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IRB Manual

IRB Manual


Table of Contents

	Introduction
1.	IRB Introduction

	General IRB Information
1.1	Scope of the IRB's Authority
	1.1.1	General
	1.1.2	Research Involving More Than One Institution
	1.1.3	Procedures for IRB Review of Multi Site Studies Within OMH

1.2	Definitions

	Composition and Appointment of the IRB
2.1	IRB Membership
2.2	Legal Liability of IRB Members
2.3	Confidentiality of Information Received as an IRB Member

	Review of Research
3.1	Basis of Approval
	3.1.1	Basis of Approval
	3.1.2	Inclusion of Minorities and Women in Research Populations

3.2	Categories of Review
	3.2.1	Federal Exempt
	3.2.2	Expedited Review
	3.2.3	Full Board Review

3.3	Monitoring and Continuing Review
	3.3.1	Continuing Review
	3.3.2	Continuing Review: Reports from multi center clinical trial monitoring
	3.3.3	Monitoring
	3.3.4	Review of the IRB Documentation Process
		Checklist for Review of IRB Documentation

3.4	IRB Meetings
	3.4.1	Frequency
	3.4.2	Quorum

3.5	Appeal Against IRB Decisions
3.6	Review by the Director, RFMH and Department
	3.6.1	Review by the Director
	3.6.2	Review by RFMH
	3.6.3	Review by the Department
		OPWDD
		OMH
	3.6.3.1	Oversight Procedures for NYSPI

3.7	Approval Process for Amendments to Previously Approved Protocols
3.8	Reporting Requirements
3.9	Criteria to Determine unanticipated problems and Adverse Events

	The Informed Consent Process
4.1	The Informed Consent Process
	4.1.1	Components of the Informed Consent Process

4.2	Basic Elements of Informed Consent
	4.2.1	Purpose of the Study
	4.2.2	Study Procedures
	4.2.3	Risks
	4.2.4	Benefits
	4.2.5	Reimbursement
	4.2.6	Alternative Treatment
	4.2.7	Confidentiality
	4.2.8	Medical Treatment and Compensation
	4.2.9	Other Required Information

4.3	Additional Elements - When Applicable
4.4	Signature Statements
	4.4.1	Patient Consent to Research Participation(Signature Form)
	4.4.2	Person Obtaining Consent(Signature Form)
	4.4.3	Capacity Assessment(Signature Form)
	4.4.4	Treatment Team Approval(Signature Form)

4.5	Consent Procedures and Assessment of Capacity
	4.5.1	OMH Inclusion of Subjects Who Lack the Capacity to Consent
	4.5.2	OMH Facilities - Consent, Assent and Objection: Minors
	4.5.3	OPWDD Facilities - Capacity, Surrogate Consent, Objection and Conditions for Involving Adult Persons as Subjects
	4.5.4	OPWDD Facilities - Consent, Assent and Objection: Minors

4.6	Documentation of Informed Consent(All Facilities/Agencies)
	4.6.1	Waivers or Alterations of Informed Consent Components
	4.6.2	Deception and/or Incomplete Disclosure

4.7	Retention of Signed Consent Documents
	4.7.1	FDA Requirements

	Confidentiality
5.1	Confidentiality
	5.1.1	Alcohol and Drug Abuse Programs

5.2	Confidentiality Certificates
	5.2.1	Department of Health & Human Services (42 CFR 2a)
	5.2.2	Department of Justice (21 CFR 1316.21)
	5.2.3	Department of Justice Law Enforcement Assistance Administration (LEAA) (28 CFR Part 22)

5.3	Inclusion of Research Records In Subject's Medical Records
5.4	New York State Reporting Requirements
	5.4.1	Child Abuse
	5.4.2	AIDS
	5.4.3	Alzheimer's Disease

	IRB Records
6.1	Documenation for Each Project
6.2	IRB Minutes
6.3	Membership Records
6.4	Procedures

	Special Categories of Research
7.1	Research Involving the Use of Placebos
7.2	Drugs, Devices and Biologics for Human use that have not Received Marketing Approval and Investigational use of Marketed Drugs
	7.2.1	IND's and IDE's
	7.2.2	Clinical Investigations of Marketed Drugs
	7.2.3	Emergency Use of An Investigational Drug or Biologic
	7.2.4	Treatment Use of and Charging for Investigational Drugs
	7.2.5	Waiver of IRB Requirements

7.3	Research Involving Children
	7.3.1	Research Which Does Not Involve Greater Than Minimal Risk
	7.3.2	Research Involving Greater Than Minimal Risk But Presenting The Prospect of Direct Benefit to the Individual Subjects
	7.3.3	Research Involving Greater Than Minimal Risk and No Prospect of Direct Benefit to Individual Subjects, But Likely to Yield Generalizable Knowledge About the Subject's Disorder or Condition
	7.3.4	Research Not Otherwise Approvable Which Presents An Opportunity To Understand, Prevent or Alleviate A Serious Problem Affecting The Health or Welfare of Children
	7.3.5	Requirements For Permission By Parents or Guardians and For Assent By Children
	7.3.6	Objection to Participation by Children
	7.3.7	Waiver of Parental or Guardian Permission
	7.3.8	Wards

7.4	Research Involving Pregnant Women, Human Fetuses, and Neonates
	7.4.1	Research Involving Pregnant Women and Fetuses
	7.4.2	Research involving neonates
	7.4.3	Research involving, after delivery, the placenta, the dead fetus or fetal material
	7.4.4	Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates

7.5	Research Involving Prisoners
7.6	AIDS Research (Includes Research which will use HIV Status as an Inclusion or Exclusion Criterion)
	7.6.1	Phs Supported Research Involving HIV Testing

7.7	Research Involving Genetic Testing
7.8	Brain Dead Subjects
7.9	Use of Computerized OMH Records for Research Purposes

	Training
8.1	Training in the Protection of Human Research Participants
8.2	Regulatory Basis for Training
8.3	Training Requirements
	8.3.1	A. Requirement for CITI Training Program
	8.3.2	B. Applicability of Requirement
	8.3.3	C. Equivalent Training
	8.3.4	D. Continuing Education and Additional Training
8.4	Access to the CITI Program
	8.4.1	Frequently Asked Questions
	8.4.2	Procedures for Accessing CITI Training-Refresher Course
	8.4.3	Procedures for Accessing CITI Training-New Users
	Appendix
9.1	Forms