Human Subjects

The following materials comprise the MSC Manual on the Protection of Human Subjects.

POLICIES:

• MSC Human Subjects Policy (WORD.doc)
  
  
• Types of Human Subjects Research (WORD.doc)
  
  
• Responsibilities of the Principal Investigator/Researcher in the Conduct of Research Involving Human Subjects (WORD.doc)
  
  
• The Federal Policy (45 CFR 6)
  
  

• The Belmont Report

• Research Involving Individuals with Questionable Capacity to Consent
  
  

PROCEDURES:

• Consent of Participating Agencies (WORD.doc)

• Human Subject Protocol Renewal/Review Procedures (WORD.doc)

• Human Subject Protocol Modification/Change Procedures (WORD.doc)

• Adverse Event Reporting (WORD.doc)

• Human Subject Protocol Closure (WORD.doc)

• Instructional Demonstration Activities (WORD.doc)
  
  
• Student Research (WORD.doc)

FORMS:

• Application for Exempt Review of a Human Subject Protocol (WORD.doc)

• Application for Standard or Expedited Review of a Human Subject Protocol (WORD.doc)

• Human Subject Annual Renewal/Review Form (WORD.doc)

• Application for Modification or Change to an Approved Human Subject Protocol (WORD.doc)

• Adverse Event Reporting Form (WORD.doc)

• Human Subject Protocol Closure Form (WORD.doc)
  
  
  

INFORMED CONSENT:

• Informed Consent Process (WORD.doc)

• How to Construct a Written Consent Form (WORD.doc)
  

• Tips on Informed Consent (WORD.doc)
  
  
  

INFORMED CONSENT FORMS:

• Informed Consent Form (WORD.doc)

• Sample Assent Form for Minors (WORD.doc)

• Sample Parental Signature for a Minor Format (WORD.doc)
  
  
• Short Form Written Consent Document for Subjects Who Do Not Speak English (WORD.doc)
  
  

INSTITUTIONAL REVIEW BOARD (IRB) PROCEDURES:

• IRB Operating Procedures (WORD.doc)

• Checklist Used by IRB for Review of Protocols (WORD .doc)

• Decision Charts
  
  
  

TRAINING MATERIALS:

• NIH Computer Based Training for Researchers using Human Subjects
  
  
  

OTHER LINKS OF INTEREST:

• DHHS Office for Human Research Protections
  

• Glossary of Lay Terms for use in Preparing Consent Forms for Human Subjects
  (*Note: This glossary is created by Standford University and is on the UC-Davis website.)
  

 

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