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Ethical Review of Quality Improvement Activities in Health Services submission

This submission reflects the views of
Organisation Name: 
Royal Australasian College of Surgeons
Please identify the best term to describe the Organisation: 
Medical college
Personal Details
Specific Comments
General Comments

The NHMRC National Statement on Ethical Conduct in Human Research 2007 stated that research proposals, including quality assurance activities, which are deemed to be of low or negligible risk can be excluded from the usual Human Research Ethics Committee (HREC) processes. The Royal Australasian College of Surgeons (The College) agrees that, where risk is deemed to be low or negligible, formal ethical clearance from an HREC is not required. It is the view of the College, therefore, that Quality Improvement (QI) activities which fall into this category should not be required to submit for HREC approval, regardless of patient consent status and primary purpose of data collection. To force these activities to do so would place an inordinate burden and constraint on the administrative processes of many health care institutions.

For activities involving retrospective collection of data, it is difficult to gain patient consent specifically for audit. Data which is collected about patients by institutions, and particularly clinical data which might be used for in-house audit and quality assurance activities, might subsequently and retrospectively be subjected to various types of research analyses. It would not be feasible or practical to obtain individual consent for these varied assessments, particularly as these activities would have no impact on the patient’s management at that time. It is therefore perfectly reasonable for the institution concerned to simply collect a generic consent which indicates that their non-identified data may be used for various research and audit activities having no implications in regard to their existing treatments.

Patients do, on admittance to hospital, sign a general release form which may mention using their data for quality assurance. This has, in the past, been considered to fully cover the use of data for audit purposes, both internally and in a larger nation-wide context. It is our view that a patient would reasonably expect their surgeon to undertake such activities using the data available to them and that organisations are acting within the regulations of Commonwealth privacy legislation in doing so.

The flowchart in the draft document, Using the National Statement: Ethical Review of Quality Improvement Activities in Health Services, also seems to assume that all data will be collected in the same manner. This is not always the case. The NBCA collects the majority of its data (87%) directly from individual surgeons, however, 13% of cases are imported from existing databases such as hospital systems or local registries.

The situation with large national audits is not clear. The NBCA, for example, collects data Australia-wide, both directly from surgeons and from existing databases in institutions. Data collected for audit purposes is protected under both Australian and New Zealand law as part of the Qualified Privilege schemes in those countries. This protection ensures that information which identifies individuals remains confidential and is used for audit purposes only. As the data is also used as a tool for research into breast cancer treatment in this country, the audit has Ethical Approval from the College Ethics Committee. This research takes the form of peer reviewed publications on aspects of care that are highlighted for education and quality improvement. Nation-wide data collection such as this does not seem to be covered in the draft document and it remains unclear what our ethical obligations are/should be from this document.

In our experience, large nation-wide audits primarily use the data for QI, however, publications do result from using the data to research specific aspects of care.  If formal HREC ethics approval is required from each hospital about which data is being collected, the administrative burden and time-lag involved would unnecessarily constrain the activity perhaps to the point of either preventing growth into a national audit or even leading to disbanding the project altogether. It is recommended that this kind of activity should only be required to seek a central approval for the entire project describing how the envisaged research projects will be conducted according to the National Statement and to the benefit of patient care.

The central approval described above for national audits may not necessarily be from an HREC.  In relation to research which is deemed to be low risk or of negligible risk, it is reasonable for an institution to have some method of non-HREC oversight which might include a departmental head, a unit chairperson, a hospital low risk review committee or peer review by members of a specialist hospital unit. Anything more than this for low risk or negligible risk activities would be an unnecessary administrative and bureaucratic burden.

Where research, or QI, is deemed exempt from Ethics Review, there appears to be some confusion in the wider community regarding the process of exemption. Many Ethics Committees request project leaders to formally apply for exemption, while others have a more informal process. The document is not clear on who should be making the final decision on whether a project is exempt from review, whether this can be determined by the QI team (as is suggested by the flowchart) or whether this needs to be confirmed by an HREC.

In summary, the College believes that QI and research activities which involve more than low risk or negligible risk need to be subjected to standard HREC review processes. Projects which can be classified as low or negligible risk, including such processes as everyday institutional QI activities, should not be required to submit to an HREC assessment. To subject these standard quality assurance activities to such a high level of ethical review scrutiny is unnecessary and would result in administrative overload.

Additionally, we feel that national audits should be required to gain approval (whether HREC or non-HREC) from one central location only. Placing unnecessarily restrictive ethics requirements on quality improvement activities will impede improvement in the quality of patient care and undermine the goals of these activities.

Page reviewed: 17 June, 2013