OHRP has issued two sets of decision charts: one set is dated February 16, 2016 and titled, “Human Subject Regulations Decision Charts: Pre-2018 Requirements,” and is consistent with the Pre-2018 Requirements. The second set of decision charts is dated June 23, 2020 and titled, “Human Subject Regulations Decision Charts: 2018 Requirements,” and is consistent with the 2018 Requirements.
The term “pre-2018 Requirements” refers to subpart A of 45 CFR part 46 (i.e., the Common Rule) as published in the 2016 edition of the Code of Federal Regulations. The pre-2018 Requirements were originally promulgated in 1991, and subsequently amended in 2005. The term “2018 Requirements” refers to the Common Rule as published in the July 19, 2018 edition of the e-Code of Federal Regulations. The 2018 Requirements were originally published on January 19, 2017 and further amended on January 22, 2018 and June 19, 2018.