 | Albert I. Wertheimer - Medical - 1996 - 882 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. Informed consent is not a one-time event, but an ongoing process that requires investigators to continually... | |
 | Robert M. Veatch - Medical ethics - 1997 - 482 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... | |
 | Administrative law - 1997 - 756 pages
...courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing trie extent, if any, to which confidentiality of records...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... | |
 | Adil E. Shamoo - Medical - 1996 - 340 pages
...members of the research team to answer questions about subjects' rights and research-related injury. 8. A statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled. Each of these three conditions must be stated explicitly. Again, HHS regulations generally require... | |
 | Baruch A. Brody - Medical - 1998 - 412 pages
...experimental; (2) a description of any reasonably foreseeable risks or discomforts to the subject; (4) a disclosure of appropriate alternative procedures...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... | |
 | DIANE Publishing Company - 1998 - 437 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. OPRR implements these regulations by: (i) negotiating formal, written assurances of compliance with... | |
 | Administrative law - 1999 - 692 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. (t>) Additional elements of informed consent. When appropriate, one or more of the following elements... | |
 | Nancy M. P. King, Gail Henderson, Jane Stein - Medical - 1999 - 300 pages
...injury occurs and, if so, what they consist of, or where further information may be obtained; (7) A1l explanation of whom to contact for answers to pertinent...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... | |
 | Administrative law - 1999 - 530 pages
...may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about tlie research and research subjects' rights, and whom 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... | |
 | Edward P. Richards, Katharine C. Rathbun - Health & Fitness - 1999 - 538 pages
...subjects' rights, and whom to contact in the event of a research-related injury to the subject; and loss of benefits to which the subject is otherwise...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... | |
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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... 
