Exemption from formal review

Research that may be exempt from formal ethics review

Most research activities involving human participants will require a human research ethics review and approval prior to their commencement.

However, an institution may choose to exempt from formal ethics review any research that satisfies both of the following criteria:

• Involves only ‘negligible risk’, (i.e. there is no foreseeable risk of harm or discomfort to participants and any foreseeable risk involves no more than inconvenience to participants); and,
• Involves the use of existing collections of data or records that contain only non-identifiable data about people, e.g. publicly accessible records, archives or publications.

Please note: The definition of ‘negligible risk’ is documented in the National Statement on Ethical Conduct in Human Research, Chapter 2.1, Paragraph 2.1.7, i.e. ‘negligible risk’ means there is no foreseeable risk of ‘harm’ or ‘discomfort’ to participants, and any foreseeable risk involves no more than ‘inconvenience’ to participants. The definition of ‘existing data or records’ that are ‘publicly available’ is self evident. If you will be collecting data, then the data are not ‘existing data’.

Application procedure for a research project

Seeking ethics exemption for a ‘research’ project on the grounds that the activity is ‘negligible risk’ and uses only ‘existing, publicly available’ data or records requires an application

When complete, please submit your application document to the Human Ethics office.

Quality assurance activities that may be exempt from formal ethics review

An institution may also exempt from formal human research ethics review any evaluation activity undertaken in the normal course of conducting the business of the institution, e.g. educational assessments, student feedback surveys, audits of organisational activities and systems, and quality assurance reviews.

Guidelines and requirements in relation to the ethics review of quality assurance audits have historically focused on activities in the health care sector. However, other fields also implement quality assurance audit functions to determine the efficacy of programs of activity, for example, in the field of education, where teaching and learning methods are examined to assess their impact. Therefore, the University of Western Australia’s procedures for seeking exemption from formal ethics review for ‘quality assurance’ audits extend to all health sector and non-health care sector activities.

Quality assurance in the health sector

The advice paper ‘When does quality assurance in health care require independent ethical review? (2003)’ has been archived on the advice of the Australian Health Ethics Committee (AHEC). The advice received from the AHEC indicated that the revised National Statement on Ethical Conduct in Human Research (2007) adequately addresses ethical review issues relating to quality assurance activities in health care.

As a result, a proposal that could be considered a ‘quality assurance’ activity may be appropriately addressed through institutional processes that allow review of low and/or negligible risk research as outlined in the National Statement.

These processes should consider the need for, or the level of, ethical review required for quality assurance activities.

Chapters of relevance in the National Statement are:

• Chapter 2.1 – RISK & BENEFIT
• Chapter 5.1 – INSTITUTIONAL RESPONSIBILITIES
• Oversight and review of ethical review procedures (5.1.10 – 5.1.17)
• Research involving no more than low risk (5.1.18 – 5.1.21)

In seeking exemption from formal ethics review, researchers should be mindful that some journals expect evidence of ethical review of research irrespective of whether the research can be described as a quality assurance activity.

What is quality assurance in health care?

There is no clear line separating ‘quality assurance’ activities from ‘clinical research’ activities. However, generally, quality assurance is an activity where the primary purpose is to monitor, evaluate or improve the quality of health care delivered by a health care provider, which may be an individual, a service, or an organisation.

Quality assurance is also known as ‘peer review’, ‘quality improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’. There is an increasing appreciation for the need for health care institutions and health professionals to undertake quality assurance. On the other hand, there is a need to protect privacy and personal information about individuals.

In some circumstances, where low-risk health studies can be considered quality assurance and not clinical research, it is not necessary for the person conducting the study to apply for formal ethics review.

An appropriately planned activity can proceed without formal ethics review if:

Both

Advice for use of Privacy Act guidelines

Researchers requiring advice in the use and interpretation of the Privacy Act and the Privacy Act Guidelines should refer to the following publications:

• Guidelines under Section 95 of the Privacy Act, 1988
• Guidelines under Section 95A of the Privacy Act, 1988
  
• Advice for the use of Privacy Act Guidelines
  

What is quality assurance in teaching?

A teaching and learning project undertaken to monitor, evaluate or improve the quality of an existing teaching program delivered by the University may represent ‘quality assurance’ and may not require formal ethics review.

Quality assurance of teaching activities is viewed as an essential and integral part of the delivery and development of professional practice. However, differentiating ‘quality assurance’ from ‘research’ is sometimes difficult. The guidelines in this section should be followed by all researchers seeking exemption from formal ethics review on the grounds that their activity is a ‘quality assurance’ project rather than ‘human research’.

Application procedure for a quality assurance project

Seeking ethics exemption for a ‘quality assurance’ project, whether in the health sector, the education sector, or in another area of professional practice, requires researchers to complete the following Quality Assurance Exemption Application Form, which includes a checklist of questions to determine whether a project is eligible for exemption.

Deciding if a research or quality assurance activity is exempt from ethics review

The HREO will evaluate all applications for exemption from formal ethics review and obtain advice from University ethics reviewers, if required. You will then be advised of the outcome of your application. If exemption from formal ethics review is granted, you will receive a letter confirming this decision. If exemption is not granted, you will be required to submit a standard human research ethics application to obtain approval to commence your project.

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