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 23
... fact , the U.S. Department of Justice has issued guidelines relaxing antitrust strictures thereby enabling and encouraging collaborations involving many competing companies . Financing for such consortia generally is a mix of corporate ...
... fact , the U.S. Department of Justice has issued guidelines relaxing antitrust strictures thereby enabling and encouraging collaborations involving many competing companies . Financing for such consortia generally is a mix of corporate ...
Page 47
... 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 the country ...
... 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 the country ...
Page 50
... fact that every human body has genes in every single cell , and any one of those cells con- tains all the genetic information of the body , and that genetic in- formation is what we need . Sometimes we can take that genetic in ...
... fact that every human body has genes in every single cell , and any one of those cells con- tains all the genetic information of the body , and that genetic in- formation is what we need . Sometimes we can take that genetic in ...
Page 54
... 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 , I think ...
... 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 , I think ...
Page 60
... facts to contemplate for a Nation trying to maintain and / or regain technological leadership . It is true , we are losing scientists to industry . But it isn't all bad . We hope to get more back . But the problem is there is a shortage ...
... facts to contemplate for a Nation trying to maintain and / or regain technological leadership . It is true , we are losing scientists to industry . But it isn't all bad . We hope to get more back . But the problem is there is a shortage ...
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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 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 licensing lymphokines MCCARTHY minimal risk monoclonal antibodies MOORE Murray NATIONAL RESEARCH ACT obtained October 29 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 Thank tion tissue TRAFICANT unique university-industry vitro fertilization VOLKMER
Popular passages
Page 174 - Act, or other public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (Hi) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and (2) The research could not practicably be carried out without the waiver or alteration. (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements...
Page 171 - IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
Page 172 - Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) 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 168 - Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement...
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 169 - Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Page 172 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
Page 174 - That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
Page 169 - Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
Page 181 - Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under § 46.404 or § 46.405. Where research is covered by § § 46.406 and 46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.