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We respect you… we just don’t need to hear from you any more: Should the consumer and their community participate in research as partners instead of just being subjects?1

 

By
Dr Gary Allen| Senior Policy Officer, Office for Research Griffith University | Ambassador Council the Hopkins Centre|
Ambassador MS Qld | Member Labor Enabled| Senior Consultant AHRECS

Associate Professor Carolyn Ehrlich| the Hopkins Centre| Research fellow at Griffith University

On behalf of the consumer inclusion in ethics research project, The Hopkins Centre, Griffith University

Much has already been said about the significance of the 2018 update to the Australian Code for the Responsible Conduct of Research. The Australian Code describes the national framework for the responsible conception, design, conduct, governance and reporting of research. Collectively this is referred to as research integrity. The Australian Code has changed from a 37-page book of detailed and prescriptive rules to a six-page book of high-level principles and responsibilities.

This is not another piece arguing the pros and cons of the flexibility of principles or the certainty of a single national standard.

Instead, this is a discussion about an important idea, which was present in the 2007 version of the Australian Code, but that was discarded without explanation or acknowledgement in the 2018 update. This important idea relates to consumer and community participation and its extension to consumer and community involvement in research.

At provision 1.13 of the 2007 version of the Australian Code there was a simple statement that Australian research institutions and researchers should encourage and facilitate consumer and community participation in research. The provision was included in the 2007 version as one part of the implementation of the Statement on Consumer and Community Participation in Health and Medical Research (NHMRC and Consumers’ Health Forum of Australia Inc, 2002) and went on to underpin the updated version of that statement, which was released in September 2016.  The absence from the 2018 version of the Australian Code of even a brief reference to consumer/community participation in research is (or SHOULD be) a significant cause for concern.

That brief encouragement provided support for consumer-guided designs, research participants as co-researchers and action research across most disciplines. With a few sentences, it mainstreamed the Statement on Consumer and Community Participation in Health and Medical Research and reinforced the importance of consumers and communities beyond ‘just’ research subjects in medical research.

Examples of that participation include the role of consumers and community members:

  1. On a reference/advisory group (including providing lived-experience with regard to the focus, objectives and deliverables of a project)
  2. As co-researchers
  3. In providing lived-experience into the significance of risks, harms and burdens, and the degree to which the risks are justified by the anticipated benefits (see Pär Segerdah 2019).
  4. In providing valuable insights for service/clinical decisions (see Carlini 2019 for an example).

A real example of this working well is of Cancer Australia which mandates the inclusion of consumers in their funding scheme, both in terms of applicants articulating how consumers are engaged (in the ways outlined above and also as reviewers and members of the review panels that evaluate grants). The inclusion of consumers improves projects immeasurably.  Cooperative cancer trials groups have a consumer advisory panel or committee. It would be unimaginable to do cancer trials without consumer involvement in their design. Such community participation is also evident in the recently approved research strategy at Epworth Health.

The above matters (such as whether a project is addressing a genuine community need and whether the risks of the project are justified by its benefits) can be especially significant for vulnerable individuals, especially persons living with ‘invisible conditions’, whereby people may have symptoms or disabilities that might not be immediately obvious to others, and/or when the ‘subjects’ of research are vulnerable, over-researched, or historically disenfranchised. Rather than protecting them from harm, and without a clear mandate for involving them more fully in the co-design and co-production of research that directly impacts their lives, there is a real risk of unintended consequences whereby these people may become even more disenfranchised, over-researched and vulnerable research ‘subjects’.

It is important to acknowledge that the 2016 Statement remains in place, the National Statement on Ethical Conduct in Human Research (2007 updated 2018) continues to articulate the core values of justice and respect, and the new Chapter 3.1 of the 2018 update of the National Statement on Ethical Conductmentions co-researcher designs. More specifically, paragraphs 1.1(a) and 2.1.5 identify community engagement as an important element in research design and planning. The omission from the Australian Code (2018) is out of step with the National Safety and Quality Health Service Standard which calls (2012 p15) for consumer and community involvement in deliberations about risk.

What is a concern now is that the overarching Australian Code for the Responsible Conduct of Research no longer urges publicly-funded research institutions to encourage consumer and community participation in research beyond them being the subjects of research.  On balance, this appears to be inconsistent with other relevant national research standards issued by the same agencies as the Code.

Those voices and perspectives were around before the 2007 version of the Australian Code and hopefully, they will continue to be into the future. That is true because it is becoming more widely accepted that consumers, such as people living with a chronic disease or disability and their carers, have a valuable perspective and a voice that should be listened to. One way a research project can have impact is by heeding those voices and meeting the needs of those Australians. However, in the 2018 update of the Australian Code, there is no longer an obligation on Australian institutions and researchers to encourage and facilitate consumer and community participation in research.

But will the same amount and scope of consumer and community-engaged research be conducted without that encouragement in the Australian Code?

It seems we are about to find out. We just wished there had been a national discussion about that change first – including targeted engagement with the populations who are now no longer encouraged to collaboratively participate in research, and who will potentially be relegated back to a position of being a subject within researcher designed projects and studies.

One way the current situation could be addressed would be in a good practice guide. The Australian Code (2018) is complemented with good practice guides, which suggest how institutions and researchers should interpret and apply the Australian Code’s principles and responsibilities to their practice. A good practice guide for collaborative research could reinforce the importance of consumer and community participation in research.

REFERENCES

Carlini, J. (18 January 2018) Consumer Co-design for End of Life Care Discharge Project. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/consumer-co-design-for-end-of-life-care-discharge-project

NHMRC(2007) Australian Code for the Responsible Conduct of Research

NHMRC(2007 updated 2018) National Statement on Ethical Conduct in Human Research

NHMRC (2016) Statement on Consumer and Community Involvement in Health and Medical Research

NHMRC (2018) Australian Code for the Responsible Conduct of Research

NSQHS (2012) National Safety and Quality Health Service Standards

Pär Segerdah (2019) Ask the patients about the benefits and the risks. The Ethics Blog. Retrieved from: https://ethicsblog.crb.uu.se/2019/01/16/ask-the-patients-about-the-benefits-and-the-risks/

ACKNOWLEDGEMENTS

With grateful thanks to the following people for their contributions:

Delena Amsters, QHealth
Mark Israel, AHRECS
Mandy Nielsen, QHealth
Michael Norwood, Griffith University
Maddy Slattery, Griffith University
Colin Thomson AM, AHRECS
Nik Zeps, AHRECS, Epworth Healthcare

This post may be cited as:
Allen, G. & Ehrlich, C. (21 June 2019) We respect you… we just don’t need to hear from you any more: Should the consumer and their community participate in research as partners instead of just being subjects? Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/we-respect-you-we-just-dont-need-to-hear-from-you-any-more-should-the-consumer-and-their-community-participate-in-research-as-partners-instead-of-just-being-subjects

Update on the new subscribers’ area0

 

We are currently expecting the new service to go live prior to us sending the July 2019 edition of the Research Ethics Monthly.

It is being built by some talented designers and coders we are excited to be working with.

The service will be located at AHRECS.vip, will be far more easily browsed and used, with an annual subscription of $360 (Plus GST and a 2% charge if you pay by credit card).

We will have more about this new service in the next edition.  Email VIP@ahrecs.com if you have any questions.

“Reminder about service options and an easy way to pay AHRECS,” we say… aware of how corporate sleazy that sounds0

 

Dr Gary Allen, Senior Consultants AHRECS
Prof. Mark Israel
Prof. Colin Thomson AM
  
   .

Just in time for the end of the financial year (though we know many research institutions budget around calendar year), AHRECS has the capacity to receive payments by credit card. We thought this a good time to remind you of those of our services that lend themselves nicely to credit card payment.

In-meeting 30-minute professional development for HREC members ($900) – Workshops/briefings/guided discussion about your selected topic.  An easy way to tick the HREC member training box with minimum interruption to the work of a busy committee.  An experienced AHRECS team member will provide a PowerPoint with pre-recorded audio that could be played in a meeting (and retained for five years for viewing by absent and new members); the team member will ‘phone or Zoom into the meeting for Q&A/discussion. If so AHRECS can also record that component for your later use.

Access the new subscription area ($360) – Thank you to everyone who expressed interest and support for the new in-house subscribers’ area.  This is scheduled to go live in July/August.  By subscribing, you will get access to an impressive (and growing) set of HRE and RI resources that are Creative Commons so you can use them within your organisations as much as you want.

Bespoke webinar for your research community ($1500) – A one-hour webinar on a human research ethics or research integrity topic of your choice, tailored to your institution. The price allows for up to 200 attendees and provision of a recording for your later use.

3-hour orientation workshop for new RIAs ($2300) – Provide your new Research Integrity Advisers with a practical, topical and engaging orientation through this four-hour workshop.

Ten hours of on-call advice ($3400) – On-call advice can be used for both human research ethics and research integrity advice.  We can offer advice on everything from review feedback on a difficult application to commenting on a draft policy and providing advice on a tricky question with which the committee has been struggling.  In the research integrity space, we can suggest an appropriate investigation approach for an alleged breach, comment on a RI resource, or suggest references on a key topic.  The purchased time can be used in 15min, 30min, 1h, 4h and 8h blocks

Send an email to gary.allen@ahrecs.comif you have any questions.

The prices above exclude GST and a 2% credit card processing fee

Is it something I said (or the way I said it)?0

Posted by Admin in Human Research Ethics on May 29, 2019 / Keywords: ,
 

Dr Gary Allen, Senior Consultants AHRECS
Prof. Mark Israel
Prof. Colin Thomson AM
  
   .

Reflecting on review feedback

Feedback from the research ethics review of a project is often one of the first interactions between a researcher and a research ethics committee. It helps define, and can permanently tarnish, the relationship between an institution’s committee and research community – for good, or for bad. So, it’s centrally important to an effective ethics research culture.

Unfortunately, typically, it only receives cursory attention in national human research ethics arrangements and institutional policy. It does not feature highly in review body member training, standard operating procedures or the orientation of secretaries and chairpersons.

Having worked with many review bodies during the last few decades, we thought it might be helpful to share some ideas and experiences.

1 NATIONAL ARRANGEMENTS– review feedback should be based clearly upon the relevant national arrangements: these provide the justification for the feedback and establish a neutral ground on which to resolve differences. For example, in Australia it should be located in and cite a provision of the National Statement (see Common Missteps 6).

Feedback on revision should make its ethical consideration explicit if it is not based on national or institutional policies. (Dr Gan Zhen-Rong, Human Research Ethics Committee, National Cheng Kung University, Taiwan)

2 INSTUTIONAL ARRANGEMENTS– when the host institution’s policy or procedures discuss a matter relevant to the project being reviewed, the review feedback should be located in and cite those arrangements.

3 GUIDANCE MATERIAL– A valuable role can be played by guidance material, such as suggesting ways a national/institutional policy can be applied in a situation, or how a researcher might justify an alternative. The Griffith University Research Ethics Manual (GUREM) is one such document, which Griffith University has licensed[1] so other institutions can copy and modify its booklets to create its own resource manual.

4 FACILITATION AS A CORE OBJECTIVE– A central objective of research ethics review is facilitating the ethical conduct of research. This can be promoted by constructive feedback with clear explanations and prompts (for what is needed to satisfy the committee) and how the matter can be resolved.

Research regulators in general, including HRECs, have not only a responsibility to uphold the principles of the regulatory ‘ecosystem’, but must ensure and enable a ‘growth mindset’ that fundamentally has the research participant at its core… fostering and nurturing novice researchers as well as redirecting and upskilling seasoned researchers is vital. To this end, removing a punitive viewpoint and replacing it with an opportunity to educate and highlight the principles of the framework is required.  Not only will it foster a strong collaborative research culture, after all we are all on it for the participants’ benefit, but such an approach will assist in removing the ‘us’ versus ‘them’ mindset that currently pits researchers against research administrators. (Sonia Hancock, Manager, Research Integrity and Compliance, Metro South Health Research, Queensland)

We do this at CQU (Chair chats [with researchers about specific items in their proposal]), it promotes a collegial interaction between HREC and researchers and actually reduces workload for the committee as applications don’t bounce around. (Prof. Tania Signal, Chair, Central Queensland University Human Research Ethics Committee)

It’s really important to have a review process that models the respect that the committee would want the applicants to show to participants in the research. (Lindsey Te Ata o Tu MacDonald, University of Canterbury Human Ethics Committee, New Zealand).

— COMMON MISSTEPS —

5 ‘BECAUSE WE ALWAYS INSIST ON THIS’ – When crafting review feedback, a  review body should be wary of matters that do not adhere to one of the above, but are consistently included in the review body’s feedback to applicants, primarily because the committee always insists upon it. Ignoring the circular logic, if there is no other basis for the feedback item (see above), it is almost certainly time to change that habit.

Too often committees can lose sight of the differences in context, participant populations and the myriad other variables that make it difficult to apply precedents. The principles and values of committee members (within the context of applicable regulations and legislation) should drive review. (Lindsey Te Ata o Tu MacDonald, University of Canterbury Human Ethics Committee, New Zealand

Some review bodies still insist on participants signing a consent form (see Wynn and Israel, 2018). Fetishising such standards is dismissive of the agency of potential participants, is excessively paternalistic and may also create a barrier to participation for some demographic groups. There may be circumstances where such practices are warranted, but it should not be an automatic requirement. And don’t get us started on insisting on witness signatures on consent forms.

Discussion of what the National Statement actually requires can also be used to show how familiarity with, rather than prescriptive use of, the National Statement can avoid unnecessarily constraining ethical research.  References to such passages as paragraph 2.2.4 and this paragraph on p.11 of the National Statement speaks to this idea:

These ethical guidelines are not simply a set of rules. Their application should not be mechanical. It always requires, from each individual, deliberation on the values and principles, exercise of judgement, and an appreciation of context.

6 FIXATING ON ONE PROVISION RATHER THAN THE WIDER MESSAGE– In circumstances when a review body is working from a detailed set of arrangements (such as the National Statement (2007 updated 2018) in Australia) there is a danger the review body will focus on one provision, while missing the wider intention of a section. This bad habit can easily become a standard requirement of the review body (see 5). For example, some well-meaning review bodies can insist recruitment material and consent material are depersonalised, written in the passive so that friendly courtesy is removed even from interaction involving peers.  Review bodies may believe in so doing they are faithfully applying NS item 2.2.1 (consent needs to be voluntary) and avoiding language that might be seen as persuasive and therefore in some way manipulative. In doing so they are ignoring NS 2.2.3 and 5.2.17 (be relevant to the participants’ circumstances). Some review bodies still insist on participants signing a consent form (see Wynn and Israel, 2018). Fetishising such standards is dismissive of the agency of potential participants, is excessively paternalistic and may also create a barrier to participation for some demographic groups. There may be circumstances where such practices are warranted, but it should not be an automatic requirement.

7 PROOFREADING– A review body should not spend more than a few moments of meeting time/words in the review feedback proofreading recruitment/consent material or a data collection instrument. Instead the review body should indicate proofreading is required, provide some examples and indicate there are more requiring attention. Consideration of the revised material should be delegated and handled outside a later meeting.

8 MANY WAYS TO SOLVE A PROBLEM– There is rarely only one solution to an ethical challenge (so there can be difference of view between researchers and reviewers). In addition to project-specific matters such as conventions of the (sub)discipline, methodology, potential participant pool and contextual considerations, there can be more than one ethically acceptable solution. Consequently, a feedback item should not imply there is only one way to tackle a problem.

Committees need to be genuinely open to rebuttal or alternate approaches from researchers if that argument is couched within the framework of the National Statement. (Prof. Tania Signal, Chair, Central Queensland University Human Research Ethics Committee)

Too often committees can lose sight of the differences in context, participant populations and the myriad other variables that make it difficult to apply precedents. The principles and values of committee members (within the context of applicable regulations and legislation) should drive review. (Lindsey MacDonald, University of Canterbury Human Ethics Committee)

9 RISK-AVERSE– The review body should take care to ensure (and reflect on over time) its decisions to ensure they aren’t overly risk-averse or conservative.

— TIPS —

10 POSITIVE FEEDBACK– Learn from the broader literature on effective feedback and identify a component of the proposed project to compliment, such as the importance of the research question, the care and thought demonstrated by the approach to a problem, the described respectful approach to a participant cohort, or perhaps thoroughly addressing a matter that was missed by the applicants in earlier proposals.

Common courtesies go a long way within ethics processes. Thank applicants for applying for review committee, start most requests with ‘please… (comment/consider/explain)’, and rephrase demands as questions. In my experience adding those phrases help to soften even harsh criticism of applications, so that productive – not defensive – relationships thrive between the committee and researchers. Encouraging researchers to ring the Chair as soon as they have a problem with a committee’s feedback was the single most important time-saving device for my time as chair  – a minute or two on the phone is so much more constructive than emails. (Lindsey Te Ata o Tu MacDonald, University of Canterbury Human Ethics Committee, New Zealand)

11 NOT A CONDITION OF APPROVAL– If a review body is aware a matter is beyond its remit but could impact upon the project’s chances of success, its quality or impact, it could be framed in the following way, ‘The following is not a condition of ethics approval, but the reviewers noted… Have the applicants considered this?’.

12 LIMITS OF ETHICS APPROVAL– In some cases, a review body might only feel able to grant approval because of the involvement of a specific individual team member or support service. The implication is that if her/his involvement ends, or the service is no longer available, the project must be paused until alternative arrangements can be made. Similarly, the review body might not want the ethics approval of the project to be seen as a precedent where similar projects without the involvement of that experienced person, or service, will also be approved. In such circumstances, the reasons/limits of the approval should be specified in the review feedback.

13 INVITE REFLECTION– Assuming an applicant has missed a matter or is indifferent to a problem might not only be incorrect, it might make the review process more adversarial. A more positive approach could be: ‘Given the experience of the applicants, <review body> would be interested to hear how you have previously handled… and the degree to which you feel that would be useful in this case.’

14 REAs– If your institution has established a network of collegiate Research Ethics Advisers and the review body is concerned applicants have not understood their responsibilities and/or the review feedback will require considerable explanatory text, the review body could direct the applicants to consult their REA before resubmitting. The Chair (or nominee) could speak with the REA to explain the situation.  If your institution does not have such a network, face to face conversations with researchers, the Chair and/or some committee members can usually achieve agreed resolutions.

15 PILOT TESTING– In circumstances where a review body is uncertain about the described risks/proposed risk mitigation strategy, the review body might suggest a limited pilot test. Such a test might involve a smaller number of participants for a specified period of time, with a view to the researchers reporting back on the actual experience of those matters. The ethics approval could either be converted a full approval or the project modified on the basis of the experienced.

16 CONTINUE TO BUILD YOUR EXPERTISE – No research ethics committee can be experts in everything. Once a committee accepts this, there are various strategies that it can adopt. First, it can engage in collective professional development making sure it receives regular briefings on new methods, disciplines, groups of participants or regulations. In some cases, these can be provided by researchers (either individuals or groups); in others, the committee may need to bring in external expertise. Second, it might increase the size of the committee to add expertise but look for more flexible ways of deploying that membership.

…if a research team is about to begin utilising a new technique/procedure/machine that beeps etc. consider inviting them to provide a short briefing presentation to the HREC ahead of any submissions. This allows a two-way conversation, HREC can highlight issues that will need further consideration and researchers can address misconceptions. (Prof. Tania Signal, Chair, Central Queensland University Human Research Ethics Committee)

17 PROPORTIONAL CONSIDERATION– If the practice of your review committee is that all researcher responses are considered at the next meeting of the review body, consider delegating this task to administrative review, executive review or to a small panel of the review body depending on the level of the review that might be required for any particular case. Perhaps the response should only go back to the review body in the most sensitive of circumstances. Nevertheless, those delegated bodies should be able to escalate the consideration to a higher pathway.

Distinguish between the problems of submitted proposals to see if they reflect substantial ethical issues or just raise minor matters such as failure to provide sufficient information, demonstrate a lack of submission experience or careless editing. If the latter, consider delegating this task to administrative or executive review.(Dr Gan Zhen-Rong, Human Research Ethics Committee, National Cheng Kung University, Taiwan)

Acknowledgements

We want REM to start conversations among its readers. In this issue, we are grateful to Dr Gan Zhen-Rong (National Cheng Kung University, Taiwan), Prof. Tania Signal (Chair of HREC, Central Queensland University), Dr Lindsey Te Ata o Tu MacDonald (University of Canterbury) and Sonia Hancock (Metro South Health, Queensland) for providing comments (at short notice) on this article.

Bibliography

Wynn, LL and Israel, M (2018) The Fetishes of Consent: Signatures, Paper and Writing in Research Ethics Review. American Anthropologist120(4) pp795–806.

[1]Dr Gary Allen is the principal author of the GUREM and receives a proportion of all sales, so AHRECS acknowledges the conflicts of interest in mentioning the manual.

This post may be cited as:
Allen, G., Israel, M. & Thomson, C. (29  May 2019) Is it something I said (or the way I said it)? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/is-it-something-i-said-or-the-way-i-said-it

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