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 1
... enforce- ment provide a false sense of security that difficult issues are being confronted . The regulatory scheme lacks specific provisions to pro- ( 1 ) tect mentally ill , drug addicted and cognitively impaired persons.
... enforce- ment provide a false sense of security that difficult issues are being confronted . The regulatory scheme lacks specific provisions to pro- ( 1 ) tect mentally ill , drug addicted and cognitively impaired persons.
Page 2
... specific research projects . Given these constraints , can the NBAC function in the role envi- sioned by the permanent Ethics Advisory Board ? The weakness of the current system became more apparent recently when the NIH had to convene ...
... specific research projects . Given these constraints , can the NBAC function in the role envi- sioned by the permanent Ethics Advisory Board ? The weakness of the current system became more apparent recently when the NIH had to convene ...
Page 4
... specific provisions to protect mentally ill , drug addicted and cognitively impaired persons involved in biomedical research . Local Institutional Review Boards ( IRBs ) , considered the cornerstone of the entire bioethics review ...
... specific provisions to protect mentally ill , drug addicted and cognitively impaired persons involved in biomedical research . Local Institutional Review Boards ( IRBs ) , considered the cornerstone of the entire bioethics review ...
Page 9
... specific projects only as illustrations for such principles . ( c ) NBAC shall not be responsible for the review and approval of specific projects . ( d ) In addition to responding to requests for advice and recommendations from the ...
... specific projects only as illustrations for such principles . ( c ) NBAC shall not be responsible for the review and approval of specific projects . ( d ) In addition to responding to requests for advice and recommendations from the ...
Page 11
... specific topics for which they desired additional informa- tion , and they provided guidance to ÑBAC staff regarding leading experts in relevant scientific or professional disciplines who might be sources of or at least links to sources ...
... specific topics for which they desired additional informa- tion , and they provided guidance to ÑBAC staff regarding leading experts in relevant scientific or professional disciplines who might be sources of or at least links to sources ...
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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 consent process Department developing countries Director disease drug users evaluate FDA's Federal FLYNN funding going Harold Varmus hepatitis A vaccine HIV infection HIV vaccine human research subjects human subject protection Human Use Review individuals informed consent informed consent form Institutional Review Board interventions IRB review KUCINICH LURIE Malawi measles measles vaccine minimal risk monitoring NAMI National Institute needle exchange program Neuropharmacological Drug Nuremberg Code OPRR oversight participate in research patients PENDERGAST placebo placebo controlled policies potential problems protection of human Public Citizen public health questions RAUB research participants research protocols responsibility rights and welfare SATCHER severe mental illnesses SHAYS standards Subcommittee Thank Towns treatment Uganda University vaccine trials Varmus vulnerable waiver WILFOND
Popular passages
Page 66 - ... 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, and...
Page 122 - 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 65 - ... 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.
Page 84 - ... obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings.
Page 173 - 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 53 - When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Page 91 - 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 65 - 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 21 - Service - namely, the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Agency for Health Care Policy and Research.
Page 91 - The human subjects are in a lifethreatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebocontrolled investigations, is necessary to determine the safety and effectiveness of particular interventions.