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" Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm... "
The Code of Federal Regulations of the United States of America - Page 20
1998
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The Use of Human Biological Materials in the Development of Biomedical ...

United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight - 1986 - 288 pages
...mat is not being conducted in accordance with the IRB's requirements or that has been associated wim unexpected serious harm to subjects. Any suspension...investigator, appropriate institutional officials, and the Secretary. ' 1 Reports should be filed with the Office for Protection from Research Risks, National...
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Ethics and Regulation of Clinical Research

Robert J. Levine - 1988 - 484 pages
...suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected...investigator, appropriate institutional officials, and the Secretary.1 § 46.114 Cooperative research. Cooperative research projects are those projects, normally...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1989 - 464 pages
...suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected...investigator, appropriate institutional officials, and the Food and Drug Administration. § 56.114 Cooperative research. In complying with these regulations,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1993 - 1114 pages
...suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected...institutional officials, and the department or agency head. C Approved by the Office of Management and Budget under control number 99990020) 9 60.114 Cooperative...
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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 - 1994 - 396 pages
...suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected...agency head. (Approved by the Office of Management and Budget under control number 99990020) 8 219.114 Cooperative research. Cooperative research projects...
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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 - 1994 - 290 pages
...suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected...institutional officials, and the Department or Agency head. § 46. 11 6 General requirements for informed consent. Except as provided elsewhere in this policy,...
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Validation Compliance Annual: 1995

International Validation Forum - 1995 - 1114 pages
...suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected...investigator, appropriate institutional officials, and the Food and Drug Administration. §56.774 Cooperative research. In complying with these regulations, institutions...
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Beyond Regulations: Ethics in Human Subjects Research

Nancy M. P. King, Gail Henderson, Jane Stein - 1999 - 300 pages
...suspend or terminate approval of research that is not being conducted in accordance with the IRB s requirements or that has been associated with unexpected...agency head. (Approved by the Office of Management and Budget under Control Number 9999-0020.) 114 Cooperative Research Cooperative research projects are...
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Pharmacoethics: A Problem-Based Approach

David A. Gettman, Dean Arneson - 2003 - 452 pages
...suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected...investigator, appropriate institutional officials, and the FDA. Disqualification of an IRB or an institution: The commissioner may disqualify an IRB or the parent...
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Agent GCP and the Bloody Consent Form Guidebook

Daniel Farb, Bruce Gordon - 2005 - 337 pages
...suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected...investigator appropriate institutional officials, and the Food and Drug Administration. B 56.114 Cooperative research. In complying with these regulations, institutions...
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