Beginning in January 2023, applicants must submit a GDS plan for large-scale human or non-human data as part of the new Data Management and Sharing Plan, rather than submitting a separate Genomic Data Sharing Plan.
Sample GDS Plan Template for Non-Human Genomic Data
The University will share [Data Type] by depositing this data in [Data Repository]. This data will be submitted and released by [Data Submission and Release Timeline].
Example:
The University will share individual-level genotype data from 1,500 viral surveillance samples by depositing these data in GenBank (repository funded by National Center for Biotechnology Information) and Influenza Research Database (IRD) (repository funded by the National Institute of Allergy and Infectious Diseases). In addition, the study protocol, manual of operations, and phenotype data will be submitted. The genotype data will be made publicly available no later than the date of initial publication or six months after the receipt of final sequencing data, whichever comes first. We anticipate sequencing completion will occur during year 3 of the proposed research.
Sample GDS Plan Template for Human Genomic Data
The University will share [Data Type] by depositing this data in [Data Repository]. This data will be submitted and released by [Data Submission and Release Timeline]. [Institutional Review Board (IRB) Assurance of Genomic Data Sharing Plan]
Example:
The University will share anonymized genomic sequence data from 1,500 human samples by depositing these data in the database of Genotypes and Phenotypes (dbGaP) (a controlled-access database funded by NIH). The genotype data will be made publicly available no later than the date of initial publication or six months after completion of sequencing, which we anticipate during year 3 of the proposed research, whichever comes first. After careful review, the IRB of the University determined that data submission was consistent with the terms outlined in the consent.
Sample for GDS Plans That Require Some Discussion of IRB Ruling Related to Human Sample Collection
The University will share [Data Type] by depositing this data in [Data Repository]. This data will be submitted and released by [Data Submission and Release Timeline].
[Discussion of IRB concerns related to GDS plan] [IRB ruling related to GDS plan] [Appropriate use of data as established by IRB] [IRB Assurance of Genomic Data Sharing Plan]
Example:
Data are generated from human specimens collected before the effective date of the GDS policy, and the data will be shared through NIH-designated data repositories. Genomic data will be generated from specimens that were previously collected from 2,000 study participants. We will share the genotype and relevant phenotype data for participants through the database of Genotypes and Phenotypes (dbGaP), a controlled-access database, once the genotyping data have been cleaned, which we expect to be completed no more than two months after genotyping is finished. Submission of individual-level genome-wide genotype data produced as part of Specific Aim 1 and individual-level phenotypic data related to mood disorders included in the analyses under Specific Aim 2 is anticipated in year 2 of the proposed study.
The consent for the collection of specimens did not directly address the broad sharing of participants’ data but did denote their desire to advance science. After careful review, the IRB determined that data submission was not inconsistent with the terms outlined in the consent. The Institutional Certification, which will be provided before award along with any other just-in-time information, will include the following Data Use Limitation: “Use of these data is limited to health/medical/biomedical purposes, which do not include the study of population origins or ancestry.” The IRB advised that the genotyping data generated from 2,000 specimens may be shared through NIH-designated data repositories, consistent with data sharing under the NIH GDS policy. The IRB has reviewed the study protocol and assures that:
- The protocol for the collection of genomic and phenotypic data is consistent with 45 CFR Part 46
- Data submission and subsequent data sharing for research purposes are consistent with the informed consent of study participants from whom the data were obtained
- Consideration was given to risks to individual participants and their families associated with data submitted to NIH-designated data repositories and subsequent sharing
- To the extent relevant and possible, consideration was given to risks to groups or populations associated with submitting data to NIH-designated data repositories and subsequent sharing
- The investigator’s plan for de-identifying datasets is consistent with the standards outlined in the GDS policy.
Sample for GDS Plans That Require an Exception Due to Consent Related to Human Sample Collection
[Request for an Exception to Submission] [Justification for Necessity of Exception]
As an alternative data sharing plan, the University has agreed to share [Data Type] by deposition in [Data Repository] under appropriate IRB oversight. This data will be submitted and released by [Data Submission and Release Timeline]. [IRB Assurance of Genomic Data Sharing Plan]
Example:
Data are generated from human specimens collected before the effective date of the GDS policy and cannot be shared through NIH-designated data repositories. Genomic data from more than 100 genes in the genome will be generated from specimens previously collected from 700 study participants from a small population in Africa. The consent form did not directly address the broad sharing of participants’ data nor the risks associated with broad data sharing of these data. Because of the small population and the lack of information in the consent form, the IRB concluded that it is not appropriate to share these individual-level data collected from existing specimens through any NIH-designated repository and is requesting an exception to the GDS policy. Pursuing a re-consent process for these participants is not a viable option due to the time lapse between acquiring the samples and generating the data.
As an alternative data sharing plan, the University has agreed to share aggregate-level data that will be submitted to the database of Genotypes and Phenotypes (dbGaP), a controlled-access database, and to provide a mechanism to facilitate data sharing through direct collaborations with other investigators under appropriate IRB oversight. The aggregate-level data will include aggregated minor allele frequencies and associated p-values, and will be submitted within six months of sequencing or at the time a paper is published, whichever comes first. Other investigators may contact the principal investigator if interested in collaborating on a project that requires use of the individual-level data. All future research participants will be asked to sign an amended consent form that is consistent with the expectation of broad data sharing.