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Ethical Review of Quality Improvement Activities in Health Services submission

ID: 
17
This submission reflects the views of
Organisation Name: 
Dept of Nutrition & Dietetics, Princess Alexandra Hospital
Please identify the best term to describe the Organisation: 
Health service
Personal Details
Specific Comments
Comments: 
Introduction

The document Using the National Statement: Ethical Review of Quality Improvement Activities in Health Services provides a description of the core values and ethical considerations of activities that involve humans. Non-research staff who are considering undertaking quality activities will be able to use the information in the document to help make decisions about the ethical risk associated with their projects.

Flowchart

1. Confirmation of exemption from review by HREC

It is unclear from the flow diagram that the Exempt from Ethical Review still requires that the institutions HREC to formally exempt it from the review process, in writing. In its current form it could be interpreted that the staff member could deem it exempt from review and commence the activity.

Recommendation: add “Consult with HREC for exemption” after exempt from review box.

 

Research merit and integrity, justice, beneficence and respect

2. Circumstances whereby consent waiver is appropriate

General examples whereby the need for written consent may be waivered would be beneficial in order to place many of the very low or negligible risk quality activities into context and assist staff to make decisions about whether a waiver of consent process is appropriate.

Recommendation: Provide some examples of projects whereby waiver of consent process is appropriate and not appropriate

Institutional responsibilities for ethical review of QI activities

3. Department Responsibilities

It seems appropriate that Departments also keep a local register of their quality activities within the department and the process of ethical review and approval. This may also assist with decision making regarding level of risk by reviewing historical examples of the process within the department. It also supports retaining corporate knowledge in this field for when research staff or experienced staff may transition from the department.

Recommendation: Department responsibilities to include maintaining a register of quality activities and process of ethical review and approval.

Page reviewed: 17 June, 2013