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Report of the Review of the Role and Functioning of Institutional Ethics Committees : a report to the Minister for Health and Family Services.

By: Review of the Role and Functioning of Institutional Ethics Committees (Australia)Contributor(s): Chalmers, Donald Roderick Curr | Australia. Dept. of Health and Family ServicesMaterial type: TextTextPublication details: Canberra : Australian Govt. Pub. Service, 1996. Description: xi, 104 p. ; 30 cmISBN: 0644302555; 0644302550Subject(s): | | | Ethics, Research | Ethics committees -- organization and administraton | Human experimentation | AustraliaDDC classification: 174.20994 NLM classification: W 20.5 96RE
Contents:
1. Introduction -- 2. Background to ethics review of research in Austarlia -- 2.1. Ethics review of research in Australia -- 2.2. Medical Research Ethics Committee -- 2.3. National Bioethics Consultative Committee -- 2.4. Australian Health Ethics Committee -- 3. The institutional ethics committee (IEC) system: functions and composition -- 3.1. Functions -- 3.2. Composition -- 3.3. Current IEC details -- 3.4. Diversity in the IEC system -- 4. The role and functions of IECs -- 4.1. The role and functions generally -- 4.2. Research, experimentation and innovative clinical practice -- 4.3. Issues of concern to women -- 4.4. Social science research -- 4.5. Cultural issues -- 4.6. Scientific assessment -- 4.7. Multicentre research -- 4.8. Clinical trial notification scheme -- 4.9. Monitoring of research -- 4.10. Privacy -- 5. Procedures for institutional ethics committees -- 5.1. Proposed procedures -- 5.2. Consent and the protection of research subjects -- 5.3. Expedited review -- 5.4. Manual of procedures -- 5.5. Independent complaints mechanisms -- 6. Composition -- 6.1. Membership -- 6.2. Payment of members -- 7. Education and training of IEC members -- 8. Resources -- 8.1. IEC resources -- Australian Health Ethics Committee resources -- 9. Accountability in the IEC system -- 9.1. Accountability in research generally -- 9.2. Sanctions -- 9.3. The role of the Australian Health Ethics Committee -- 10. National Health and Medical Research Council statement on human experimentation -- Appendix 1. Invitation to provide submissions and list of submissions received -- Appendix 2. NHMRC statement on human experimentation and supplementary notes 1-3 -- Appendix 3. International ethics systems -- Appendix 4. Information privacy principles.nformatio
Subject: This Independent Review of the Role and Functioning of Institutional Ethics Committees (IECs) in Australian was initiated by the Commonwealth Minister for Human Services and Health, the Hon. Dr Carmen Lawrence, in August 1994. The Review Committee was requested by the Minister to: investigate the operation of existing arrangements for IECs, particularly in terms of their appropriateness for the discharge of IECs' responsibilities under the clinical trial notification scheme; consider the suitability of the existing arrangements for monitoring of IECs by the Australian Health Ethics Committee of the National Health and Medical Research Council; make recommendations on any changes which need to be made in the NHMRC guidelines on human experimentation, in the operation of IECs and the level and degree of support required for IECs to operate effectively; have special regard to issues of concern to women particularly in trials relating to reproductive technology; and examine and report on recommendation 10 of the Report of Inquiry into the Use of Pituitary Derived Hormones in Australia and Creutzfeldt-Jakob Disease (the Allars Report). The Review Committee was not requested to investigate the functioning of individual institutional ethics committees.tabil.ithin Defence f
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Chairman of the Review: Professor Donald Chalmers.

"March 1996"

Bibliography: p. 95-104.

1. Introduction -- 2. Background to ethics review of research in Austarlia -- 2.1. Ethics review of research in Australia -- 2.2. Medical Research Ethics Committee -- 2.3. National Bioethics Consultative Committee -- 2.4. Australian Health Ethics Committee -- 3. The institutional ethics committee (IEC) system: functions and composition -- 3.1. Functions -- 3.2. Composition -- 3.3. Current IEC details -- 3.4. Diversity in the IEC system -- 4. The role and functions of IECs -- 4.1. The role and functions generally -- 4.2. Research, experimentation and innovative clinical practice -- 4.3. Issues of concern to women -- 4.4. Social science research -- 4.5. Cultural issues -- 4.6. Scientific assessment -- 4.7. Multicentre research -- 4.8. Clinical trial notification scheme -- 4.9. Monitoring of research -- 4.10. Privacy -- 5. Procedures for institutional ethics committees -- 5.1. Proposed procedures -- 5.2. Consent and the protection of research subjects -- 5.3. Expedited review -- 5.4. Manual of procedures -- 5.5. Independent complaints mechanisms -- 6. Composition -- 6.1. Membership -- 6.2. Payment of members -- 7. Education and training of IEC members -- 8. Resources -- 8.1. IEC resources -- Australian Health Ethics Committee resources -- 9. Accountability in the IEC system -- 9.1. Accountability in research generally -- 9.2. Sanctions -- 9.3. The role of the Australian Health Ethics Committee -- 10. National Health and Medical Research Council statement on human experimentation -- Appendix 1. Invitation to provide submissions and list of submissions received -- Appendix 2. NHMRC statement on human experimentation and supplementary notes 1-3 -- Appendix 3. International ethics systems -- Appendix 4. Information privacy principles.nformatio

This Independent Review of the Role and Functioning of Institutional Ethics Committees (IECs) in Australian was initiated by the Commonwealth Minister for Human Services and Health, the Hon. Dr Carmen Lawrence, in August 1994. The Review Committee was requested by the Minister to: investigate the operation of existing arrangements for IECs, particularly in terms of their appropriateness for the discharge of IECs' responsibilities under the clinical trial notification scheme; consider the suitability of the existing arrangements for monitoring of IECs by the Australian Health Ethics Committee of the National Health and Medical Research Council; make recommendations on any changes which need to be made in the NHMRC guidelines on human experimentation, in the operation of IECs and the level and degree of support required for IECs to operate effectively; have special regard to issues of concern to women particularly in trials relating to reproductive technology; and examine and report on recommendation 10 of the Report of Inquiry into the Use of Pituitary Derived Hormones in Australia and Creutzfeldt-Jakob Disease (the Allars Report). The Review Committee was not requested to investigate the functioning of individual institutional ethics committees.tabil.ithin Defence f

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