...of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or...routine physical or psychological examinations or tests. Although the National Commission for the Protection of Human Participants in Research (1977) offers...

...risk Beans that "th« probability and Magnitude of har* or di*coaf ort . . . are not greater . . . than those ordinarily encountered in daily life or...the performance of routine physical or psychological t*»ts." To Bale* it more confusing, the FDA statutory language has different standards for drugs and...

...circumstances pertain: g] the research involves no more than minimal risk to the subjects; ("Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are nut greater in and of themselves than those ordinarily encountered in daily life or during the performance...

...minimal. In this case, minimal risk is defined as not greater, considering the probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine medical tests, which are otherwise indicated BENEFITS State potential benefits of participation for...

...subjects; ("Minimal risk" means that the probability and magnitude of harm or disconu . e ordinarily anticipated in the research are not greater in and of themselves than tno encountered in daily life or during the performance of routine physic"1 psychological examinations...

...Controversies in Social Science (New York: Praeger, 1986). 7. Federal regulations define "minimal risk" to mean "that the probability and magnitude of harm or discomfort...the performance of routine physical or psychological examination or tests" (45 Code of Federal Regulations 46.io2[i]). 8. A good discussion of this question...

...act or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n). in daily life or during the performance of routine physical or psychological examinations or tests. (m) Legally authorized representative means an individual or judicial or other body authorized under...

...circumstances pertain: 1. the research involves no more than minimal risk to the subjects ("Minimal risk" means that the probability and magnitude of harm or...routine physical or psychological examinations or tests (45 CFR 2. the waiver, or alteration, of consent will not adversely affect the rights and welfare of...

...other than those already mentioned. According to the definition in the federal regulations: "Minimal mk means that the probability and magnitude of harm or...physical or psychological examinations or tests." Examples of procedures presenting no more than minimal risk are: routine immunizations, modest changes...

...46.405 (c), and at § 46.406 (d). 15. Id. at §46. 116 (d). 16. The regulations define "minimal risk" as "the probability and magnitude of harm or discomfort...physical or psychological examinations or tests." 45 CFR § 46.102 (h)(i). Tom L. Beauchamp et al. "Ethical Guidelines for Epidemiologists," Journal...