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IRB-HSR > Special Issues > GWAS

 

 

 

 

 

 

Genomic Data Sharing (GDS)

Background
Submission of Data To NIH Designated Data Repository: Institutional Certification
Use of Data From dbGaP
Additional Information/Resources

Background

Sharing research data supports the mission of the National Institutes of Health (NIH) and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health. To set forth expectations that ensure the broad and responsible sharing of genomic research data, NIH issued the Genomic Data Sharing (GDS) Policy on August 27, 2014, in the NIH Guide Grants and Contracts , and on August 28, 2014, in the Federal Register. The GDS Policy became effective on January 25, 2015, and 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. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) data, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data. Supplemental Information to the GDS Policy provides examples of genomic research projects that are subject to the Policy and the timeline for submission and sharing of data from such projects. See more information on the NIH GDS Policy. Questions about the Policy can be e-mailed.

Data Sharing Plan:
The data sharing plan of the research plan (grant application) should include:

  • Documentation that the data submission is consistent with applicable federal and Virginia laws and institutional policies
  • The appropriate research uses of the data and any specific research exclusions per the intent of the study and as outlined in the informed consent document
  • If samples have not yet been collected the informed consent document should include information regarding the data sharing.  The informed consent must be clear that DNA/samples will undergo genomic analysis and that genotype and phenotype will be shared for research purposes with investigators who submit proposals to the NIH Designated Data Repository.  (The IRB-HSR consent form template contains suggested language for use).
  • If samples have already been collected the IRB must review the informed consent documents which were signed by participants to confirm whether or not the initial consent under which genetic materials were obtained is consistent with the submission of data to the NIH Designated Data Repository and the sharing as outlined in the GDS policy.
    • The IRB may determine that the original consent is not inconsistent with the submission of data to the NIH Designated Data Repository and provide certification as documentation.
    • The IRB may determine that the original consent is not consistent with submission of data to the NIH Designated Data Repository and may request re-consent of subjects.
    • The IRB may determine that the original consent is not consistent with submission of data to the NIH Designated Data Repository and determine that it cannot verify that the criteria outlined in the NIH Designated Data Repository have been met for submission of data to the NIH Designated Data Repository and therefore, such submission is not appropriate.

Submission of Data To an NIH Designated Data Repository: Institutional Certification

Background:
All submissions to an NIH Designated Data Repository should be accompanied by a certification by the responsible Institutional Official(s) of the submitting institution that they approve submission to the NIH designated data repository. 

In order to determine if a certificate may be given, the PI will need to submit to the IRB the consent form templates under which the original specimens were collected.  If the consent version changed over time, the IRB will need to see all versions of the consent used.    

The certification should assure that:

  • The proposed data submission is consistent with applicable federal and Virginia laws and regulations, as well as institutional policies ;
  • The research uses of the data and the uses that are specifically excluded by the intent of the study and the informed consent documents are described.
  • The proposal provides that the identities of research participants will not be disclosed to the NIH Designated Data Repository; and
  • The institutionís IRB for Health Sciences Research (IRB-HSR)/ Privacy Board has reviewed the relevant aspects of the proposal and verified that
    • To the extent applicable, the genotype and phenotype data proposed to be submitted were collected/will be collected in a manner consistent with 45 C.F.R. Part 46.
    • The proposed data submission and subsequent data sharing for research purposes is not inconsistent with the informed consent of study participants from whom the data were obtained;7
    • Based on the characteristics of the subject population and the data involved in the primary study, and within the limits of its knowledge of the future potential uses and users of the data, it has considered submission of the data to the general NIH designated data repository. NIH understands that the IRB is not in a position to assess the risks associated with specific future secondary uses and
    • The investigatorís plan for de-identifying datasets is consistent with the standards outlined in this Policy (see section IV.C.1.).

Privacy Protections:
Due to the potentially sensitive nature of the data, steps must be taken to protect the privacy of the individual data.

  • De-identification or Coding of Data:  Before data are submitted to the NIH Designated Data Repository, submitting investigators will be expected to de-identify the data per HIPAA regulations or assign a random, unique code to the data to protect the subjects privacy and confidentiality. 
  • The key to the code will remain at UVa and will never be shared with the NIH Repository.
  •   This information must be stipulated in the protocol.

Procedure:
If you do not already have IRB approval to receive/ collect the data /specimens see  Receipt of Data/ Specimens to determine type of IRB approval required. 

 If UVa holds NIH grant application:

  • Review Sending Data/ Specimens to determine what type or IRB approvals are required.
  • The IRB-HSR will review the NIH grant application when submitted to the IRB. The IRB-HSR Grant Information form includes information the IRB-HSR needs to process the request for an institutional certification to deposit data into the NIH Repository.
  • In order to determine if a certificate may be given, the PI will need to submit to the IRB the consent form templates under which the original specimens were collected.  If the consent version changed over time, the IRB will need to see all versions of the consent used.    
  • The IRB-HSR will work with the Office of the VP for Research to determine the applicability of the certification
  • If certification is granted, the document will be given back to the PI of the Grant Proposal Application along with the IRB-HSR approval of the grant.

If UVa DOES NOT hold an NIH grant application:

  • Review Sending Data/ Specimens to determine what type or IRB approvals are required.
  • Submit a Genomic Data Sharing Submission Certification Request Form to the IRB-HSR
  • In order to determine if a certificate may be given, the PI will need to submit to the IRB the consent form templates under which the original specimens were collected.  If the consent version changed over time, the IRB will need to see all versions of the consent used.    

Investigators Accessing and Using Genomic Data

Background:

Access to human data is through a tiered model involving unrestricted and controlled data access mechanisms.

  • The Unrestricted-Access Data contains the study information deposited as required under the GDS Policy.  Data in unrestricted-access repositories are publicly available to anyone (e.g., The 1000 Genomes Project).
  • The Controlled-Access data in NIH-designated data repositories are made available for secondary research only after investigators have obtained approval from NIH to use the requested data for a particular project. Requests for controlled-access data are reviewed by NIH Data Access Committees (DACs).

The IRB-HSR does not generally consider the access and use of either open-access data or controlled access data to meet the definition of human subjects’ research.  Therefore, IRB review of the researcher’s plans for using such data is not required.  This is based on Office for Human Research Protections (OHRP) advisement to NIH that the dbGaP does not currently involve human subjects’ research because the data will be coded and the identity of individuals with whom the data were obtained will not be readily ascertainable to the investigators maintaining the repository. 

Some controlled-access datasets have restrictions on the use of the data and may require IRB review and approval prior to their release to the requesting researcher. This information is outlined in the Data Use Certification Agreement document located on the GDS website.  

The NIH document "NIH Points to consider for IRBs and Institutions" provides the following information regarding this certification.

For more detailed instructions, refer to the dbGaP request procedures to access genomic data available at: http://dbgap.ncbi.nlm.nih.gov/aa/dbgap_request_process.pdf

Procedure:

  • To determine the type of IRB application required see Receipt of Data/ Specimens.  
  • If IRB approval is required, submit Determination of Human Subjects Research Form including Appendix A.
  • Contact School of Medicine Grants and Contracts Office to obtain Material Transfer Agreement (MTA).  Complete their Data Request Form in order to obtain UVa Institutional Certification.
  • If you have additional questions, contact the IRB-HSR Director at 434-924-9634.     

Additional Information/Resources

Additional information may be found on the Genomic Data Sharing website and specifically under: