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Ethical Review of Quality Improvement Activities in Health Services submission

ID: 
15
This submission reflects the views of
Organisation Name: 
WA Department of Health
Please identify the best term to describe the Organisation: 
Government department – State / Territory
Personal Details
Specific Comments
Comments: 
Introduction
  • The Department of Health WA supports in-principle the NHMRC’s proposal that:
    • all quality improvement that is conducted with or about people requires ethical consideration; and
    • The NHMRC National Statement which outlines the ethical review of research provides a basis for the ethical review of Quality Improvement activities. 
QI and the National Statement on Ethical Conduct in Human Research (2007)
  • The Department of Health WA believes that the NHMRC does not sufficiently explain the differences between Quality Improvement and Research.  A more detailed definition would be welcome.
  • The draft NHMRC Quality Improvement Document confuses Quality Improvement and Research too much.  The Department ofHealthWAis concerned that this will confuse researchers as there is no reference to Quality Improvement in the National Statement.
  • Rather than inserting the words Quality Improvement into an extract from the National Statement, the Department of Health WA recommends that the NHMRC creates two separate National Statements on: (1) ethical conduct in Quality Improvement and (2) ethical conduct on Research.
Institutional governance for QI

The Department of Health WA believes there should be greater clarity around the responsibilities of those involved with the process i.e. institution, HRECs, departmental managers and staff.

Senior executive responsibilities
  • On Page 6 of the draft Quality Improvement Document it mentions that Senior Executives should maintain a register all Quality Improvement activities. It also mentions that the register should indicate the process of ethical review and approval within a health service organisation. 
  • The Department ofHealthWAbelieves that this requirement does not reflect current practice.  It was noted that if a project has been assessed as being Quality Improvement, as opposed to Research, it gets reviewed by a clinical governance/QI officer/QI Committee (depending on whether medical, nursing, mental health etc).  The document should clarify  the following:
    • If the project has been deemed as not requiring review by the HREC is this information recorded on the register? 
    • Are the staff reviewing the QI registration going to be undertaking an ethics review? 
    • Will the QI registration forms need to be more aligned with the research ethics application so as to pick up the four core values that apply to research (similar to low/negligible risk ethics applications or the NEAF)?
  • The Department of Health WA believes that the only way a register could be maintained is if all Quality Improvement activity was registered with one area and then if required sent to a HREC for additional review.
  • The register would have to indicate that the ethical review was carried out by the Quality Improvement committee/person or was sent to the HREC for ethical review.
  • If this principle is supported by the NHMRC, the Quality Improvement application forms used across Health Services may need to be changed and further education provided to staff regarding ethics involved in reviewing the Quality Improvement projects.
Institutional responsibilities for ethical review of QI activities
  • On Page 7 of Quality Improvement Document it states that a HRECs responsibility is to ‘Ethically review any QI activities that are not low or negligible risk’.
  • The Department of Health WA believes that this requirement may stymie most Quality Improvement activity in WA hospitals.  The NHMRC Quality Improvement Document needs to provide scope for more than low risk Quality Improvement activities to be exempted from HREC review.
  • There are many exceptions to the review of low risk research that require HREC review as outlined in the Section 5.1.7 of the National Statement “For research that carries only low risk (see paragraph 2.1.6, page 18) and does not fall under any of the chapters listed in paragraph 5.1.6, institutions may choose to establish other levels of ethical review”. These exemptions outlined in Section 5.1.6 of the National Statement do not appear in the draft Quality Improvement Document.
  • Therefore it is hard to know if these exceptions only apply to Research and not Quality Improvement. This is a significant omission as it may mean that all Quality Improvement, irrespective of risk, dealing with aboriginals, mental illness, pregnant women etc may have to be reviewed by a HREC.
  • Page 7 (HREC responsibilities) suggests that it is a HREC’s responsibility to provide advice to staff undertaking Quality Improvement activities regarding ethical requirements.  This advice would usually be given by staff in the HREC Office or by the staff responsible for reviewing QI projects, not the actual HREC.
  • The Department of Health WA are concerned that the document does not assist people who are required to assess Quality Improvement projects in considering the ethical implications and determining whether a project requires review by a full HREC.
  • To suggest that people who assess Quality Improvement projects have to consider ethical implications if they do not have the knowledge, or experience to do this may result in more Quality Improvement projects being unnecessarily referred to the HREC for review.  
  • There is already little training available for HREC Members on how to apply the National Statement yet the NHMRC is expecting staff who review Quality Improvement to apply the values of the National Statement when reviewing Quality Improvement projects. 
  • It is already quite difficult to draw the line with what is considered research and what is Quality Improvement and whether a project requires review by a HREC. 
    • Unlike the previous NHMRC National Statement “When does Quality Assurance in health care require independent ethical review” this Quality Improvement Document gives no guidance on how WA Health staff are to assess when review by a full HREC is required.  
    • The Department of Health WA requests that the NHMRC provides further information in the Quality Improvement Document to advise those reviewing Quality Improvement on their responsibilities and training.  Quality Improvement application forms may need to ensure they include ethical principles.
    • The Department ofHealthWAbelieves that any Quality Improvement statement needs to include ethical considerations and specifications for publication of Quality Improvement activities in journals.
      • On page 7 of the Quality Improvement Document, the NHMRC should indicate who is required to supply the evidence of ethical review of a quality improvement activity before it is published in a journal. If researchers are wishing to publish they will require a letter from the HREC indicating that their project either underwent ethics approval by a HREC or non-HREC level of ethical review or were exempted from ethical review.
Excerpts from the National Statement on Ethical Conduct in Human Research (2007)
  • The draft NHMRC Quality Improvement Document confuses Quality Improvement and Research too much.  The Department ofHealthWAis concerned that this will confuse researchers as there is no reference to Quality Improvement in the National Statement.
  • Rather than inserting the words Quality Improvement into an extract from the National Statement, the Department of Health WA recommends that the NHMRC creates two separate National Statements on: (1) ethical conduct in Quality Improvement and (2) ethical conduct on Research.

Page reviewed: 17 June, 2013