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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 270
1999
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The Code of Federal Regulations of the United States of America

Administrative law - 2002
...has obtained the legally effective informed consent of the subject or §46.112 Department of Justice the subject's legally authorized representative. An...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 - 2007
...policy unless the invesi&ator has obtained the legally effec«« informed consent of the subject or '"e subject's legally authorized representative. An investigator...describing the extent, if any, to which confidentiality of recor&s identifying the subject will be maintained; (6) For research involving more than minimal risk,...
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The Code of Federal Regulations of the United States of America

Administrative law - 1991
...liability for negligence. (a) Basic elements of informed consent. Except as provided in paragraph 0-91 10 (c) or (d) of this section, in seeking informed consent...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 Gift of Participation: A Guide to Making Informed Decisions about ...

Kenneth Getz - Clinical trials - 2007 - 360 pages
...51528, Oct. 2, 1996] § Sec. 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information...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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The Code of Federal Regulations of the United States of America

Administrative law - 1992
...section, in seeking informed consent the following information shall be provided to each subject: (DA statement that the study involves research, an explanation...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 - 1996
...subject's participation, a description of the procedures to be followed, and identification of жну procedures which are experimental; (2) A description...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 - 1997
...of any reasonably foreseeable risks or discomforts to the subject; 45 CFR Ch. Vi (10-1-97 Edition) (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...
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