Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent : Hearing Before the Subcommittee on Human Resources of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, First Session, May 8, 1997 |
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Page 6
... by those not associated with the re- search facilities and provide a Federal ombudsman specifically to receive questions or complaints of study participants . I hope that this hearing does not advocate eliminating Federal 6.
... by those not associated with the re- search facilities and provide a Federal ombudsman specifically to receive questions or complaints of study participants . I hope that this hearing does not advocate eliminating Federal 6.
Page 10
... receive oral and / or written testimony , NBAC staff make the req- uisite contractual and logistical arrangements ... receiving intensive effort from all the commissioners . This unforeseen development cause both subcommittees to refor ...
... receive oral and / or written testimony , NBAC staff make the req- uisite contractual and logistical arrangements ... receiving intensive effort from all the commissioners . This unforeseen development cause both subcommittees to refor ...
Page 16
... receive oral and / or written testimony , NBAC staff make the requisite contractual and logistic arrangements . In ... receiving intensive effort from all the Commissioners . This unforeseen development caused both subcommittees to ...
... receive oral and / or written testimony , NBAC staff make the requisite contractual and logistic arrangements . In ... receiving intensive effort from all the Commissioners . This unforeseen development caused both subcommittees to ...
Page 22
... received either higher or standard dosages of EZ vaccine and standard doses of the Moraten vaccine . The protocol ... received high potency measles vaccine compared to girls who received the standard potency vaccine . So October 1991 ...
... received either higher or standard dosages of EZ vaccine and standard doses of the Moraten vaccine . The protocol ... received high potency measles vaccine compared to girls who received the standard potency vaccine . So October 1991 ...
Page 27
... receive , and whether the risks are justified in light of the potential benefits to be gained from the study . They pay careful attention to the selection of subjects , particularly the inclusion of traditionally under - represented ...
... receive , and whether the risks are justified in light of the potential benefits to be gained from the study . They pay careful attention to the selection of subjects , particularly the inclusion of traditionally under - represented ...
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Common terms and phrases
agencies approved Belmont Report benefits bioethics biomedical research CAPLAN Chairman Christopher Shays clinical investigator clinical trials Committee concerns conducted CONGRE CONGRESS THE LIBRARY consent process Department developing countries Director disease drug users evaluate FDA's Federal funding going Harold Varmus hepatitis A vaccine HIV infection HIV vaccine human subject protection Human Use Review individuals informed consent informed consent form Institutional Review Board interventions IRB review KUCINICH LIBRA LIBRARY OF CONGRESS LURIE Malawi measles measles vaccine minimal risk monitoring NAMI National Institute NBAC staff needle exchange program Neuropharmacological Drug Nuremberg Code OPRR oversight participate in research patients PENDERGAST placebo potential problem protection of human Public Citizen question RARY RAUB research participants research protocols responsibility RESS rights and welfare SATCHER severe mental illnesses SHAYS standards Subcommittee Towns treatment Uganda University vaccine trials Varmus vulnerable waiver WILFOND
Popular passages
Page 56 - ... any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; 7. 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.
Page 91 - ... 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 to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled...
Page 179 - IRB finds that: a. the risk represents a minor increase over minimal risk; b. the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or educational situations; c. the intervention or procedure is likely to yield generalizable knowledge about the subjects...
Page 119 - Given these persistent and growing concerns about immunization safety, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) recognized the need for an independent, expert group to address immunization safety in a timely and objective manner.
Page 64 - ... 1 . A statement that the study involves research, an 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 identification of any procedures which are experimental; 2. A description of any reasonably foreseeable risks or discomforts to the subject; 3.
Page 178 - Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Page 64 - A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained...
Page 153 - Chairman, Subcommittee on Human Resources and Intergovernmental Relations Committee on Government Reform and Oversight US House of Representatives Washington, DC 20515-6143 Dear Mr.
Page 88 - 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 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 animal...
Page 20 - PHS agencies, including the National Institutes of Health, the Centers for Disease Control and Prevention, and the...