Oversight and Review of Clinical Gene Transfer Protocols

Oversight and Review of Clinical Gene Transfer Protocols

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2014-03-27

Total Pages: 78

ISBN-13: 030929665X

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Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.


Recombinant DNA: Genes and Genomes

Recombinant DNA: Genes and Genomes

Author: James D. Watson

Publisher: Macmillan

Published: 2007

Total Pages: 500

ISBN-13: 9780716728665

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Recombinant DNA, Third Edition, is an essential text for undergraduate, graduate, and professional courses in Genomics, Cell and Molecular Biology, Recombinant DNA, Genetic Engineering, Human Genetics, Biotechnology, and Bioinformatics. The Third Edition of this landmark text offers an authoritative, accessible, and engaging introduction to modern, genome-centered biology from its foremost practitioners. The new edition explores core concepts in molecular biology in a contemporary inquiry-based context, building its coverage around the most relevant and exciting examples of current research and landmark experiments that redefined our understanding of DNA. As a result, students learn how working scientists make real high-impact discoveries. The first chapters provide an introduction to the fundamental concepts of genetics and genomics, an inside look at the Human Genome Project, bioinformatic and experimental techniques for large-scale genomic studies, and a survey of epigenetics and RNA interference. The final chapters cover the quest to identify disease-causing genes, the genetic basis of cancer, and DNA fingerprinting and forensics. In these chapters the authors provide examples of practical applications in human medicine, and discuss the future of human genetics and genomics projects.


Recombinant DNA Methodology

Recombinant DNA Methodology

Author:

Publisher: Academic Press

Published: 2014-05-19

Total Pages: 793

ISBN-13: 1483295974

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Recombinant DNA methods are powerful, revolutionary techniques that allow the isolation of single genes in large amounts from a pool of thousands or millions of genes and the modification of these isolated genes or their regulatory regions for reintroduction into cells for expression at the RNA or protein levels. These attributes lead to the solution of complex biological problems and the production of new and better products in the areas of medicine, agriculture, and industry. Recombinant DNA Methodology, a volume in the Selected Methods in Enzymology series produced in benchtop format, contains a selection of key articles from Volumes 68, 100, 101, 153, 154, and 155 of Methods in Enzymology. The essential and widely used procedures provided at an affordable price will be an invaluable aid to the graduate student and the researcher. - Enzymes in DNA research - DNA isolation, hybridization, and cloning - DNA sequence analysis - cDNA cloning - Gene products - Identification of cloned genes and mapping of genes - Monitoring cloned gene expression - Cloning and transferring of genes into yeast cells - Cloning and transferring of genes into plant cells - Cloning and transferring of genes into animal cells - Site-directed mutagenesis - Protein engineering - Expression vectors


Recombinant DNA

Recombinant DNA

Author: James D. Watson

Publisher: Macmillan

Published: 1992-02-15

Total Pages: 644

ISBN-13: 9780716722823

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An overview of recombitant DNA techniques and surveys advances in recombinant molecular genetics, experimental methods and their results.


The Recombinant University

The Recombinant University

Author: Doogab Yi

Publisher: University of Chicago Press

Published: 2015-03-23

Total Pages: 331

ISBN-13: 022614383X

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This title examines the history of biotechnology when it was new, especially when synonymous with recombinant DNA technology. It focuses on the academic community in the San Francisco Bay Area where recombinant DNA technology was developed and adopted as the first major commercial technology for genetic engineering at Stanford in the 1970s. The book argues that biotechnology was initially a hybrid creation of academic and commercial institutions held together by the assumption of a positive relationship between private ownership and the public interest.


Enzymology Primer for Recombinant DNA Technology

Enzymology Primer for Recombinant DNA Technology

Author: Hyone-Myong Eun

Publisher: Elsevier

Published: 1996-06-03

Total Pages: 727

ISBN-13: 008053113X

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Enzymes are indispensable tools in recombinant DNA technology and genetic engineering. This book not only provides information for enzymologists, but does so in a manner that will also aid nonenymologists in making proper use of these biocatalysts in their research. The Enzymology Primer for Recombinant DNA Technology includes information not usually found in the brief descriptions given in most books on recombinant DNA methodology and gene cloning. - Provides essential basics as well as up-to-date information on enzymes most commonly used in recombinant DNA technology - Presents information in an easily accessible format to serve as a quick reference source - Leads to a better understanding of the role of biocatalysts in recombinant DNA techniques


Sources of Medical Technology

Sources of Medical Technology

Author: Committee on Technological Innovation in Medicine

Publisher: National Academies Press

Published: 1995-01-15

Total Pages: 255

ISBN-13: 0309587611

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Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.


DNA Technology in Forensic Science

DNA Technology in Forensic Science

Author: National Research Council

Publisher: National Academies Press

Published: 1992-02-01

Total Pages: 199

ISBN-13: 0309045878

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Matching DNA samples from crime scenes and suspects is rapidly becoming a key source of evidence for use in our justice system. DNA Technology in Forensic Science offers recommendations for resolving crucial questions that are emerging as DNA typing becomes more widespread. The volume addresses key issues: Quality and reliability in DNA typing, including the introduction of new technologies, problems of standardization, and approaches to certification. DNA typing in the courtroom, including issues of population genetics, levels of understanding among judges and juries, and admissibility. Societal issues, such as privacy of DNA data, storage of samples and data, and the rights of defendants to quality testing technology. Combining this original volume with the new update-The Evaluation of Forensic DNA Evidence-provides the complete, up-to-date picture of this highly important and visible topic. This volume offers important guidance to anyone working with this emerging law enforcement tool: policymakers, specialists in criminal law, forensic scientists, geneticists, researchers, faculty, and students.


Recombinant Gene Expression

Recombinant Gene Expression

Author: Paulina Balbas

Publisher: Springer Science & Business Media

Published: 2008-02-04

Total Pages: 505

ISBN-13: 1592597742

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Since newly created beings are often perceived as either wholly good or bad, the genetic alteration of living cells impacts directly on a symbolic meaning deeply imbedded in every culture. During the earlier years of gene expression research, te- nological applications were confined mainly to academic and industrial laboratories, and were perceived as highly beneficial since molecules that were previously unable to be separated or synthesized became accessible as therapeutic agents. Such were the success stories of hormones, antibodies, and vaccines produced in the bacterium Escherichia coli. Originally this bacterium gained fame among humans for being an unwanted host in the intestine, or worse yet, for being occasionally dangerous and pathogenic. H- ever, it was easily identified in contaminated waters during the 19th century, thus becoming a clear indicator of water pollution by human feces. Tamed, cultivated, and easily maintained in laboratories, its fast growth rate and metabolic capacity to adjust to changing environments fascinated the minds of scientists who studied and modeled such complex phenomena as growth, evolution, genetic exchange, infection, survival, adaptation, and further on—gene expression. Although at the lower end of the complexity scale, this microbe became a very successful model system and a key player in the fantastic revolution kindled by the birth of recombinant DNA technology.