Regulatory issues for clinical gene therapy trials.

Kenneth Cornetta, Franklin O. Smith

Research output: Contribution to journalArticle

23 Citations (Scopus)

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.

Original languageEnglish
JournalHuman Gene Therapy
Volume13
Issue number10
StatePublished - Jul 1 2002

Fingerprint

Genetic Therapy
Research
Research Personnel
Clinical Trials

ASJC Scopus subject areas

  • Genetics

Cite this

Regulatory issues for clinical gene therapy trials. / Cornetta, Kenneth; Smith, Franklin O.

In: Human Gene Therapy, Vol. 13, No. 10, 01.07.2002.

Research output: Contribution to journalArticle

@article{142893ef5000430aa9eb1631c619df26,
title = "Regulatory issues for clinical gene therapy trials.",
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.",
author = "Kenneth Cornetta and Smith, {Franklin O.}",
year = "2002",
month = "7",
day = "1",
language = "English",
volume = "13",
journal = "Human Gene Therapy",
issn = "1043-0342",
publisher = "Mary Ann Liebert Inc.",
number = "10",

}

TY - JOUR

T1 - Regulatory issues for clinical gene therapy trials.

AU - Cornetta, Kenneth

AU - Smith, Franklin O.

PY - 2002/7/1

Y1 - 2002/7/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0036019187&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036019187&partnerID=8YFLogxK

M3 - Article

VL - 13

JO - Human Gene Therapy

JF - Human Gene Therapy

SN - 1043-0342

IS - 10

ER -