KEP LPEM FEB UI is a review committee established to help protect the rights and welfare of human research subjects. To clarify when an ethical clearance is required, the table that follows reviews some definitions from federal regulations and guidance. A research activity must meet the definitions of “research” and “human subjects” in order to be considered human subjects research by the regulations. The following are the definition related to the research involving human subjects:
Protection of Human Subjects, 45 CFR § 46 (2018)
KEPPKN 2017 Guidelines
KEPPKN 2011 Guidelines
Download this Guideline: Glossary.