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" ... available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 129
1996
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Suspension of Medical Research at West Los Angeles and Sepulveda VA Medical ...

United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations - Law - 2000 - 268 pages
...research subjects' rights, and whom to contact in the event of a research-related injury to the subject. (8) A statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled. A researcher who seeks to recruit an individual for research without conveying all of these elements...
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Suspension of Medical Research at West Los Angeles and Sepulveda VA Medical ...

United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations - Law - 2000 - 268 pages
...subjects' rights, and whom to contact in the event of a research-related injury to the subject. (11) A statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled. (12) A statement that a veteran-subject will not be required to pay for treatment received as a subject...
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Contrasts in American and Jewish Law

Daniel Pollack - Law - 2001 - 294 pages
...of whom to contact for answers to pertinent questions about the research and the research subject's rights, and whom to contact in the event of a researchrelated...benefits to which the subject is otherwise entitled." Id. § 46.116(a). There are additional elements of informed consent that may be appropriate depending...
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Surgical Research

Wiley W. Souba, Douglas W. Wilmore - Health & Fitness - 2001 - 1526 pages
...subjects, and whom to contact in the event of a research-related injury to the subject. 8. Statements that participation is voluntary, refusal to participate...benefits to which the subject is otherwise entitled. The IRB judges the adequacy of the content of the information. Additional information may be required...
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Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

Allen Cato, Lynda Sutton, Allen Cato III - Medical - 2002 - 451 pages
...more than minimal risk, an explanation as to whether any compensation and an explanation as to whether medical treatments are available if injury occurs...benefits to which the subject is otherwise entitled (41). In addition to these basic elements of informed consent, IRBs shall also require that information...
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Clinical Contact Lens Practice

Edward S. Bennett, Barry A. Weissman - Medical - 2005 - 1102 pages
...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 disclosure of appropriate...benefits to which the subject is otherwise entitled These regulations also provide that, when appropriate, one or more of the following elements of information...
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Case Studies in Nursing Ethics

Sara T. Fry, Robert M. Veatch - Bioethics - 2006 - 494 pages
...to the subject; 3. A description of any benefits to the subject or to others which may reasonably be expected from the research; 4. A disclosure of appropriate...benefits to which the subject is otherwise entitled. Additional elements of informed consent that should be included when appropriate: 1. A statement that...
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What the Doctor Didn't Say: The Hidden Truth about Medical Research

Jerry Menikoff, Edward P. Richards - Philosophy - 2006 - 336 pages
...what will be done to the patient. 8. 45 CFR § 46.116(a)(l)-(4). Other items that must be included are (5) a statement describing the extent, if any, to...benefits to which the subject is otherwise entitled. 45 CFR § 46.116(a)(5)-(8). In addition, the following information must be given to the subject "when...
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Handbook of Neuroemergency Clinical Trials

Wayne M. Alves, Brett E. Skolnick - Science - 2006 - 360 pages
...subjects' rights, and whom to contact in the event of a research-related injury to the subject • A statement that participation is voluntary, refusal...benefits, to which the subject is otherwise entitled Additional elements when appropriate: • A statement that the particular treatment or procedure may...
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Federal Protection for Human Research Subjects

Lee O. Jastone - Bioethics - 2006 - 120 pages
...subjects' rights, and whom to contact in the event of a research-related injury to the subject; and • a statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled. When informed consent is sought, the Common Rule also requires other information to be provided if...
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