IRC Independent Review Consulting, Inc. - Human Research - Institutional Review Board - Medical Ethics

The IRB

How does our IRB work?
Tab 3 - IRB OPERATIONS
Times, Decisions, Guides,
and other logistical things.

Please call with any questions.

3.01. IRB OPERATIONS
Rosters Old and New,
Review times
(Fees in 2.1)

3.02 INITIAL REVIEW
Review processes (Exempt, Expedited, Full Board)
Review criteria
Protocol guides
Advertising and Recruitment

	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
After approval, real life happens...
Modifications, Violations
Harms, risks and problems

	3.3.00	What is a Post Approval Activity?
	3.3.01	Informed Consent
	3.3.02	Study Oversight
	3.3.03	Adverse Events
	3.3.04	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 A (.doc download)
	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
Biological specimens
Devices, NSR/SR, HUD

	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.	FDA Guidance
	3.xx	another sub


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