What is a Federal Wide Assurance (FWA)?
The Office of Human Research Protections (OHRP) mandates that each institution's Institutional Review Board be registered with the OHRP. Our Portland VA Medical Center IRB operates under an OHRP approved Federal Wide Assurance (FWA). We, as an institution, must be compliant with the terms set forth in the FWA for protecting human subjects and renew this FWA every three years. The FWA states that our IRB and the VA Central IRB (applicable for studies determined by ORD to be candidates for review by the VA Central IRB) are responsible for abiding by the federal regulations set forth in Title 45 Part 46, regarding the protection of human subjects, and that the Medical Center Director is the Signatory Official legally authorized to represent the institution.

The Portland VA Medical Center FWA number is FWA00000517. Information regarding that FWA can be found by accessing the U.S. Department of Human Services Office for Human Research Protections web site and entering the FWA number.

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Reporting Unanticipated Problems

Reporting Unanticipated Problems (125KB, MSWord)
Examples of Unanticipated Problems (49KB, MSWord)
Guidelines for Reporting Unanticipated Problems (151KB, MSWord)
Addendum for FDA-regulated Research (67KB, MSWord)

Effective July 15, 2008, unanticipated problems other than adverse events should be reported using the new Unanticipated Problem Report Form (125KB, MSWord). However, until you receive approval for your Data Safety Monitoring Plan (74KB, MSWord) from the IRB, you must continue to submit ALL adverse events using the old AE Report Form (94KB, MSWord).

Unanticipated problems other than adverse events include non-compliance, protocol deviations, changes to approved research to eliminate immediate hazards (also requires submission of a Protocol Revision/Amendment Form (72KB, MSWord)), and events that are not a result of research procedures, such as a publication, that may indicate a change to risk vs. benefit. For more examples of unanticipated problems, see the document link above.

Once the IRB has approved your Data Safety Monitoring Plan you may begin using the Unanticipated Problem Report Form to report unanticipated adverse events as follows:

See Guidelines for Reporting Unanticipated Problems (151KB, MSWord) for guidance for the timelines by which the above events and other required reports to the IRB must be submitted.

HRPP Policies and Procedures