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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Page 24
... practice is much more prevalent in Germany than in the U.S. 4.9 · SHARED EQUIPMENT USE Opportunities for collaborative use of expensive research equipment are often underexploited . There are several reasons for this . One is the ...
... practice is much more prevalent in Germany than in the U.S. 4.9 · SHARED EQUIPMENT USE Opportunities for collaborative use of expensive research equipment are often underexploited . There are several reasons for this . One is the ...
Page 40
... practice of most biotechnology companies is to accept the academic system as it stands and to acknowledge the ... practices of the individual investigator . Effective collaboration between an industrial laboratory and an academic ...
... practice of most biotechnology companies is to accept the academic system as it stands and to acknowledge the ... practices of the individual investigator . Effective collaboration between an industrial laboratory and an academic ...
Page 42
... obligations to the company and a variety of financial understandings . It is the general practice of biotechnology companies to develop such relationships only after conversation with the university officials to establish that 42.
... obligations to the company and a variety of financial understandings . It is the general practice of biotechnology companies to develop such relationships only after conversation with the university officials to establish that 42.
Page 46
... practices of universities and government laboratories are consistent with the public's best interest . The availability of gene libraries , human cell lines , and specific human tissue have played a major role in the rate of progress of ...
... practices of universities and government laboratories are consistent with the public's best interest . The availability of gene libraries , human cell lines , and specific human tissue have played a major role in the rate of progress of ...
Page 73
... practice of sharing research results , not only information but also the actual biological materials , has been a major strength of our nation's biomedical enterprise . The NIH recognizes that the vast majority of scientists currently ...
... practice of sharing research results , not only information but also the actual biological materials , has been a major strength of our nation's biomedical enterprise . The NIH recognizes that the vast majority of scientists currently ...
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Common terms and phrases
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...