Quality assurance and improvement projects
This requirement for an ethical review is part of the response to the March 2014 National Health and Medical Research Council (NHMRC) paper.
ACT Health's policy on the requirements for ethical review relating to Quality Assurance and Improvement (QAI) projects is in line with the guidance provided in paragraphs 2.1.1 – 2.1.8 of the National Statement on Ethical Conduct in Human Research that the level of institutional review should be appropriate to the level of risk involved in the activity.
Ethical approval is not always required for publication of QAI projects as long as the institutional policies exempt such projects from ethical review. The NHMRC position is referenced below and provides guidance to ethics committees on QAI activities.
A QAI project may not require ethical review/approval through ACT Health Human Research and Ethics Committee (HREC) however the project must still be conducted in an ethical manner and be compliant with relevant legislation. This includes privacy and medical records and relevant procedures.
Consent of participants may be required depending on the method of data collection. In this case, participants should also be provided with an information sheet to ensure informed voluntary consent.
Assessing ethical review requirements
Under NHMRC guidance most cases of QAI and evaluation activities do not require ethical review. Find out more in the March 2014 NHMRC paper.
The key tests for when ethical review is required are:
- Is the project designed only to evaluate, audit, quality assure or improve services provided by Canberra Health Services (CHS) or ACT Health (ACTH)?
- Does the project team include only CHS or ACTH staff and contractors?
- Does the project only involve observations, surveys or interviews that pose minimal risk, burden or inconvenience to participants?
- Will the results of the project only be reported and used internally within CHS or ACTH or published in a journal or resource not requiring ethical review for publication?
If you answer yes to all four questions below your project does not require ethical approval to proceed.
Find out more about the ethical review policy on the requirements for ethical review relating to QI/QA and evaluation projects.
It is recommended that you use an internal department checklist to assist in your assessment of a projects status. View the sample checklist which you can adapt for your business.
If your QAI project is being conducted at CHS you need to email Qualityathealth@act.gov.au before commencing your project.
Advice for medical staff
Medical staff who have not yet attained the level of Specialist or Career Medical Officer are considered to be undertaking training. As part of the training, you are advised to submit QAI projects for ethical review. This will generally be through the low risk ethics committee. For more information go to about submitting research.
Advice for students
Student projects are considered to be research training and are categorised as research rather than QAI. The advice above does not apply to student projects. Students are advised to submit proposals for review. For more information go to about submitting research.
If you are unsure around the requirement for ethical review, please contact the Research Ethics and Governance Office prior to commencement by calling 02 5124 3949 or email ethics@act.gov.au.
The HREC cannot provide retrospective review or approval of quality assurance and improvement activities and projects.