IRB Manual

 

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Chapter 1

WFH Regional Organization

Chapter 2

Ethical Principles/Regulations

Chapter 3

Definitions

Chapter 4

IRB Jurisdiction
IRB Autonomy and Function 
IRB Institutional Official 
IRB Chair 
IRB Members
Consultants, Observers and Guests 
Legal Counsel 
PI Responsibilities
IRB records and files
Storage of Consent Documents
Maintenance of Policies

Chapter 5

PI & Research Staff Education
IRB Education

Chapter 6

Full Board Review
Exemptions
Expedited Review
Amendments and Revisions
Planned Exceptions and Unplanned Deviations
Continuing Review
Activation and Approval Dates
Verification- No changes
Emergency Use
Disapprovals and Appeals 
Facilitated Review

Chapter 7      

IRB Reporting to regulatory agencies 
Reportable Events (unanticipated problems)
Noncompliance
Suspension and Termination
Managing subject complaints
Communication of Staff concerns

Chapter 8

 

Definition of Informed consent Principles of informed consent
Obtaining informed consent
Subjects lacking capacity to consent
Change of status to consent
Documentation of consent
Verbal consent-consent w/o signature
Types of consent form documents
Required elements for consent
Permission from one or both parents
Signature of individual obtaining informed consent
Witness signature
Waiver of informed consent
Exception from informed consent Emergency Settings
Wards of the State
Illiterate subjects
Translation of consent documents

 

Chapter 9

Children Prisoners
Inclusion of women and pregnancy testing
Pregnant women, fetuses and neonates
Multicenter research and Engagement  
Data and Safety Monitoring Plans
Drugs, Biologics and Dietary supplements

Investigational Devices

Recruitment Payments to Subjects
QA – QI vs. Research
Innovation vs. Research
Certificate of Confidentiality
Using the internet to conduct research

 

 

 
Chapter 11
Use of PHI for Research

Chapter 12
Conflict of Interest

Disclosure, Management, and Reporting Financial COI

Chapter 13
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