Federal regulation of human experimentation, 1975U.S. Government Printing Office, 1975 - 256 pages |
Common terms and phrases
abortus accepted activities involving addition adequate agency applicable appropriate behavioral research biomedical and behavioral BUMED BUMEDINST CICC clinical investigation clinical research concerning conducted consent committee contractor Department of Defense Department of Health DHEW grant document Drug Administration Education established Ethical Review Board evaluation experiment facilities Federal Register fetus Food and Drug funds grant or contract guidelines human experimentation human research individual informed consent institutional review committee investigational drug investigational new drugs involving human subjects ment mittee NASA National Research Act obtained officer Organizational Review Committee paragraph participation patient personnel principal investigator prior prisoners procedures project or activity proposed Protection Committee protection of human protocol purpose RDT&E recommendations regulations research involving responsibility review and approval rights and welfare Secretary Section special assurance sponsor subjects at risk submitted subpart Surgeon Thalidomide tion U.S. Congress vitro fertilization volunteer
Popular passages
Page 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...
Page 63 - ... identification of any procedures which are experimental; (2) A description of any...
Page 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.
Page 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.
Page 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...
Page 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.
Page 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...
Page 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...
Page 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...
Page 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...