH-designated data repository. The policy became effective January 2015 and expands the scope of the original 2007 policy that was specific to genome-wide association studies (GWAS) studies. The GDS policy applies to all NIH-funded research that generates large-scale genomic data, as well as the use of these data for subsequent research. Examples of large-scale genomic data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data. Institutions are responsible for assuring, through an institutional certification, that plans for the submission of large-scale human genomic data to the NIH meet the expectations of the GDS policy. An Institutional Certification must accompany the submission of all large-scale human data to the NIH repository. Investigators are responsible for requesting this institutional certification from the IRB prior to the sharing of any data with the federal repository.
How do I know if the NIH GDS policy applies to my study?If a study is NIH-funded and involves the creation of large-scale genomic data, the GDS policy applies. The policy requires that investigators provide a basic genomic data sharing plan in the Resource Sharing Plan section of grant applications at the time of submission. A more detailed plan should be provided prior to award. The Institutional Certification also should be provided prior to award, when possible. Guidance on genomic data sharing plans is available on the NIH GDS website. If researchers are unclear whether the GDS policy applies to their study, they are encouraged to consult with their NIH program officer.
What do I do if the GDS policy applies to my study?Requests for institutional certification may be submitted at the time of initial review, or, for already approved studies, as a full change of protocol. In either case, the investigator must provide certain information in order for the IRB to evaluate the request, along with a template certification letter. The NIH provides single-site and multicenter template institutional certification forms, which can be found at https://osp.od.nih.gov/scientific-sharing/institutional-certifications/. Study teams are responsible for identifying the correct certification template letter and providing the letter with applicable fields filled out to the IRB with the request for certification. Investigators who have been awarded grants through the NIH grant program should use the appropriate extramural template. Study teams should also address the following in the specific pages of ARROW OR protocol:
- Research Design General page, question 1.4 should describe the genetic research that will result in large-scale genomic data.
- Risk/Benefit Ratio page should describe the risks of genomic data sharing and how they will be minimized, including:
- any study populations that may be at higher risk, such as distinct ethnic or cultural groups, populations with stigmatizing traits, or identifiable or or isolated study populations
- how risks to these populations will be minimized when their data are shared with federal repositories, such as by limiting the phenotypic data or limiting access.
- Privacy/Confidentiality Continued page, question 2.2 should be “yes” to indicate that the study team will release genomic data outside the UW.
- Biological Information: Genetic Analysis should describe:
- specific federal repository(ies) to which genomic data will be submitted. If the specific repository is not known at initial review, the study team should indicate this.
- types of genomic data that will be deposited (e.g., whole genome or whole exome vs. particular SNPs)
- whether the genomic data will be created prospectively or already exist (e.g., from prior genetic testing)
- whether the genomic data are or will be derived from specimens collected before January 25, 2015
- whether genomic data will be shared for all study participants or only those who gave consent for such data sharing
- whether the genomic data to be shared with the repository will be for:
- general research use (which could include the study of population origins or ancestry),
- limited to health/medical/biomedical use (does NOT include the study of population origins or ancestry), or
- limited to disease-specific research (e.g., participants signed consent forms restricting research use of their data or specimens to particular diseases such as hypertension, diabetes, cancer, neurodegenerative diseases)
- how the study team will code data for transmission to the repository and maintain the code key; this description should confirm that the code will never be shared with the repository and that the dataset will be stripped of all HIPAA identifiers.
- Consent Overview page should provide copies of consent forms the study team will use to collect specimens for genetic research. Consent forms should explain that genomic data will go to a federal repository and the scope of its future use (including possible commercial uses), and identify the risks of broad sharing of the data and any risks to certain individuals/populations. The HS IRB has model template language that should be used. [LINK] See the Supplemental Information section if the genomic data will or have been derived from existing specimens.
- Supplemental Information section OR Secondary Use Pages:
- If consent for genomic data sharing was obtained previously under a different study, the study team should upload the relevant consent forms and identify their source (i.e., the UW IRB number under which the forms were approved or documentation of approval by an external IRB). Upload the template certification form with applicable fields filled out.
What do I do if I know my study falls under the GDS policy, but do not have all the information I need at this point to request institutional certification from the IRB?In some cases, a study includes plans to conduct genetic analysis that would fall under the GDS policy at some point in the future, but does not currently have the details necessary to issue a certification, OR it is anticipated that federal funds may be received in the future. As institutional certification cannot be granted until these details are available, a full change of protocol should be submitted to request institutional certification at the time data is ready to be submitted to the federal repository. In cases such as these, where the genomic analysis and/or data sharing is not immediate, the initial application should include as many details as possible about the type of genetic analysis that is planned in the future, as well as the possibility of sharing with a federal repository. Additionally, the consent form should include template language about the sharing; this will facilitate the certification process in the future.
What is a Provisional Certification and how do I get one?
In some cases, a study team may need a Provisional Institutional Certification, such as for a prospective study where the IRB has not completed its review of the protocol and therefore the Institution cannot attest to all the elements of the formal Institutional Certification. These are typically required to be submitted with Just In Time paperwork.
If there is an active submission in ARROW that is currently under review, study teams should follow these steps:
- Complete the Provisional Institutional Certification letter template [available here: https://osp.od.nih.gov/scientific-sharing/institutional-certifications/] and provide either in the ARROW application or in an email to the assigned staff reviewer.
- The staff reviewer will facilitate obtaining the Institutional Official’s (IOs) signature on the letter and forward the signed letter to the study PI and main study point of contact (POC).
- A signed coy of the Provisional Institutional Certification should be uploaded to the supplemental Information page of ARROW.
- study PI and main study point of contact (POC).
- The Provisional Institutional Certification should be uploaded to the Supplemental Information page of ARROW.
If there is not yet an active submission in ARROW, study teams should email the IRB office at AsktheIRB@wisc.edu. The process will then be handled outside of ARROW.
Note that in the case of Provisional Certification, a finalized Institutional Certification must still be obtained prior to sharing any genomic data with federal repositories.
What language should I include in the consent form?If you know that your study falls under the scope of the GDS policy, whether sharing is expected to occur immediately or at some point in the future, or if you think it is likely that you may obtain NIH funding in the future and/or collaborate with someone who has NIH funding and your study otherwise appears to fall under the scope of the policy, language regarding the sharing should be included in any applicable consent forms. Suggested language is available at Informed Consent: Additional Model Language.
What happens after I submit the request for institutional certification?The IRB will review the letter, IRB application, protocol, and/or consent document(s) to confirm that the certification requirements have been met. If the IRB confirms that certification requirements have been met and the letter to the repository is complete and accurate, the IRB staff will ask the Principal Investigator (PI) to sign the proposed letter then the IRB will forward the signed document to the University of Wisconsin-Madison Institutional Official for Human Subjects Protection (IO). The IO then countersigns the letter and the finalized letter will be provided to the PI, who can then provide this document to the relevant NIH repository.