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" A description of any benefits to the subject or to others which may reasonably be expected from the research: (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement... "
The Code of Federal Regulations of the United States of America - Page 251
1997
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1998 - 902 pages
...manner. (Approved by the Office of Management and Budget under control number 9999-0020) §1028.116 General requirements for informed consent. Except...otherwise entitled, and the subject may discontinue parló CFR Ch. It (1-1-98 Edffion) ticlpation at any time without penalty or loss of benefits to which...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1995 - 754 pages
...reasonable manner. (Approved by the Office of Management and Budget under control number 9999-0020) §97.116 General requirements for informed consent. Except...benefits to which the subject is otherwise entitled. 294 and the subject may discontinue participation at any time without penalty or loss of benefits to...
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The Code of Federal Regulations of the United States of America

Administrative law - 2004 - 556 pages
...manner. (Approved by the Office of Management and Budget under control number 9999-0020) § lc.116 General requirements for informed consent. Except...participation is voluntary, refusal to participate wfil involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject...
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The Code of Federal Regulations of the United States of America

Administrative law - 1990 - 460 pages
...maintained and that notes the possibility that the Food and Drug Administration may inspect the records. (6) For research involving more than minimal risk,...event of a research-related injury to the subject. (8) A statement that participation is voluntary, that refusal to participate will involve no penalty...
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The Code of Federal Regulations of the United States of America

Administrative law - 2004 - 1132 pages
...extent, if any, to which confidentiality of records identifying the subject will be maintained; (61 For research involving more than minimal risk, an...event of a research-related injury to the subject; and 407 203-121 0-14 (8) A statement that participation is voluntary, refusal to participate will involve...
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The Code of Federal Regulations of the United States of America

Administrative law - 1995 - 440 pages
...than minimal risk, an explanation as to whether any compensation and an ex§50.25 §50.40 planatlon as to whether any medical treatments are available...event of a research-related injury to the subject. (8) A statement that participation is voluntary, that refusal to participate will involve no penalty...
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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
...if injury occurs and, if so, what they consist of, or where further information may be obtained; (g) an explanation of whom to contact for answers to pertinent...event of a researchrelated injury to the subject; and (h) a statement that participation is voluntary, refusal to participate will involve no penalty or...
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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 - 320 pages
...procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A state-ient describing the extent, if any, to which confidentiality...a researchrelated injury to the subject; and (8) A statenent that participation is voluntary, refusal to participate will involve no penalty or loss of...
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Biomedical-ethical Issues: A Digest of Law and Policy Development

Frank Harron - Law - 1983 - 192 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...event of a research-related injury to the subject; and 132 Informed Consent (8) A statement that participation is voluntary, refusal to participate will involve...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1984 - 466 pages
...occurs and, if so, what they consist of, or where further information may be obtained. 33-056 O— 84-14 (7) An explanation of whom to contact for answers...event of a research-related injury to the subject. (8) A statement that participation is voluntary, that refusal to participate will involve no penalty...
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