Setup actions for your federal award will vary based on the type of award (contract vs. grant) and the awarding agency.
See the Human Subjects Division (HSD) website for information about all aspects of human subjects research.
Almost all federally funded human subjects research must comply with several specific requirements that are part of setting up the project.
Obtain Institutional Review Board (IRB) approval or an exempt determination before conducting any human subjects activities or spending any research funding on such activities.
Complete Required Training
Federal sponsors require senior/key personnel to complete training in human subjects protections. In addition, principal investigators and clinical trial staff conducting NIH supported clinical trials must complete a Good Clinical Practice (GCP) course every three years.
Establish a single IRB for multi-site clinical trials
Any multi-site clinical trial funded by NIH on or after January 25, 2018, must use a single IRB to review all domestic sites participating in the trial. Contact HSD.
Register Clinical Trials
Studies that meet the definition of “clinical trial” must register at ClincalTrials.gov.
Genomic Data Certification
NIH funded studies that will create human genomic data are required to send the data to a NIH database, for broad sharing with other researchers. This data must be “certified” by the PI’s institution prior to sending the data. The certification process is usually part of the Just-in-Time process and part of the initial IRB process.
Specific Federal Agency Requirements
See HSD’s Worksheets for information about specific human subjects requirements for the following federal agencies: Department of Defense, Department of Justice (includes the National Institute of Justice), Environmental Protection Agency, and Department of Energy.
Many sponsors have their own post award grants management systems. Set up access for required individuals including the PI.
Post Award Management Systems
|Department of Energy||Portfolio Analysis and Management System (PAMS)||
|Department of Justice||Grants Management System (GMS)||
|National Institutes of Health||eRA Commons||
|National Science Foundation||FastLane and Research.gov||
Department of Defense (DoD)
US Army Medical Research and Materiel Command (USAMRMC)
Awards under the Congressionally Directed Medical Research Program (CDMRP) may need approval from the USAMRMC’s Office of Research Protections, in addition to UW Institutional Review Board and UW Institutional Animal Care and Use Committee protocol approvals.
Resources including the Funded Investigators Guide from CDMRP, will guide the PI through setting up awards from USAMRMC.
Department of Education (DoEd)
New to DoEd grants? Check out DoEd’s e-learning opportunities.
Department of Energy (DoE)
The Portfolio Analysis and Management System (PAMS) is used for:
- Viewing award documents
- PI submission of Progress Reports
- OSP submission of Award Modification Requests
Department of Justice (DoJ)
Work closely with your OSP reviewerto setup your DoJ award. A Financial Point of Contact (POC) from Grant and Contract Accounting (GCA) needs to be designated in GMS before the DoJ posts the award document in GMS.
OSP must sign the award document and return to the DoJ.
Department of Health and Human Services (HHS)
Many agencies that fall under the HHS 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) use eRA Commons for certain pre-award, post award, and closeout activities.
More select agency guidance is available below.
Health Resources and Services Administration (HRSA)
HRSA Electronic Handbook (EHB) is the single access point for all HRSA grant and non-grant programs for grant submission and administration. Create your EHB account following HRSA instructions.
National Institutes of Health (NIH)
Notice of Grant Awards (NOAs) from NIH are sent directly to the Office of Sponsored Programs. PIs do not need to provide a copy to OSP. NOAs are also available in the eRA Commons.
Be sure to review the NIH Grants Policy Statement in addition to the terms of your award.
National Oceanic and Atmospheric Administration (NOAA)
NOAA uses the Department of Commerce’s Grants Online for post award grants management. Department/PI creates action (rebudget, extension, progress report) in Grants Online and forwards to OSP for submission. Contact email@example.com for access.
National Science Foundation (NSF)
Awards from NSF are sent directly to OSP. PIs do not need to provide a copy to OSP. Awards are also available in the sponsor system (FastLane or Research.gov).
Federal Contracts require compliance with numerous federal rules and regulations including the Federal Acquisition Regulation (FAR).
Project set up, reporting and management must be handled according to the specific requirements in the contract. In many cases a significant amount of work may be needed to implement and follow them. Failure to comply, perform or follow deadlines in federal contracts can result in criminal/civil and financial consequences for the PI and the University.
Many federal contracts and flow-through federal contracts require use of E-Verify to establish employment eligibility of designated employees. This requirement does not apply to grants.
During the award set up process, OSP notifies departments and PIs if their federal contracts contain the E-Verify clause. Visit the Payroll website for details on the process.
Vendor Diversity Goals
Pay attention to time frames in your award document for when diversity goals need to be in place and work with UW Procurement to develop those goals.
Learn more about the UW Procurement Services policies related to requirements for supplier diversity.
Small Business Subcontracting Plans
If the contract proposal requires the submission of a Small Business Subcontracting plan, review the Procurement Services small business subcontracting plan instructions and worksheet.
Information and Security Requirements
Check your contract to determine whether it includes requirements related to Homeland Security Presidential Directive 12 (HSPD-12), Federal Information Processing Standards (FIPS), and/or Federal Information Security Management Act (FISMA).
Keep in mind these requirements may impact your budget, consider costs when preparing your proposal.
Typical HSPD-12/FIPS/FISMA Requirements:
Information Technology (IT) Security Plans, Risk Assessment and FIPS 199 Assessment are all due within 30 days of the contract being awarded. Security Certification & Accreditation is due within 3 months after a contract has been awarded.
Due within 30 Days After Contract Award
IT Security Plans (IT-SP)
These plans must describe the process and procedures that will be followed to ensure security of IT resources. It must also comply with numerous federal regulations such as: FISMA, National Institute of Standards and Technology (NIST) 800-18 and 800-26, HHS Office of the Chief Information Officer (OCIO) Information Systems as well as others.
IT Risk Assessment (IT-RA)
FIPS 199 Assessment
Must follow the NIST standard.
Due within 3 Months After Contract Award
IT Security Certification & Accreditation (IT-SCA)
Must follow HHS Chief Information Security Officer’s Certification & Accreditation Checklist, NIST 800-37, and 800-53.
Contractors must submit written proof that an IT-SCA was performed for applicable information systems. The draft IT-SCA must be signed by a senior management official.
Forms, Tools, and Resources
- Data Management Resources at UW
- Human Subjects Division (HSD)
- Advance Budget Request Eligibility Tool
- ClinicalTrials.gov Registration
- PAFC: Federal Regulation Hierarchy Pyramid
- How to Read the Code of Federal Regulations (CFR)
- NIH: What is FISMA?
- Procurement Services: Small Business Subcontracting Plan Instructions & Worksheet
- Procurement Services: Supplier Diversity
- Payroll: E-Verify
- eRA Commons
- Office of Sponsored Programs
- What is an “award”?
- SciENcv: Researcher Profile System
- NIH: Virtual Learning Podcasts
Policy, Regulation, and Guidance
- GIM 02 – Acceptance of Sponsored Program Awards and Fiscal…
- GIM 19 – Internal Deadlines for Proposals to External Entities
- GIM 09 – Advance Budget Numbers
- Federal Uniform Guidance
- Export Control Measures
- APS 2.4 Information Security and Privacy Roles, Responsibilities, and Definitions
- APS 2.6 Information Security Controls and Operational Practices
- Code of Federal Regulations (CFR)
- Homeland Security Presidential Decision Directive 12 (HSPD-12)
- Federal Information Protection Standard (FIPS)
- National Institute of Standards and Technology (NIST) Special Publications (SPs)
- Federal Information Security Management (and Modernization) Act (FISMA)
- Classified or Restricted Research
- Set up: Classified Research
- Federal Acquisition Regulation
- Export Control
- Federal-Wide Research Terms & Conditions (RTCs)
- NIH: Changing PD/PI Status? Prior Approval Policy Reminder