IRB University is a set of classes aimed at helping the research community become familiar with submission requirement and the IRB process. Classes are divided into IRB 101 and IRB 201. IRB 101 provides an introduction to the role of the IRB and guidance through the electronic submission process. IRB 201 explores the content and requirements of the protocol template and consent document. ATTEND IRB UNIVERSITY

When creating a new submission, always start with clean templates you downloaded from the PPHS Form and Document Kiosk. That way, you’ll always be sure that you’ve started out using the most current template that’s available. USE CURRENT TEMPLATE VERSIONS

Consent forms should be written at no higher than a 6 th grade reading level. Avoid lengthy, difficult-to-understand medical jargon. Spell out acronyms the first time they’re used. Think to yourself, “Would my niece/nephew understand this?” WRITE READABLE CONSENT FORMS

Transferring to a new consent template? Developing a new Protocol Template? Don’t simply cut and paste! The Maintaining Confidentiality, What is a Research Study, Ending Participation, and Disclosure of Financial Interests sections have changed. Avoid cutting and pasting from other projects. DON’T CUT AND PASTE

There’s a submission deadline (almost) every Friday at 5:00 p.m. Submissions from the previous week are assigned to analysts on Monday morning. By submitting early in the week, you won’t lose time if your submission is rejected and you have to resubmit. SUBMIT EARLY IN THE WEEK

When you submit a modification to approved research, make sure to provide justification for the modification being made. Please speak to the reason behind the modification. “The Sponsor updated the protocol” doesn’t count! HAVE PROPER JUSTIFICATION

Use the E-Submission Checklist, available on our website, to make sure you’re submitting everything you have to. Remember to submit questionnaires, survey tools, advertisements, text for online postings, etc. when applying for initial review or continuing review. For chart reviews, always submit a copy of the data collection tool. When the form you’re submitting requires a signature, make sure it’s signed. MAKE SURE YOUR SUBMISSION IS COMPLETE

Before you submit an initial or continuing review, make sure that everyone listed on HRP-211 has submitted their Financial Conflict of Interest attestation in Sinai Central and has completed CITI training. Can anyone name the required CITI modules? Investigators/Research Staff Data Security/HIPAA Training HIPAA Research Update Good Clinical Practice (for FDA-regulated research) Start a submission in InfoEd for GCO. AVOID GETTING REJECTED

Feel free to contact us! PPHS Main Line: (212) PPHS ANY QUESTIONS?