Policies and Procedures

Introduction & Statement Of Principles

Policies & Objectives

1. NGHS IRB Policies & Procedures
2. NGHS Board Policy 0-060
3. Organizational Position
4. Jurisdiction
5. NGHS IRB Objectives
6. Duties & Responsibilities
   1. Northeast Georgia Health System Administration
   2. IRB Coordinator
   3. NGHS IRB
   4. IRB Chair
   5. IRB Members
   6. Researchers/Investigators
   7. IRB Relationships
7. IRB Composition & Membership
   1. Selection
   2. Membership
   3. Alternate Members
   4. Ad Hoc Members
   5. Tenure
   6. Member Privacy

Operating Procedures

1. Meetings
   1. Regular Meeting
   2. Called Meeting
   3. Quorum & Voting
   4. Conflict Of Interest
   5. Telephonic Participation
2. Review Decisions
   1. Approval
   2. Return For Clarification
   3. Disapproval
   4. Suspension or Termination of Approval
3. Review Categories
   1. Full Board Review
   2. Expedited Review
   3. Facilitated Review
   4. Post Approval Modifications
   5. Continuing Review
4. Review Processes
   1. Investigator & Site Review
   2. Protocol Review
   3. Informed Consent Review
   4. Consent Documentation Review
5. Waiver Of Informed Consent
6. Special Circumstances
   1. Medical Devices
   2. Single Patient Use
   3. Marketed Product Usage
   4. Study Participant Hospitalized At
      NGHS: Study Being Conducted
      Elsewhere
7. Special Participant Populations
   1. Children
   2. Prisoners
   3. Pregnant Women and Fetuses
8. Post Approval Procedures
   1. Continuing Review
   2. Adverse Event Reports
   3. Changes In Or From Protocol
   4. Report From FDA Clinical Investigator
      Audit
9. Reports And Records
   1. IRB Reports To The NGHS Board Of Directors
   2. Other Reports
   3. Records Of NGHS IRB
   4. Record Retention