What is 45 Code of Federal Regulations Part 46 (45 CFR 46)?
Often called the “Ccommon Rrule,”, 45 Code of Federal Regulations PartFR 46 outlines contains the Department of Health and Human Services (DHHS) National Institutes of Health’s Office for the Protection from Research Risks policy for regulations governing the protection of federally-backed human subjects’ research at institutions where such research is conducted with DHHS collaboration or support. Included areThis legislation describes descriptions of the mandated structure, and function and membership of an IRB; its membership requirements, operations; types of review available; criteria for approval; informed consent, requirements; additional safeguards required for vulnerable populations; reporting rules; and other fundamental issues. The OHRP website provides a link to the full text of 45 Code of Federal Regulations Part 46 at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htminternational/index.html#NatlPol. What is 21 Code of Federal Regulations Part 50 (21 CFR 50)? The l
