IRB Policies

The links listed below represent documents displaying the policies of the Avera Institutional Review Board.

General Administration

• Policies and Procedures Maintenance
• Training and Education
• Training and Education Attachment
• Management of IRB Personnel
• Signatory Authority
• Definitions Relating to Signatory Authority
• Payment of Research Subjects
• IRB Fees

Informed Consent

• Informed Consent - General Requirements
• Waiver of Informed Consent
• Documentation of Informed Consent
• Assent

IRB Organization

• Composition of the IRB
• Management of the IRB
• Duties of IRB Members

IRB Communication

• Investigator Communication
• Communication with Other Entities
• Communication Compliance

Functions and Operations

• Research Submission Requirements
• Exempt Research
• IRB Meeting Administration
• Document Management
• Research vs. Quality Improvement

Quality Assurance

• Quality Monitoring Program
• Audits by Regulatory Agencies
• Responding to Allegations of Research Misconduct

Responsibilities of Investigators

• IRB-required Principal Investigator Responsibilities

Review of Research

• Expedited Review
• Criteria for IRB Approval
• Protocol Amendment Review
• Continuing Review -- Criteria for Renewal
• Study Completion
• Adverse Events and Unanticipated Problems
• Categories of Action
• Protocol Deviation/Violation Reporting Policy

Reviews Requiring Special Consideration

• Vulnerable Populations
• Additional Vulnerable Populations
• Categories of Research
• Emergency Use