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, 1985U.S. Government Printing Office, 1986 - 278 sider |
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Side 38
... probably in the position to fur- ther this science at a pace that would effectively contribute to worldwide health . So I would be cautious about making major shifts in what's hap- pening , because it's working very effectively , and we ...
... probably in the position to fur- ther this science at a pace that would effectively contribute to worldwide health . So I would be cautious about making major shifts in what's hap- pening , because it's working very effectively , and we ...
Side 43
... probably been more successful in getting open communication among a group of such advisors than has generally been the case in the past . Another area that has been better developed by new biotechnology companies has been the ...
... probably been more successful in getting open communication among a group of such advisors than has generally been the case in the past . Another area that has been better developed by new biotechnology companies has been the ...
Side 48
... to remove some of the public opin- ion and therefore have some effect upon the public reception and public support of the high quality of medical research that's being done ? Mr. REIMERS . Sure , it probably could , and 48.
... to remove some of the public opin- ion and therefore have some effect upon the public reception and public support of the high quality of medical research that's being done ? Mr. REIMERS . Sure , it probably could , and 48.
Side 49
... probably could , and that would be a trage- dy , I think , for the Nation , for the academic institutions and for the competitiveness of our industry . Mr. PACKARD . Could it have an effect upon further support from Federal sources ...
... probably could , and that would be a trage- dy , I think , for the Nation , for the academic institutions and for the competitiveness of our industry . Mr. PACKARD . Could it have an effect upon further support from Federal sources ...
Side 50
... probably submit some of them to you by writing . Now , about how widespread is the use of the human biological materials in the development of biomedical products ? Dr. RATHMANN . We have no patents on what I would call " human ...
... probably submit some of them to you by writing . Now , about how widespread is the use of the human biological materials in the development of biomedical products ? Dr. RATHMANN . We have no patents on what I would call " human ...
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Vanlige uttrykk og setninger
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
Populære avsnitt
Side 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.
Side 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.
Side 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.
Side 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.
Side 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.
Side 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.
Side 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...
Side 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...
Side 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...
Side 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...