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Ethical Review of Quality Improvement Activities in Health Services submission

This submission reflects the views of
Organisation Name: 
Australian Defence Human Research Ethics Committee
Please identify the best term to describe the Organisation: 
Personal Details
Specific Comments

1.1 Purpose

a.         “The purpose of this document is to provide an effective and efficient framework to manage the ethical issues related to QI in health services.”

b.         The National Statement states that “Human research is research conducted with or about people, or their data or tissue.” (page 8) and may include surveys, interviews, observation, access to their personal details or materials, and other human involvement. HRECs frequently see research which is “human” but not necessarily “health” research, and as such ADHREC queried why the document was limited to health services. As the National Statement encompasses human research, the committee feels it would be more appropriate to broaden the focus to be inclusive of human, but not necessarily health, quality assurance activities, and those which exist outside of a health care setting.

 c.         An example in the Defence context includes reviewing the effectiveness of Personal Protective Equipment. This may include the use of health records to show injuries sustained or prevented during the use of such equipment, but may not be a review of “patient” outcomes, or conducted in a health service setting. This type of Quality Assurance activity requires considerations of individuals’ privacy, and other considerations as outlined under the previous document[1], but is not necessarily research activity.

d.         As this document is a “Using the National Statement” supplement, the committee queried the purpose for the use of “Quality Improvement” as opposed to “Quality Assurance”, as both terms are referenced through the National Statement.

e.         We also note this was previously explicitly stated:

AHEC considers that the information may be adapted and applied to non-health quality assurance activities.(op cit).

f.          Page 5 “Beneficence”- as this is the first instance low or negligible risk are mentioned in the document, a reference to the National Statement sections should be listed here, e.g. “… low or negligible risk, as defined in Section 2, page 16, of the National Statement..”.

[1] When does Quality Assurance in Health Care Require Independent Ethical Review, NHMRC, 2003.


2.1 Flowchart

a.         The flowchart could be used as an example if it is preceded by the original consultation document "Considerations in determining if an activity such as quality assurance requires ethical review", or in conjunction with sections 4 and 5 of “When does Quality Assurance in Health Care Require Independent Ethical Review”.

b.         Noting specifically that the new flowchart asks about existing or new data, but doesn’t consider existing datasets combined to create a new one; the flowchart leaves it open to interpretation about whether the use is consistent with the primary purpose and then it merely flows into low, negligible or more than low risk - which is already defined by the NS.

c.         Visually it is poor, with overlapping arrows and unclear endpoints

d.         The original document provided a better picture to the non-research office individual.

Research merit and integrity, justice, beneficence and respect


3.1 “Respect” Section

a.         This is the only section of the new document which mentions the Privacy Act (1988) and any detail on what privacy considerations should be applied.

b.         We feel that, with this exclusion, the document has lost one of the clear, key pieces of guidance from “When does quality assurance in health care require independent ethical review?”. We suggest reinsertion of the following excerpt, after editing to incorporate appropriate language for the audience as per the comments at 1.2:


AHEC therefore advises that an appropriately planned activity can proceed without review by an HREC if:



(a) the activity is undertaken with the consent of the patients, carers, health

care providers or institutions involved;




is consistent with National Privacy Principle 2.1(a), which states:

‘An organisation must not use or disclose personal information about an

individual for a purpose (the secondary purpose) other than the primary

purpose of collection unless’ … ‘both of the following apply:

(i) the secondary purpose is related to the primary purpose of collection

and, if the personal information is sensitive information, directly

related to the primary purpose of collection;

(ii) the individual would reasonably expect the organisation to use or

disclose the information for the secondary purpose’;



(b) it is an activity where participants, including patients, carers, health care

providers or institutions are unlikely to suffer burden or harm (physical, mental, psychological, spiritual or social). (Page 5)

General Comments

1.2 Audience and Language

a.         We note this document is aimed at “..institutions, managers and staff who oversee or undertake quality improvement…” (page 4), but that it is also acknowledged that “QI may include activities involving staff, patients or members of the community …” (page 4). In acknowledging this, the document does not appear to be worded at a health literacy level appropriate for “patients” or community members, and is somewhat inconsistent with the “Statement on Consumer and Community Participation in Health and Medical Research” (NHMRC, 2002) recommendations about being inclusive of community input and the National Statement recommendations on providing communication in language which is understandable: “… that the participants clearly understand the risks they are assuming.” (page 17), 5.2.16, 5.2.17 and 5.2.6.

b.         We also query if “patients” is the appropriate term to use when referring to health care consumers, members of the community and individuals whose data/ information may be utilised in QI activities in this context.


Page reviewed: 17 June, 2013