 | Edward S. Bennett, Barry A. Weissman - Medical - 2005 - 1102 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...benefits to which the subject is otherwise entitled These regulations also provide that, when appropriate, one or more of the following elements of information... | |
 | Sara T. Fry, Robert M. Veatch - Bioethics - 2006 - 494 pages
...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...benefits to which the subject is otherwise entitled. Additional elements of informed consent that should be included when appropriate: 1. A statement that... | |
 | Daniel Farb, Bruce Gordon - Medical - 2005 - 337 pages
...description of any benefits to the subject or to others which may reasonably be expected from the research; (5) a statement describing the extent, if any, to...information shall also be provided to each subject: (1) a statement that the particular treatment or procedure may involve risks to the subject (or to... | |
 | Dorothea Magnus - Children - 2006 - 356 pages
...involving more than minimal risk, an explanation äs to whether any compensation and an explanation äs to whether any medical treatments are available if...information shall also be provided to each subject: (1) A Statement that the particular treatment or procedure may involve risks to the subject (or to... | |
 | Elizabeth A. Bankert, Robert J. Amdur - Institutional review boards (Medicine) - 2006 - 568 pages
...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...information shall also be provided to each subject: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to... | |
 | 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... | |
 | 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... | |
 | 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... | |
 | Sana Loue, Earl C. Pike - Medical - 2007 - 344 pages
...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...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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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; and (8) A statement that participation is voluntary, refusal... 
