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Ethical Review of Quality Improvement Activities in Health Services submission

This submission reflects the views of
Organisation Name: 
ACT Health Human Research Ethics Committee
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Specific Comments

The HREC wishes to express thanks for the opportunity to comment on the draft paper. The Committee has consulted its members and senior administrative staff of the Canberra Hospital and ACT Health Directorate, and finds problems with the draft report, as set out below.

General Comments

1.      Role of HRECs. The Chair of AHEC tells of consultation for the initial draft among a large number of HREC managers, but the current document appears to disregard the impact of its proposals upon HRECs. A common response from HREC members and Institution senior administrators is that ethical review of all Quality Improvement (QI) conducted with or about people would  add greatly to Committee workload. It is believed that ethical review of research projects will be hampered by the introduction of what most believe is an unnecessary bureaucratic addition. Also important is the effect of such an addition on the secretarial and management of ethical review. It is not reasonable to require institutions to fund the resources required for the additional work. Finally, the draft paper gives scant comment on HREC tasks, saying simply that they will review any QI activities that are not low or negligible risk.   

2.      Role of health care staff in QI activities. The view of HREC members and hospital senior executives is that the suggested increase in governance of QI will discourage staff in undertaking what is now a required and helpful part of patient care. Many health staff request ethical review to enable publication of the results, as noted in the AHEC paper. Others will see the demand for ethics committee review as a barrier to QI and effectively diminish what is and should be an ongoing cycle in most hospital departments.

3.      Role of senior executives of institutions. Specific questions were asked of senior administrators at Canberra Hospital and the ACT Health Directorate. Was anyone consulted in preparation of the draft paper? The paper had not been seen and no consultation was known. How does senior management view the responsibilities set out on page 6 of the draft paper? They are seen as interference in institution management and quite unnecessary. As above, the progress of QI work will be dampened. Moreover, there is already a system of oversight;  QI activities in ACT public health institutions require endorsement  by the Head of Division and sending to the Quality and Safety office, where a register is maintained.

4.      The National Statement. The draft paper helpfully includes excerpts from the National Statement but it is noted that words about QI have been added without explanation. This is unsatisfactory in any document and should be corrected.  

5.      ‘Quality Improvement’ and ‘Research’. The draft paper sets out to apply the health research ethical review processes in the National Statement to all QI activities in health provider institutions.

  • We see most QI activities as quite distinguishable from research, the former mostly consisting of number crunching and interpretation of non- or low-sensitive information. As one member put it, if the combining of research and QI evaluation is accepted we may shortly be reviewing the content of the suggestion box in the staff canteen. We do not support the contention in the draft paper.

6.      Consent issues. The paragraphs under ‘Respect’ on page 6 of the draft document have been noted, and sections 95 and 95a of the Privacy Act 1988 and associated guidelines reviewed. It seems to us that a main issue in preparing the draft paper is the disclosure, or potential for unauthorized disclosure of personal health information collected during Ql. We note that the majority of QI does not relate to identifiable personal health information. Where it does, these are issues that have been covered in the privacy legislation and guidelines. In line with the Section 95A guidelines, we believe that health research ethics review should not be applied to the collection, use and disclosure of  information, provided it is within the reasonable expectations of the individual  in circumstances such as: An organisation’s quality  assurance or clinical audit activities, where they evaluate and seek to improve the delivery of a particular treatment or service.[1] 

7.      Conclusion. In short, we do not accept the validity of the principle that all QI that is conducted with or about people requires consideration by an ethics committee, believing this will inhibit quality improvement. In relation to the second underpinning item, the ethical principles in the National Statement are a sound basis for ethical review of research but are not appropriate for application to all QI activities. Finally, we believe there has been insufficient consultation with HRECs in preparation of the document and recommend that HREC Chairs be represented when the paper comes to be revised. 

[1] Guidelines approved under Section 95A of the Privacy Act 1988

Professor John Biggs

Chairman, ACT Health HREC

26 September 2012


Page reviewed: 17 June, 2013