Guidance and Resources

Ethical Guidelines for Observational Studies

Guidance on undertaking Observational Studies, including when ethics committee review is required.

• Is your study an observational study?
• Does your observational study require ethics committee review?
• Is expedited ethics committee review appropriate for your study?
• Observational Studies: Definitions
• Expedited review application form and processes

Is your study an observational study?

(Guidelines paras. 2.1–2.7)

Observational studies:

• include observational research and also audits and related activities
• are studies where the investigator has no control over study variables and merely observes outcomes
• differ from intervention or experimental studies, in that no intervention other than the recording, classifying, counting and analysing of data takes place.

Does your observational study require ethics committee review?

(Guidelines, paras. 11.1–11.11)

• All observational research requires ethics committee review.
• Public health investigations do not require ethics committee review.
• Audits and related activities do not require ethics committee review, unless they reach a threshold of risk by having one or more of the following features:
  • Departure from normal care.
  • Use of stored samples.
    Exception: A health professional undertaking a recognised quality assurance programme, an external audit of services, or an external evaluation of services.
  • Secondary use of data without consent.
    Exception: The secondary use of data for quality assurance, outcome analysis, or resource review done by people employed or contracted by the service provider holding the information.
  • Extra data collected in a health or disability support setting.
    Exception: The collection of non-sensitive data or an observation in which participants remain anonymous, when undertaken by people employed or contracted by the service provider.
  • Extra data collected outside a health or disability support setting. Exception: An innocuous questionnaire or focus group to discuss new forms of care delivery.

Is expedited ethics committee review appropriate for your study?

(Guidelines, paras. 11.12–11.17)
If your study is an audit or related activity (see definitions below) and requires ethics committee review, complete the Expedited Review of Observational Studies Application Form [4.2] and forward to the appropriate committee administrator

If your study is observational research, expedited review is appropriate if it is:

• a case report or a case series
• a descriptive study
• questionnaire or survey for research purposes that does not involve the collection of sensitive, personal information.

Observational studies undertaken as part of an educational qualification and that require timely ethics committee review may also qualify for expedited review.

If your study requires ethics committee review but does not qualify for expedited review, complete the National Application Form

If you are in doubt

• consult the Guidelines
• consult the relevant ethics committee

Observational Studies: Definitions

Observational research

Primarily observational research is to add to generalisable knowledge about a health or disability issue

• Case control studies examine the relationship between an attribute and a disease, by comparing people with and without the disease with respect to the presence of the attribute or level of exposure to it.
• Cohort studies examine the relationship between exposure to a factor or factors and the probability of the occurrence of a disease, by observing large numbers of people over a long period and comparing incidence rates of the disease in relation to exposure levels (eg, a clinical cohort study where a group of patients with a given disease is followed to examine the prognosis).
• Cross-sectional studies examine the relationship between diseases (or other health-related characteristics) and other variables in a defined population at one particular point by collecting health and other information about members of the population, and include questionnaires or surveys done for research purposes.
• Case reports report cases from health or disability service or research settings
• Case series describe a set of cases of a disease (or similar problem)
• Descriptive studies examine the existing distribution of variables in populations (eg, the analysis of cancer registry data or emergency department data by person, place or time).

Audits and related activities

• Primarily an audit or related activity is to improve the delivery of the particular health or disability support service being studied or to control a threat to public health.
• Audits involve the systematic evaluation of aspects of health or disability support service delivery by considering measurable indicators of performance and/or quality
• Programme evaluation is an audit where a whole programme is evaluated rather than specific interventions
• Evaluation studies determine the relevance, effectiveness and impact of activities in the light of their objectives and may evaluate an activity’s structure, process or outcome
• Quality assurance activities aim to improve health and disability support services by assessing the adequacy of an existing practice against a standard
• Outcome analyses involve assessing health and disability support service quality by reviewing health care information to evaluate outcomes, without comparing outcomes against standards
• Benchmarking improves practice by comparing two or more health and disability support services
• Public health investigations explore possible risks to public health, and are often of an immediate or urgent nature, and are often required by legislation. They include investigations into outbreaks or clusters of disease, analyses of vaccine safety and effectiveness, and contact tracing for communicable diseases
• Public health surveillance monitors health risks by, for example, systematically collecting, analyzing and disseminating information about disease rates
• Pharmacovigilance (post-marketing surveillance) involves monitoring the adverse effects of pharmaceuticals after their introduction into the general population by such methods as the spontaneous reporting of adverse events and the monitoring of all adverse events for a restricted group of medicines (prescription event monitoring)
• Resource utilisation reviews evaluate resource use in a particular health or disability service activity (eg, by reviewing health records to determine health care inputs.)

Expedited review application form and processes

There is an Expedited Review of Observational Studies Application Form, along with guidelines on how to complete it. There is also information about the processing of applications.

Page last updated: 13 December 2007