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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 130
1996
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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
...form" written consent document stating that the elements of informed consent required by § 46.116 have been presented orally to the subject or the subject's...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 Code of Federal Regulations of the United States of America

Administrative law - 2003
...wants documentation linking the subject with the research, and the subject's wishes will govern; or 12) That the research presents no more than minimal risk...research. Approved by the Office of Management and Buditet under control number 9999-0020) • 16.118 Applications and proposals lacking definite plans...
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The Code of Federal Regulations of the United States of America

Administrative law - 1996
...representative. When this method is used, there shall be a witness to the oral presentation. Also, the IBB shall approve a written summary of what is to be said...regarding the research. (Approved by the Office of Manairoment and Budget under control number 9999-0020) §1028.118 Applications and proposal* lacking...
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The Code of Federal Regulations of the United States of America

Administrative law - 1996
...representative. When this method is used, there shall be a witness to the oral presentation. Also, the ШВ shall approve a written summary of what is to be said...which the documentation requirement is waived, the ЮВ may require the investigator to provide subjects with a written statement regarding the research....
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1991
...require"Ģit for the investigator to obtain a signed consent form for some or all Ejects if ft fmds either: (1) That the only record linking the subject...research. (Approved by the Office of Management and Budget under control number 99990020) §11.118 Applications and proposals lacking definite plans for...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1991
...That the only record linking the subject and the research would be the 38 CFR Ch. i (7-1-91 Edition) consent document and the principal risk would be potential...research. (Approved by the Office of Management and Budget under control number 99990020) § 16.118 Applications and proposals lacking definite plans for...
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The Code of Federal Regulations of the United States of America

Administrative law - 1994
...waive the requirenent for the investigator to obtain a igned consent form for some or all lUbjects if it finds either: (1) That the only record linking...which the documentation requirement is waived, the ШВ may require the investigator to provide subjects with a written statement regarding the research....
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