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 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, 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.

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

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.

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.