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 1
... blood and bone marrow to develop products useful in fighting disease . However , advances in genetic engineering techniques have caused a surge in research and development of biomedical products derived from human biological material ...
... blood and bone marrow to develop products useful in fighting disease . However , advances in genetic engineering techniques have caused a surge in research and development of biomedical products derived from human biological material ...
Side 31
... blood results from an inherited bleeding disorder called hemophilia . At present , Factor VIII is obtained from fractionating large pools of human blood plasma . The important short - coming with this supply is increased risk of ...
... blood results from an inherited bleeding disorder called hemophilia . At present , Factor VIII is obtained from fractionating large pools of human blood plasma . The important short - coming with this supply is increased risk of ...
Side 33
... blood plasma . Heart , and other organ transplants are now becoming more routine . What is , however , of greater recent interest has been the use of patient materials for product development in the biotechnology industry , which are ...
... blood plasma . Heart , and other organ transplants are now becoming more routine . What is , however , of greater recent interest has been the use of patient materials for product development in the biotechnology industry , which are ...
Side 45
... blood specimen which is suspected to contain a biological material of interest . These can be normal specimens or highly selected based on a particular pathology or disease state . A second type of material can be placental material or ...
... blood specimen which is suspected to contain a biological material of interest . These can be normal specimens or highly selected based on a particular pathology or disease state . A second type of material can be placental material or ...
Side 77
... blood and tissue specimens . These are commonly obtained from pa- tients but may also be obtained from nonpatient research subjects or blood donors . Informed consent is required if the material is being obtained solely for research ...
... blood and tissue specimens . These are commonly obtained from pa- tients but may also be obtained from nonpatient research subjects or blood donors . Informed consent is required if the material is being obtained solely for research ...
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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...