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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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Code of Federal Regulations: Containing a Codification ..., Issue 21, Parts 1-99

Administrative law - 1993
...52817, Dec. 21, 1990] 50.25 Elements of informed consent. (a) Basic elements of informed consent In seeking informed consent, the following information...of appropriate alternative procedures or courses of treat21 CFR Ch. I (4-1-93 Edition) ment, if any, that might be advantageous to the subject. (5) A statement...
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Children As Research Subjects : Science, Ethics, and Law: Science, Ethics ...

Program in Medical Ethics Michael A. Grodin Director, Leonard H. Glantz Associate Director and Professor of Health Law both at the Boston University Schools of Medicine and Public Health - Medical - 1994 - 272 pages
...the investigator, appropriate institutional officials, and the Department or Agency head. 46. 11 6 General requirements for informed consent. Except...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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Human Radiation Experimentation, Ethics, and Gene Therapy: Hearing ..., Volume 4

United States, United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Energy - Gene therapy - 1994 - 145 pages
...the federal regulations: lal SAS/C elements of informed consent. Except as provided in paragraph (c) of this section, in seeking informed consent the following...describing the extent, if any, to which confidentiality of ecords identifying the subject will be maintained; (6) For research involving more than minimal risk,...
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Radiation Experiments Conducted by the University of Cincinnati Medical ...

United States, United States. Congress. House. Committee on the Judiciary. Subcommittee on Administrative Law and Governmental Relations - Government publications - 1994 - 389 pages
...section, in seeking informed consent the following information shall be provided to each subject: (DA 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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Human Radiation Experimentation, Ethics, and Gene Therapy: Hearing ..., Volume 4

United States, United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Energy - Gene therapy - 1994 - 145 pages
...research and the expected duration of the subject's participation, a description of the prccedures to be followed, and identification of any procedures...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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Problems in Securing Informed Consent of Subjects in Experimental ..., Volume 4

United States, United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology - Clinical trials - 1994 - 270 pages
...experimental. 2) A description of any reasonably foreseeable risks or discomforts to the subjects. 3) A description of any benefits to the subject or...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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Problems in Securing Informed Consent of Subjects in Experimental ..., Volume 4

United States, United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology - Clinical trials - 1994 - 270 pages
...any reasonably foreseeable risks or discomforts to the subjects. 3) A description of any benefits lo the subject or to others which may reasonably be expected...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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Vaccines and World Health: Science, Policy, and Practice

Paul Frederick Basch, Emeritus Professor Department of Health Research and Policy Paul F Basch - Medical - 1994 - 274 pages
...identification of any procedures which are experimental 2. A description of any reasonably forseeable risks or discomforts to the subject 3. A description...might be advantageous to the subject 5. A statement concerning the extent, if any, to which confidentiality of records identifying the subject will be...
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Problems in Securing Informed Consent of Subjects in Experimental ..., Volume 4

United States, United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology - Clinical trials - 1994 - 270 pages
...reasonably foreseeable risks or discomforts to the subjects. 3) A description of any benefits lo Ihe subject or to others which may reasonably be expected...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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Problems in Securing Informed Consent of Subjects in Experimental ..., Volume 4

United States, United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology - Clinical trials - 1994 - 270 pages
...of any benefits to the subject or lu others which may reasonably be expected from the research. 4l A disclosure of appropriate alternative procedures...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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