Ethics for Quality Assurance/Improvement and Evaluation Projects.
In response to a March 2014 NHMRC paper ethical approval is not always required for QI/QA projects. ACT Health HREC has developed a policy on the requirements for ethical review relating to Quality Improvement/Quality Assurance (QI/QA) and Evaluation 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
Advice for ACT Health Staff
The ACT Health Human Research Ethics Committee (the HREC) is currently receiving a number of applications for ethical approval of quality assurance/improvement activities where ethical approval is not required. The purpose of this advice is to clarify when ethical
approval is and is not required for projects undertaken within ACT Health.
In most cases quality assurance (QA), quality improvement (QI) and evaluation activities do not require ethical approval. The key tests for when ethical approval is required are:
1. Is the project designed only to evaluate, audit, quality assure or improve services provided by ACT Health?
2. Does the project team include only ACT Health staff and contractors?
3. Does the project only involve observations, surveys or interviews that pose minimal risk, burden or inconvenience to participants?
4. Will the results of the project only be reported and used within ACT Health or published in a journal or resource not requiring ethical approval for publication?
If you answer YES to all four questions your project does not require ethical approval to proceed.
Ethical approval is not usually required for publication of QI projects. The British Medical Journal, Quality and Safety (BMJ) does not require ethical approval for publication of QI projects as long as the researcher’s institution exempts such projects from ethics approval. The NHMRC recently released a statement, referenced below, providing guidance to ethics committees on QI and evaluation activities.
Although a QI 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 ACT Health 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 before they make the decision to participate.
Queries regarding the need for ethical approval may also be directed to the Ethics and Governance Office.
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 QA/QI projects for ethics approval. This will generally be through the low risk ethics committee. Please contact the Ethics and Governance Office to the requirements.
Advice for Students
Student projects are primarily undertaken for the purposes of research training and are therefore categorised as research rather than QI. As such, the advice above does not cover student projects.