Research Regulations

Federal Regulations and Policies

 

Federal Regulations and Policies – Regulations of  IRB Oversight and Investigator Requirements for research with drugs, biologicals, and devices in the United States (FDA) and overseeing all federally funded (and some non-federally funded) research in the US (OHRP).

 

 

     FDA

            21 CFR §50 – Protection of Human Subjects

            http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50

 

            21 CFR §56 – Institutional Review Boards

            http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=56

 

 

      OHRP (Office for Human Research Protection)

            http://www.hhs.gov/ohrp/