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Instructions for Principal Investigators to follow when seeking NIH funding review.
University of Michigan Guidelines for Compliance
Prior to Proposal Preparation:
- Review the NIH Genomic Data Sharing Policy (GDS) and visit NIH's Genomic Data Sharing Website for further clarification and understanding.
- Review NIH's Supplemental Information to the NIH Genomic Data Sharing Policy to ascertain whether the GDS policy applies to their research.
PI responsibilities if GDS policy applies:
- Contact appropriate NIH Institutes or Centers (IC) Program Official or Project Officer as early as possible to discuss data sharing expectations and timelines that would apply.
- Provide a basic "Genomic Data Sharing Plan" for following the GDS Policy in the Resource Sharing Plan section of the proposal. Include resources needed to support a proposed genomic data sharing plan in the project's budget.
- NIH forwards Just-In-Time (JIT) request following proposal review. U-M will respond if instructed by the PI that he/she wishes to move forward (generally based upon the proposal's score and NIH Institute/Center payline). The JIT response varies depending on whether human or non-human genomic data will be generated.
- Non-Human Genomic Data
For proposals generating non-human genomic data, U-M's response to the JIT request includes a more detailed genomic data sharing plan consistent with the GDS Policy and NIH's expectations for data sharing and timing of data release, as described in the Supplemental Information referenced above. Data is made available through any widely used data repository, whether NIH- funded or not, such as the Gene Expression Omnibus (GEO), Sequence Read Archive (SRA), Trace Archive, Array Express, Mouse Genome Informatics (MGI), WormBase, the Zebrafish Model Organism Database (ZFIN), GenBank, European Nucleotide Archive (ENA), or DNA Data Bank of Japan (DDBJ).
- Human Genomic Data
For proposals generating human genomic data, U-M's response to the JIT request will include:
A more detailed genomic data sharing plan that:
- Is consistent with the GDS Policy and NIH's expectations for data sharing and timing of data release, as described in the Supplemental Information referenced above.
- Includes submission of any information necessary to interpret the submitted human genomic data, such as study protocols, data instruments, and survey tools.
- Ensures data submitted to NIH-designated data repositories have been stripped of any data identifiers that, alone or in combination, allow for the re-identification of an individual.
- Ensures data submitted to NIH-designated data repositories do not consist of individually identifiable health information according to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. See 45 CFR 164.514(b) at: http://www.gpo.gov/fdsys/pkg/CFR-2002-title45-vol1/pdf/CFR-2002-title45-vol1-sec164-514.pdf.
- Ensures the de-identified data are assigned random, unique codes by the PI, and the key to other study identifiers held by U-M.
- Ensures data are registered in dbGaP (see Database of Genotypes and Phenotypes at http://www.ncbi.nlm.nih.gov/gap) by the time that data cleaning and quality control measures begin.
- Ensures data are submitted to the relevant NIH-designated data repository (e.g., dbGaP, GEO, SRA, the Cancer Genomics Hub), regardless of whether the data will also be submitted to a non-NIH-designated data repository.
- An Institutional Certification signed by a signing official from the Office of Research and Sponsored Projects (ORSP) that:
- Assures that submission of data from the study in question to an NIH-designated data repository meets the expectations of the GDS Policy.
- Certifies on behalf of all collaborating sites in a multi-center study, when applicable. (As an alternative, each collaborating site may provide its own Institutional Certification.)
- States whether the data will be submitted to an unrestricted- or controlled-access database.
- Assures the data submission is consistent, as appropriate, with applicable national, tribal, and state laws and regulations as well as relevant institutional policies;
- Delineates any limitations on the research use of the data, as expressed in the informed consent documents, including whether any aggregate-level data are appropriate for general research use;
- Assures identities of research participants will not be disclosed to NIH-designated data repositories; and
- Assures a U-M IRB has reviewed the PI's proposal for data submission and that:
- The protocol for the collection of genomic and phenotypic data is consistent with 45 CFR Part 46;
- Data submission and 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; and
- The investigator's plan for de-identifying datasets is consistent with the standards outlined in the GDS Policy.
- To the extent the study will use genomic data from cell lines or clinical specimens created or collected after the effective date of the GDS Policy and they lack consent for research use and data sharing, the Institutional Certification need only provide a justification for the use of such data. The NIH funding Institute/Center will review the justification and decide whether to grant an exception to the GDS policy.
- Process for Obtaining a Signed Institutional Certification
- The PI completes an abbreviated U-M IRB application in eResearch and assures that the following are included: (1) research protocol, (2) the detailed data sharing plan, (3) a draft informed consent document delineating in section 4 whether participants’ individual-level data will be shared through unrestricted or controlled access repositories (4) any known data use limitations (4) an indication of whether any aggregate-level data are appropriate for general research use, and (5) the contact information of the relevant NIH GDS Program Administrator.
- U-M IRB reviews and approves the information provided in (i) above, and notifies the assigned ORSP Project Representative of its approval via a posted comment to the Proposal Approval Form (PAF) in eRPM. (This activity may take place at any time prior to submission of the JIT response.)
- An ORSP PR with delegated signature authority signs the Institutional Certification and forwards both the Institutional Certification to NIH as part of the JIT response.