IRB Revisions and Modifications

IRB Revision/Modification Request

Research protocols that have been approved by the IRB must have prior approval for any deviation from the original approved protocol. The IRB Protocol Revision/Modification Request (this form) is to be used to request approval to implement changes to a previously approved protocol. Such changes may include:

  • Revisions to the study’s research procedures
  • Revisions to recruitment materials and/or procedures
  • Revisions to consent, assent, and/or parent/guardian permission form(s) and/or procedures
  • Revisions to data collection instrument(s)
  • Revisions to the number of subjects to be recruited
  • Revisions to study personnel
  • Other revisions

 

Submission Instructions:

  1. All requests must be submitted online by the principal investigator.
  2. Gather the materials needed to request the change and access the online submission system at https://wpunj.infoready4.com
  3. Choose  IRB Protocol Revision/Modification Request from the list of available opportunities and click the Apply button on the right.
  4. If you are a current WP faculty, staff, or student, click the option to log in as an WP user. Your user name and password are the same as what you use to log in to WP’s network
  5. Complete the basic information in the online application and upload this form and all required attachments in their original file formats (i.e., Microsoft Word documents). Please do not convert files to PDFs. PDFs are allowable for signed documents, CITI training documentation, and other files that were provided to you in PDF format.
  6. Upon receipt of a new online submission, an IRB administrator or IRB staff person will review the submission for completeness and return incomplete applications for updates prior to processing.
  7. If a revision request is submitted by a student, it will be routed to the faculty advisor for approval prior to being reviewed by the IRB.
  8. If the IRB reviewers have questions or request updates to the study documents, the principal investigator will be notified by email and asked to submit revised files.
  9. Once the IRB has approved the request, the principal investigator will be notified by email. You may not implement any changes to your research protocol until your Protocol Revision Request has been approved by the IRB.

 

Link to IRB’s instructional video: IRB Instructional Video