Institutional Review Board

USM Policies, Procedures and Guidance For Human Subjects Research

Office of the Provost and Vice President for Academic Affairs

Revised: 2007
Original Approval Date: December 10, 2001

IRB Registration # IRB00001953
FederalWide Assurance # 00001748

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Contents

1. Introduction
   1. Ethical Principles Governing Human Subjects Research
      1. Respect for Persons
      2. Beneficence
      3. Justice
   2. Purpose
   3. Scope
   4. Applicability
   5. Assurance
   6. Definitions and Operational Concepts
2. The Institutional Review Board (IRB)
   1. The Role of the IRB
   2. Institutional Review Board Responsibilities
   3. IRB Authorized Powers
   4. Categories of Review
   5. Withdrawal or Termination of Research
   6. Foreign Research
   7. Collaborative Research
   8. Application Requirements for Research Involving Human Subjects
      1. Contents of the Research Proposal Summary
   9. Informed Consent: General Requirements
   10. Informed Consent in Vulnerable Populations
       1. Research Involving Minors (subjects under 18 years of age)
       2. Research Involving Subjects with a Diminished Capacity to Consent
       3. Research Involving Experimental Biological or Behavioral Interventions
       4. Research Involving Pregnant Women, Fetuses and Products of Labor and Delivery
       5. Research Involving Non-English Speaking Populations
       6. Research Involving Prisoner Populations
       7. Research Involving University of Southern Maine Students
       8. Use of Specimens for Future Research
   11. Documentation of Informed Consent
       1. Written Consent Forms
       2. Full Form Written
       3. Short Form – Written (Oral Summary)
       4. Alteration or Waiver of Informed Consent Requirements
   12. IRB Procedure for Protocol Violations
   13. Procedure for Adverse Research Events
   14. IRB Membership
       1. Board Composition
       2. Appointment to the IRB
       3. Chairperson
       4. Vice Chairperson
       5. Membership Terms and Voting Rights
          1. General Members
          2. Chairperson
       6. General Member Responsibilities and Obligations
       7. IRB Member Education
       8. IRB Registration with the Department of Health and Human Services (DHHS)
       9. Termination of Membership
          1. Voluntary
          2. Involuntary
   15. IRB Meetings
   16. Meeting Minutes
   17. IRB Policy Updates, Changes and Additions
       1. Strict regulatory/statutory requirements
       2. Discretionary Regulatory/Statutory Requirements
       3. Emergency Changes
       4. All Other Requirements
3. The Office of Research Compliance
   1. Administrative Support
   2. Record Keeping, File Retention and File Destruction
   3. ORC Granted Powers
   4. IRB Annual Report
   5. Human Protections Administrator (HPA)
   6. Complaints, Adverse Events, Privacy Breaches and Allegations of Research Misconduct