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" IRB review; and (iii) for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 325
2001
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Ethics and Regulation of Clinical Research

Robert J. Levine - Language Arts & Disciplines - 1988 - 484 pages
...(3) for insuring prompt reporting to the IRB of changes in a research activity, (4) for insuring that changes in approved research, during the period for...be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects; and (5) for insuring...
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The Code of Federal Regulations of the United States of America

Administrative law - 2004 - 1046 pages
...certified to the department or agency head that the research has been reviewed and approved by an 1KB provided for in the assurance, and will be subject...been given, may not be initiated without IRB review ami approval except when necessary to eliminate apparent immediate hazards to the subject. (5) Written...
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The Code of Federal Regulations of the United States of America

Administrative law - 1999 - 900 pages
...often than annually and which projects need verification from sources other than the investipators that no material changes have occurred since previous...Written procedures for ensuring prompt reporting to the IRB. appropriate institutional officials, and the department or agency head of (i) any unanticipated...
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The Code of Federal Regulations of the United States of America

Administrative law - 1995 - 736 pages
...projects need verification from sources other than the investigators that no material changes ha« occurred since previous IRB review: and (iii) For...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated...
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The Code of Federal Regulations of the United States of America

Administrative law - 2007 - 1094 pages
...than the Investigators that no material changes have occurred since previous IRB review; and (ill) for ensuring prompt reporting to the IRB of proposed...has already been given, may not be initiated without ERB review and approval except when necessary to eliminate apparent immediate hazards to the subject....
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Children As Research Subjects : Science, Ethics, and Law: Science, Ethics ...

Program in Medical Ethics Michael A. Grodin Director, Leonard H. Glantz Associate Director and Professor of Health Law both at the Boston University Schools of Medicine and Public Health - Medical - 1994 - 290 pages
...be reported to the Office for Protection from Research Risks, National Institutes of Health, DHHS. (4) Written procedures which the IRB will follow:...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head of: (i) any unanticipated...
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Radiation Experiments Conducted by the University of Cincinnati Medical ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Administrative Law and Governmental Relations - Education - 1994 - 408 pages
...sources other than the investigators that no material changes have occurred since previ§219.103 ous IRB review, and (iii) for ensuring prompt reporting...Written procedures for ensuring prompt reporting to the IRB, appropriate Institutional officials, and the department or agency head of (I) any unanticipated...
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Radiation Experiments Conducted by the University of Cincinnati Medical ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Administrative Law and Governmental Relations - Education - 1994 - 396 pages
...investigators that no material changes have occurred since previ§219.103 ous IRB review; and (ill) for ensuring prompt reporting to the IRB of proposed...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1994 - 508 pages
...than the Investigators that no material changes have occurred since previous IRB review; and (ill) for ensuring prompt reporting to the IRB of proposed...hazards to the subject. (5) Written procedures for enearin? prompt reporting to the ERB, appropriate institutional officials, and the department or agency...
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Validation Compliance Annual: 1995

International Validation Forum - Science - 1995 - 1114 pages
...for ensuring prompt reporting to the IRB of changes in research activity; and (4) for ensuring that changes in approved research, during the period for...be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects. (b) Follow written procedures...
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