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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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The Code of Federal Regulations of the United States of America

Administrative law - 2004
...documentation linking the subject with the research, and the subject's wishes will govern; or (2 1 That the research presents no more than minimal risk...subjects with a written statement regarding the research. lApproved by the Office of Management and Budget under control number 9999-0020) i 219.1 18 Applications...
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The Code of Federal Regulations of the United States of America

Administrative law - 1998
...breach of confidentiality. Each subject will be asked whether the subject want» documentation Unking the subject with the research, and the subject's wishes...which the documentation requirement is waived, the ГОВ may require the investigator to provide subjects with a written statement regarding the research....
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The Code of Federal Regulations of the United States of America

Administrative law - 2002
...research presents no more than minimal risk of harm to subjects and involves no procedures for §745.118 which written consent is normally required outside...research. (Approved by the Office of Management and Budget under control number 9999-0020) §745.118 Applications and proposals lacking definite plans...
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The Code of Federal Regulations of the United States of America

Administrative law - 2004
...than minimal risk of harm to subjects and involves no procedures for 7 CFR Subtitle A (1-1-04 Edition) which written consent is normally required outside...research. (Approved by the Office of Management and Budget under control number 9999-0020) §1 cl 18 Applications and proposals lacking definite plans...
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Protecting Human Subjects: First Biennial Report on the Adequacy and ...

United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research - Government publications - 1981 - 271 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...normally required outside of the research context. 99 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 - 1983
..."short 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 - 1998
...the research would be the consent document and the principal risk would be potential harm resulting1 from a breach of confidentiality. Each subject will...research. (Approved by the Office of Management and Budget under control number 9999-0020) §46.118 Applications and proposals lacking definite plans for...
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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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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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