IRB Handbook (Interim)

The interim IRB Handbook stands to explain human subjects research based on the regulations under 45 CFR 46. The IRB Handbook also contains the written procedures surrounding human subjects research at Emerson College.

IRB Handbook Table of Contents

  • Introduction to Human Subjects Research
  • When IRB Review is Required
  • Types of IRB Review
  • Risks and Benefits
  • Informed Consent
  • Privacy, Confidentiality, and Data Security
  • Recruitment of Participants
  • Vulnerable Populations
  • Submitting a Research Study
  • Continuing your Research Study
  • Unanticipated Problems and Adverse Events
  • Student Researchers
  • International Human Subject Research
  • Contact and Resources
  • Written Procedures

Federal Regulations (45 CFR 46)

The U.S. Department of Health and Human Services codified its regulations for the protection of human subjects in research in the code of federal regulations at 45 CFR 46, which includes five subparts. Subpart A, known as the Common Rule, handles a majority of the regulations to be followed for human subjects research.