Handbook for Human Research Protections Program

These materials are being prepared as updated guidance for investigators, IRB members, and the research community and will be submitted for certification by the Association for the Accreditation of Human Research Protection Programs.

We solicit your comments and feedback for usefulness and clarity. As documents are prepared and updated, this work in progress will be expanded.

1. Human Research Protection Program
   • Human Research Participant Protection (HRPP) Program - Statement of Commitment and Institutional Oversight of Assurance Policy
   • Federal-wide Assurance with the U.S. Office of Human Research Protections
   • Education and Training
     • IRB Member Training and Education SOP
   • Conflict of Interest
     • IRB Member Conflict of Interest Policy
     • IRB Member Conflict of Interest Procedure
     • IRB Member Conflict of Interest Guidelines
     • Research Conflict of Interest
     • Research Conflict of Interest Procedure
     • Guidelines for Research Conflict of Interest Limits of Disclosure
2. IRB Oversight
   • Principles and authority of IRB
     • Authority and Independence of the Institutional Review Board Policy
   • Institutional Official
     • Institutional Official for Human Subject Research Policy
   • Research Protection Programs
     • Assignment of IRB Reviewers SOP
   • Membership
     • Institutional Review Board Membership Policy
     • IRB Membership SOP
     • Roles and Responsibilities of IRB Members Q-Tip
3. IRB Application Process
4. Review Procedures
   • Determination of Human Subject Research Policy
   • Review Level - Initial Submissions of Human Subjects Research Policy
   • Exempt
   • Expedited
   • Convened Board
     • Initial Full Board Review SOP
     • Conduct of Convened Institutional Review Board Meetings Policy
     • Conduct of Convened Institutional Review Board Meetings Procedure
     • Conduct of IRB Meetings SOP
     • Specific Findings SOP
     • Risk Table
   • Research Involving Investigational Products
     • Use of Devices in Human Subject Research Policy
     • Procedures for Significant Risk (SR) / Non-Significant Risk (NSR) Device Determination
     • LLU Device Study Worksheet
   • Humanitarian Use
     • Humanitarian Use Device Policy
     • Humanitarian Use Device SOP
     • Humanitarian Use Device Application
   • Adverse Event Reporting
     • Adverse Event / Unanticipated Problem Reporting and Reviewing Policy
     • Adverse Event / Unanticipated Problem Reporting and Reviewing Procedure
     • Examples of Unanticipated Problems
5. Recruiting and Informed Consent Process
   • Informed Consent Process
     • Informed Consent in Human Studies Research Policy
     • Informed Consent Procedure
     • Waiver or Alteration of Informed Consent Procedure
     • Checklist for the Informed Consent Document - Investigators
     • LLU Informed Consent Document Template for Research in Clinical Settings
6. IRB Documentation
7. Special Conditions and Populations
   • Protection of Vulnerable Subjects and Special Populations SOP
     • Permitted Categories of Research in Children
       • Summary Table of Requirement Protections for Children in Research
       • General Consent Guidelines for Research Involving Children
       • Rationale for Inclusion of Children in Research
       • Waiver of Child's Assent
8. Clinical Trials
   • Clinical Trials Registration Policy
   • Clinical Trials Registration Procedure
9. Conduct of Research
10. Glossary of Lay Terms