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" The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and (iii) There is no reasonable way to identify prospectively the individuals likely to become eligible for participation... "
Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent ... - Page 91
by United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - 1997 - 228 pages
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2000 - 544 pages
...administered before consent from the subjects' legally authorized representatives is feasible; and (iii) There is no reasonable way to identify prospectively...likely to become eligible for participation in the clinical investigation. (3) Participation in the research holds out the prospect of direct benefit...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2001 - 524 pages
...prospectively the individuals likely to become eligible for participation in the clinical investigation. (3) Participation in the research holds out the prospect of direct benefit to the subjects because: (i) Subjects are facing a life-threatening situation that necessitates intervention; (ii) Appropriate...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1999 - 508 pages
...prospectively the individuals likely to become eligible for participation in the clinical investigation. (3) Participation in the research holds out the prospect of direct benefit to the subjects because: (i) Subjects are facing a life-threatening situation that necessitates intervention; (ii) Appropriate...
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Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent ...

United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - Medical - 1997 - 244 pages
...ensure that they meet the narrow criteria of the rule before the study is allowed to proceed. The IKB and a physician free of conflict-of-interest must...research are reasonable in light of what is known 30 about the condition, the risks and the benefits of current therapy, and what is known about the...
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Clinical Trial Subjects: Adequate FDA Protections? : Hearing Before the ...

United States. Congress. House. Committee on Government Reform and Oversight - Law - 1998 - 238 pages
...representative because the intervention must be administered before they could feasibly be reached, ind there is no reasonable way to identify prospectively...research are reasonable in light of what is known 30 about til* condition, the risks and the benefits of current therapy, and what is known about the...
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The Ethics of Biomedical Research: An International Perspective

Baruch A. Brody - Medical - 1998 - 412 pages
...administered before consent from the subjects' legally authorized representatives is feasible; and (iii) There is no reasonable way to identify prospectively...likely to become eligible for participation in the clinical investigation. (3) Participation in the research holds out the prospect of direct benefit...
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Ethics in Medical Research: A Handbook of Good Practice

Trevor Smith - Medical - 1999 - 428 pages
...in the research must be administered before consent from the patient's next of kin is feasible; (c) there is no reasonable way to identify prospectively...research holds out the prospect of direct benefit to the patients because: (a) patients are facing a life-threatening situation that necessitates intervention;...
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Beyond Regulations: Ethics in Human Subjects Research

Nancy M. P. King, Gail Henderson, Jane Stein - Medical - 1999 - 300 pages
...administered before consent from the subjects' legally authorized representatives is feasible; and iii) There is no reasonable way to identify prospectively...likely to become eligible for participation in the clinical investigation. 3. Participation in the research holds out the prospect of direct benefit to...
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Agent GCP and the Bloody Consent Form Guidebook

Daniel Farb, Bruce Gordon - Medical - 2005 - 337 pages
...representatives is feasible. C. The subjects oversleep on the morning of the consent interview. D. There is no reasonable way to identify prospectively...likely to become eligible for participation in the clinical investigation. Answer: C. Authentication accepted! Suddenly Michele was face-to-face with...
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Institutional Review Board: Management and Function

Elizabeth A. Bankert, Robert J. Amdur - Institutional review boards (Medicine) - 2006 - 568 pages
...administered before consent from the subjects' legally authorized representatives is feasible; and (iii) There is no reasonable way to identify prospectively...likely to become eligible for participation in the clinical investigation. (3) Participation in the research holds out the prospect of direct benefit...
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