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" ... 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 297
1993
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The Code of Federal Regulations of the United States of America

Administrative law - 1998 - 956 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...reasonably foreseeable risks or discomforts to the subject; §745.116 (3) A description of any benefits to the subject or to others which may reasonably be expected...
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The Code of Federal Regulations of the United States of America

Administrative law - 1994 - 1184 pages
...provided to each subject: (1) A statement that the study involves research, an explanation of the §26.116 purposes of the research and the expected duration...foreseeable risks or discomforts to the subject; (3) Л description of any benefits to the subject or to others which may reasonably be expected from the...
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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 - 1999 - 670 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...followed, and identification of any procedures which are experi mental; (2) A description of any reasonably foreseeable risks or discomforts to the subject;...
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The Code of Federal Regulations of the United States of America

Administrative law - 1990 - 460 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...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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The Code of Federal Regulations of the United States of America

Administrative law - 1992 - 464 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...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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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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