Ethical Guidelines

Topics: Health care, Epidemiology, Ethics Pages: 42 (11745 words) Published: June 16, 2012
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

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

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 interests of participants, and underpin public assurance of good study conduct. They are published here together with a two-page summary guidance sheet for easy reference. The Guidelines have several internationally significant features. One of these is their wide scope, covering observational research, and audits and other activities that are related to observational research. These other activities are: programme evaluation, evaluation studies, quality assurance activities, outcome analysis, benchmarking, public health investigations, public health surveillance, pharmacovigilance, and resource utilisation review. Second, the Guidelines are directed primarily to investigators, who have ethical responsibility for good study conduct. They are also directed to ethics committees that review studies against established ethical standards, and to other interested communities and individuals. Third, the Guidelines are structured around the process of study conduct, from formulation of the study question through to dissemination of its findings. Fourth, the Guidelines set out the circumstances, mainly related to risk, in which observational studies require ethics committee review. The Guidelines base their requirements for ethical review on the principle that intensity of ethical scrutiny should be proportional to the level of risk of the activity. On this basis, they state that: observational research requires ethics committee review; audits and related activities do not require ethics committee review unless there is a specified requirement for this; and public health investigations do not require ethics committee review. For audits and related activities and for low-risk observational research, ethics committee review should take an expedited form. For operational information about ethics committee review, see: The National Ethics Advisory Committee has generated the Guidelines through a thorough and inclusive process over three...
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