Table of Contents

About the IRB

• Responsibilities of the IRB
• Board Members

SCDMH Documents Governing Human Subject Research

• What Constitutes Human Subject Research
• Principles of Ethical Research
• DMH Directive # 886-07
• DMH Directive # 837-03

Research that Requires Approval

• Exempt Projects
• Expedited Review Procedures
• Full Board Review Projects
• Continuing Review Requirement

Approval Process

• Required Protocol Information
  Required Informed Consent Information
• Steps, Timelines and Deadlines
• Required Training for Investigators
• Non-DMH Employees Requesting Research Permission

HIPAA and Research

• What is the Privacy Rule
• How it Affects Researcher
• Conditions for Use/Disclosure of PHI
• Obtaining Authorizations from Subjects
• De-Identified Data
• Criteria for and Requesting Waivers

Special Population Requirements

• Children
• Prisoners

Resource Material

• Informed Consent Guidelines
• Informed Consent Example #1
• Informed Consent Example #2
• Informed Consent Example #3
• Informed Consent Example #4

Forms

• Project Application for Research
• Unaffiliated Investigator Agreement (Non-SCDMH Employee)
  Privacy Practices Agreement (HIPAA)
• Non-Employee Signature Page
• Continuing Review Form
• Request for a Waiver or an Alteration of Individual Authorization

 

Institutional Review Board Manual

Quick Links

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• Belmont Report: http://ohsr.od.nih.gov/guidelines/belmont.html
  
  
• Directive: SCDMH Institutional Review Board-Policies and Procedures for the Protection of Human Subjects http://dmhhome/directives/886-07.htm
  
  
• FDA Investigational Devise Exemptions http://www.access.gpo.gov/nara/cfr/waisidx_98/21cfr812_98.html
  
  
• FDA Regulations Protecting Human Subjects http://www.access.gpo.gov/nara/cfr/waisidx_99/21cfr312_99.html
  
  
• Federal Regulations Protecting Human Subjects
  http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
  
  
• Full List of Exempt Research Categories http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101
  
  
• Full List of Expedited Research Categories http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
  
  
• Grants Process Manual, SCDMH http://dmhhome/coneducation/grant.htm
  
  
• Nuremburg Code http://www.ushmm.org/research/doctors/Nuremberg_Code.htm