Description
This course covers an Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IEC. Content includes key components of human subject protection, definitions and scope for Part 50, informed consent requirements, elements, and language; the informed consent process; exceptions to informed consent; vulnerable populations; and 21 CFR 56 – the regulation section for Institutional Review Boards.
This course can be used alone or as part of the full curriculum.






