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.

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

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.