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 4
... 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 to be the national ...
... 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 to be the national ...
Page 21
... results in children under 12 months of age . Because of measles cases and deaths in children less than 12 months of age in this country , CDC undertook a study , in May 1990 , of U.S. infants to determine whether results found in other ...
... results in children under 12 months of age . Because of measles cases and deaths in children less than 12 months of age in this country , CDC undertook a study , in May 1990 , of U.S. infants to determine whether results found in other ...
Page 31
... results in children below 12 months of age . The EZ vaccine was not a new vaccine . It was being produced in several countries , including some European vaccine manufacturers , and approximately 200 million doses of the vaccine had been ...
... results in children below 12 months of age . The EZ vaccine was not a new vaccine . It was being produced in several countries , including some European vaccine manufacturers , and approximately 200 million doses of the vaccine had been ...
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... results found in other countries could be duplicated in this country . Beginning in June 1990 , under the auspices of the Kaiser Foundation Research Institute and the Los Angeles County Health Department , approximately 1500 children ...
... results found in other countries could be duplicated in this country . Beginning in June 1990 , under the auspices of the Kaiser Foundation Research Institute and the Los Angeles County Health Department , approximately 1500 children ...
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... results , and any reasonably foreseeable future risks of participation in the research . In response to the recommendations from the OPRR report , a letter signed by Kaiser Permanente was sent in June 1996 covering the topics required ...
... results , and any reasonably foreseeable future risks of participation in the research . In response to the recommendations from the OPRR report , a letter signed by Kaiser Permanente was sent in June 1996 covering the topics required ...
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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...