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Guidelines for ethical review of research proposals for human somatic cell gene therapy and related therapies / National Health and Medical Research Council
Bib ID 1719756
Format BookBook, OnlineOnline
Author
National Health and Medical Research Council (Australia)
 
Online Versions
Description Canberra : NHMRC, 1999 
29 p. ; 25 cm. 
ISBN 1864960973
Summary

Somatic cell gene therapy is an innovative form of therapy and is under systematic investigation to determine its safety and efficacy. It is thus considered to be research. This document contains guidelines for ethical review of research proposals for human somatic cell gene therapy and related therapies, and an accompanying background information paper. The guidelines identify the following as matters for Human Research Ethics Committee (HREC) consideration: assessment of risks and benefits for those to be treated; the objectives and rationale of the research; the method to be used for gene modification; how the effects of treatment will be measured; the process for obtaining consent; the proponent's capacity to perform the research; the purity of the material to be administered; information gathered from previous similar research which is relevant to the proposed research; assessment of the likelihood that the administered DNA or RNA will enter germ cells or result in harm to others; and the approvals required before the research can proceed. Section 1 comprises the Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies, and replaces Supplementary Note 7 of the NHMRC Statement on Human Experimentation and Supplementary Notes (1992). Section 2 provides background information about human gene therapy and replaces the NHMRC information paper Human Gene Therapy and Related Procedures (1994). Guidelines on human genetic research, and research in general, are provided by the NHMRC's National Statement on Ethical Conduct in Research Involving Humans (1999), known as the National Statement. Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies should be read in conjunction with the National Statement.llection me

Full contents
  • Chapter 1. Guidelines for ethical review of research proposals for human somatic cell gene therapy and related therapies
  • 1.2. Appendix to the Guidelines: bodies involved in the assessment of gene therapy proposals
  • ch. 2. Human somatic cell gene therapy - an information paper providing background to the guidelines
  • 2.1. Preface
  • 2.2. What are genes?
  • 2.2.1. What do genes do?
  • 2.2.2. The chemical composition of genes and the way they work
  • 2.3. Genetic diseases
  • 2.4. Gene therapy of genetic diseases
  • 2.4.1. Techniques for inserting genes into cells
 
Notes

Cat. no. 9927407.

Includes bibliographic notes (p. 27-29).

http://www.nhmrc.health.gov.au

Subjects Gene therapy -- Research -- Moral and ethical aspects.  |  Gene therapy -- Government policy -- Australia.  |  Gene therapy.  |  Ethics, Medical.
Terms of Use Commonwealth of Australia 1999. 

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