EPA began implementing the principles of the Belmont Report in 1977 through EPA Order 1000.17, which was subsequently modified in 1999 and 2011 through EPA Order 1000.17 Change A1.
As the EPA experiments in question commenced after 1999 but before the 2011 changes to EPA Order 1000.17, we will focus on the 1999 version of the Order.
Summarized below are the EPA Order 1000.17 provisions that are most relevant to the subject of this web site.
- “Research” means a “systematic” investigation contributing to “generalizable knowledge.” [Section 3.a]
- “Material non-compliance means failure to comply with the Common Rule and [EPA Order 1000.17] necessary to carry out their essential policies of protecting human subjects of research from anything more than minimal risk.” [Section 3.e]
- “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life…” [Section 3.f]
- “Risk of substantial injury means a significant probability that the research may lead to a substantial impairment of normal activities or long-lasting or irreversible damage to the health of a human being.” [Section 3.g]
- There is a presumption that studies involving risk of substantial injury to a human subject from the conduct of a study and that studies testing for the irreversible health effects in humans will not be approved… unless strongly persuasive additional justification acceptable to the Review Official is submitted.” [Section 4.c]
- “To obtain the approval of the Review Official, submitted documents must include… written approval from each institution’s IRB…” [Section 5.b]
- “The Review Official has the authority to have any study suspended or terminated… (iii) if there is good reason to believe that the rights and welfare of human research subjects are not being adequately protected, or (iv) if there has been unexpected serious harm to one or more human subjects.” [Section 6.a(4)]
- Any EPA employee who has knowledge that EPA supported or conducted research has been associated with unexpected serious harm to one or more human subjects shall immediately notify the Review Official.” [Section 6.e]