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" ... short form. (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 253
2000
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Biomedical-ethical Issues: A Digest of Law and Policy Development

Frank Harron - Law - 1983 - 166 pages
...linking the subject with the research, and the subject's wishes will govern; or 134 Informed Consent (2) That the research presents no more than minimal...required outside of the research context. In cases where the documentation requirement is wavied, the IRB may require the investigator to provide subjects...
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Health and the Law: A Primer for Health Professionals

Tom Christoffel - Law - 1985 - 468 pages
...the oral presentation." An IRB may waive the requirement of a signed consent form for research that "presents no more than minimal risk of harm to subjects...normally required outside of the research context" or if "the only record linking the subject and the research would be the consent document and the principal...
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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 - Biomedical engineering - 1986 - 278 pages
...witness shall sign both the short form and a copy of the "immary, and the person actually oDuiming consent shall sign a copy of the summary. A copy of...required outside of the research context. In cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects...
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Designer Drugs: Hearing Before the Subcommittee on Crime of the Committee on ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Crime - Designer drugs - 1986 - 199 pages
...summary shall be given to the subject or the representative, in addition to a copy of the ' 'short (c)* An IRB may waive the requirement for the investigator...consent is normally required outside of the research In cases where the documentation requirement is waived, the IRB may require the investigator to provide...
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Designer Drugs: Hearing Before the Subcommittee on Crime of the Committee on ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Crime - Designer drugs - 1986 - 199 pages
...be given to the subject or the representative, in addition to a copy of the "short form." (c) An lRB may waive the requirement for the investigator to...normally required outside of the research context. ln cases where the documentation requirement is watved, the lRB may require the investigator to provide...
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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 - Biomedical engineering - 1986 - 278 pages
...the investigator to obtain a signed consent form for some or all subjects if it finds either 1 I ) That the only record linking the subject and the research...required outside of the research context. In. cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects...
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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 - Biomedical engineering - 1986 - 278 pages
...documentation linking the subject with the research, and the subject's wishes will govern; or (2) That me research presents no more than minimal risk of harm...required outside of the research context. In cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects...
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Ethics and Regulation of Clinical Research

Robert J. Levine - Language Arts & Disciplines - 1988 - 452 pages
...subject or the subject's legally authorized representative sign a written consent form if it finds that the research presents no more than minimal risk...which written consent is normally required outside the research context. In cases where the documentation requirement is waived, the IRB may require the...
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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 - 272 pages
...representative. When this method is used, there shall be a witness to the oral presentation. Also, the 1RB shall approve a written summary of what is to be said...which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research....
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Validation Compliance Annual: 1995

International Validation Forum - Science - 1995 - 1200 pages
...subject or the subject's legally authorized representative sign a written consent form if it finds that the research presents no more than minimal risk...which written consent is normally required outside the research context. In cases where the documentation requirement is waived, the IRB may require the...
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