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 14
... CHANGES IN THE SEQUENCE OF INNOVATION Stanford President Donald Kennedy , former head of the Food and Drug Administration , observes that there appears to be a fairly standardized historical sequence of innovation following World War II ...
... CHANGES IN THE SEQUENCE OF INNOVATION Stanford President Donald Kennedy , former head of the Food and Drug Administration , observes that there appears to be a fairly standardized historical sequence of innovation following World War II ...
Page 16
... changes were made in the capital gains tax , the investment funds available for such ventures have jumped from an estimated $ 70,000,000 in the mid - 1970s to about $ 1.5 billion in 1982 . The result is an entirely novel mixture of ...
... changes were made in the capital gains tax , the investment funds available for such ventures have jumped from an estimated $ 70,000,000 in the mid - 1970s to about $ 1.5 billion in 1982 . The result is an entirely novel mixture of ...
Page 21
... changes are now occurring in science and engineering which have enormous potential payoffs in industrial use . These include recombinant DNA research and solid state physics as it applies to microelectronics . Other areas that have been ...
... changes are now occurring in science and engineering which have enormous potential payoffs in industrial use . These include recombinant DNA research and solid state physics as it applies to microelectronics . Other areas that have been ...
Page 39
... change may be occurring in the relationship among patients , researchers , universities and private companies . This ... changes and their impact . University / Industry Relations -- Based on the relationships which Amgen has developed ...
... change may be occurring in the relationship among patients , researchers , universities and private companies . This ... changes and their impact . University / Industry Relations -- Based on the relationships which Amgen has developed ...
Page 43
... for clinical investigations at their institutions . The issue of stock ownership by university professors has been the subject of considerable concern . It can be argued that it does not represent a significant change from the past , 43.
... for clinical investigations at their institutions . The issue of stock ownership by university professors has been the subject of considerable concern . It can be argued that it does not represent a significant change from the past , 43.
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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.