Version Date: March 4, 2015
The National Institutes of Health (NIH) issued a Genomic Data Sharing Policy (hereafter NIH Policy) in effect as of January 25, 2015 that requires the submission of large-scale genomic data as well as relevant associated data to an NIH-designated data repository. This NIH Policy applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research. The policy defines large-scale data as including genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data. Further, the policy clarifies that its requirements apply irrespective of NIH funding level or funding mechanism (e.g., grant, contract, cooperative agreement, or intramural support).
NIH requires institutions for which researchers will submit genotype or phenotype information to the central NIH repository to assure through a certification, signed by the Institutional Official, that:
If you are an investigator who is required or voluntarily wishes to submit data to an NIH repository, in order to obtain the required institutional certification the following must be submitted to the IRB that has approved or will approve the research from which the information was or will be derived:
The IRB will review the request to determine whether the consent documents:
Please note that any investigator conducting prospective research involving large-scale human genomic data should ensure the consent form informs participants of the intention to share genotype and phenotype information derived from their samples with the NIH repository; describes the information that will be shared; and describes the protections in place to protect their confidentiality. Participants are still expected to be able to decline providing consent to include their information in the NIH repository.
If the IRB determines that the initial consent forms are not consistent with submission of data to the NIH Repository the data cannot be submitted. This will be communicated to the investigator making the request by the IRB Office reviewing the request. In some cases, participants may need to be re-contacted in order to obtain their consent for the submission of their data to the NIH Repository. This would require the investigator to submit a Change of Protocol to the IRB and the IRB would evaluate whether re-contacting participants to obtain additional consent for the use of their samples is possible and appropriate.
For assistance or further information, please contact the IRB office that you are working with. Contact information for the IRB offices is located on their websites.
1Although the data in the NIH database of Genotypes and Phenotypes (dbGaP) are de-identified by both the Common Rule (45 CFR 46) and HIPAA Privacy Rule standards, NIH has obtained a Certificate of Confidentiality for dbGaP as an additional precaution because genomic data can be re-identified. NIH encourages investigators and institutions submitting large-scale human genomic datasets to NIH-designated data repositories to seek a Certificate of Confidentiality as an additional safeguard to prevent compelled disclosure of any personally identifiable information they may hold.