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" ... 1 . a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 268
1999
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Suspension of Medical Research at West Los Angeles and Sepulveda VA Medical ...

United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations - Informed consent (Medical law) - 2000 - 253 pages
...picture. Federal regulations specify l4 elements of informed consent, 8 of which are required: ( l ) A statement that the study involves research, an explanation...confidentiality of records identifying the subject will be maintained. (6) For research involving more than minimal risk, an explanation as to whether any...
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Do Current Federal Regulations Adequately Protect People who Participate in ...

United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources - Electronic government information - 2000 - 144 pages
...that picture. DHHS regulations specify I4 elements of informed consent, 8 of which are required: l) A statement that the study involves research, an explanation...confidentiality of records identifying the subject will be maintained. 6) For research involving more than minimal risk, an explanation as to whether any compensation...
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The Code of Federal Regulations of the United States of America

Administrative law - 2001
...understandable to the subject or the representative. No informed consent, whether oral or written, ma; include any exculpatory language through which the...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any...
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Surgical Research

Wiley W. Souba, Douglas W. Wilmore - Medical - 2001 - 1460 pages
...risks or discomforts to the subject. 3. A description of any benefits to the subject or to others that may reasonably be expected from the research. 4. A...confidentiality of records identifying the subject will be maintained. 6. If the research presents more than minimal risk, potential subjects must also be...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2002
...manner. (Approved by the Office of Management and Budget under control number 9999-0020) 16.116 Genera] requirements for informed consent. Except as provided...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2002
...manner. (Approved by the Office of Management and Budget under control number 9999-0020) 745.116 General requirements for informed consent. Except...procedures or courses of treatment, if any, that might be advs tageous to the subject; (5) A statement describing the extent, if any, to which confidentiality...
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Ownership of Human Tissues and Cells: New Developments in Biotechnology

Office of Technology Assessment United S, United States. Congress. Office of Technology Assessment - Science - 2002 - 180 pages
...institution or its agents from liability for negligence. (a) Basic elements of informed consent. Fjccept as provided in paragraph (c) or (d) of this section,...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any...
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Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

Allen Cato, Lynda Sutton, Allen Cato III - Medical - 2002 - 368 pages
...(3) A description of any benefits to the subject or to others which may reasonably be expected from research; (4) A disclosure of appropriate alternative...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any...
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Clinical Trials in Osteoporosis

Derek Pearson - Medical - 2002 - 258 pages
...may be societal benefit if the study adds to knowledge of the disease or treatment of the disease. 4. A disclosure of appropriate alternative procedures...confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration, other regulatory...
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The Dementias: Diagnosis, Treatment, and Research

Myron F. Weiner, Anne M. Lipton - Medical - 2008 - 596 pages
...risks or discomforts to the subject 3. A description of any benefits to the subject or to others that may reasonably be expected from the research 4. A...confidentiality of records identifying the subject will be maintained 6. For research involving more than minimal risk, an explanation as to whether any compensation...
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