Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies (1999)

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Human somatic cell gene therapy remains experimental. The purpose of the Guidelines is to provide guidance to Human Research Ethics Committees that are asked to review and approve research proposals involving somatic cell gene therapy, and to assist researchers to prepare their submissions for ethical review. The Guidelines identify bodies other than Human Research Ethics Committees from which approval may need to be obtained. An information paper on human somatic cell gene therapy, that provides background information to the Guidelines, is published in conjunction with the Guidelines.

Somatic cell gene therapy involves the introduction of DNA (deoxyribonucleic acid) or RNA (ribonucleic acid) into the somatic (non-reproductive) cells of humans, or the introduction into humans of cells whose genetic material has been modified, in order to provide an alternative form of treatment to improve the health of individuals.

This document was rescinded on 24 April 2008.

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