IRB Modification Request Policy
regulations require that primary investigators must file a Modification Request
to alter any aspect of the original IRB approved protocol. The request must be
submitted and approved prior to implementing any modification except when
necessary to eliminate apparent immediate hazards to subjects. Implementing modifications to a
research protocol without IRB approval is a violation of Federal regulations
and Seattle University IRB policy, and may result in sanctions including
termination or halting of the research process.
All forms may be accessed at: http://www.seattleu.edu/irb
Exception: If seeking IRB approval beyond the 365-day
expiration date, the PI may use the Continuing Review Application (CRA) to
request minor modifications that fall into one or more of the following categories:
New study title
Removal of key personnel. (Follow
instructions on the CRA for listing names and reasons.)
Correction of typos on the informed
consent form(s). (A corrected form must be attached to the CRA.)
All other changes
require a Modification Request, which must be submitted in a timely manner to
obtain approval within the timeline of the research goals and requirements.
Modification Request Instructions
the Modification Request form and complete using MS Word or similar
word-processing software (no handwritten applications).
w Respond to all items as applicable,
and attach explanations as necessary, or the Modification Request may be
returned to you for additional information, thereby causing a delay in
processing your request and potentially requiring a pause in research
w Obtain all necessary signatures
before submitting your Modification Request: PI, Faculty Advisor (if not the
PI), and Co-Investigators.
w Submit all forms as 1) hard copy in
a sealed envelope to:
IRB, Office of Research Services
& Sponsored Projects, University Services Building #203.
(After business hours, place materials in mail slot.) OR 2)
scanned and signed PDF documents sent to: firstname.lastname@example.org
Please direct all questions to: email@example.com or (206) 296-2585