TAB 3 - How does our IRB work?

3.00 Moving to IRC

3.00

Moving a Study to IRC

3.01. IRB OPERATIONS

	3.1.00	IRB Fee ($$) Schedule
	3.1.01	Timing and Planning
	3.1.02	IRC ROSTER POLICY
	3.1.02.a	IRB rosters 1999-2004
	3.1.02.k	IRB Roster 2005 March
	3.1.02.l	IRB Roster 2005 June
	3.1.02.m	IRB Roster 2006 March
	3.1.02.n	IRB Roster 2007 May
	3.1.02.o	IRB Roster 2008 April
	3.1.02.p	IRB Roster 2009 January
	3.1.03	- - - reserved
	3.1.04	- - - reserved
	3.1.05	Parts of a Submission
	3.1.06	IRB Decisions
	3.1.07	IRB Approval Letter Sample

3.02 INITIAL REVIEW - Processes & Criteria & Guides

	3.2.01	IRB Review Processes - Exempt/Expedite/Full
	3.2.01.a.	Exemption Categories
	3.2.01.b.	Expedited Review Categories
	3.2.02	IRB Review Criteria
	3.2.03	Non-Local Review Issues
	3.2.04	Risk Assessment
	3.2.05	Multi-center study issues
	3.2.06	Design issues
	3.2.06A	Design the Ethics in (PowerPoint)
	3.2.07	Recruitment and Advertising
	3.2.08	- - - reserved
	3.2.09	GUIDE to Evaluating your Protocol

3.03 DURING THE LIFE OF THE STUDY - Life Happens

	3.3.00	What is a Post Approval Activity?
	3.3.01	Informed Consent
	3.3.02	Study Oversight
	3.3.03a	Report: Adverse Events
	3.3.03a2	FDA Guidance - Adverse Event Reporting to IRBs with IRC Comments
	3.3.03b	Report: Problem
	3.3.04	Modification: Changes in research (activity)
	3.3.05	Continuing Review

3.04 INFORMED CONSENT
--More than you ever wanted to know.
---Divided into bite size chunks.

	3.4.0.	IC What is here?
	3.4.1	IC Ethics
	3.4.2	IC Process
	3.4.2.A.	Advertising
	3.4.3	IC Elements
	3.4.3.A.	Rule Comparison
	3.4.4	IC Documentation
	3.4.4.A	CF Template
	3.4.4.B.	CF Sample - Green Hat Syndrome
	3.4.4.C.	CF Sample 1 page IVD
	3.4.5	IC Signatures
	3.4.6	SPECIAL ISSUES
	3.4.6.A.	Proxy consent
	3.4.6.B.	Waiver of consent
	3.4.6.C.	Translation
	3.4.7.A	CALIF Experimental Subjects Bill of Rights
	3.4.7.B	CALIF Medical Experimentation
	3.4.8	- - - reserved
	3.4.9	GUIDE to INFORMED CONSENT
	3.4.9.A.	Presentation-Informed Consent

3.05 IRB SPECIAL TOPICS

	3.5.1.A.	Biol Spec - Points to Consider
	3.5.1.B.	Biol Spec -OIG report
	3.5.1.C.	Biol Spec Consent form sample 1
	3.5.2.A.	Device_Basics
	3.5.2.B.	Device_SR/NSR
	3.5.2.C.	Device_IRC's_NSR_Policy
	3.5.2.D.	Device_SR_Evaluation_Tool
	3.5.3.A.	HUD and HDE
	3.5.3.B.	HUD_812.100
	3.5.3.C.	HUD FDA Guidance