- Human Subjects Research Considerations
- Selection of Federal Agency Guidance
- Department of Defense (DoD)
- Department of Education (DoEd)
- Department of Energy (DOE)
- Department of Justice (DoJ)
- Department of Health and Human Services (HHS)
- Health Resources and Services Administration (HRSA)
- National Institutes of Health (NIH)
- Department of Agriculture (USDA)
- Department of Veterans Affairs
- National Aeronautics and Space Administration (NASA)
- National Oceanic and Atmospheric Administration (NOAA)
- National Science Foundation (NSF)
The majority of UW’s sponsored funding comes from US federal agencies in the form of grants, cooperative agreements, fellowships, contracts, and intergovernmental personnel agreements (IPAs).
The Uniform Guidance (UG) is the regulatory foundation for federal grants and cooperative agreements. To apply for a grant or cooperative agreement, you respond to a funding opportunity that contains instructions on how to apply.
Each federal agency has its own requirements, and some have an alternate system for proposal submission.
Proposal Submission Methods
- Grants.gov: review details on Grants.gov submissions at the UW
- System to System: SAGE Grant Runner
- Sponsor Specific Systems
The Federal Acquisition Regulations (FAR) and agency-specific supplements are the regulatory foundation for federal contracts. To apply for a federal contract, you apply to a solicitation that contains specific requirements and the anticipated terms and conditions for a resulting contract. It is especially important to start early when preparing a federal contract proposal.
These proposals are lengthy, extremely detailed, and require additional review by The Office of Sponsored Programs (OSP). Plan ahead for requirements in federal contracts that will impact your budget.
Federal agencies have a variety of systems used for external funding administration. Some are used strictly to submit proposals to the agencies and others are for pre-award and post-award management of the application and award.
In addition to following sponsor instructions and guidelines, the UW has internal deadlines and proposal submission requirements that must be followed.
For industry sponsored clinical studies and trials review Industry Clinical Trials.
Most federal funding agencies have specific requirements for human subjects research. A few of these need to be addressed at the planning/proposal stage.
A growing number of funding agencies (e.g., NIH) and organizations require or recommend the use of a single IRB to review the human subjects activities for collaborative or Multi-site studies. This has significant staffing and budget implications.
Emergency medicine research
Federally-funded emergency medicine research must meet some special compliance requirements. These have budgeting and staffing implications.
Federal non-discrimination laws must be considered when developing subject inclusion/exclusion criteria. Specifically, participants cannot be excluded from a study on the basis of age, gender, race, ethnicity, disability, or not speaking English (in a domestic study), unless there is a scientific rationale for doing so.
If you are not using a sponsor specific system (e.g. NIH ASSIST, NSF FastLane, NASA NSPIRES, etc.) Grants.gov is a source to find and apply for federal grants. OSP is registered in Grants.gov and submits the proposal on behalf of the UW, after it is routed to OSP and reviewed.
There are currently two ways to complete a Grants.gov application package:
- Download an Adobe application package, or
- Create a Workspace Package
After 12/31/17, Workspace will be the only Grants.gov submission method.
Note: Grant Runner is the UW’s system to system solution for NIH Grants.gov applications.
You must register as an Organization Applicant to create a workspace.
- For Department of Education (DoEd) applications, register with DUNS number 042803536
- ALL other federal agency applications use DUNS number 605799469
After you complete Workspace registration, the OSP Central Operations Team receives an email and will authorize your “Manage Workspace” role, which allows you to create Workspaces.
Need to prepare both DoEd and other federal agency proposals? Link your account to both DUNS numbers.
- Log into Workspace, go to ‘Manage Account’, select: “create an additional ‘Profile’ to associate the additional DUNS number with your profile.
- If you already have 2 accounts, merge those accounts so you have a single login for both DUNS.
Be sure to create your Workspace under the correct DUNS number. You cannot change DUNS numbers on a Workspace. The only way to correct a DUNS number is to create a new Workspace.
UW receives funding from various agencies within the Department of Defense, some of which are mentioned below:
Air Force Office of Scientific Research (AFOSR)
Post-award reporting is submitted via an online form.
US Army Medical Research and Materiel Command (USAMRMC)
US Army Medical Research Acquisition Activity (USAMRAA) is the grants and contracts office for the USAMRMC. See site for terms & conditions and reporting information.
Congressionally Directed Medical Research Program (CDMRP) is a DoD grant program, managed by USARMC and USAMRAA. The application process requires a pre-application in the Electronic Biomedical Research Application Portal (eBRAP), a full application via Grants.gov, and application verification in eBRAP. Contact email@example.com for access to eBRAP.
Defense Advanced Research Projects Agency (DARPA)
DARPA funds both grants and contracts using program specific funding opportunities and broad agency announcements (BAA). Check your funding announcement closely for submission instructions.
DARPA uses Grants.gov for submitting grant and cooperative agreement proposals.
Contract proposals could be accepted in paper or via DARPA BAA. BAA Instructions:
- PIs must create a separate account for each submission.
- Accounts are only issued to the PI.
- Proposals are created in two volumes and must be encrypted per DARPA instructions.
- Prepare and submit an eGC1 in SAGE and route to OSP.
- After OSP review of eGC1, PI submits proposal in the sponsor site.
- Once submitted, the PI receives an email indicating that the submission account is deactivated.
Defense Threat Reduction Agency (DTRA)
DTRA’s application process consists of Phase I, Pre-application White Paper and Phase II, Invited Proposal. Review the funding opportunity carefully. Submissions can occur via Grants.gov or the DTRA submission system, depending on the opportunity.
There is only one UW account for the DTRA submission system.
- OSP uploads proposal documents in the DTRA submission system
- PI or departmental designee reviews and approves the uploaded materials here at the OSP office with their OSP reviewer.
- OSP submits the proposal
Office of Naval Research (ONR)
ONR proposals are submitted via Grants.gov. Login to Grants.gov and look for the Opportunity Number desired and download the proposal package. Search Grants.gov Department of Defense Agency specific opportunities.
When creating Grants.gov Workspace for DoEd, be sure to use your Grants.gov account that is linked to the DoEd DUNS number.
The DoE has an online funding opportunity and application portal called Advanced Research Projects Agency – Energy (ARPA-E) Funding Opportunity Exchange. The UW PI must forward their DoE proposal to OSP for submission.
DoE has other funding opportunities that are submitted via Grants.gov.
The Portfolio Analysis and Management System (PAMS) is used to submit pre-applications, letters of intent, revised budgets, and receive merit reviewers’ comments for the DoE Office of Science.
Many agencies that fall under the HHS use eRA Commons to capture proposals after submission through Grants.gov or ASSIST, such as: National Institutes of Health (NIH), Agency for Healthcare and research Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and Substance Abuse and Mental Health Services Administration (SAMHSA).
Review the eRA Commons roles and follow specific agency and funding opportunity guidance for your proposal submission.
More select agency guidance is available below.
HRSA Electronic Handbook (EHB) single access point for all HRSA grant and non-grant programs for grant submission and administration.
NIH, AHRQ, CDC, FDA, SAMHSA and the VA all use eRA Commons .
There are roles in eRA Commons. You must have an active, UW affiliated eRA Commons user name (ID) to use NIH systems related to grants, fellowships and cooperative agreements.
Contact your department administrator or firstname.lastname@example.org to have a username assigned or affiliated with the UW.
NIH Application Submission System & Interface for Submission Tracking (ASSIST)
- Use eRA Commons Login and prepare your proposal in ASSIST
- Change the status of your ASSIST application to “all components final”.
- Validate the application in ASSIST and resolve any issues.
- On your eGC1, answer “No” on the Ready to Submit (RTS) question.
- Route it to OSP with draft science.
- If you need to make changes or add final version of science, change the status of your ASSIST application to “work in progress”
- Run the validation checks again if you make changes to the core or project sections of the applications.
- Once your application is FINAL and ready to submit to NIH, change the status in ASSIST to “Ready for Submission”.
- Change your eGC1 Ready to Submit (RTS) question to ”Yes”
OSP submits your proposal in ASSIST and monitors progress to eRA Commons.
NIH uses the term “Multiple PD/PI” (not co-PI). The UW PD/PI listed as PI on the eGC1 will be the contact PD/PI, responsible for communication between NIH and the rest of the leadership team.
Applications that involve more than one PD/PI must include a Leadership Plan that describes roles, responsibilities, and working relationship of identified PD/PIs. All UW PD/PIs must certify an assurance statement.
NIH Multiple PI Guide
Review Federal-Wide Research Terms & Conditions (RTCs) guidance for the USDA National Institute for Food and Agriculture (NIFA).
NASA Solicitation and Proposal Integrated Review and Evaluation System (NSPIRES)
NASA Application Process:
- Complete all elements in NSPIRES, including Proposal Summary, Business Data, Budget, Program Specific Data, and Proposal Team.
- Upload final proposal as an attachment and link the proposals to allow OSP to view.
- To allow OSP to submit, lock the proposal in NSPIRES.
- Download a PDF copy of the application from NSPIRES and attach it to the eGC1. This is used during the review process and meets audit requirements.
NOAA uses Grants.gov for proposal submission.
OSP heavily discourages the use of Grants.gov for proposal submitted to NSF. Prepare proposals to NSF within FastLane.
Some NSF funding opportunities require pre-proposals or letters of intent submitted via FastLane. Most are submitted by OSP, but some are submitted by the PI. Check the funding opportunity. If OSP is submitting a pre-proposal, an eGC1 is required and internal deadlines apply.
Instructions for Proposal Submission
- PI must register in FastLane. Email email@example.com to request access.
- Review NSF proposal preparation instructions in the NSF Proposal and Award Policies and Procedures Guide (PAPPG).
- Complete the FastLane proposal.
- “Allow SRO access” to give OSP the ability to review the proposal.
- FastLane automatically runs validations; resolve errors/warnings.
- Click to “Allow AOR to view, edit, and submit proposal”
- Download a PDF copy of the application from FastLane and attach it to your SAGE eGC1.This PDF is used during the review process and meets audit requirements.
- OSP reviews the proposal in SAGE and in FastLane
- OSP submits final proposal in FastLane
NSF Collaborative Proposals
When UW is not the lead institution on an NSF proposal, we may submit our portion of a collaborative proposal ahead of the lead institution.
When the UW is the lead institution follow NSF instructions for submission of a collaborative proposal from multiple organizations in section II.D.3.b of the PAPPG.
Forms, Tools, and Resources
Policy, Regulation, and Guidance
- GIM 01 – Review and Submission Requirements for Proposals
- GIM 19 – Internal Deadlines for Proposals to External Entities
- GIM 13 – Facilities and Administrative (F&A) Rates
- Federal Uniform Guidance
- Code of Federal Regulations (CFR)
- National Institute of Standards and Technology (NIST) Special Publications (SPs)
- Set up: Classified Research
- Export Control
- Federal-Wide Research Terms & Conditions (RTCs)