Welcome. I'm Natalie Klein with the U.S. Department of Health and Human Services Office for Human
Research Protections, or OHRP.
This tutorial was created to help explain how to complete the application for a Federal
Wide Assurance, or FWA.
This tutorial is intended to provide you with information about OHRP’s FWA application
form and how to complete it.
This information is designed to be useful to both investigators and administrators.
But, I want to emphasize that investigators should always coordinate with appropriate
officials at their institution regarding FWA application and management.
Please visit hhs.gov/ohrp and click on the ‘Register IRBs and Obtain FWAs’ tab to
explore more online resources about this topic. A screenshot of this tab is shown here.
These next several slides are important because they identify the information you should prepare
before you initiate an FWA application.
Once you know that your institution needs an FWA, there are some key preparatory steps
to take before applying for one. First of all, for any investigator viewing this, be
sure to coordinate with your institution’s appropriate officials. An FWA is a commitment
by the entire institution, so it is essential to involve the right people.
Secondly, check to see whether your institution already holds an FWA with OHRP.
Our public-facing database allows you to search. This database is at ohrp.cit.nih.gov/search.
If you locate a record that your institution has a deactivated FWA, please contact our
office at IRBorFWA@hhs.gov and ask for help renewing it. Do not apply for a duplicate FWA.
Also, try searching the database several different ways, since any abbreviations, alternate names, etc.,
could make your institution’s FWA more difficult to locate.
Before proceeding, review the application form, instructions, and Frequently Asked Questions
or FAQs, all of which can be found at hhs.gov/ohrp under the tab to ‘Register IRBs and Obtain FWAs’.
Use these resources to gather the information you will need ahead of time, and to discuss
plans with your institution’s leadership when appropriate.
Make sure that your institution’s Signatory Official has the opportunity to read the terms
of the FWA, which are also posted online. The application will ask for verification
that this has occurred.
The application includes a section to designate the Institutional Review Board or IRB that
will review research covered by the FWA. You will need the IRB’s OHRP registration number
to complete the FWA application. IRB registration is a separate process in our office and is
not discussed in this tutorial.
When you've prepared the information you need, you will then go online and request a submission
number by navigating to ohrp.cit.nih.gov/efile and selecting the tab for FWAs.
The webpage will provide additional instructions on how to obtain the submission number.
You will need the submission number to create an application on OHRP’s electronic submission system.
Finally, before starting, we're often asked whether the FWA is a type of accreditation,
so I want to clarify that this is not the case.
Holding an FWA means that an institution has submitted all of the documentation OHRP requires
to constitute a commitment by the institution to comply with the regulations for human research
protections in the Common Rule, but it's not a compliance or accreditation determination.
I will now briefly go through the elements of the FWA application in more detail, including
institution name and location, components, principles, applicability, assurance of compliance,
IRB designation, Human Protections Administrator, and the Signatory Official. This tutorial
focuses on the substance of the FWA application form. We also have a companion tutorial that
demonstrates the use of our online software platform to complete the FWA application that
you can check out online.
Just to note for those of you wondering about the revised Common Rule and its impact on FWAs.
The 2018 Common Rule included burden-reducing changes to assurance related requirements.
For instance, these changes eliminated the requirement for assurances to include a statement
about ethical principles and designation of an IRB.
The revised Common Rule also eliminated the requirement to provide IRB membership rosters,
although this is a requirement that our office has operationalized through the IRB registration
process and not through the FWA application.
Please note that OHRP is working to implement each of these regulatory changes for institutions
engaged in research under the 2018 Common Rule.
For now, the FWA application still requires identification of ethical principles and IRB
designation, both of which I will discuss in more detail later in the tutorial.
We expect the pre-2018 requirements will continue to apply to institutions engaged in research
subject to the pre-2018 Common Rule.
At the beginning of the FWA application, you'll be prompted to enter the institution’s name
and location.
The name should be the legal name of the institution applying for the FWA.
Please avoid abbreviations or shorthand because those will make it more difficult for others
to find your FWA in the database.
In the component section, you have the option to list components of your institution that
are covered under the FWA. This can be useful if there are legal entities that are part
of your institution, but which operate under different names. This section may not apply
to all institutions.
You should not list the names of individual investigators or other institutions unless
they're both legally part of your institution and represented by your Signatory Official.
The Principle section requires all institutions applying for an FWA to identify the ethical
principles that govern the institution’s human subjects research, regardless of funding source.
The Belmont Report and the Declaration of Helsinki are provided as options for institutions
that abide by these principles, and there's also an option to upload other ethical principles.
The Applicability section informs institutions of their obligation when the FWA applies.
It also allows institutions in the United States to voluntarily elect to extend the
terms of the FWA or even the subparts of the Common Rule for special populations to the
institution’s research, regardless of the source of support. This is what's commonly
referred to as “checking the box”.
When institutions check the box, they are voluntarily giving OHRP compliance authority
over their research. Note that OHRP has no expectation that institutions make this selection.
In fact, the preamble to the revised Common Rule already announced plans to eliminate
this option, which will eventually be phased out.
This next section, Assurance of Compliance, is a statement of the institution’s intent
to comply with the FWA’s terms.
Non-US institutions are also prompted to indicate the procedural standards that they follow.
These procedural standards are not considered equivalent protections, and do not replace
the non-US institution’s requirements to comply with the Common Rule when the FWA applies.
The FWA application requires designation of all internally operated IRBs that review research
to which the FWA applies.
If the institution does not operate an internal IRB, then at least one external IRB must be designated.
It should be the external IRB reviewing the largest proportion of research to which the
assurance applies. There is no need to designate all external IRBs on which your institution relies.
To designate an IRB, you must have the IRB’s OHRP registration number available, which
means that the IRB must be registered first.
Whether or not an IRB is designated on an FWA, if the IRB is reviewing HHS-supported
research, it must be registered in accordance with Subpart E of the Common Rule. For now,
institutions need to complete this section of the FWA application to move forward, even
if their research is subject only to the 2018 requirements.
In the next section of the application, you will need to name the Human Protections Administrator,
or HPA, and provide their contact details. This person should be a primary contact for
human research protections at the institution.
You will also need to name the Signatory Official, or SO. This should be a high-level official
who has the authority to represent the whole institution and all named components.
The SO needs to be able to commit the entire institution to the terms of the FWA. Usually,
their institution title reflects this authority - President, CEO, Vice President for Research,
Superintendent, or similar.
If the person's authority is not clear from their institution title, OHRP reviewers may
ask for additional information. This is a very common source of FWA delays. For example,
if the Signatory Official’s job title is identified as Principal Investigator, our
office will flag the application for further questions.
The intent in requiring that the Signatory Official be a high level individual is twofold.
First, this helps promote a culture of ethical conduct of human subjects research throughout
the institution. Second, the Signatory Official should be at a level of responsibility that
would allow authorization of necessary administrative or legal action should that be required.
To avoid the appearance of a conflict of interest, OHRP also recommends that the Signatory Official
not be the Chair or member of any IRB designated on the assurance.
When you're ready to submit, make sure to carefully follow the instructions online.
Unsubmitted applications are automatically deleted 30 days after a submission number
is issued, which is why we recommend preparing all of the information you need before you
request a submission number.
Be aware that OHRP may contact you with questions about your application.
Once OHRP reviews and approves the FWA, the points of contact on the application will
receive formal notice of the approval through email.
For your awareness, the FWA is issued for a 5-year period, at which point it will expire
unless your institution applies for renewal.
If there are changes to the legal name of the institution, or if the HPA or SO changes,
the FWA must be updated within 90 days of the change.
Every time OHRP processes an update, a new 5-year period is issued so the clock for expiration resets.
There are several common issues that cause delays for institutions seeking an FWA, so
these should be avoided through appropriate preparation and coordination.
Common issues include duplicate applications for institutions that already hold an FWA.
Inclusion of the names of individual people rather than organizations in the component
section of the application.
And missing street or mailing address information.
Another common issue occurs when the Signatory Official’s job title is listed as Principal
Investigator or something else that doesn't reflect their ability to agree to the terms
of the FWA on behalf of the entire institution.
Other issues arise when applicants saved, but do not submit the application.
Please remember to follow the instructions in the online portal very carefully to make
sure the application is submitted and not merely saved. If you encounter any difficulties,
please reach out to our office for assistance.
Finally, many groups ask whether there are alternatives to the FWA.
Please be aware that OHRP does not accept any assurance other than the FWA.
That said, there are 3 different options for ensuring coverage by an FWA when needed.
The engaged institution can apply for its own FWA from OHRP as described already.
An FWA-holding institution can also recognize collaborators as their employees or agents
for the purposes of the research.
An example might be students performing research at a hospital with an FWA.
Finally, the FWA-holding institution can, in some specific circumstances, agree to extend
its FWA to individual investigators who are not their employees or agents. A detailed
discussion about this is outside of the scope of this particular tutorial, but our online
resources include more information and guidance.
Thank you very much for watching. Remember, if you have additional questions, please be
sure to visit us at hhs.gov/ohrp or contact us at IRBorFWA@hhs.gov.