Regulatory issues for clinical gene therapy trials

Kenneth Cornetta, Franklin O. Smith

Research output: Contribution to journalReview articlepeer-review

24 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)1143-1149
Number of pages7
JournalHuman Gene Therapy
Issue number10
StatePublished - Jul 20 2002

ASJC Scopus subject areas

  • Molecular Medicine
  • Molecular Biology
  • Genetics

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