Overview
The Office for Human Research Protections (OHRP) has announced significant upcoming changes to the Federalwide Assurance (FWA) process. These changes will streamline compliance, modernize the assurance mechanism, and align the FWA with the 2018 Requirements of the Common Rule. These updates will also temporarily affect access to OHRP’s electronic submission system for both FWAs and Institutional Review Board (IRB) registrations.
For institutions engaged in U.S. Department of Health and Human Services (HHS)–conducted or supported human subjects research, understanding these changes is essential. Below is a clear breakdown of what’s changing, why it matters, and how to prepare.
Why OHRP Is Updating the FWA
OHRP is revising the FWA form to reflect the 2018 Requirements of the Common Rule and reduce administrative burden. As the Supporting Statement explains, OHRP is “seeking to remove this information from the FWA form to adopt the changes at 45 CFR 46.103 of the 2018 Requirements and reduce burden on respondents.”
These updates also modernize the assurance process and clarify expectations for both U.S. and non-U.S. institutions.
Key Changes to the Federalwide Assurance (FWA)
1. Removal of “Check the Box”
One of the most notable changes is the elimination of the option for U.S. institutions to voluntarily apply the Common Rule to all research regardless of funding source.
As the document states:
OHRP seeks “to eliminate the option on the current FWA form for U.S. institutions to voluntarily apply the Common Rule… to all of an institution’s nonexempt human subjects research regardless of the source of support.”
Institutions may still choose to apply these standards internally, but such voluntary extensions will no longer be part of the FWA and will no longer fall under OHRP oversight.
2. Removal of Ethical Principles and IRB Designation Requirements
Under the pre‑2018 Common Rule, institutions had to include a statement of ethical principles and designate IRBs on the FWA. These requirements are being removed to align with the 2018 Requirements.
3. Clarification for Non‑U.S. Institutions
OHRP is reiterating that non‑U.S. institutions must comply with the Terms of the FWA and is removing references to alternative international standards. The Supporting Statement notes this change will “eliminate any confusion about whether they are permitted to substitute a different standard for the FWA.”
4. A Shorter, Streamlined FWA Form
OHRP anticipates a shorter form and faster submission process. The burden estimate decreases from 30 minutes per submission to 20 minutes, reflecting the simplified requirements.
5. Temporary Impact on OHRP’s Electronic Submission System
Because these changes require updates to OHRP’s software systems, institutions should expect temporary downtime or limited access to the FWA and IRB registration portals during implementation.
What Information the FWA Will Still Collect
Despite the changes, the FWA will continue to gather essential institutional information, including:
- Legal name and location of the institution
- Component organizations and alternate names
- Applicability statement for when the FWA applies
- Agreement to comply with the Terms of Assurance
- Confirmation that only OHRP‑registered IRBs will be used
- Contact information for the Human Protections Administrator
- Contact information and signature of the Signatory Official
These elements support OHRP’s oversight, communication, and compliance functions. As the document notes, this information helps OHRP “conduct its compliance oversight program” and “provide clarification and guidance concerning ethical issues related to human subjects research.”
Why These Changes Matter for Institutions
- Reduced Administrative Burden – The streamlined FWA form and removal of outdated requirements will make compliance more efficient.
- Clearer Regulatory Alignment – Institutions will now operate under a single, consistent assurance mechanism aligned with the 2018 Common Rule.
- Implications for State Laws and Institutional Policies – Some states, such as Virginia, tie their human subjects protections to the FWA’s previous “check the box” option. OHRP acknowledges this and notes that institutions may need to coordinate with state legislatures or adjust internal policies.
- Improved Clarity for International Institutions – By removing references to alternative international standards, OHRP ensures consistent expectations for all institutions holding an FWA.
Burden Estimates and Institutional Impact
OHRP projects approximately 13,000 institutions will submit an FWA annually, with an estimated 20 minutes per submission, resulting in 4,290 total burden hours. The
Supporting Statement explains:
“This represents a decrease in annual burden hours of 9,710 hours compared to the previously approved burden.”
This reduction reflects both the simplified form and a decrease in the number of active FWAs.
How Institutions Should Prepare
- Review internal policies that reference “checking the box.”
- Prepare for temporary downtime in OHRP’s electronic submission system.
- Ensure Human Protections Administrators and Signatory Officials are aware of the new requirements.
- Update IRB reliance agreements and related documentation as needed.
- Monitor OHRP announcements for implementation timelines.
Final Thoughts
OHRP’s upcoming revisions to the Federalwide Assurance represent a major modernization of the assurance process. By aligning with the 2018 Common Rule, removing outdated requirements, and simplifying the FWA form, OHRP is reducing burden while strengthening clarity and consistency across the research landscape.
Institutions should begin preparing now by reviewing policies, updating procedures, and ensuring their teams understand what’s changing.
