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Ethical Review of Quality Improvement Activities in Health Services submission

ID: 
11
Personal Details
First Name: 
Erol
Last Name: 
Digiusto
Specific Comments
Comments: 
QI and the National Statement on Ethical Conduct in Human Research (2007)

Thank you for the opportunity to offer comment on the draft of Using the National Statement: Ethical review of Quality Improvement Activities in Health Services (the Draft Document).

As is noted in the Draft Document, health service staff who undertake QI activities commonly do not regard those activities as being ‘research’, and commonly do not regard themselves as being ‘researchers’. As a consequence, many of the health service staff members who undertake QI activities lack a clear understanding of, and experience in making decisions about, ethics issues.

I have worked as an evaluator / researcher / health service manager in a public hospital setting and two non-government organisations for more than 15 years. I have, on many occasions, found that these circumstances lead to uncertainty and, frankly, reluctance about the need for ethical review of QI activities, given the extra work and time delays which may be involved.

The Draft Document states that (health service) Department responsibilities include education of staff in the policies and processes for ethical conduct of QI activities. The Draft Document also states that Staff and QI Team responsibilities include considering all the ethical issues and determining the level of risk when planning and conducting QI activities.

The National Statement on Ethical Conduct in Human Research (2007, pp.12-13) identifies four core values which guide ethical consideration of research, including Research Merit and Integrity, Justice, Beneficence, and Respect. Given the broad and generally experienced audience which the National Statement is written for, these concepts are outlined only in a generic and abstract manner.

Similarly, the National Statement (p.16) provides a few examples of harms, discomfort, and inconvenience. However, these examples are quite brief and are neither clear enough nor comprehensive enough to provide effective guidance for the new audience which the NHMRC QI ethical review guideline document will be aimed at.

Thus, to provide clear guidance for QI Team staff members, and for the Department staff who will be required to train and oversee them, it would be helpful if the final version of the new QI ethical review guideline document were to include explicit, detailed guidance regarding:

What actually constitutes “research” specifically in the QI context - a set of dictionary definitions would be helpful, as would a flowchart decision guide.

  1. How to assess whether research is “justifiable by its potential benefit” specifically in the QI context (Research Merit and Integrity);
  2. What are the ethical risks (harms, discomforts, and inconvenience) that might commonly be encountered specifically in the QI context, and how such risks couild be minimized (Beneficence);
  3. How research outcomes should be made accessible to QI participants (Justice);
  4. What information and experience should be included in relevant training for staff, and the form in which such training should be conducted.

Finally, it should not be assumed that staff who work on QI projects will have available, or will read and correctly understand, the National Statement.  A simplified, much shorter version tailored to QI would be helpful.

 

Kind regards

Erol Digiusto, PhD 

Page reviewed: 17 June, 2013