The Amendment process is not part of PHIRST (yet!), and requires submission of one of the two forms below. Please submit to the IRB Office email box at email@example.com. Please complete the form online, then save to your computer before attaching to an email. 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, why the PI is making them, 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. (See Guidance on “Submitting Research Changes to the IRB”)
· Administrative Amendment Application for Minor Changes to Research: Submit this form for the following changes:
o 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, HIPAA training if personnel will see, access or use Protected Health Information, and GCP training if the study is a clinical trial;
o Changes to study funding;
o Changes to previously approved recruitment materials or study instruments consistent with approved study objectives and that add no additional risk to participants;
o Administrative changes to consent documents, e.g., IRB contact information, changes to formatting.
The JHSPH IRB Office will acknowledge receipt of Administrative Amendments, and for changes to study personnel or funding, will respond by email confirming approval. The email from the firstname.lastname@example.org email address will serve as documentation of IRB approval. Changes to consent forms and recruitment materials require stamping, so those approvals will be processed in the same way as other Amendments (see below).
- Amendment Application: Submit for all other changes.
The IRB Office will process these amendments by setting them up for review by an IRB member.The PI may receive questions from the IRB Office or from the reviewer about the proposed changes.The IRB Office will issue an approval memo documenting the IRB’s action, and will list newly approved study documents.
Note: Grammatical corrections and clarifications to instruments do not require IRB review until the next Progress Report is submitted. List those changes and explain them at that time on the Progress Report.