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

Research that Requires Approval
Continuing Review Requirement

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All research approved by the SCDMH Institutional Review Board is subject to Continuing Review, and no project may continue beyond one (1) year without re-approval. The time limit for submission of the Continuing Review Form is established during the initial review of the project.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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