Institutional Review Board Policies & Reference Manuals

Below is a comprehensive list of the Institutional Review Board policies and reference manuals. Click on any of the links below to download the corresponding policy or reference manual.

Note: Downloading IRB documents for editing may require additional steps beyond clicking on the link, especially for team members of the Christ Hospital who are on the network. Please click the button to view the instructions for downloading IRB documents for editing.

Instructions for downloading IRB documents for editing

Standard Operating Procedures

SOP 1.01 Continuing Review
SOP 1.02 FWA
SOP 1.03 IRB Records
SOP 1.04 Meeting Minutes
SOP 1.05 Resource Allocation
SOP 1.06 Not Human Subjects Research Determinations
SOP 1.07 Full Board Guidelines
SOP 1.08 IRB Mailing
SOP 1.09 Quality Improvement and Audits
SOP 1.10 Emergency Use
SOP 1.11 Expanded Use - Investigational New Drugs
SOP 1.12 IRB Members
SOP 1.13 Reporting Communicable Diseases
SOP 1.14 Outreach
SOP 1.15 State and Local Laws
SOP 1.16 Exempt Research
SOP 1.17 Expedited Review
SOP 1.18 Institutional Official
SOP 1.19 Signature Authority
SOP 1.20 Undue Influence
SOP 1.21 Establishing Authorization Agreements
SOP 1.22 Reliance on External IRBs
SOP 1.23 IRB of Record
SOP 1.24 Expanded Access – Investigational Devices
SOP 1.25 Suspension or Termination of IRB Approval of Research
SOP 1.26 Response Plan for Emergencies
SOP 1.27 Use of Mentor IRB for Electronic Records and Electronic Signatures
SOP 2.01 Guidelines for Protocol Submission
SOP 2.02 Informed Consent
SOP 2.03 Amendments
SOP 2.04 Complying with IRB Decisions
SOP 2.05 Reporting Unanticipated Problems
SOP 2.06 News Releases

SOP 2.07 Study Closure
SOP 2.08 Investigator Compliance
SOP 2.10 Recruitment
SOP 2.11 Communication to Sites
SOP 2.12 Ethical Standards
SOP 2.13 Financial Conflict of Interest
SOP 2.14 Compensation for Research Related Injury
SOP 2.15 Consent Translation
SOP 2.16 Remote Consent
SOP 2.17 Electronic Signatures
SOP 3.01 Scientific Review
SOP 3.02 IRB Maintenance
SOP 3.03 Safety Resources
SOP 3.04 Policy Development
SOP 3.05 IRB Jurisdiction
SOP 3.06 Compliance with Human Subjects Regulations
SOP 3.07 Planned Emergency Research
SOP 3.08 Complaints or Questions
SOP 3.09 Protocol Violation, Deviation, and Non-Compliance Reporting
SOP 3.10 Misconduct in Research
SOP 3.11 Use and Investigation with Drugs
SOP 3.12 Education
SOP 3.13 Sponsor Expectations
SOP 3.14 Data and Safety Monitoring
SOP 3.15 Waiver of Consent
SOP 3.16 Confidentiality
SOP 3.17 Pregnant Women and Fetuses
SOP 3.18 Decisionally Impaired
SOP 3.19 Other Vulnerable Groups
SOP 3.20 Periodic Review and Assessment of IRB Members, Chair and Staff
SOP 3.21 Humanitarian Use Device
SOP 3.22 Children
SOP 3.23 Definitions

Reference Manuals

RM 01 Preface
RM 02 IRB Review of Research
RM 03 Continuing Review of Research Protocols
RM 04 Investigator Communications
RM 05 Recruitment
RM 06 Vulnerable Populations
RM 07 Protocol and Format Requirements
RM 08 UAPs and Adverse Events
RM 09 Investigator Responsibilities

RM 10 Conflicts of Interest
RM 11 Criteria for Approval
RM 12 Allegations of Noncompliance
RM 13 Expanded Access
RM 14 Sponsor Requirements
RM 15 Investigative Devices
RM 16 Informed Consent
RM 17 Surrogate Consent

​​​​​​​Institutional Review Board Policies & Reference M​anuals

Standard Operating Procedures

Reference Manuals

Institutional Review Board Policies & Reference Manuals