Proposal Preparation and the Funding Process

An excellent starting place for more information on starting the funding application process in general is the Fred Hutch Office of Sponsored Research site and specifically the section on sponsored projects (meaning externally-funded research).

This section will more specifically provide information related to this process with large scale molecular data generation from human specimens in mind, as requirements for documentation and timing are continually evolving. Please let us know by emailing sciwiki if you notice NIH or other funding agency policy changes and we can update our site and refer content reviews to the relevant staff at our institution.

Using De-Identified Human Specimens for Genomics Research

For funding agencies like the NIH, the increased use of genomic data sets from human specimens outside of the context of the definition of human subjects research has resulted in some changes when submitting proposals for funding. NIH provides the Infopath Questionnaire, found here. which can help determine if the study would need to be categorized as Human Subjects Research, or if it is exempt in some way. For Fred Hutch studies that propose to generate or use data generated from human specimens for which neither the investigator nor anyone on the team can re-identify the specimens, a new Fred Hutch document helping explain why data does not qualify as Human Subjects (the Human Subjects Research determination form, to be submitted along with a Human Specimens/Data Application) is required when submitting a protocol to FH review.

Use the information in the Infopath Questionnaire to describe why your particular study is not required to be subjected to Human Subjects based restrictions and reporting. When (not if!) the proposal is funded, the investigator will not be required to address the Human Subjects reporting (such as Inclusion Reports and training), but WILL be required to address the need to share any genomic data sets used via public repositories as is consistent with the consents of the original tissue donors.

Using Identified Human Specimens for Genomics Research

The NIH currently (as of 7/12/2018) requests assurance through an Institutional Certification that investigators intend to submit any datasets generated to the appropriate public repository, such as dbGaP. For those NIH grants that specify genomic data sets will be generated from human specimens, the requirement for submitting an institutional certification will be requested as part of the JIT. NIH information for dbGaP Study Registration and Data Submission to an NIH Designated Controlled-Access Data Repository can be found here. In the JIT information the investigator will see this request:

The current policy behind this request seems to be an ever-changing set of guidelines that depending on the type of data generated as part of the study, the date upon which the human specimen was collected, and the details of the consent in place at that time all currently have implications for the process the investigator needs to address. At the time of this writing, the NIH Office of Science Policy provides this site describing Institutional Certifications, though again, even the links in the JIT document from the NIH itself are already broken, so additional searching may be required.

For NIH Submissions, it is also prudent to check GDS requirements within the specific institutes within NIH. For example, The National Institute of Allergy and Infectious Diseases (NIAID) has data sharing requirements above and beyond NIH GDS. NIAID expectations can be found here.

NIH Funding of Research Involving Genomic Data

Data Sharing Plan and the NIH Genomic Data Sharing Policy

For NIH extramural investigators, genomic data sharing plans are required to be submitted as part of an application for funding if the project proposed will entail using or generating large scale genomic data sets.

Elements of a Genomic Data Sharing Plan:

1. Data Type

2. Data Repository

3. Data Submission and Release Timeline

4. IRB Assurance of the Genomic Data Sharing Plan

5. Appropriate Uses of the Data

6. If necessary, Request for an Exception to Submission

NIH Just-In-Time (JIT) Information

JIT allows applicants and signing officials to submit certain elements of a competing grant application after the peer review and as the application is being considered for funding. This includes information on Institutional Review Board (IRB) approval of the use of human subjects approval (or verification of IACUC’s approval of the proposed use of live vertebrate animals, etc). Upon the return of scientific review panel percentile rankings of an NIH proposal submitted to the NIH, if the percentile rank is in the range that is potentially fundable (typically an impact score of 30 or less), investigators will receive a request for more information called the Just-In-Time (JIT) Request. To some degree, the investigator can decide, given the Institute to which they applied, their particular percentile ranking and the previous paylines of that particular Institute, whether it is beneficial to immediately follow-up action to respond to the JIT is needed or to wait. You can learn more about support for Fred Hutch investigators regarding their JIT requests and using the Hutch Grants system to manage the submission of information, including from the NIH and Department of Defense at this Centernet site from the Office of Sponsored Projects.

NIH Application Revision on January 15, 2018

For NIH grant applications submitted after January 25, 2018, the application entitled “Form D” was updated to “Form E”. An annotated instruction sheet on Form E is here. Form E highlights include:

• Consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms

• Expansion and use of discrete form fields for clinical trial information to:
  • provide the level of information needed for peer review;
  • lead applicants through clinical trial information collection requirements;
  • present key information to reviewers and agency staff in a consistent format; and
  • align with ClinicalTrials.gov (where possible) and position us for future data exchange with ClinicalTrials.gov
• Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms

Additional Resources

• A list of federal agencies involved in Genomic Research is listed at the NIH National Human Genome Research Institute.

• The NIH Office of Science Policy FAQ on Genomic Data Sharing Policy can be found here.

• NIH information for dbGaP Study Registration and Data Submission to an NIH-Designated Controlled-Access Data Repository can be found here.

• The Fred Hutch Policy on IRB Review of Genomic Data Sharing Policies can be found here. This policy provides an overview of FH requirements and pathways for submitting for review proposals including genomic data.

• A full NIH Genomic Data Sharing Plan plan template can be found here.

• Information about all of the Fred Hutch Shared Resources in PHS 398 or SF 424 (R&R) formats can be found here.

• The Shared Resources Quick Reference list (current version 2017) is a useful list of existing resources and the relevant contact information which may be required or helpful for a new study.

• Information about the data management and statistical assistance provided by Collaborative Data Services can be found here.

• Boilerplate text for proposals that require a description of what facilities, shared resources, instruments and services are available at the Fred Hutch can be obtained at the Shared Resources site.

• A description of computational and storage resources from Scientific Computing for grant writers can be found here.