Institutional Review Board for Health Sciences Research (IRB-HSR)

Special Issues

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:

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:

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

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:

If UVa DOES NOT hold an NIH grant application:

Investigators Accessing and Using Genomic Data

Background:

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

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:

Additional Information/Resources

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

Last Modified: Thursday, 08-Jun-2017 14:33:58 EDT