1. 18. Id., at 241.
2. 24. Yesley, M. , “Oral History of the Belmont Report and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Interview with Michael Yesley, April 19, 2004,” Office of Human Research Protections, at 6–7, available at (last visited June 28, 2011).
3. 16. Id., at 238.
4. 29. Id. According to the National Commission, “Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical or psychological examination, of healthy children” (see supra note 4 [1977], at xx). This definition was not incorporated into the Common Rule, Subpart D, which regulates pediatric research. According to the Common Rule, “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 or during the performance of routine physical or psychological examinations or tests” (45 C.F.R. 46.102.i). For research involving prisoners, the Common Rule stipulates that “Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons” (45 C.F.R. 46.303.d). The indexing to healthy persons in the definition of minimal risk in research regarding prisoners but not children has been the subject of extensive discussion.
5. 25. Toulmin, S. , “Oral History of the Belmont Report and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Interview with Stephen Toulmin,” May 14, 2004, Office of Human Research Protections, at 9, available at (last visited June 28, 2011).