Federal regulation of human experimentation, 1975

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U.S. Government Printing Office, 1975 - 256 էջ
 

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Էջ 58 - The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion...
Էջ 63 - ... identification of any procedures which are experimental; (2) A description of any...
Էջ 167 - ... the nature, duration, and purpose of the experiment ; the method and means by which it is to be conducted ; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
Էջ 132 - The investigator certifies that he will inform any patients or any persons used as controls, or their representatives, that drugs are being used for investigational purposes, and will obtain the consent of the subjects, or their representatives, except where this is not feasible or, in the investigator's professional judgment, is contrary to the best interests of the subjects.
Էջ 63 - Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. (d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research...
Էջ 168 - ... 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
Էջ 130 - Notice of claimed investigational exemption for a new drug." (4) The sponsor maintains adequate records showing the investigator to whom shipped, date, quantity, and batch or code mark of each such shipment and delivery, until 2 years after a...
Էջ 129 - Information to the committee) ; that the Investigator will report to the committee for review any emergent problems, serious adverse reactions, or proposed procedural changes which may affect the status of the Investigation and that no such change will be made without committee approval except where necessary to eliminate apparent immediate...
Էջ 100 - Subject at risk" means any individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet his needs...
Էջ 28 - ... (3) a description of any benefits reasonably to be expected; (4) a disclosure of any appropriate alternative procedures that might be advantageous for the...

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