Recombinant DNA Research, Volume 9U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, 1986 Documents relating to "NIH guidelines for research involving recombinant DNA molecules," Feb. 1975/June 1976- . |
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Page 9
... possible general side effects of gene therapy be monitored ? Is natural history of disease known so that assessment of success of gene therapy is clear and straightforward ? 8 . 9. Can longterm follow - up be assured ? Autopsy , if ...
... possible general side effects of gene therapy be monitored ? Is natural history of disease known so that assessment of success of gene therapy is clear and straightforward ? 8 . 9. Can longterm follow - up be assured ? Autopsy , if ...
Page 20
... possible on the biology of the donor and recipient organisms . Dr. Gottesman agreed saying that in most cases this information will be the only data available on which to predict the probable outcome of a field test of a modified ...
... possible on the biology of the donor and recipient organisms . Dr. Gottesman agreed saying that in most cases this information will be the only data available on which to predict the probable outcome of a field test of a modified ...
Page 24
... possible ; he felt it was unfair not to offer investigators this guidance as soon as possible . Dr. Gottesman asked if this points to consider document for microorganisms would influence the outcome of the lawsuit filed by the ...
... possible ; he felt it was unfair not to offer investigators this guidance as soon as possible . Dr. Gottesman asked if this points to consider document for microorganisms would influence the outcome of the lawsuit filed by the ...
Page 40
... the final population of engineered organisms with emphasis on the desired effect and any other possible pathological , ecological , physiological , or genetic effects . IV . 2 . 3 . DRAFT 4 Provide data [ 40 ] Attachment IV Page 3 -
... the final population of engineered organisms with emphasis on the desired effect and any other possible pathological , ecological , physiological , or genetic effects . IV . 2 . 3 . DRAFT 4 Provide data [ 40 ] Attachment IV Page 3 -
Page 46
... possible situations which should be considered : Agrobacterium , Rhizobium , plant viruses , etc. Dr. Pirone said the language is too limited in that it uses the word pathogenicity ; other characteristics might be important ...
... possible situations which should be considered : Agrobacterium , Rhizobium , plant viruses , etc. Dr. Pirone said the language is too limited in that it uses the word pathogenicity ; other characteristics might be important ...
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Common terms and phrases
agencies amendment animals Appendix applications approval assessment Bethesda biological safety cabinets Biosafety Level biotechnology Brinster cells containing recombinant DNA December 31 decontaminated developed Director disease DNA Advisory Committee Drug Elizabethtown environment environmental evaluation experimentation Federal Register field testing FIFRA Gartland gene transfer genetically engineered genetically engineered microorganisms germ line Gottesman group document Group on Release Health Bethesda human gene therapy Institutes of Health investigator Involving Recombinant DNA issues Jeremy Rifkin laboratory mammalian species McGarrity microbial pesticides microorganisms modified organism National Institutes NIH Guidelines Office of Recombinant ORDA organisms containing recombinant pesticides Ph.D physical containment plant pests plasmids Points to Consider potential preamble procedures protocols Recombinant DNA Activities Recombinant DNA Advisory recombinant DNA molecules recombinant DNA research regulations regulatory request requirements Rifkin's proposal risk scientific Section species integrity suggested techniques TSCA USDA vector virus
Popular passages
Page 98 - ... medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. 7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
Page 97 - A 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 96 - 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 119 - Environmental Assessment": (a) Means a concise public document for which a Federal agency is responsible that serves to: (1) Briefly provide sufficient evidence and analysis for determining whether to prepare an environmental Impact statement or a finding of no significant impact.
Page 237 - Protection of Proprietary Data. In general, the Freedom of Information Act requires Federal agencies to make their records available to the public upon request. However, this requirement does not apply to, among other things, "trade secrets and commercial and financial information obtained from a person and privileged or confidential.
Page 363 - any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses.
Page 117 - The working group also has representatives from the US Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA), and ad hoc consultants.
Page 394 - October 29. 1984 meeting of the Recombinant DNA Advisory Committee of the National Institutes of Health.
Page 230 - Definition of Recombinant DNA Molecules. In the context of these Guidelines, recombinant DNA molecules are defined as either: (i) Molecules which are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) DNA molecules that result from the replication of those described in (i) above.
Page 96 - Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.