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 2
... OPRR- faces both institutional barriers and logistic obstacles in attempting to police thousands of research projects . The third leg of what is supposed to be the national bioethics triad doesn't even exist . Department of Health and ...
... OPRR- faces both institutional barriers and logistic obstacles in attempting to police thousands of research projects . The third leg of what is supposed to be the national bioethics triad doesn't even exist . Department of Health and ...
Page 4
... ( 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 bioethics triad doesn't even exist . Department of Health ...
... ( 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 bioethics triad doesn't even exist . Department of Health ...
Page 12
... OPRR , any NBAC assessments that relate to OPRR's activities , whether favorable or otherwise , might lack credibility in the eyes of some observers . After weighing these concerns , Secretary Shalala , on No- vember 1 , 1996 ...
... OPRR , any NBAC assessments that relate to OPRR's activities , whether favorable or otherwise , might lack credibility in the eyes of some observers . After weighing these concerns , Secretary Shalala , on No- vember 1 , 1996 ...
Page 19
... ( OPRR ) . The Director , OPRR , established the NBAC office , recruited the initial complement of staff , and participated with them and Chairman Shapiro in planning and implementation of the initial NBAC activities . During the fall of ...
... ( OPRR ) . The Director , OPRR , established the NBAC office , recruited the initial complement of staff , and participated with them and Chairman Shapiro in planning and implementation of the initial NBAC activities . During the fall of ...
Page 22
... [ OPRR ] concluded in 1995 that the EZ measles vaccine study was scientifically and ethically justified , however , the consent form was deficient . In response to the recommendations from OPRR , a letter signed by Kaiser Permanente was ...
... [ OPRR ] concluded in 1995 that the EZ measles vaccine study was scientifically and ethically justified , however , the consent form was deficient . In response to the recommendations from OPRR , a letter signed by Kaiser Permanente was ...
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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...