Quality Assurance (QA) is an activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or organisation and includes terms such as ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘clinical audit’ and ‘audit’.
The National Health and Medical Research Council (NHMRC) has published Ethical Considerations in Quality Assurance and Evaluation Activities (NHMRC; 2014) to facilitate oversight of Quality Assurance activities for individuals and organisations conducting quality assurance activities who are responsible for ensuring that:
participants are afforded appropriate protections and respect
QA activities comply with all relevant legislation and regulations
organisations provide guidance and oversight to ensure activities are conducted ethically including a pathway to address concerns
At the Eye and Ear, staff are encouraged to undertake QA activities.
The answer is not simple and does require consideration and judgement.
Irrespective of whether an activity is QA, evaluation or research, the activity must be conducted in a way that is ethical.
In many situations, oversight of the activity is required, but ethical review is not necessary.
As explained in the NHMRC guidance, where ethical review by an HREC is not required, organisations should consider providing a statement which affirms that an alternative approach to ethical review was considered to be appropriate for the specific QA/evaluation activity if this is required for publication purposes.
The Research Office provides an oversight process to facilitate QA activities (and clinical audit).
Staff are required to also seek approval from the Head of Unit / Clinic / Department prior to undertaking any QA activity.
The Clinical Improvement and Risk and Quality teams initiate and support quality improvement activities to improve models of care, patient safety programs and compliance with accreditation standards.
Medical Practitioners do not usually need HREC approval for writing and publishing a Case Report. However, researchers are encouraged to determine the requirements of specific journals early as some journals require HREC review and approval.
Staff are required to also seek approval from the Head of Unit / Clinic / Department.
Medical Practitioners should obtain patient consent.
The Medical Journal of Australia provides a template Consent Form you could use.
Some journals do require evidence of review if there are more than a minimal number of cases, e.g., 3 cases.
Eye and Ear staff can submit Case Reports to the Research Office for review at ethics@eyeandear.org.au and letter of organisational endorsement.
The Eye and Ear can provide a letter of endorsement for use of Eye and Ear patient health information. If you are proposing to use health information of patients at other organisations, then you will also need to seek organisational authorisation from each organisation according to their requirements.
