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 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 ...
Page 31
... blood results from an inherited bleeding disorder called hemophilia . ཝཱ 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 . ཝཱ 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 ...
Page 33
... blood plasma . Heart , and other organ What is , however , of transplants are now becoming more routine . 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 What is , however , of transplants are now becoming more routine . greater recent interest has been the use of patient materials for product development in the biotechnology industry , which are ...
Page 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 ...
Page 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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Common terms and phrases
academic activity applied research appropriate approved basic research BELMONT REPORT benefits biotechnology BLAKE blood body cancer cell line Chairman commercial conducted conflicts of interest CONGRESS THE LIBRARY consent form Department of Health discovery disease doctor donation ethical example Federal fetus funding Genentech genetic engineering gift Government human biological materials hybridomas individual industry informed consent Institutes of Health Institutional Review Board investigator involving human subjects issues LEVINE LIBRARY OF CONGRESS licensing MCCARTHY minimal risk monoclonal antibodies MOORE Murray NATIONAL RESEARCH ACT obtained organ organ donation PACKARD participation particular patient Patrick Ewing physician pituitaries potential problem procedures profit programs PROTECTION OF HUMAN question RATHMANN RAUB regulations REIMERS relationship reporting research involving human research subjects scientific scientists Secretary specific statement subcommittee subpart tion tissue TRAFICANT unique university-industry vitro fertilization VOLKMER
Popular passages
Page 171 - ... statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental...
Page 158 - ... 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 170 - 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 - Risks to subjects are reasonable In relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Page 172 - A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable...
Page 171 - No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
Page 186 - 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 169 - IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall...
Page 176 - 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 174 - 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 Registei guidelines to assist in determining whether a fetus is viable for purposes of this subpart.