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
... of review and 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.
... of review and 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
... regulations . As a re- sult , the NIH Office of Protection for Research Risks - the OPRR- faces both institutional barriers and logistic obstacles in attempting to police thousands of research projects . The third leg of what is ...
... regulations . As a re- sult , the NIH Office of Protection for Research Risks - the OPRR- faces both institutional barriers and logistic obstacles in attempting to police thousands of research projects . The third leg of what is ...
Page 4
... regulations . As a result , the NIH Office for Protection from Research Risks ( OPRR ) faces both institutional barriers and logistical obstacles in attempting to police thousands of research projects . The third leg of what is supposed ...
... regulations . As a result , the NIH Office for Protection from Research Risks ( OPRR ) faces both institutional barriers and logistical obstacles in attempting to police thousands of research projects . The third leg of what is supposed ...
Page 7
... regulatory restrictions on the receipt of Government funding for research that few institutions are able to meet . I ... regulations to improve our system for the benefit of all future pa- tients and study participants . That's what I ...
... regulatory restrictions on the receipt of Government funding for research that few institutions are able to meet . I ... regulations to improve our system for the benefit of all future pa- tients and study participants . That's what I ...
Page 9
... regulations as they relate to bioethi- cal issues arising from research on human biology and behavior ; and ( 2 ) applications , including the clinical applications of that research . ( b ) NBAC shall identify broad principles to govern ...
... regulations as they relate to bioethi- cal issues arising from research on human biology and behavior ; and ( 2 ) applications , including the clinical applications of that research . ( b ) NBAC shall identify broad principles to govern ...
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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.