Recombinant DNA Research, 9. sējumsU.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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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
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98. lappuse - ... 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.
97. lappuse - 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...
96. lappuse - 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.
119. lappuse - 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.
237. lappuse - 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.
363. lappuse - 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.
117. lappuse - 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.
394. lappuse - October 29. 1984 meeting of the Recombinant DNA Advisory Committee of the National Institutes of Health.
230. lappuse - 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.
96. lappuse - 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.