THRIVING

Spring 2021

Clarifying the NIH Genomic Data Sharing policy

by Medard Ng, iTHRIV Research Quality Manager

 

Dr. John designed a research study involving specimen banking (keeping specimens for future research). He did not include the genomic data sharing language in the informed consent form because he considered it unlikely that the specimens will be used for genetic research. Three years later, Dr. Jane proposed an exciting research project to Dr. John involving large-scale genomic research on the banked specimens. To conduct this research with Dr. Jane, Dr. John has to re-consent the participants regarding sharing of the genomic data – a labor intensive task that could have been avoided if the consent form was worded differently.

 

If your investigator initiated research project involves genetic research or specimen banking, you may want to include the genomic data sharing language in the consent form from the beginning. This will avoid the possibility of re-consenting subjects in the future.

 

The genomic data sharing language in the consent is one of the requirements of the NIH Genomic Data Sharing (GDS) Policy. Even though your current research project may be outside the purview of the GDS policy, the policy may still impact your research, for examples:

 

  1. The small-scale genetic data obtained in a pilot grant application may be included in future grant application that falls under the purview of the GDS policy.

  2. The banked specimens may be used for large-scale genomic research in the future - even if it seems unlikely now.

  3. Genetic data may need to be deposited in a NIH repository. The use of such data repository usually requires participants be informed of the sharing of their genomic data.

 

​The NIH Genomic Data Sharing (GDS) Policy

The GDS Policy set forth expectations that ensure the broad and responsible sharing of genomic research data. The policy became effective for competing grant applications submitted for the January 25, 2015, receipt date; contract proposals submitted to NIH on or after January 25, 2015; and for intramural projects generating genomic data on or after August 31, 2015. The NIH GDS Policy applies to NIH-funded research (e.g., certain 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) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.

 

According to the GDS Policy, investigators who intend to use research or clinical specimens collected or cell lines created after January 25, 2015, to generate genomic data may only do so when informed consent processes explicitly discuss future research use and broad data sharing, even if the data are generated from specimens that are de-identified. NIH-designated data repositories will not accept genomic data derived from specimens or cell lines collected or created after January 25, 2015, without this type of consent. NIH strongly encourages the broadest appropriate future use and sharing of genomic and phenotypic data.

 

NOT-OD-14-111: The GDS Policy has no direct cost threshold associated with it and applies only to grant activities requesting support for research, such as:

  • Research project grants (Rs);

  • Program projects (Ps) and SCORs (Ss);

  • Cooperative agreements for research (Us);

  • Individual career development awards (Ks) that include a research component;

  • S activities that include a research component; and

  • All other activities that include a research component.

 

The GDS Policy does not apply to:

  • Institutional training grants (T32s, T34s, T35s, and TL2s);

  • K12 career development awards (KL2s);

  • Individual fellowships (Fs);

  • Resource grants and contracts (Ss);

  • Linked awards derived from previously reviewed applications (KL1, KL2, RL1, RL2, RL5, RL9, TL1, UL1);

  • Facilities or coordinating centers funded through related initiatives to provide genotyping, sequencing, or other core services in support of GDS.

 

Additional information about the GDS policy can be viewed in the iTHRIV portal.

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