OU HRPP Policies and Procedures

 

The following Presidential Policies are available from the HRPP Director upon request:

  • Independent Authority of the Institutional Review Boards
  • Establishment of an Institutional Conflicts of Interest Committee
  • Organizational Official for Human Research Protection Program

 
Note: The effective date of an individual policy can be found in its footer. The current effective date is September 9, 2016.
           If you need older versions of a policy, please contact the HRPP office.

 

NEW! Searchable Policies and Procedures

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 II     Introduction

 III    List of Abbreviations

 IV   Glossary

 VI   Mission Statement

 VII  Statement of Authority and Purpose

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100  General Information

101 - Standard Operating Procedures Maintenance

102 - Training and Education:

102A - IRB Member

102B - Key Personnel

102C - IRB Staff

103 - Management of IRB Personnel

104 - Conflict of Interest:

104A - Conflicts of Interest in Human Participant Research

104B - Conflict of Interest - IRB Members

105 - Signatory Authority

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200  IRB Organization

201 - Composition of IRB

202 - Management of IRB

203 -  Duties of IRB Members

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300 Functions & Operations

301 - Research Submission Requirements

302 - Administrative Review and Distribution of Materials

303 - IRB Meeting Function and Operation

303A - IRB Meeting Agenda

303B - IRB Meeting Administration

303C - IRB Meeting Minutes

304 - Documentation and Document Management

305 - Filing & File Folders

306 - IRB Fees and Invoicing

307 - Copy & Data Requests

308 - Reporting to Regulatory Agencies and Institutional Officials

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400 Review of Research

401 - Research Exempt from IRB Review

402 - Expedited Review

403 - Initial Review - Criteria for IRB Approval

404 - Continuing Review

405 - Modifications

406 - Determination of Human Research

407 - Unanticipated Problems Involving Risks to Participants or Others and Protocol Deviations

408 - Study Completion

409 - Categories of Action

410 - Study Recruitment and Advertisements

411 - Suspension or Termination of IRB Approval

412 - NCI Central Institutional Review Board

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500 - Specific Review Consideration

501 - Special Populations

502 - Categories of Research

502A - Clinical Research Involving Drugs

502B - Clinical Research Involving Biologics

502C - Clinical Research Involving Devices

502D - Medical Records, Chart Reviews, and Case Reports

502E - Treatment Use Protocols

502F - Humanitarian Use Devices

502G - Emergency Use of FDA Regulated Products

502H - Banking of Biological Specimens, Genetic Testing, and Gene Transfer

502I - Cell Lines and Cloned DNA/RNA

502J - Social/Behavioral Research

502K - International Research

502L - Internet / Social Media-Based Research

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600  IRB Communication & Notification

601 - IRB Communication and Notification

602 - Other Entities (Internal)

602A - Office of Compliance

602B - Office of Legal Counsel

602C - Office of Research Administration (ORA) - Oklahoma City Campus

602D - Office of Research Services (ORS) - Norman Campus

602E - Healthcare Billing Compliance Office (HBC)

602F - Institutional Biosafety Committee (IBC)

602G - IRB of Record

602H - OU Cancer Institute Scientific Review Committee (SRC)

602I - Radiation Safety Office (RSO)

603 - Other Entities (External)

603A - Veterans Affairs Medical Center

603B - Office for Human Research Protection (OHRP)

603C - Food and Drug Administration (FDA)

603D - Communication with Research Participants

603E - Participant Outreach Program

603F - Department of Defense

603G - Other Federal Agencies

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700 Informed Consent

701 - Consent Process and Documentation

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800 Responsibilities of Investigators & Sponsors

801 - Investigator Qualifications & Responsibilities

802 - Sponsor Responsibilities

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900 Quality Improvement

901 - Quality Improvement Program

902 - Audits by Regulatory Agencies

903 - Non-compliance / Scholarly Misconduct

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1000 Research-Related Privacy Issues, Privacy Board

1001 - Health Insurance Portability and Accountability Act (HIPAA Privacy Rule)

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1100 Oklahoma State Laws

1101 - Oklahoma State Law Pertaining to Research

 

Appendices