HRPP Home Page

What is a Human Research Protection Program (HRPP)?
A HRPP is the systematic and comprehensive approach of an organization, such as the Portland VA Medical Center (PVAMC), to ensure human subject protection in all human research conducted under the auspices of the institution. The implementation of any part of the program may be delegated to specific committees, individuals, or entities by the organization. The PVAMC's HRPP is established in the Medical Center Memorandum No. 151-01, "Responsible Conduct of Research at the VA Medical Center."

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 is 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.

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:

Unanticipated Serious Adverse Event (SAE) – On-protocol SAEs that are unanticipated and related or possibly related to the research

Anticipated SAEs or AEs – On-protocol SAEs or AEs that are anticipated and related or possibly related, but are occurring at a significantly higher frequency or severity than expected.

Unanticipated SAEs or AEs – On or off-protocol Unanticipated SAEs or AEs that are related or possibly related, regardless of severity, that may alter the risks for subjects and, as a result, warrant changes to the protocol and/or consent process.

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