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