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 15
... matters as scale , rates and means of economical production . The innovative emphasis is on products ; funding is by private risk capital ; and the environment tends to be close for proprietary reasons and tightly managed . Essentially ...
... matters as scale , rates and means of economical production . The innovative emphasis is on products ; funding is by private risk capital ; and the environment tends to be close for proprietary reasons and tightly managed . Essentially ...
Page 47
... matter of fact , I agree with Niels that the strength of the collaboration between industry and academia has been benefi- cial on both sides . They see the benefits of what they're doing reaching out into the potential health care of ...
... matter of fact , I agree with Niels that the strength of the collaboration between industry and academia has been benefi- cial on both sides . They see the benefits of what they're doing reaching out into the potential health care of ...
Page 54
... matter of fact , there is selective communication to some degree on a timing basis . Ultimately , every good academician pub- lishes all the very important information he has ever acquired , but he is somewhat selective on timing , and ...
... matter of fact , there is selective communication to some degree on a timing basis . Ultimately , every good academician pub- lishes all the very important information he has ever acquired , but he is somewhat selective on timing , and ...
Page 64
... matter closely related to the focus of this proceeding , I will complement rather than reiterate those earlier discussions . In general , virtually all of the substantive information provided in my statements on June 8 , 1981 , and June ...
... matter closely related to the focus of this proceeding , I will complement rather than reiterate those earlier discussions . In general , virtually all of the substantive information provided in my statements on June 8 , 1981 , and June ...
Page 67
... matter closely related to the focus of this proceeding , I will complement rather than reiterate those earlier discussions . In general , virtually all of the substantive information provided in my statements of June 8 , 1981 , and June ...
... matter closely related to the focus of this proceeding , I will complement rather than reiterate those earlier discussions . In general , virtually all of the substantive information provided in my statements of June 8 , 1981 , and June ...
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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...