Applications Proposing Non-Human Genomic Data (3 elements)
- Data Type (see below for details)
- Data Repository (see below for details)
- Data Submission and Release Timeline (see below for more details)
- Data Submission: No later than the date of publication
- Data Release: No later than time of publication.
Applications Proposing Human Genomic Data (6 elements)
- Data Type: Explain whether the research being considered for funding involves human data, non-human data, or both. Denote the type of genomic data that will be shared (e.g., sequence, transcriptomic, epigenomic, and/or gene expression data) and whether it is individual-level data, aggregate-level data, or both. Also list any other information that is anticipated to be shared such as relevant associated data (e.g., phenotype or exposure data) and information necessary to interpret the data (e.g., study protocols, data collection instruments, survey tools).
- Data Repository: Identify the data repositories to which the data will be submitted, and for human data, whether the data will be available through unrestricted or controlled-access. For human genomic data, investigators are expected to register all studies in the database of Genotypes and Phenotypes (dbGaP) by the time data cleaning and quality control measures begin in addition to submitting the data to the relevant NIH-designated data repository (e.g., dbGaP, Gene Expression Omnibus (GEO), Sequence Read Archive (SRA), the Cancer Genomics Hub) after registration. Non-human data may be made available through any widely used data repository, whether NIH-funded or not, such as GEO, SRA, Trace Archive, Array Express, Mouse Genome Informatics, WormBase, the Zebrafish Model Organism Database, GenBank, European Nucleotide Archive, or DNA Data Bank of Japan.
- Data Submission and Release Timeline: Provide a timeline for sharing data in a timely manner. The Supplemental Information to the GDS Policy provides expectations for the timelines of data submission and release based on the level of data processing. In general, NIH will release human genomic data no later than six months after the data have been submitted to NIH-designated data repositories and cleaned, or at the time of acceptance of the first publication, whichever occurs first, without restrictions on publication or other dissemination of research findings - in other words, no publication embargo. However, availability before publication may be expected for certain data, projects (e.g., data from projects with broad utility as a resource for the scientific community such as microbial population-based genomic studies), or by the funding NIH IC.
- IRB Assurance of the Genomic Data Sharing Plan: State whether an Institutional Review Board (IRB) or analogous review body has reviewed the genomic data sharing aspects of your project, or provide a timeline for such review. IRB review of the investigator’s proposal for data submission is an element of the Institutional Certification which assures that the proposal for data submission and sharing is appropriate. Please keep in mind that an Institutional Certification is generally required for extramural investigators prior to NIH grant award along with other Just-in-Time information or finalization of a contract. For NIH intramural investigators, an Institutional Certification memorandum should be completed and sent from the SD, or delegate, to the IC Genomic Program Administrator (GPA) before research is begun, whenever possible.
- Appropriate Uses of the Data: The appropriate use of the data should be described. Under the GDS Policy, data is expected to be shared for broad research purposes. If such use of the data is not appropriate, as expressed in informed consent documents of the research participants whose data are included in the dataset, any limitations on the data use should be described in the Institutional Certification. NIH provides standard language to guide the development of data use limitations.
- Request for an Exception to Submission: If submission of human data generated in the study would not be appropriate because the Institutional Certification criteria cannot be met, the investigator should explain why in the genomic data sharing plan and describe an alternative mechanism for data sharing. If the funding IC grants an exception to submission, the research will be registered in dbGaP and the reason for the exception and the alternative sharing plan will be described. For NIH intramural studies, the NIH Deputy Director for Intramural Research will make the final decision on the exception request, after the IC has made its determination.