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Ethical Review of Quality Improvement Activities in Health Services submission

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Specific Comments

Quality Improvement activities needs to be further expanded to include different data collection approaches such as interviews, surveys, focus groups etc.

I also think there needs to be further clarification on what might consistitute health research versus evaluation of health policy, programs or services.

I would like to see a stronger association explained between evaluation activities and QI, as both are common practice in health services, but not often viewed separately. The National Statement needs to have relevance to both.

QI and the National Statement on Ethical Conduct in Human Research (2007)

The core values appear based heavily on research terminology. Given that evaluation practice is more relevant to QI activities, there should be consideration of other relevant values such as: validity, credibility, feasibility, accountability, propriety.

I suggest some cross referencing with the Australasian Evaluation Society - "Guidelines for the ethical conduct of evaluations"

Under Senior executive responsiblities - I strongly support the notion of a register of ALL QI activities  and the ethical review process undertaken, but I would like to see this register recording the objectives of the activity and the intended outcomes.

There is not mention in the document about reimbursement or remuneration arrangements. These do occur on occassions in evaluation and QI activities within health services, and requires some documentation and ethical check to ensure appropriateness.



Institutional responsibilities for ethical review of QI activities

Reinterate that all QI activities need to be recorded on a central register and the ethical process undertaken also noted.

Given that QI activities occur frequently across different areas of the health service, most organisations will need to establish new processes to review QI activities (including evaluation activities) for ethical consideration.  The option to outsource this role to a designated experienced 'independant' evaluator/assessor could be also mentioned. An internal committee needs to have some element of expertise and independance - it should not be made up soley of internal staff.


The flowchart is a great idea, but this version needs more clarity for it to be used consistently by health services.

QI activities tend to "obtain information" from patients, families, clinicians, or health service staff - this type of terminology is prefered over the more research approach such as "using data about, or samples taken from people".

The flow chart outlines the QI team - but the document describes variations to having a QI team. If this is the term to be used, it needs to outline who is on "the team" eg: independant evaluator/assessor, Quality Unit staff, consumer representative etc.

There is no definitions to describe the differences between low and negligible risk or "more than low risk"  - I think this is important to ensure consistency in decisions. 

I would like to see some objective criteria used to differentiate between, more than low, low, and negligible risk, otherwise decisions will be based on subjective interpretation and may even be biased if no independance is mandated in the sub-committees or QI teams making these decisions.

General Comments

I have been supporting  health service staff plan and conduct good evaluations of their programs and services for many years. There is a huge need for this type of NHMRC document to advise health service staff on the ethical appropriateness of the activities they undertake under the umbrella of QI activites and/or evaluation. As an evaluator I strongly support a consistent approach, but I am also mindful of the limited time and capacity health service staff often experience, so the processes need to be simple and efficient for staff to comply. They cannot be as lengthy and arduous as the standard research proposal, or health service staff will not complete them.

This document would also be enhanced by having a checklist or a template with a set of key questions health service staff need to provide responses to when submitting their QI proposals for ethical reivew. Having these type of support tools will enable a more consistent approach to be applied across all health services.

Page reviewed: 17 June, 2013