The Amendment process is not part of PHIRST (yet!), and requires submission of one of the forms below. Use the Amendment Application(s) fill-in form and submit to the IRB Office electronically. Please complete the form online, then save to your computer. Otherwise, the fill-in boxes will not work.
A PI must submit proposed changes to an IRB approved research application and obtain IRB approval of those changes before implementing them. The Amendment Application must explain the proposed changes and how they will affect the ongoing study. If the changes include modifications to any of the previously submitted documents, provide a track/change and clean version of each revised document, and give each document a clear version name consistent with the title on the document (see Guidance on Document Control and Naming Conventions.)
There are two Amendment Application forms, each of which addresses specific types of changes to the study:
• Amendment Application: For changes to PI, Funding, Study Procedures, Documents
• Administrative Amendment Application for Change to Study Personnel: For additions/deletions of co-investigators, student investigators, study personnel who will interface with human subjects and/or their identifiable private information. Submissions of personnel changes must include an Investigator Agreement for each new person, and documentation of human subjects research ethics training.
There are some very minor changes to recruitment materials and study instruments like surveys/questionnaires that may be reviewed on a “Fast Track.” Please review the “Fast Track” Guidance for further information.