Course Code: ELM-901-06

Major Responsibilities of the Institutional Review Board (IRB)

The major responsibilities of Institutional Review Board (IRB) / Independent Ethics Committee (IEC) include:

  • Safeguarding the rights, safety and welfare of all clinical trial subjects
  • Obtaining proposed research documentation
  • Reviewing the proposed clinical trial plans within a stipulated time frame
  • Considering Investigator qualification
  • Providing review points in written form
  • Obtaining consent of the trial subjects
  • Conducting the continuous review of each ongoing trial at least once per year
  • Ensuring that all the information about payment methods, payment amounts, payment schedule to subjects etc. are written in informed consent form and are provided to the clinical trial subjects

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering