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Ethical Review of Quality Improvement Activities in Health Services submission

ID: 
12
This submission reflects the views of
Organisation Name: 
Univesity of Technology Sydney
Please identify the best term to describe the Organisation: 
HREC
Personal Details
Specific Comments
Comments: 
Introduction

….Furthermore, those undertaking QI often do not see their activities as being ‘research’ or themselves as ‘researchers’. However, this approach ignores the possibility that QI activities have their own ethical issues that require consideration. The Committee strongly supports this statement.

Research merit and integrity, justice, beneficence and respect

Research Merit and Integrity

We propose to add the following: The QI activity should be conducted using appropriate facilities and resources.

Justice

It is important that the QI activity considers whether inclusion of information about people is collected in a fair manner that does not burden those involved.

We propose to add the following sentence: This includes fair process of recruitment, no unfair burden on participant groups and no exploitation.

Respect

In the first sentence: “Asking a person for their consent to participate in research or QI is a mark of respect and is a universal requirement in medical research and practice”, we propose medical research practice to be changed to health research practice.

At the end of the paragraph to add the following sentence: Voluntary participation - sufficient information and adequate understanding of purpose, methods, demands, risks and potential benefits.

We propose the following wording of the second paragraph: QI activities will often use information that already exists and in many instances the QI activity will be directly related to the original purpose for which the data were collected, for example, to demonstrate the degree to which planned activities occurred as intended/ expected. However, in some instances the secondary purpose related to QI may not be consistent with the original purpose for which the information was collected.

Additional Comment:  It is important not to lose sight of the important point that this is what most QI is about, and separate consent is not needed. There is a real danger that this document can be interpreted as indicating that the default position is that all QI needs to be reviewed by an HREC.

Institutional governance for QI

We propose to include QI activities in relevant policies and guidelines.

In the second dot point we propose to change ethical review with ethical scrutiny.

Additional comment: As things stand, the individual clinician is the primary decision-maker regarding the level of ethical review required for each QI activity. Recording of QI activities on a central register within the institution provides a secondary scrutiny. For most QI activities this is adequate – a recommendation that there is a process of ethical review in place can be read as a requirement for a more elaborate system, paralleling the HRECs. This would be unnecessarily onerous for most QI activities. The new National Standards for health care institutional accreditation are requiring a very substantial increase in QI activity to demonstrate procedural compliance but have not been accompanied by any increase in funding. It is important to be clear that the intention is not to increase ethical scrutiny per se but to enhance clarity about where this may be required.

Page reviewed: 17 June, 2013