Regulatory issues for clinical gene therapy trials

Kenneth Cornetta; Franklin O Smith

doi:10.1089/104303402320138925

Regulatory issues for clinical gene therapy trials

Hum Gene Ther. 2002 Jul 1;13(10):1143-9. doi: 10.1089/104303402320138925.

Authors

Kenneth Cornetta¹, Franklin O Smith

Affiliation

¹ Departments of Medicine, Microbiology and Immunology, and Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN 46202, USA. kcornett@iupui.edu

PMID: 12133267
DOI: 10.1089/104303402320138925

Abstract

Gene therapy trials are among the most heavily regulated clinical trials. In this review, the basic tenets of human subject research are discussed in the context of the regulatory bodies which oversee this work. The challenges faced by academic research are outlined, including new and proposed regulations which impact human gene therapy investigators.

Publication types

Review

MeSH terms

Clinical Trials as Topic / ethics
Clinical Trials as Topic / legislation & jurisprudence*
Ethics Committees, Research
Genetic Therapy / ethics
Genetic Therapy / legislation & jurisprudence*
Humans
Informed Consent / ethics
Informed Consent / legislation & jurisprudence
National Institutes of Health (U.S.)
United States
United States Food and Drug Administration