MANAGE

Personnel Amendments

  • Once an exempt certification has been issued, the project is exempt from further review or oversight by the HRPP. Researchers are not required to submit personnel amendments to add key personnel but may choose to do so at their discretion. 
  • Any key personnel who join the project after initial exempt certification has been issued are expected to complete the appropriate CITI training. However, because the HRPP no longer provides oversight once a project is determined to be exempt, the PI is responsible for ensuring completion of the required courses and maintaining relevant training records. Please see the CITI Training page for further information.

To request a personnel amendment to a certified exempt protocol, please submit the following:

  • Current version of the exempt application revised with all proposed new key personnel highlighted and all removed key personnel highlighted and crossed out (Strikethrough)
  • Email your submission to irb@wsu.edu with the subject line as “Exempt Personnel Amendment Request: IRB # (#####)”

Note: If requesting a change in PI, please follow the guidance below regarding Amendments.

Amendments

  • Once an exempt certification has been issued, the project is exempt from further review or oversight by the HRPP.
  • Researchers need only submit amendments to exempt projects for review of any change in the project that may be significant enough to make the project no longer eligible for exemption or require a change in exempt category certification. If there is any uncertainty, an amendment should be submitted as it can be difficult to determine if a change would result in the project no longer being eligible for exemption or a change in category certification without conducting a full review of the proposed changes.
  • If requesting a change in PI, an amendment is required.

To request an amendment to a certified exempt protocol, please submit the following:

  • Amendment Request Form
  • Current version of the exempt application with all proposed revisions highlighted
  • Current version of any new or revised supporting materials with all proposed changes highlighted *if applicable
  • If requesting a change in PI, please attach written support from both the currently approved PI and the proposed new PI *if applicable

Personnel Amendments

  • Before key personnel changes to an approved non-exempt study can be implemented or new personnel can begin work, the proposed changes must be reviewed and approved by the HRPP/IRB.
  • Any key personnel who join the project after initial approval has been issued are expected to complete the appropriate CITI training. Please see the CITI Training page for further information.

To request a personnel amendment to an approved Non-Exempt protocol, please submit the following:

  • Last approved application revised with all proposed new key personnel highlighted and all removed key personnel highlighted and crossed out (Strikethrough)
  • CITI Certificates for non-WSU personnel only * if applicable. Please see the CITI Training page for further information
  • Email your submission to irb@wsu.edu with the subject line as “Non-Exempt Personnel Amendment Request: IRB # (#####)”

Note: If requesting a change in PI, please follow the guidance below regarding Amendments.

Amendments

  • Before changes to an approved study, or any of the supporting materials/documents used within the study can be implemented, the proposed changes must be reviewed and approved by the HRPP/IRB.
  • Changes to a study that are deemed substantial as compared to the originally approved project may require a new application. In rare instances, the overall purpose and design of the study can change after the approval, depending on the population, context, or nature of procedures.

To request an amendment to an approved non-exempt protocol, please submit the following:

  • Amendment Request Form
  • Last approved exempt application with all proposed revisions highlighted
  •  Last approved  materials with all proposed changes highlighted *if applicable
  • New proposed supporting materials *if applicable
  • If requesting a change in PI, please attach written support from both the currently approved PI and the proposed new PI

Adverse events

An adverse event is considered any unplanned event that occurs during the research that could negatively affect the research or a participant. These events may include, but are not limited to:

  • Unanticipated problems involving risks to subjects or others (UPIRSO)
  • Unfavorable medical occurrence in a participant (whether it is related to the participant’s enrollment in the research or not)
  • Data breach/breach of confidentiality regarding participant PHI
  • Unanticipated effects of an intervention that become apparent during the research

Deviations

A deviation is considered when a member of the research team does not follow the IRB-approved protocol or departs from study procedures. This includes, but is not limited to:

  • Any modification or departure from the approved protocol or use of supporting materials not approved by the HRPP/IRB.
  • Using outdated study materials
  • Failure to obtain informed consent from a participant who has been enrolled in the study

It is the PI’s responsibility to report all adverse events and deviations to the HRPP/IRB. To report an adverse event or deviation, please submit the following:

Annual Check-In/Closeout

To respond to an annual check in required notice for renewal or closeout an approved protocol that has not been assigned an expiration date, please submit:

Continuing Review/Closeout

To respond to a continuing review required notice for renewal or closeout an approved Non-Exempt protocol that has been assigned an expiration date, please submit: