Main Content
March 27, 2008
Institutional Review Board Manual
Table of Contents
March 27, 2008
Welcome to the Institutional Review Board (IRB) web page for the South Carolina Department of Mental Health (SCDMH).
The department recognizes the need for safeguarding the rights and welfare of research subjects and their private health information. In accordance with Department of Health and Human Services regulations, the SCDMH has an established Institutional Review Board which is charged with these responsibilities. This web site is dedicated to providing the researcher with the tools and information necessary to protect these obligations and facilitate the approval process.
About the IRB
SCDMH Documents Governing Research
- What Constitutes Human Subject Research
- Principles of Ethical Research
- DMH Directive # 837-03
- DMH Directive # 890-09
- DMH Directive # 891-09
Research that Requires Approval
- Case Studies
- 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
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