The Use of Human Biological Materials in the Development of Biomedical Products: Hearing Before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, House of Representatives, Ninety-ninth Congress, First Session, October 29, 1985 |
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... VOLKMER , Missouri , Chairman ** Serving on Committee on the Budget for 99th Congress . UNIVERSITY OF MICHIGAN LIBRARIES CONTENTS WITNESSES October 29 , 1985 : Page Niels Reimers. рив KF 27 .53975 1935e ROBERT A. ROE , New Jersey GEORGE ...
... VOLKMER , Missouri , Chairman ** Serving on Committee on the Budget for 99th Congress . UNIVERSITY OF MICHIGAN LIBRARIES CONTENTS WITNESSES October 29 , 1985 : Page Niels Reimers. рив KF 27 .53975 1935e ROBERT A. ROE , New Jersey GEORGE ...
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... Volkmer ( chairman of the subcommittee ) presiding . Mr. VOLKMER . The Subcommittee on Investigations and Over- sight of the Science and Technology Committee will come to order . Today this subcommittee will examine the use of human ...
... Volkmer ( chairman of the subcommittee ) presiding . Mr. VOLKMER . The Subcommittee on Investigations and Over- sight of the Science and Technology Committee will come to order . Today this subcommittee will examine the use of human ...
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... increase ( 1980-1984 ) 211 Mr. VOLKMER . At this time I would recognize the 27 183 1985e CONTENTS RECEIVED YOOO HEARING MAY 21 BEFORE THE PUBLIC HEALTH LIBRARY SUBCOMMITTEE ON нанана и аяма Beef INVESTIGATIONS AND OVERSIGHT OF.
... increase ( 1980-1984 ) 211 Mr. VOLKMER . At this time I would recognize the 27 183 1985e CONTENTS RECEIVED YOOO HEARING MAY 21 BEFORE THE PUBLIC HEALTH LIBRARY SUBCOMMITTEE ON нанана и аяма Beef INVESTIGATIONS AND OVERSIGHT OF.
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... VOLKMER . At this time I would recognize the gentleman from California for an opening statement . Mr. PACKARD . Thank you , Mr. Chairman . The issues surrounding the development of biomedical products from human biological materials is ...
... VOLKMER . At this time I would recognize the gentleman from California for an opening statement . Mr. PACKARD . Thank you , Mr. Chairman . The issues surrounding the development of biomedical products from human biological materials is ...
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... investigations , those institutions engaged in biotechnology research ? Perhaps this Committee , acting for society at large , can let us know what society's message really is . Mr. VOLKMER . Thank you very much , Mr. Reimers 37.
... investigations , those institutions engaged in biotechnology research ? Perhaps this Committee , acting for society at large , can let us know what society's message really is . Mr. VOLKMER . Thank you very much , Mr. Reimers 37.
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academic activity Amgen application or proposal applied research appropriate approved basic research BELMONT REPORT benefits biomedical biotechnology BLAKE blood body cancer cell line Chairman commercial conducted conflicts of interest consent form Department of Health discovery disease doctor ethical example Federal fetus funding Genentech genetic engineering gift Government Health and Human human biological materials hybridomas individual industry informed consent Institutes of Health Institutional Review Board investigator involving human subjects issues Levine licensing minimal risk monoclonal antibodies MOORE Murray NATIONAL RESEARCH ACT obtained organ organ donation PACKARD participation patent Patrick Ewing physician pituitaries potential problem procedures profit programs PROTECTION OF HUMAN question RATHMANN RAUB reasonably regulations REIMERS relationship reporting research subjects scientific scientists secrecy Secretary specific statement subcommittee subpart tion tissue TRAFICANT unique vitro fertilization VOLKMER
Popular passages
Page 160 - ... 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.
Page 172 - Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
Page 170 - Human subject means a living Individual about whom an Investigator (whether professional or student) conducting research obtains (1) Data through intervention or Interaction with the individual, or (2) Identifiable private information.
Page 170 - 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 174 - That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
Page 188 - This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally.
Page 177 - The purpose of the activity is to meet the health needs of the particular fetus and the fetus will be placed at risk only to the minimum extent necessary to meet such needs...
Page 180 - The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either: (1) That the research in fact satisfies the conditions of...
Page 178 - The risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks...
Page 176 - Viable" as it pertains to the fetus means being able, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heart beat and respiration. The Secretary may from time to time, taking into account medical advances, publish in the FEDERAL REGISTER guidelines to assist in determining whether a fetus is viable for purposes of this subpart. If a fetus is viable after delivery, it is a premature infant. (e) "Nonviable...