IRB, IEC, Ethics
IRB, IEC, Ethics
What is an IRB/IEC?IRB:
● IEC: Independent Ethics Committee (Global
term).
● Institutional Review Board (US term).
● Purpose: Protect participant rights and
welfare.
Historical Background
● ICH-GCP guidelines
● FDA and EMA regulations
● Declaration of Helsinki
● Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov
M. Ethics Committees: Structure, Roles, and Issues. J
Korean Med Sci. 2023 May;38(25):e198.
● ChatGPT for Infographics.
MCQs