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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 - 1994
...breach of confidentiality. Eacb subject will be asked whether the subject wants documentation Unking the subject with the research, and the subject's wishes...no procedures for which written consent is normally itquired outside of the research context In cases in which the documentation requirement is waived,...
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The Code of Federal Regulations of the United States of America

Administrative law - 1992
...breach of confidentiality. Each subject will be asked whether the subject wants documentation Unking the subject with the research, and the subject's wishes...research. (Approved by the Office of Management and Budget under control number 99990020) 219.118 Applications and proposals lacking definite plane...
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The Code of Federal Regulations of the United States of America

Administrative law - 1992
...subject with the research, and the subject's wishes will govern; or (2) That the research presents nc more than minimal risk of harm to subjects and involves...research. (Approved by the Office of Management and Budget under control number 9999 0020) 690.118 Applications and proposals lacking definite plans...
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Code of Federal Regulations: 1985-1999, Part 1

Administrative law - 1993
...and the subject's wishes will govern; or (2) That the research presents no more than minimal risk pf harm to subjects and involves no procedures for which...research. (Approved by the Office of Management and Budget under control number 99990020) • lc.118 Applications and proposals lacking definite plans...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1993
...research, and the subject's wishes will govern; or (2) That the research presents no more than minima.] risk of harm to subjects and involves no procedures...subjects with a written statement regarding the research. 24 CFR Subtitle A (4-1-93 Edition) (Approved by the Office of Management and Budget under control number...
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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...subjects with a written statement regarding the research. 46.122 Use of federal funds. Federal funds administered by a Department or Agency may not be expended...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1994
...subject's wishes will govern; or (2) That the research presents no re than minimal risk of harm to iects and involves no procedures for which written consent...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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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1996
...subjects; (3) The research could not practici bly be carried out without the waive or alteration; and summary shall be given to the subject or the representative,...research. (Approved by the Office of Management and Budget under control number 9999-0020) 60.118 Applications and proposals lacking definite plans for...
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Human Radiation Experiments: Hearing Before the Committee on Governmental ...

United States, United States. Congress. Senate. Committee on Governmental Affairs - Gene therapy - 1996 - 434 pages
...a breach of confidentiality. Informed consent can also be waived under HHS and FDA regulations when the research presents no more than minimal risk of...normally required outside of the research context GAO/HEHS-M-72 Protecting 6 • Research Subjects research motivates researchers and IKBS to follow...
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Medical Ethics

Robert M. Veatch - Medical - 1997 - 461 pages
...or the subject's legally authorized representative. A copy shall be given to the person signing the form. (c) An IRB may waive the requirement for the...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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