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Ethical Guidelines
Ethical Guidelines for Observational Studies
Observational Research, Audits and Related Activities

December 2006

Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities



Citation: National Ethics Advisory Committee. 2006. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Wellington: Ministry of Health. Published in December 2006 by the Ministry of Health PO Box 5013, Wellington, New Zealand ISBN: 0-478-29921-4 (Book) ISBN: 0-478-29922-2 (Internet) HP 4217 This document is available from http://www.newhealth.govt.nz/neac/



Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities

Foreword
Observational studies benefit all of us. For example, they show us whether our services are safe and effective, they tell us whether chemicals in the environment are harmful, they enable us to deal with clusters of disease and outbreaks of infection by determining their source, and they monitor the state of our country’s health in key areas. In short, observational studies give us vital evidence about our health and how best to protect and improve it. They do this by using personal information for public good. To do it well they must meet high ethical standards. Observational studies are relatively low-risk. There are two main reasons for this. In these studies, the investigators observe and analyse information about health or disability but do not alter the care or services that people receive, and secondly, there is generally a reduced potential for conflict between the investigator role and the clinician role. Observational studies differ from intervention studies, in which investigators intentionally alter people’s care or services to study the safety and benefit of doing so. The following Ethical Guidelines for Observational Studies (“Guidelines”) are intended to facilitate high quality studies, protect the


Bibliography: Note: This bibliography is restricted to national and international guidance statements. A full bibliography of works consulted in the preparation of these Guidelines is available on the NEAC website (http://www.newhealth.govt.nz/neac/). American College of Epidemiology. 2000. American College of Epidemiology Ethics Guidelines. Annals of Epidemiology 10(8): 487–97. Code of Health and Disability Services Consumers’ Rights. 1996. Available at: http://www.hdc.org.nz. Council for International Organisations of Medical Sciences. 1991. International Guidelines for Ethical Review of Epidemiological Studies. Geneva: Council for International Organisations of Medical Sciences. Council for International Organisations of Medical Sciences. 2006. Special Ethical Considerations for Epidemiological Research (draft). Geneva: Council for International Organisations of Medical Sciences. EMEA, CPMP. 2002. Position Paper on Terminology in Pharmacogenetics. London: The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Proprietary Medicinal Products (CPMP). Health Research Council of New Zealand. 2002. Guidelines on Ethics in Health Research. Wellington: Health Research Council of New Zealand. International Committee of Medical Journal Editors. 2004. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and editing for Biomedical Publication. Philadelphia: International Committee of Medical Journal Editors. Available at http://www.icmje.org/ Lowrance W. 2002. Learning from Experience: Privacy and the Secondary Use of Data in Health Research. London: The Nuffield Trust. Medical Council of New Zealand. 2002a. Confidentiality and Public Safety. Available at: http://www.mcnz.org.nz. Medical Council of New Zealand. 2002b. Information and Consent. Available at: http://www.mcnz.org.nz. Medical Council of New Zealand. 2004. Good Medical Practice. Wellington: Medical Council of New Zealand. Minister of Health. 2000. The New Zealand Health Strategy. Wellington: Ministry of Health. Minister of Health. 2001. National Ethics Advisory Committee: Terms of Reference. Wellington: Ministry of Health. Minister of Health. 2004. Terms of Reference for Health and Disability Ethics Committees. Wellington: Ministry of Health. Minister of Health and Associate Minister of Health. 2002. He Korowai Oranga: Maori Health ¯ Strategy. Wellington: Ministry of Health. Ministry of Health. 2002. Operational Standard for Ethics Committees. Wellington: Ministry of Health. Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities Ministry of Health. 2004. Protected Quality Assurance Activities under the Health Practitioners Competence Assurance Act 2003. Wellington: Ministry of Health. National Ethics Advisory Committee. 2003a. Ethical Review of Observational Research, Audit and Related Activities. Discussion document. Wellington: National Ethics Advisory Committee. National Ethics Advisory Committee. 2003b. Review of the Current Processes for Ethical Review of Health and Disability Research in New Zealand: Report to the Minister of Health. Wellington: National Ethics Advisory Committee. National Health and Medical Research Council. 1999. National Statement on Ethical Conduct in Research Involving Humans. Canberra: National Health and Medical Research Council. National Health and Medical Research Council. 2002. When Does Quality Assurance in Health Care Require Independent Ethical Review? Consultation draft. Canberra: National Health and Medical Research Council. New Zealand Medical Association. 2002. Code of Ethics. Available at: http://www.nzma.org.nz. Nuffield Council on Bioethics. 2003. Pharmacogenetics: Ethical Issues. A guide to the report. London: Nuffield Council on Bioethics. Royal College of Physicians. 1996. Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects. 3rd edition. London: The Royal College of Physicians of London. Tri-council. 1998. Tri-council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa: Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities 0 Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities
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