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Ethical Review of Quality Improvement Activities in Health Services submission

ID: 
19
Personal Details
First Name: 
Colin
Last Name: 
Thomson
Specific Comments
Comments: 
Introduction

Title:  It is not clear why the document is confined to "Health Services".  Quality improvement is an activity that is applied to many other services and it would be consistent with the scope of the National Statement, that applies to all huamn research, not only health research, for this document to have a similarly broad scope.  Altermnatively, some justification for confining the scope to health services shoud be provided.

Paragraph 1, 5th line: because not all program evaluation is quality improvement, it may be wiser to change this to "some prorgam evaluation"

Paragraph 2, 6th line: the description reads as if the National Statement provided only an HREC based review process.  On the contrary, the National Statement authorises institutions to establish mechanisms other than HRECs  to review research that involves no more than low risk to participants.  If these processes are used for QI projects, they may not be too onerous or time consuming.  A fair and acurate account of the review processes would include reference to those for no more than low risk projects.

Paragraph 3, lines 7 & 8: the description of the risks to people affected by QI activities could use the National Statement categorisation of inconvenience, discomfort or harm.  The expression "breach of their private information" is unfortunate.  What appears to be intended is a possible breach of the privacy that attaches to their personal information.

Paragraph 5, point 2:  the National Statement does more than "outline" ethical principles and processes and these apply to more than "health research".  Further, to say that the National Statement "provides a basis for ethical review of QI" is vague and ambiguous.  A clearer statement would say that the National Statement states ethical principles and decribes review proceses and that some of both of those can be used for the ethical review of QI.

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

It is surprising, to state it mildly, that the document ignores that fact the the National Statement contains a description of research that is used to inform decisions about the scope of the guidelines that it contains.  The description is also used in the Australian Code for the Responsible Conduct of Research.  To say that the  the National Statement can apply to QI when without considering the description of the activities to which the National Statement applies invites continuing confusion.

This is the description that appears at p. 6 of the National Statement:

"‘Research’… includes work of direct relevance to the needs of commerce, industry, and to the public and voluntary sectors; scholarship; the invention and generation of ideas, images, performances, artefacts including design, where these lead to new or substantially improved insights; and the use of existing knowledge in experimental development to produce new or substantially improved materials, devices, products and processes, including design and construction. It excludes routine testing and routine analysis of materials, components and processes such as for the maintenance of national standards, as distinct from the development of new analytical techniques. It also excludes the development of teaching materials that do not embody original research."

What presents a difficulty is the activities that are specifically excluded.  Can QI activities be described as "routine testing and routine analysis of.......processes.."?    At least this document needs to make clear that QI activities are not so excluded from the scope of the National Statement.

Paragraph 1, lines 2 & 3:  The National Statement does more than "outline" four core values - it states them and defines them.  Further, it is, in my view, a mistake to say that they "equally apply" to QI, as will be explained below.  A sounder expression would be refer to the core values as principles, drawing on the account of these that appears on pages 12-13 of the National Statement, and then say that "most of the elements" of these principles "can apply" to QI.

It will be more informative to describe these as principles so that some discerning understanding can be developed – each of them has a number of elements all of which need to be understood so that the way that they can be used as a guide to the ethical conduct of QI can be explained in a way that avoids the confusion that infects this document.   The confusion arises from blurring the distinction between QI and research.

The document needs to be clear that QI IS NOT RESEARCH AND RESEARCH IS NOT QI. 

However, some of the elements of the ethical principles that are used to determine whether research is ethically acceptable can be used to determine that QI is ethically acceptable.

Drawing the elements of the principles from pp.12-13 of the National Statement, It is suggested that those that are relevant to QI are as follows:

Research merit and integrity

1.1 Research that has merit is:

(a) justifiable by its potential benefit, which may include its contribution to knowledge and understanding, to improved social welfare and individual wellbeing, and to the skill and expertise of researchers.

What constitutes potential benefit and whether it justifies research may sometimes require consultation with the relevant communities;

NOT wholly relevant – not beyond accepting the aims and benefit of the QI activity

 

(b) designed or developed using methods appropriate for achieving the aims of the proposal;

Relevant

 

(c) based on a thorough study of the current literature, as well as previous studies. This does not exclude the possibility of novel research for which there is little or no literature available, or research requiring a quick response to an unforeseen situation;

Not relevant – there is no need to justify QI

 

(d) designed to ensure that respect for the participants is not compromised by the aims of the research, by the way it is carried out, or by the results;

Relevant

 

(e) conducted or supervised by persons or teams with experience, qualifications and competence that are appropriate for the research; and

Relevant

 

(f) conducted using facilities and resources appropriate for the research.

Relevant

 

1.2 Where prior peer review has judged that a project has research merit, the question of its research merit is no longer subject to the judgement of those ethically reviewing the research.

Not relevant

 

1.3 Research that is conducted with integrity is carried out by researchers with a commitment to:

(a) searching for knowledge and understanding;

(b) following recognised principles of research conduct;

(c) conducting research honestly; and

(d) disseminating and communicating results, whether favourable or unfavourable, in ways that permit scrutiny and contribute to public knowledge and understanding.

Not relevant

 

Justice

1.4 In research that is just:

(a) taking into account the scope and objectives of the proposed research, the selection, exclusion and inclusion of categories of research participants is fair, and is accurately described in the results of the research;

Relevant

 

(b) the process of recruiting participants is fair;

Only sometime relevant

 

(c) there is no unfair burden of participation in research on particular groups;

Only sometime relevant

 

(d) there is fair distribution of the benefits of participation in research;

Not relevant

 

(e) there is no exploitation of participants in the conduct of research; and

Unlikely to be relevant

 

(f) there is fair access to the benefits of research.

Not relevant

 

1.5 Research outcomes should be made accessible to research participants in a way that is timely and clear.

Not relevant

 

Beneficence

1.6 The likely benefit of the research must justify any risks of harm or discomfort to participants. The likely benefit may be to the participants, to the wider community, or to both.

Not relevant

 

1.7 Researchers are responsible for:

(a) designing the research to minimize the risks of harm or discomfort to participants;

(b) clarifying for participants the potential benefits and risks of the research; and

(c) the welfare of the participants in the research context.

Not relevant

 

1.8 Where there are no likely benefits to participants, the risk to participants should be lower than would be ethically acceptable where there are such likely benefits.

Not relevant

 

1.9 Where the risks to participants are no longer justified by the potential benefits of the research, the research must be suspended to allow time to consider whether it should be discontinued or at least modified. This decision may require consultation between researchers, participants, the relevant ethical review body, and the institution. The review body must be notified promptly of such suspension, and of any decisions following it (see paragraphs 5.5.6 to 5.5.9, page 91–92).

Not relevant

 

Respect

1.10 Respect for human beings is a recognition of their intrinsic value. In human research, this recognition includes abiding by the values of research merit and integrity, justice and beneficence. Respect also requires having due regard for the welfare, beliefs, perceptions, customs and cultural heritage, both individual and collective, of those involved in research.

Partly relevant

 

1.11 Researchers and their institutions should respect the privacy, confidentiality and cultural sensitivities of the participants and, where relevant, of their communities. Any specific agreements made with the participants or the community should be fulfilled.

Not relevant

 

1.12 Respect for human beings involves giving due scope, throughout the research process, to the capacity of human beings to make their own decisions.

Not relevant

 

1.13 Where participants are unable to make their own decisions or have diminished capacity to do so, respect for them involves empowering them where possible and providing for their protection as necessary.

Not relevant

 

Second paragraph:  What are the other values that “should be taken into account when undertaking ethical consideration of QI activity”?   It is totally unhelpful to leave this so vacuous.

 

Why are “only a few of the specific areas of QI that require the use of the four values” listed?  Why is there not a comprehensive account of the ethical criteria for the ethical assessment of QI?

A better approach is to identify those elements of the four National statement principles that can be effectively relied on to assess QI, as is suggested above.  Those then become a minimum set of criteria for the ethical assessment of QI, leaving, as does the National Statement for research, the possibility that there will be other matters.

Research merit and integrity, justice, beneficence and respect

Research Merit and Integrity

This paragraph overstates the aims of QI by treating all methods – the very variety listed in the opening paragraph of the Introduction – as if they always has the same aims.  This is patently untrue. Some QI processes merely establish that practice meets the relevant standards – they do not change practice.  Further, if the National Statement is to be used, it will be wiser to use the same terminology as it uses – the National Statement does not require a “thorough understanding of relevant literature”, “robust methods” or persons with appropriate “skills, knowledge and experience”. 

A sounder approach to guiding the ethical assessment of QI would be to identify the elements of Research Merit and Integrity that are relevant to the ethical assessment of QI.  The principle, as set out on p.12 of the National Statement, has 6 elements.  Of these, (a) sets too high a requirement of benefit for many QI activities, which do not need to aspire to such aims to be of value.

Justice

Line 2: the requirement that Qi activities should not burden those involved is unrealistic and an inaccurate reference to the relevant element of the justice principle.  That principles requires that the burdens of participation in research should not be unfair, not that there be no burden.

Second sentence: it is doubtful whether what is an appropriate obligation in human research applies in QI activities, nor does it make sense that, for example, patients would routinely be informed of the outcomes of QI activities in hospitals.

The last sentence of this paragraph is appears to create a new obligation concerning a defensible plan.  The function of the document is to show how the National Statement can be used: it is not to add new guidelines, nor does the document have the status of guidelines.  

Further, why should QI activities have attached to them an obligation that is not attached, except in limited circumstances, to human research projects?  Doing so appears to make doing QI more burdensome than doing research, an anomalous outcome.

Beneficence

Line 1: It is not meaningful to refer to “potential risk”.

Second sentence: the statement that the risk of QI activities need to be justified by the benefits (ought to be “potential” benefits) “to participants and/or the wider community” is another example of the document’s failure to adopt a consistent view that QI IS NOT RESEARCH.  QI activities will often is not usually have no benefits for the participants and those to the community will not be immediate, but may only follow the implementation of changes that QI activities reveal as being necessary.  The standard is simply inapplicable.

A more relevant stand would be for the risk of involvement in QI activities to justified by the potential benefits of the QI activity, which will often be slight – and so the risks need to be low.

Respect

Paragraph 1, line 6-7: the statement that “the nature of the consent process should reflect the potential(sic) risks and (potential?) benefits to an individual” is not an accurate reflection of the National Statement unless “the participant’s personal and cultural circumstances” is added.

Second paragraph: the references in this paragraph to Privacy regulation and the need for reliance on guidelines under s95 or s95A are confused and from one perspective, wrong. The confusion again arises from not adopting a consistent view that QI IS NOT RESEARCH, because the guidelines under s95 apply only to the use of information in medical research, and so do not apply to QI if it is not research. Although the s95A guidelines do have a wider application, the need to refer to them will only arise where an obligation to seek consent remains and an HREC is being asked to approve such a use in the absence of that consent. 

National Privacy Principle 2 allows organizations to use or disclose personal health information about an individual for a secondary purpose other than the primary purpose of collection where, in the case of sensitive information, the secondary purpose is directly related to the primary purpose of collection and an individual would reasonably expect the organization to use or disclose the information for that purpose.  

The Federal Privacy Commissioner issued guidelines called “Privacy in the Private Health Sector, November 2001, which stated, at pp. 14-15:

“Information on other directly related secondary purposes in the health sector

Directly related secondary purposes may include many activities or processes necessary to the functioning of the health sector.

Where the use or disclosure of de-identified data will not suffice, and provided it is within the reasonable expectations of the individual, no extra steps need be taken when using or disclosing relevant personal information in circumstances, such as:

….

an organisation’s quality assurance or clinical audit activities, where they evaluate and seek to improve the delivery of a particular treatment or service;”

State health privacy regimes have taken similar positions.  Accordingly, privacy regulation does not require that people consent to the use of their information for QI activities.  It does require that such use be in their reasonable expectation and this needs to be established by clear advice to that effect whenever such information is collected.

This document could offer a valuable service by providing a suitable form of words to be included in all documents used to collect health or other personal information, words that will establish that use for QI will be in the reasonable expectation of the providers.

There remains the ethical question of whether people’s consent should be sought to the use of their information for QI, and, if so, whether this requirement can be waived.  If there is a requirement, that waiver need not be confined to an HREC, for two reasons.  In the first place, as explained above, privacy regulation does not require an HREC decision for personal information to be used for QI and in the second place, because that constraint applies only to the use of information for research and QI IS NOT RESEARCH.  Accordingly, there is nothing in the National Statement or the privacy regulation to prevent a review body other than an HREC could waive the need for consent.

Senior executive responsibilities

First dot-point: for the reasons set out above, this should be amended to read “..complies with relevant elements of principles and relevant processes set out in the National Statement and this statement.”

 

Second dot-point: it is not clear what the boxes are that are referred to.

 

Third dot-point: this appears to be a guideline – yet this Statement does not have the status of guidelines – it is advice on how to use the National Statement.

Institutional responsibilities for ethical review of QI activities

Institutional responsibilities

The opportunity to set out clearly the responsibilities of institutions to see that their QI activities receive appropriate levels of ethical review has been missed.  It is recommended that such a statement be added as the first sub-heading.

Department responsibilities.

It is not clear what a “department” is.

The first dot-point needs to be refined as set out above to require QI activities to comply with relevant elements of the principles and process of the National Statement.

Second dot-point: this is another apparent guideline and subject to same criticisms as have been raised before in this submission.   Further, there is no obligation to establish such review processes – it is sufficient that institutions are authorized to do so.  The ambiguity of “department” remains.

Publication

Last line: an intent to publish need not affect the process of ethical review. 

The policy statement of the International Committee of Medical Journal Editors (ICJME) states:

Uniform Requirements for Manuscripts Submitted to Biomedical Journals:

Ethical Considerations in the Conduct and Reporting of Research: Protection of Human Subjects and Animals in Research

"When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5)."

Accordingly, provided the procedures used have followed the standards of the responsible committee of the institution, and these conform to this statement’s guidance, both non-HREC and HREC review will suffice.

General Comments
Comments: 

Some alternative wording for the Introduction to the document:

PURPOSE

The purpose of this addition to the “Using the National Statement” guidance is to show how some of the principles and processes set out in the National Statement can be used to determine the ethical acceptability of quality improvement (QI) activities.

 

PREMISE

The premise of the guidance contained in this document is that QI activities are not research.  However, because QI activities either use information already collected from people or collect new information from people, they often have ethical implications that are similar to those that arise in human research.

For this reason, some of the principles and processes set out in the National Statement for use when assessing the ethical acceptability of human research can be used to assess the ethical acceptability of QI activities.

 

PROCESSES

The National Statement authorises institutions to use all or any of three processes of ethical review: review by a human research ethics committee (HREC review), review by a body other than an HREC (non-HREC review) or exemption.

The level of risk to participants in an activity determines which of these processes can be used.

The National Statement defines three risk levels: more than low risk, meaning more than discomfort; not more than low risk, not more than discomfort and negligible, not more than inconvenience.

It is likely that QI activities will involve not more than low risk to participants – and some may only involve negligible risk.  Accordingly, institutions would be authorized to use non-HREC review processes.

 

PRINCIPLES

The National Statement sets out four key principles and provides guidance on their application in specific human research contexts.

Each of the principles contains a number of elements, all of which are relevant to the assessment of the ethical acceptability of any human research project.  Not all of these elements will be relevant to the assessment of the ethical acceptability of QI activities.

This document identifies those elements that are likely to be relevant to the assessment of the ethical acceptability of QI activities.

The elements of the principles are set out on pages 12-13 of the National Statement (here insert the material in this submission that appears under the heading “QI and the National Statement on Ethical Conduct in Human Research”)

Page reviewed: 17 June, 2013