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" 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... "
Protecting Human Subjects: First Biennial Report on the Adequacy and ... - Side 88
av United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research - 1981 - 271 sider
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The Code of Federal Regulations of the United States of America

1991 - 424 sider
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1990 - 460 sider
...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...
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The Code of Federal Regulations of the United States of America

1993 - 592 sider
...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....
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The Code of Federal Regulations of the United States of America

2004 - 822 sider
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 902 sider
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1994 - 738 sider
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 524 sider
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1994 - 708 sider
...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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The Code of Federal Regulations of the United States of America

1995 - 440 sider
...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...
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The Use of Animals in Medical Research and Testing: Hearings Before the ...

United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology - 1982 - 762 sider
...systematic investigation designed to develop or contribute to generalizable knowledge.' " 'Minima1 risk' means that the risks of harm anticipated in...physical or psychological examinations or tests." The Department will fund research covered by the regulations onJy if the institution has filed an assurance...
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