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" ... a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject... "
Institutional Review Boards, a System in Jeopardy: Hearing Before the ... - Page 43
by United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - 1999 - 179 pages
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The Code of Federal Regulations of the United States of America

Administrative law - 2002 - 996 pages
...this section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research,...procedures or courses of treatment, if any, that might be advar tageous to the subject; (5) A statement describing the ea tent, if any, to which confidentiality...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1993 - 816 pages
...this section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research,...procedures or courses of treatment, if any. that might be advantaiwna to the subject; (5) A statement describing the extent, if any, to which confidentiality...
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The Code of Federal Regulations of the United States of America

Administrative law - 1998 - 668 pages
...reasonably foreseeable risks or discomforts to the subject; §46.114 Deportment of Health and Human Services (3) A description of any benefits to the subject or...might be advantageous to the subject; (5) A statement describing1 the extent, If any, to which confidentiality of records Identifying the subject will be...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1994 - 708 pages
...reasonably 'oreseeable risks or discomforts to the tubject; (3) A description of any benefits to ;he subject or to others which may reasonably be expected...procedures or courses of treatment, if any, that might be ad van iageous to the subject; (5) A statement describing the extent, if any, to which confidentiality...
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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
...of any benefits to the subject or to others which may reasonably be expected from the research; (d) a disclosure of appropriate alternative procedures...if any, that might be advantageous to the subject; (e) a statement describing the extent, if any, to which confidentiality of records identifying the...
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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
...consent. ...in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research,...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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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1986 - 486 pages
...this section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research,...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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Clinical Trials: Design, Conduct, and Analysis

Curtis L. Meinert, Susan Tonascia - Clinical trials - 1986 - 502 pages
...description of any benefits to the subject or to others that may reasonably be expected from the research • A disclosure of appropriate alternative procedures...if any, that might be advantageous to the subject • A statement concerning the extent, if any, to which confidentiality of records identifying the...
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Broad Agency Announcement

Medicine - 1987 - 78 pages
...which may reasonably be expected from the research (mention remuneration if any). h. Provide a written disclosure of appropriate alternative procedures or...if any, that might be advantageous to the subject (eg, whether treatment is available outside of the protocol/proposal). i. Provide a statement to the...
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Ethics and Regulation of Clinical Research

Robert J. Levine - Language Arts & Disciplines - 1988 - 484 pages
...your physician in planning your treatment; if so. ... 8. Disclosure of Alternatives DHHS requires: "A disclosure of appropriate alternative procedures...if any, that might be advantageous to the subject" (Section 46.116a). The obligation to disclose alternatives arises when a component of the protocol...
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