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" An explanation of whom to contact for answers to pertinent questions about the research and 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, that... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 254
1996
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Handbook of Neuroemergency Clinical Trials

Wayne M. Alves, Brett E. Skolnick - Science - 2006 - 360 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...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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What the Doctor Didn't Say: The Hidden Truth about Medical Research

Jerry Menikoff, Edward P. Richards - Philosophy - 2006 - 336 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...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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Case Studies in Ethics and HIV Research

Sana Loue, Earl C. Pike - Medical - 2007 - 347 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...benefits to which the subject is otherwise entitled (United States Department of Health and Human Services, 2006). The regulations suggest that the following...
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Islet Transplantation and Beta Cell Replacement Therapy

A. M. James Shapiro, James A. M. Shaw - Medical - 2007 - 368 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...benefits to which the subject is otherwise entitled When appropriate, one or more of the following elements of information shall also be provided to each...
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Innovation in Medical Technology: Ethical Issues and Challenges

Margaret L. Eaton, Donald Kennedy - Law - 2007 - 188 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and the subject may discontinue participation at any time...benefits to which the subject is otherwise entitled. SOURCE: Director, Office for Protection from Research Risks, Testimony on Protection of Human Research...
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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 - 284 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...benefits to which the subject is otherwise entitled. (1) A statement that the particular treatment or procedure may involve risks to the subject (or to...
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Principles and Practice of Clinical Research

John I. Gallin, Frederick P Ognibene - Medical - 2011 - 448 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...benefits to which the subject is otherwise entitled. Additional Elements of Informed Consent 45 CFR 46.116 (b) When appropriate, one or more of the following...
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Clinical Trials in Rheumatoid Arthritis and Osteoarthritis

David M. Reid, Colin G. Miller - Medical - 2008 - 328 pages
...contact for answers to pertinent questions about the research and research subjects' rights, and who to contact in the event of a research-related injury...benefits to which the subject is otherwise entitled. Additional Elements of Informed Consent 9. A statement that the particular treatment or procedure may...
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The Gift of Participation: A Guide to Making Informed Decisions about ...

Kenneth Getz - Bioethics - 2007 - 377 pages
...this or a substantially equivalent investigation by that sponsor. [61 FR 51528, Oct. 2, 1996] § Sec. 50.25 Elements of informed consent. (a) Basic elements...that the subject may discontinue participation at anytime without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional...
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