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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... Protocols . Minutes of the RAC Working Group on Release into the Environment meeting , February 11 , 1985 . 289 296 . . . . . . Minutes of the RAC Working Group on Biotechnology Coordination meeting , March 1 , 1985 . • Federal Register ...
... Protocols . Minutes of the RAC Working Group on Release into the Environment meeting , February 11 , 1985 . 289 296 . . . . . . Minutes of the RAC Working Group on Biotechnology Coordination meeting , March 1 , 1985 . • Federal Register ...
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... protocols or guidelines that might be necessary to ensure compliance with the spirit of the above amendment in regard to the protection of the gem line of all species . On August 23 , 1984 , Mr. Rifkin submitted an additional letter to ...
... protocols or guidelines that might be necessary to ensure compliance with the spirit of the above amendment in regard to the protection of the gem line of all species . On August 23 , 1984 , Mr. Rifkin submitted an additional letter to ...
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... the Food and Drug Administration ( FDA ) would review protocols involving human gene therapy . Dr. Miller replied that FDA would not necessarily review every case . Dr. Miller said the FDA staff manual might be useful [ 5 ] 2.
... the Food and Drug Administration ( FDA ) would review protocols involving human gene therapy . Dr. Miller replied that FDA would not necessarily review every case . Dr. Miller said the FDA staff manual might be useful [ 5 ] 2.
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... protocols and patient rights , and a second part dealing with wider social and ethical considera- tions . Issues used to develop the document might include : ( 1 ) checking for a complete and thorough IRB review ; ( 2 ) addressing ...
... protocols and patient rights , and a second part dealing with wider social and ethical considera- tions . Issues used to develop the document might include : ( 1 ) checking for a complete and thorough IRB review ; ( 2 ) addressing ...
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... protocol be presented to parents , if patient is child ? 12 . Consent by child · at what age ? 13 . Which hospital will be used ? Regular hospital bed ? Clinical research center bed ? 14. Who supports costs of gene therapy ? Research ...
... protocol be presented to parents , if patient is child ? 12 . Consent by child · at what age ? 13 . Which hospital will be used ? Regular hospital bed ? Clinical research center bed ? 14. Who supports costs of gene therapy ? Research ...
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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.