 | Robert J. Levine - Language Arts & Disciplines - 1988 - 484 pages
...subparts, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any... | |
 | Administrative law - 1989 - 464 pages
...consent. In seeking informed consent, the following information shall be provided to each subject: (1)A statement that the study involves research, an explanation...confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the... | |
 | Robert L. Rietschel - Medical - 1990 - 258 pages
...followed, and identification of any procedures which are experimental. (2) A description of any reasonable foreseeable risks or discomforts to the subject. (3)...confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the... | |
 | Administrative law - 1991 - 826 pages
...of coercion or undue influence. The information that is given to the subject or the represei tative shall be in language understandable to the subject...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any... | |
 | Administrative law - 1994 - 1088 pages
...for negligence. (a) Bone elements of informed consent. Except as provided in paragraph (c) or id¡ of this section, in seeking informed consent the following...if any, that might be advantageous to the subject; (at Л statement describing the extent, if any, to which confidentiality of records identifying the... | |
 | Administrative law - 1991 - 1310 pages
...section, in seeking informed consent the following information shall be provided to each subject: (DA statement that the study involves research, an explanation...of appropriate alternative procedures or courses of treat§46.114 Pt. 45, Appendix ,he introduction of the 1-year bar of subsecion (b). Subsection (c)... | |
 | Administrative law - 2004 - 1046 pages
...explanation of the purposes of the research and the eipected duration of the subject's partic:pation, a description of the procedures to be followed, and...advantageous to the subject; (5) A statement describing the eJtent, if any, to which confidentiality of records identifying the subject will be maintained; (6)... | |
 | Administrative law - 1992 - 944 pages
...identification of any procedures which are experimental; (2) A description of any reasonably .'oreseeable risks or discomforts to the subject; (3) A description...advantageous to the subject; (5) A statement describing the Ktent, if any, to which confidentiality Jf records identifying the subject will * maintained; (6) For... | |
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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... 
