 | Administrative law - 2001 - 618 pages
...control number 9999-0020) (Authority: 5 USC 301; 20 USC 1221e-3, 3474; and 42 USC 300v-1(b)) 997.116 General requirements for informed consent. Except...research subjects' rights, and whom to contact in 279 194-126 D-01--10 34 CFR Subtitle A (7-1-01 Edition) the event of a research-related injury to the... | |
 | Administrative law - 1996 - 700 pages
...manner. (Approved by the Office of Management and Budget under control number 9999-0020) § 11.116 General requirements for informed consent. Except...of, or where further information may be obtained; §11.115 Office of the Secretary of Transportation (7) An explanation of whom to contact for answers... | |
 | Administrative law - 2001 - 820 pages
...extent, if any, to which confidentiality of records identifying the subject will be maintained; (б) For research involving more than minimal risk, an...and research subjects' rights, and whom to contact ÍE the event of a research-related injury to the subject; and (8) A statement that participation is... | |
 | Administrative law - 1993 - 808 pages
...extent, if any, to which confidentiality of records Identifying the subject will be maintained; (8) For research Involving more than minimal risk, an...whom to contact for answers to pertinent questions ibout the research and research subjects' rights, and whom to contact in the event of a research-related... | |
 | Administrative law - 1995 - 1170 pages
...explanation as to whether any compensation and an explanation as to whether any medical treatment« are available if injury occurs and. if so, what they...questions about the research and research subjects' right«, and whom to contact in the event of a research-related injury to the subject; and (8) A statement... | |
 | Administrative law - 1993 - 816 pages
...describing the extent, if any, to which confidentiality of records identifying the subject will >* maintained; (6) For research Involving more than minimal...if Injury occurs and, if so, what they consist of, « where further information may be obtained; (7) An explanation of whom to contact for answers to... | |
 | Administrative law - 1984 - 466 pages
...maintained and that notes the possibility that the Food and Drug Administration may inspect the records. (6) For research involving more than minimal risk,...of, or where further information may be obtained. 33-056 O— 84-14 (7) An explanation of whom to contact for answers to pertinent questions about the... | |
 | Robert J. Levine - Language Arts & Disciplines - 1988 - 484 pages
...(186). The revised DHHS regulations specify as an element of informed consent (Section 46. 1 16a): For research involving more than minimal risk, an...of, or where further information may be obtained. ..." Although there is broad consensus that no-fault compensation systems should be established for... | |
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A description of any reasonably foreseeable risks or discomforts 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 alternative procedures or... 
