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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 270
1999
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Principles of EMS Systems

American College of Emergency Physicians - Medical - 2006 - 362 pages
...regulations.42-43 These regulations state, in part, that the information provided to each patient will include: (1) A statement that the study involves research,...confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the...
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Ethical Considerations for Research Involving Prisoners

Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research, Board on Health Sciences Policy, Institute of Medicine - Political Science - 2007 - 20 pages
...and Budget under control number 0990-0260.) §46.116 General requirements for informed consent. ject or the subject's legally authorized representative....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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Case Studies in Ethics and HIV Research

Sana Loue, Earl C. Pike - Medical - 2007 - 344 pages
...to be provided to study participants in the context of the informed consent process. This includes 1 . A statement that the study involves research,...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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Innovation in Medical Technology: Ethical Issues and Challenges

Margaret L. Eaton, Donald Kennedy - Law - 2007 - 155 pages
...the informed consent process. The regulations specify eight required elements of informed consent: 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 compensation...
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Islet Transplantation and Beta Cell Replacement Therapy

A. M. James Shapiro, James A. M. Shaw - Medical - 2007 - 368 pages
...participation, a description of the procedures to be followed, and identification of any procedures that are experimental 2. A description of any reasonably...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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Principles and Practice of Clinical Research

John I. Gallin, Frederick P Ognibene - Medical - 2011 - 448 pages
...risks or discomforts to the subject. 3. A description of any benefits to the subject or to others that may reasonably be expected from the research. 4. A...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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Clinical Trials in Rheumatoid Arthritis and Osteoarthritis

David M. Reid, Colin G. Miller - Medical - 2008 - 328 pages
...may be societal benefit if the study adds to knowledge of the disease or to treatment of the disease. 4. A disclosure of appropriate alternative procedures...confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration, other regulatory...
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Miltary Medical Ethics, Volume 2

...manner. (Approved by the Office of Management and Budget under control number 9999-0020) Sec. 219.116 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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The Code of Federal Regulations of the United States of America

Administrative law - 1994
...the Office of Management and Budget under control number 9999-0020) } 2 19. 118 General requirement« for informed consent. Except as provided elsewhere...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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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1993
...reasonable manner. (Approved by the Office of Management and Budget under control number 9999-0020) §46.116 General requirements for informed consent. Except...of appropriate alternative procedures or courses of treat§46.114 Deportment of Health and Human Services ment, if any, that might be advantageous to the...
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