Ethics for Quality Assurance/Improvement Projects
In response to a March 2014 NHMRC paper ethical review is not always required for Quality Improvement/Assurance (QAI) projects. ACT Health HREC has developed a policy on the requirements for ethical review relating to QAI projects. This policy is in line with the guidance provided in the National Statement on Ethical Conduct in Human Research (paragraphs 2.1.1 – 2.1.8) that the level of institutional review should be appropriate to the level of risk involved in the activity.
Assessing Ethical Approval Requirements
The ACT Health Human Research Ethics Committee (HREC) receives applications for ethical review and approval of quality assurance/improvement (QAI) activities where ethical approval is not necessarily required. The purpose of this advice is to clarify when ethical review is and is not required for QAI projects.
In most cases QAI activities do not require ethical review. The key tests for when ethical approval 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 Directorate (ACTHD)?
- Does the project team include only CHS or ACTHD 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 ACTHD or published in a journal or resource not requiring ethical review for publication?
If you answer YES to all four questions your project does not require ethical approval to proceed.
REGO recommends the use of an internal department checklist to assist in the assessment of a projects status. A sample checklist is available. Please note, this checklist can be adapted for your division.
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, referenced below, provides guidance to ethics committees on QAI activities.
Although a QAI project may not require ethical review/approval through ACT Health HREC, the project must still be conducted in an ethical manner, be compliant with relevant legislation (including relating to privacy and medical records) and relevant procedures. Depending on the method of data collection, consent of participants may be required. In such cases participants should also be provided with an information sheet to ensure informed voluntary consent.
Queries regarding the need for ethical review may be directed to the Ethics and Governance Office on 02 5124 3949 or via email to firstname.lastname@example.org.
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 and as part of that training are advised to submit QAI projects for ethical review. This will generally be through the low risk ethics committee. All Submissions for ethical consideration are accepted via the REGIS platform. For more information, please see the Low Risk section.
Advice for Students
Student projects are considered to be research training and are therefore categorised as research rather than QAI. As such, the advice above does not apply to student projects. Students are advised to submit proposals for review via REGIS.