Guidelines & Policies

Institutional Review Board Guidelines and Policies  

• Human Subjects Protection Program
  All Children's Health System Policy
   
• Ethical Principals and Regulations
  Statement of Ethical Principals and Regulatory Requirements for 
  Human Subject Protection
   
• Definitions
  Definition of Human Subject and Research
   
• Lines of Authority and Responsibilities
  Jurisdiction of the Institutional Review Board
  Institutional Review Board Autonomy and Functions
  Institutional Official Responsibilities
  Chairperson Selection, Appointment and Responsibilities
  Institutional Review Board Members Selection and Evaluation
  Consultants, Observers and Guests
  Legal Counsel
  Principal Investigator Responsibilities
  Records and Files
  Storage of Research Data and Informed Consent Documents
   
• Education and Training
  Investigators and Research Staff
  Administrative Staff and IRB Members
   
• Review of Research Activities
  Operational Review Procedures: Full Committee Review    
  Exemptions         
  Expedited Reviews        
  Amendments and Revisions       
  Modifications: Exceptions and Deviations     
  Continuing Review        
  Approval and Expiration Dates       
  Verification that Material Changes Have Occurred    
  Additional Human Subject Protection Review     
  Emergency Exemptions        
  Disapprovals and Appeals
   
• Reporting, Unanticipated Problems, Noncompliance
  Reporting
  Unanticipated Problems Involving Risks to Research Subjects and Others
  Noncompliance Investigations and Determinations
  Suspensions, Terminations, Administrative Closures
  Research Related Injury
  Managing Research Participant/Family Concerns and Complaints
  Communication of Staff Concerns Raised During Research
    
• Informed Consent, Assent, Parental Permission
  Informed Consent/Permission/Assent Process
  Documentation of Informed Consent/Parental Permission/Assent
  Waivers and Alterations of Informed Consent/Parental Permission/Assent
   
• Special Issues and Types of Research
  Children
  Prisoners
  Women
  Pregnant Women, Fetuses and Neonates
  Multi Center Research and Engagement in Research
  Clinical Trial Data and Safety Monitoring Guide
  Drugs, Biologics,and Dietary Supplements in Research
  Investigational Devices
  Medical Record and Database Review Research
  Excess/Discarded Human Biological Specimen Use
  Conflicts of Interest: Clinical Research