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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 279
2001
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1997 - 658 pages
...reasonable manner. (Approved by the Office of Management and Budget under control number 9999-0020) §46.116 General requirements for informed consent. Except...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1982 - 444 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...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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The Code of Federal Regulations of the United States of America

Administrative law - 2004 - 822 pages
...investigator has obtained the legally effective informed consent of the subject or §46.112 §46.116 the subject's legally authorized representative. An...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1993 - 748 pages
...consent of the subject or the subject's legally authorized repre16 CFR Ch. II (1-1-93 Edition) sentative. An investigator shall seek such consent only under...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1997 - 502 pages
...representative. An investigator shall seek such consent only under circumstances 14 CFR Ch. V (1-1-97 Edition) that provide the prospective subject or the representative...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1993 - 704 pages
...legal rights, or releases or appears to release the investigator, the sponsor, the insti§11.116 tution or its agents from liability for negligence. (a) Basic...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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The Code of Federal Regulations of the United States of America

Administrative law - 2006 - 1068 pages
...release the investigator, the sponsor, the institution or its agents from liability for negligence. la) Basic elements of informed consent. Except as provided...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2000 - 676 pages
...the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Baste elements of informed consent. Except as provided in...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1994 - 1576 pages
...the institution or its agents from liability for negligence. (a) Basic elements of informed conlent. Except as provided in paragraph (c) or (d) of this...research subjects' rights, and whom to contact In the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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The Code of Federal Regulations of the United States of America

Administrative law - 2002 - 680 pages
...Basic elements of informed consent. Except as provided in paragraph 45 CFR Ch. VI (10-1-02 Edition) (c) or (d) of this section, in seeking informed consent...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,...
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