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 |
From inside the book
Results 1-5 of 39
Page 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 ...
Page 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 ...
Page 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.
Page 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 ...
Page 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 ...
Other editions - View all
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.