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What is the FWA?

3 min read

Asked by: Mike Agembovich

What is the Federal Wide Assurance?

The Federalwide Assurance (FWA) is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research.

How do I get a FWA?

File a New Federalwide Assurance (FWA)

  1. Scroll down to the bottom of the screen and click on ‘I need a submission number”
  2. Enter. Your e-mail. a password created for the submission, and. …
  3. Click on the “Submit” button.
  4. Once you receive the submission number: Repeat step 1 above.

Who must be listed on FWA?

The FWA must designate one or more IRBs that have registered with OHRP as the institution’s IRB(s) of record. The FWA must be obtained prior to conducting any research involving human subjects.

How do I find my FWA?

Information regarding registration of IORGs and IRBs, and the FWA status of an institution is available online. Click here to access the online database at http://ohrp.cit.nih.gov/search/. The status of recently submitted registrations and FWAs also can be tracked on that page.

How long does it take to get an FWA?

2-6 weeks

It may take from 2-6 weeks to complete the FWA application and IAA process, depending on the availability of site personnel and signatories. The process to obtain this is described in the next section. 1. Must be completed by the site authorized representative electronically.

How do I renew my FWA?

Update or Renew a Federalwide Assurance (FWA)

  1. Scroll down to the bottom of the screen and click on ‘I need a submission number”
  2. Enter. Your institution’s FWA number. …
  3. Click on the “Submit” button.
  4. Once you receive the submission number: Repeat step 1 above.

What does an institution have to do to receive HHS funding?

In order to receive HHS funding to conduct certain human subjects research, institutions must have an active assurance on file with OHRP. This assurance is called an FWA, which stands for Federalwide Assurance.

What is IRB registration?

An institution or organization that has not registered an Institutional Review Board (IRB) or been assigned an IORG number must complete an initial IRB registration application on-line using the Electronic Submission System (ESS).

What is an FWA number for the IRB?

A Federal Wide Assurance (FWA) is the documentation of an institution’s commitment to comply with Federal regulations and maintain policies and procedures for the protection of human participants.

What is the purpose of IRB?

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.