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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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Designer Drugs: Hearing Before the Subcommittee on Crime of the Committee on ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Crime - Designer drugs - 1986 - 199 pages
...research and the expected duration of the subject's participation, a description of the procedures (o be followed, and identification of any procedures...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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The Use of Human Biological Materials in the Development of Biomedical ...

United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight - Biomedical engineering - 1986 - 278 pages
...EXPERIMENTAL; 2- A DESCRIPTION OF ANY REASONABLY FORESEEABLE RISKS OR DISCOMFORTS TO THE SUBJECT; PAGE 6 3- A DESCRIPTION OF ANY BENEFITS TO THE SUBJECT OR...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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Ethics and Regulation of Clinical Research

Robert J. Levine - Language Arts & Disciplines - 1988 - 452 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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1989
...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...
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Methods for Cutaneous Investigation

Robert L. Rietschel - Medical - 1990 - 248 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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1991
...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...
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The Code of Federal Regulations of the United States of America

Administrative law - 1994
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

United States. Department of Justice - Administrative law - 1991
...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)...
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The Code of Federal Regulations of the United States of America

Administrative law - 2004
...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)...
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The Code of Federal Regulations of the United States of America

Administrative law - 1992
...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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