Institutional Review Board
Policies for On-going Actions Post-Approval

Unanticipated Problem and Adverse Event

  • Modification Request Form

    Federal 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.

    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:

    1. New study title
    2. Removal of key personnel. (Follow instructions on the CRA for listing names and reasons.)
    3. 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

    1. Download the Modification Request form and complete using MS Word or similar word-processing software (no handwritten applications).

    2. 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 procedures.

    3.  Obtain all necessary signatures before submitting your Modification Request: PI, Faculty Advisor (if not the PI), and Co-Investigators.

    4.  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: irb@seattleu.edu.