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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... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 263
2002
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2000
...subject to regulation, and similar terms are intended to encompass those research activities for which 1 Institutions with HHS-approved assurances on file...the official notification by the institution to the sapporting department or agency, In accordance with the requirements of this policy, that a research...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2000
...observations of public behavior when the investigator(s) do not participate in the activities being observed. (whether professional or student) conducting research...institution to the supporting department or agency, in яс~ cordance with the requirements of this policy, that a research project or activity involving...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1992
...information) in order for obtaining the information to constitute research involving human subjects. (g) 1KB means an institutional review board established in...requirements of this policy, that a research project or i activity involving human subjects has been reviewed and approved by an IRB in accordance with an...
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The Code of Federal Regulations of the United States of America

Administrative law - 1997
...information) in order for obtaining the information to constitute research involving human subjects. (g) 1KB means an institutional review board established in...agency, in accordance with the requirements of this 45 CFR Subtitle A (10-1-97 Edition) policy, that a research project or activity involving human subjects...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2000
...has been reviewed and may be conducted at an institution within the constraints set forth by the 1KB and by other institutional and federal requirements....examinations or tests. (j) Certification means the officiai notification by the Institution to the supporting department or agency, in accordance with...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1997
...event of an investigation conducted by a team of individuals, is the responsible leader of that team. (i) Minimal risk means that the probability and magnitude...physical or psychological examinations or tests. (j) Sponsor means a person or other entity that initiates a clinical investigation, but that does not actually...
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The Code of Federal Regulations of the United States of America

Administrative law - 1993
...act or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n). (i) Minimal risk means that the probability and magnitude...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 ...

Administrative law - 1996
...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 probability and magnitude...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 ...

Administrative law - 1995
...anticipated in the research are not greater in and of themselves than those ordinarily encountered in dally life or during the performance of routine physical...requirements of this policy, that a research project or activ§46.102 Department of Health and Human Services ity involving human subjects has been reviewed...
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The Code of Federal Regulations of the United States of America

Administrative law - 1996
...within the constraints set forth by the IBB and by other institutional and Federal requirements. (1) Minimal risk means that the probability and magnitude...examinations or tests. (j) Certification means the officiai notification by the institution to the supporting: department or agency, in accordance with...
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