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... The Use of Human Biological Materials in the Development of Biomedical ... - Page 170by United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight - 1986 - 278 pagesFull view - About this book
| Administrative law - 1991 - 424 pages
...or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n). (1) Minimal risk means that the risks of harm anticipated...routine physical or psychological examinations or tests. (m) Legally authorized representative means an individual or judicial or other body authorized under... | |
| Administrative law - 1990 - 460 pages
...of an investigation conducted by a team of individuals, is the responsible leader of that team. (i) "Minimal risk" means that the risks of harm anticipated...routine physical or psychological examinations or tests. (j) "Sponsor" means a person or other entity that initiates a clinical investigation, but that does... | |
| Administrative law - 1993 - 592 pages
...this rule. (h) "Minimal risk" as defined by US Department of Health and Human Services (see 45 CFR 46) means that the risks of harm anticipated in the proposed...life or during the performance of routine physical or pyschological examinations or tests. § 512.12 Requirements for research projects and researchers.... | |
| Administrative law - 1998 - 902 pages
...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...routine physical or psychological examinations or tests. (j) Certification means the official notification by the Institution to the supporting department or... | |
| Administrative law - 2004 - 822 pages
...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...routine physical or psychological examinations or tests. (j) Certification means the official notification by the institution to the supporting department or... | |
| Administrative law - 1994 - 738 pages
...magnitude of harm or discomfort anticipated in the research are not greater in and of themselves that those ordinarily encountered in daily life or during...routine physical or psychological examinations or tests. (j) Certification means the official notification by the institution to the supporting department or... | |
| Administrative law - 1998 - 524 pages
...research are not greater in and of themselves than those ordinarily encountered in daily §1c.102 §1c.!03 life or during the performance of routine physical or psychological examinations or tests. (j) Certification means the official notification by the institution to the supporting department or... | |
| Administrative law - 1995 - 440 pages
...in the research are not greater in and of themselves than those ordinarily encountered in daily Ufe or during the performance of routine physical or psychological examinations or tests. (j) Sponsor means a person or other entity that initiates a clinical investigation, but that does not... | |
| Administrative law - 1994 - 708 pages
...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 rou§11.103 I tine physical or psychological examinations or tests. (j) Certification means the official... | |
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