BRANY IRB Forms and Downloads
IRB Membership List
- IRB Membership List (updated 10/05/2011)
- BRANY IRB is registered in accordance with 21 CFR 56.106.
- BRANY IRB's registration number is IRB00000080.
Compliance Statement
BRANY IRB Meeting Schedule
INITIAL SUBMISSION
- Submission Requirements Checklist
- Request for User Access for IRBManager (file updated November 16, 2011)
- Research Application - fillable form [WORD] (file updated December 12, 2011)
- Research Application with embedded comments & guidance (file updated December 12, 2011)
- IRB Authorization Agreement Template [WORD] (file updated December 21, 2011)
- 1572 Form
- Transfer of IRB Oversight
- Requirements for Human Subject Protection Training
- FORM 01: Conflict Disclosure Statement (file updated January 4, 2012)
- FORM 02: Conflict Report Form (only needed if answered "YES" on Form 01) (file updated January 4, 2012)
- How to Submit (file updated November 30, 2011)
Informed Consent
- Sample Consent Form [WORD] - with embedded comments & guidance (file updated September 19, 2011)
- Sample Assent Form
- Genetic Testing
- HIV Antibody Test Info Sheet & Consent Template
- Informed Consent Feedback Tool
- Informed Consent Feedback Tool - Spanish Translation
- Consent Waiver Request
- Glossary
HIPAA Authorization
Request for IRB Review of Modifications Form
- Request for IRB Review of Modifications
- Modification submission guidance (file updated December 28, 2011)
Personnel Changes
- Submission Guidance: Adding Study Personnel (file updated December 12, 2011)
- Requirements for Human Subject Protection
- FORM 01: Conflict Disclosure Statement (file updated January 4, 2012)
- FORM 02: Conflict Report Form (only needed if answered "YES" on Form 01) (file updated January 4, 2012)
- Request for User Access for IRBManager (file updated November 16, 2011)
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Continuing Review Forms
- Application for Continuing Approval
- Sponsor Supplement for Multi-Center Research Projects
*For Sponsors of Multi-Center Research Projects -- BRANY IRB requires the Sponsor of multi-site research studies 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.
Reportable Events
- Reportable Events Form (file updated January 12, 2011)
- Information Sheet for Researchers - Reportable Events (file updated March 24, 2011)
Unanticipated Problems
- Reportable Events Form (file updated January 12, 2011)
- Information Sheet for Researchers - Unanticipated Problems
External (off-site) Adverse Events
- IND Safety Report Submission Form
- Information Sheet for Researchers - Reportable Events (file updated March 24, 2011)
Change of PI or Site Location / Addition of Research Site Location
Notification of Study Status Changes
Exemptions
Guidance
- What does & doesn't need BRANY IRB review? (file updated November 16, 2011)
- To Add BRANY IRB to Your FWA (file updated November 16, 2011)
- IRB Approval Stamps and Original Hard Copy Documents (file updated September 19, 2011)
- Guidelines for Drafting Protocols
- Manual for Researchers
- Guidelines for Research Sponsors
- BRANY IRB Institutional Officer
Not sure what form to use or how to fill it out? Please contact us.