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" 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 experimental... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 203
1984
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The Code of Federal Regulations of the United States of America

Administrative law - 1990 - 460 pages
...obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the...the subject's participation, a description of the proce§50.20 Food and Drug Administration, HHS dures to be followed, and identification of any procedures...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1995 - 886 pages
...section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research, an explanation...identification of any procedures which are experimental; (2) A | foresees subject! (3) A the sub] sonablj (4) A native ment, tageous (5) Al tent, if I recordsl maintaj...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1998 - 688 pages
...section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research, an explanation...identification of any procedures which are experimental; (2) Л description of any reasonably foreseeable risks or discomforts to the subject; (3) A description...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1994 - 708 pages
...section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research, an explanation...Identification of any procedures which are experimental; §11.116 (2) A description of any reasonably 'oreseeable risks or discomforts to the tubject; (3) A...
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The Code of Federal Regulations of the United States of America

Administrative law - 1992 - 464 pages
...(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information...research and the expected duration of the subject's par§1230.116 ticipation, a description of the procedures to be followed, and identification of any...
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The Code of Federal Regulations of the United States of America

Administrative law - 1991 - 712 pages
...section, in seeking informed consent the following information shall be provided to each subject: (DA statement that the study involves research, an explanation...description of the procedures to be followed, and identifica49 CFR Subtitle A (10-1-91 Edition) tion of any procedures which are experimental; (2) A...
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Protecting Human Subjects: First Biennial Report on the Adequacy and ...

United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research - Government publications - 1981 - 286 pages
...elements must be disclosed to subjects for valid informed consent: (a) an explanation of the purpose of the research and the expected duration of the subject's...identification of any procedures which are experimental; (b) a description of any reasonably foreseeable risks or discomforts to the subject; (c) a description...
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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 - 216 pages
...;\ -: 9 seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research, an explanation...subject's participation, a description of the procedures (o be followed, and identification of any procedures which are experimental; (2) A description of any...
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Clinical Trials: Design, Conduct, and Analysis

Curtis L. Meinert, Susan Tonascia - Clinical trials - 1986 - 502 pages
...General elements of an informed consent • A statement that the study involves research, an explanation of the research and the expected duration of the subject's...be followed, and identification of any procedures that are experimental • A description of any reasonably foreseeable risks or discomforts to the subject...
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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 - 304 pages
...FORTH IN THE HHS REGULATIONS REQUIRE THAT THE FOLLOWING INFORMATION BE PROVIDED TO EACH SUBJECT: 1- A STATEMENT THAT THE STUDY INVOLVES RESEARCH/ AN EXPLANATION...PURPOSES OF THE RESEARCH AND THE EXPECTED DURATION OF THE SUBJECTS' PARTICIPATION/ A DESCRIPTION OF THE PROCEDURES TO BE FOLLOWED/ AND IDENTIFICATION OF ANY...
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