Forms & Downloads
IRB Forms & Downloads
IRB Membership List — Compliance Statement — Meeting Schedule
- IRB Membership List (Updated 07/20/2018)
- 2018 IRB Meeting Schedule
- BRANY IRB Compliance Statement (2015 version is current)
- BRANY IRB Registration
BRANY IRB is registered per 45 CFR 46 Subpart E and 21 CFR 56.106 (Registration #IRB00000080 and #IRB00010793)
Initial Submission or Exemption Request
- Submission Requirements Checklist
- IRB Authorization Agreement Template
- Guideline for drafting a clinical protocol
- Transfer of IRB Oversight – Contact BRANY IRB
- Requirements for Human Subject Protection Training
- FORM 01: Conflict Disclosure Statement
- FORM 02: Conflict Report Form (only needed if answered “YES” on Form 01)
IRBManager™ Getting Started
- Request for User Access – Submit form to obtain an IRBManager account.
Send completed Request for User Access Forms by email to Svetlana Abramova (or fax# 516-706-5066)
- Which xForm should I use?
- IRBManager™ Demonstration Webinar
- Check the box to request a demonstration on the Request for User Access form
- Email firstname.lastname@example.org
- Sample Consent Form [WORD] – with embedded comments – Updated 3/19/2018
- Sample Assent Form [WORD] – with embedded comments – Updated 3/19/2018
- Short Form Consent Guidance
- Minor Deviation Log
- Supplement for Multi-Center Research Projects
For Multi-Center Research Projects — BRANY IRB requires a representative of the Study Sponsor, the Lead Investigator, or the Master File site PI for a multi-site study to provide a brief summary of study-wide progress and findings, including study-wide subject accrual data, adverse event data, unanticipated problem reports, safety updates, recent literature, and any other interim findings or available study-wide progress information. This information is intended to assist the IRB in evaluating how the site-specific data and progress reported by local PIs with continuing review applications compare to the study-wide data and progress.
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs)
External (off-site) Adverse Events
BRANY IRB does not require submission of external (off-site) adverse event reports unless they meet the criteria for an Unanticipated Problem.
Notification of Study Status Changes