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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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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 - 271 pages
...at reasonable times and in a reasonable manner. 46.116 General requirements for informed consent. subject's legally authorized representative. An investigator...of appropriate alternative procedures or courses of 97 treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent,...
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Oversight of the Drug Development Program of the National Cancer Institute ...

United States. Congress. Senate. Committee on Labor and Human Resources. Subcommittee on Investigations and General Oversight - Cancer - 1982 - 300 pages
...FDA may inspect the medical records. HHS 45 CFR 46.116 (a) (a) Basic elements of informed consent. ...in seeking informed consent the following information...any, that might be advantageous to the subject; (5) A state-ient describing the extent, if any, to which confidentiality of records identifying the subject...
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The Code of Federal Regulations of the United States of America

Administrative law - 1998
...release the investigator, the sponsor, the institution or its agents from liability for negligence. (а) Basic elements of Informed consent. Except as provided...confidentiality of records identifying the subject will be maintained; (б) For research involving more than minimal risk, an explanation as to whether any...
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Biomedical-ethical Issues: A Digest of Law and Policy Development

Frank Harron - Law - 1983 - 166 pages
...liability for negligence. (a) Basic elements of informed consent. Except as provided in paragraph (c) of this section, in seeking informed consent the following...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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Health and the Law: A Primer for Health Professionals

Tom Christoffel - Law - 1985 - 468 pages
...regulations do both. In obtaining informed consent, the prospective subject must be provided with: 1. A statement that the study involves research, an...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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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
...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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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
...and that minimize the possibility of coercion or undue influence. The information that is given lo the subject or the representative shall be in language...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minima] risk, an explanation as to whether any...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1986
...information that is given to the subject or the representative shall be in language under standable to the subject or the representative. No informed...the subject; (5) A statement describing the extent, it any, to which confidentiality of records identifying the subject will be maintained; (6) For research...
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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
...elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in i'V~s 9 seeking informed consent the following information...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
...section, in seeking informed consent the following information shall be provided to each subject: (I)A 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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