| Description |
29 pages ; 25 cm |
| 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 -- 2.4.2. Weighing the risks and benefits of gene therapy -- 2.4.3. Benefits and limitations of gene therapy -- 2.4.4. Hazards of gene therapy -- 2.4.5. Selection of diseases for gene therapy -- 2.4.6. Experience to date -- 2.4.7. Is there a place for gene therapy of embryos? -- 2.5. Other experimental forms of treatment for genetic diseases -- 2.6. Cancer and gene therapy -- 2.7. Viruses and gene therapy -- 2.8. Genetic enhancement |
| 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 |
| Analysis |
Diseases |
|
Ethics |
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Federal issue |
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Medical ethics |
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Medical genetics |
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Reviews of research |
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Safety |
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Treatment |
| Notes |
Cat. no. 9927407 |
| Bibliography |
Includes bibliographic notes (pages 27-29) |
| Notes |
http://www.nhmrc.health.gov.au |
|
Commonwealth of Australia 1999 |
| Subject |
Medical ethics.
|
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Gene therapy -- Government policy -- Australia.
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Gene therapy -- Research -- Moral and ethical aspects.
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Gene therapy.
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Genetic Therapy -- ethics.
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Advisory Committees.
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Ethics Committees, Research.
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Ethics, Medical.
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Genetic Therapy.
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| SUBJECT |
Australia. https://id.nlm.nih.gov/mesh/D001315 |
| Author |
National Health and Medical Research Council (Australia)
|
| ISBN |
1864960973 |
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