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" ... 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 experimental; (2) A description of any reasonably foreseeable risks or discomforts... "
Gulf War Veterans' Illnesses: The Research Agenda : Hearing Before the ... - Стр. 40
авторы: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - 1998 - Страниц: 206
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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 - 2000 - Страниц: 156
...experimental. 2) A description of any reasonably foreseeable risks or discomforts to the subject. 3) A description of any benefits to the subject or to others...which may reasonably be expected from the research. 4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be...
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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 - 2000 - Страниц: 268
...experimental. (5) A description of any reasonably foreseeable risks or discomforts to the subject (6) A description of any benefits to the subject or to others which may reasonat expected from the research. NOTE: An explanation will be provided as to v/hether compensation...
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Neural Grafting: Repairing the Brain and Spinal Cord, New Developments in ...

Congress of the United States Office of - 2002 - Страниц: 208
...requires "[a] description of any reasonably foreseeable risks or discomforts to the subject [and] a description of any benefits to the subject or to others...which may reasonably be expected from the research" [45 CFR 46. 116], each patient must conduct a risk-benefit analysis of his or her own. This entails...
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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 - 2002 - Страниц: 184
...experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others...which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might...
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Clinical Trials in Osteoporosis

Derek Pearson - 2002 - Страниц: 280
...not being on active treatment, the risks of additional investigations, DXA and multiple X-rays. 3. A description of any benefits to the subject or to others...which may reasonably be expected from the research. Therapeutic research may be of no direct benefit and may not reduce the subject's risk of fracture,...
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Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

Allen Cato, Lynda Sutton, Allen Cato III - 2002 - Страниц: 451
...experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subjects; (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 procedures or courses of treatment, if any, that...
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Environmental Contaminants: Assessment and Control

Daniel A. Vallero - 2004 - Страниц: 842
...experimental 2 a description of any reasonably foreseeable risks or discomforts to the subject 3 a description of any benefits to the subject or to others...which may reasonably be expected from the research 4 a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be...
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Agent GCP and the Bloody Consent Form Guidebook

Daniel Farb, Bruce Gordon - 2005 - Страниц: 337
...this study. The fee will depend on my cooperation with the staff. (FDA (CFR) Part 50.25 (a): (3) A description of any benefits to the subject or to others...which may reasonably be expected from the research.) (FDA (CFR) Part 50.25 (a): (4) A disclosure of appropriate alternative procedures or courses of treatment,...
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Measurement in Nursing and Health Research

Carolyn Feher Waltz - 2005 - Страниц: 462
...experimental; (2) a description of any reasonably foreseeable risks or discomforts to the subject; (3) a description of any benefits to the subject or to others...which may reasonably be expected from the research; (4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might...
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Medizinische Forschung an Kindern: rechtliche, ethische und ...

Dorothea Magnus - 2006 - Страниц: 356
...experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others...which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might...
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