Oversight and Review of Clinical Gene Transfer Protocols

Oversight and Review of Clinical Gene Transfer Protocols PDF

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 PDF

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 PDF

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 Research

Recombinant DNA Research PDF

Author:

Publisher:

Published: 1975

Total Pages: 608

ISBN-13:

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Documents relating to "NIH guidelines for research involving recombinant DNA molecules," Feb. 1975/June 1976- .

Recombinant DNA

Recombinant DNA PDF

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.

Recombinant DNA

Recombinant DNA PDF

Author: John Richards

Publisher: Elsevier

Published: 2012-12-02

Total Pages: 383

ISBN-13: 0323153062

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Recombinant DNA: Science, Ethics, and Politics emerged from papers presented at a conference, Ethical and Methodological Dimensions of Scientific Research: Recombinant DNA, A Case Study, held at the University of Georgia, April 15-16, 1977. Starting with an introduction to the methods and uses of recombinant DNA technology, the remaining contributions made by researchers at the symposium are organized into four parts. The first part contains papers on the development and utilization of recombinant DNA technology; genetic engineering in agriculture; and the dangers of unrestricted research. The second part focuses on the ethical aspects of recombinant DNA research. It includes studies such as ethical prerequisites for examining biological research; the limitations of broad moral policies; and ethical theories underlying the recombinant DNA controversy. The third part examines the legal aspects of recombinant DNA research and examines the issue of whether such research should be regulated. The papers in the fourth part consider directors for future research.

The Recombinant University

The Recombinant University PDF

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.