NHMRC Public Consultations

Skip Navigation and go to Content
Visit NHMRC website

Ethical Review of Quality Improvement Activities in Health Services submission

This submission reflects the views of
Organisation Name: 
La Trobe University
Please identify the best term to describe the Organisation: 
Educational institution – tertiary
Personal Details
Specific Comments
QI and the National Statement on Ethical Conduct in Human Research (2007)
  • Patients can fear disadvantage if they raise concerns or do not comply with organisational requests. The patient population is highly dependent on the healthcare organisation and the complexities arising from unequal relationships with the organisation, or its representatives in the Quality Improvement (QI) department, pose consent challenges that could be undervalued.
  • In some organisational cultures the research-QI dichotomy persists, resulting in a reduced awareness of the need for ethical review of QI activities. Perceived efficiency demands may further deflect from the ethical review of QI activities.
  • The NHMRC draft paper is particularly relevant but not confined to facilities without established ethics committees.
Institutional responsibilities for ethical review of QI activities

 Ensure ethical procedures are enacted during QI activities


  • Require education of staff about ethical conduct processes of QI activities, with particular reference and staff access to the National Statement.
  • Processes exist that ensure patients are able to decline to participate with advanced notice, have time to discuss with significant others and receive participant information statements.
  • The definition of QI provided in the Introduction (p. 4) covers some activities that are defined as research in other situations. Clarify if the difference is in the primary aim of the activity - data collected during QI activities is primarily used to improve health service delivery within a specific service whereas the outcomes of research may ultimately be used to improve health service delivery for a wider community through the generation of new knowledge.
  • Determine whether quality improvement/assurance activities become research if they are conducted by people from outside the health service organisation.
  • Under senior executive responsibilities - provide more guidance on the processes for conducting ethical review of low and negligible risk QI activities, such as determining who should review.  Section 5.1.29 of the National Statement is definitive about the composition of HRECs.

In recognition of the underpinning principle, “all QI that is conducted with or about people requires ethical consideration”: Ensure competency of the team undertaking the ethical review process.

The flow chart states, “QI team to consider all the ethical issues and determine the level of risk.” This requires assessment informed by the principles contained within the National Statement rather than decisions potentially influenced by organisational objectives.


  • Ensure a senior member of the QI team has undertaken training or has experience in ethical review processes and that such credentials are recorded.
  • Reiterate the need for healthcare facilities to maintain a register of all QI activities which indicate the process of ethics review and approval.
  • Recommend that both these points be incorporated in the formalised healthcare assessment and accreditation processes.

Page reviewed: 17 June, 2013