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.)
For all studies Active in the PHIRST2.0 system, submit Amendments and Administrative Amendments through the electronic system. Contact email@example.com if you need assistance.
Studies that are not yet Active in the PHIRST2.0 system require submission of the Amendment Application and Administrative Amendments via email. Please complete the form online, then save to your computer before attaching to an email. Otherwise, the fill-in boxes will not work.
The IRB will not accept Amendment Applications via email once all active studies are in the PHIRST2.0 system.
There are two Amendment Applications, each of which addresses specific types of changes to the study. The links below go to the Application forms; you do not need these forms if submitting electronically in PHIRST.
· Administrative Amendment Application for Minor Changes to Research: Submit 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 (or electronic acceptance of role if investigator is registered in PHIRST), documentation of human subjects research ethics training, and HIPAA training if personnel will see, access or use Protected Health Information;
o changes to study funding;
The JHSPH IRB Office will acknowledge receipt of Administrative Amendments, and for changes to study personnel or funding. Changes to consent forms and recruitment material 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. An approval memo will issue documenting the IRB’s action on the submission.