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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

“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
  
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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

A call for a national inquiry into the burden of research ethics and governance1

 

Adrian Barnett, Queensland University of Technology

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Do we need a national inquiry into the burden of research ethics and governance in health and medical research Australia? Many Australian researchers would cry “yes!” because they have repeatedly experienced application systems that are time-consuming and illogical.

I have never met a researcher who did not think that ethics and research integrity wasn’t vitally important, but many current application systems have more to do with risk aversion than the safety of patients or the public.

This risk aversion means that millions of dollars worth of Australian researchers’ time is being wasted on submitting the same forms to multiple ethical review committees. For example, getting approvals for our group’s low-risk survey of nurses in 50 hospitals cost an estimated $348,000 in staff time and delayed the study by six months (Barnett et al 2016).

Another Australian study of 60 nationwide hospitals spent an estimated $264,000 on approvals and the researchers’ experienced puzzling variations in submission requirements and decisions about the study’s level of risk (Clay-Williams et al 2018).

Another Australian study found that the time taken to complete the ethics and governance forms for a negligible risk study took eight times longer than the actual research (Rush et al 2018).

These are not isolated experiences and the current processes are driving researchers crazy. In our recent one-day meeting on improving research quality, we asked attendees to vote on the changes most needed to improve research and reduce research waste. The idea of a national inquiry into ethics and governance was voted fourth highest out of 21 policies (the full survey results are available here).

What should a national inquiry consider? The primary question should be: why can’t we have a national system? A national system that has standardised forms and is used by every state and territory health department. A national system that covers all types of research, not just clinical trials.

An inquiry into ethics processes could have been part of the Chubb inquiry (had Labor won the election) that promised a root-and-branch examination of Australia’s overall research framework and to “ensure that Australia maintains its international competitive advantage”. Other countries use simpler approval processes and we hamper our ability to conduct research by tying up researchers in wasteful knots of unnecessary paperwork.

A national inquiry should engage with the people doing the hard work of reviewing applications on ethics committees. These people should also welcome a streamlined system that cuts-out the requirement for them to review already reviewed applications, giving them more time to focus on important ethical considerations.

Researchers should also acknowledge that some delays and duplication are their own fault. A key problem is that ethics applications can be so badly written that committee members cannot judge the ethical implications of the study.

Australian researchers want a system that improves and facilities their research, not one that puts “virtually insurmountable and costly barriers in place” (Clay-Williams et al 2018). We want a “tailored and harmonised” system (Rush et al 2018).

Many researchers have been talking about the need for change for over a decade, but have seen only small improvements and plenty of backwards steps too. A national inquiry would cost time and money, but the potential long-term savings to researchers and the public from this important reform could be enormous.

Declaration of conflicts of interest: Adrian Barnett receives funding from the National Health and Medical Research Council.

References

  • Rush, A., Ling, R., Carpenter, J. E., Carter, C., Searles, A., & Byrne, J. A. (2018). Research governance review of a negligible-risk research project: Too much of a good thing? Research Ethics, 14(3), 1–12. https://doi.org/10.1177/1747016117739937
  • Clay-Williams, R., Taylor, N. & Braithwaite, J. (2018) Potential solutions to improve the governance of multicentre health services research. Med J Aust; 208 (4): doi: 10.5694/mja16.01268
  • Barnett, A. G., Campbell, M. J., Campbell, Shield, C., Farrington, A., Hall, L., Page, K., Gardner, A., Mitchell, B.G. & Graves, N. (2016) The high costs of getting ethical and site-specific approvals for multi-centre research. Research Integrity and Peer Review 1:16 https://doi.org/10.1186/s41073-016-0023-6

This post may be cited as:
Barnett, A. G. (22  May 2019) A call for a national inquiry into the burden of research ethics and governance. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/a-call-for-a-national-inquiry-into-the-burden-of-research-ethics-and-governance

Why do we need Category D appointments on HRECs and how should we find suitable people?0

 

Judith C S Redman

The compulsory presence of the Category D members on Australian Human Research Ethics Committees (HRECs) can be controversial. Category D used to be termed ‘minister of religion’ and most HRECs recruited ordained Christian ministers to fill these roles, although at least one of the Monash University HREC Category D members has been a rabbi (recruited by me). People question the need for a ‘religious perspective’ on HRECs, especially on those that regularly look at research concerning issues like abortion, contraception or euthanasia, or stem-cell research where ‘the Church’ is seen to have negative stances. I am a Uniting Church minister and a long-term university chaplain, which makes me a prime target for recruitment to the Category D position on university HRECs. I am currently in my 18th year as a Category D appointment, serving my fourth university. Clearly, it is something I find interesting and rewarding and I would like to offer some comments on the nature of the position.

First, referring to the category as ‘minister of religion’ is misleading, because the role is not to provide a religious perspective per se. ‘Minister of religion’ was included as a category (along with lay woman, lay man and member external to the institution) in the First Report by the NH&MRC Working Party On Ethics in Medical Research published in 1982 (p 20) and incorporated into the first National Statement published in 1983. In the 1999 version of the National Statement, the position was listed as: ‘at least one member who is a minister of religion, or a person who performs a similar role in a community such as an Aboriginal elder’ (NHMRC, 1999, p 16 – emphasis mine), thus hinting that it was not the minister’s religious perspective that was being sought. In fact, even when Australian society was far less multi-faith than it is today, no one clergy-person could provide a representative religious perspective. The 2007 National Statement made the purpose more overt in describing the category as ‘at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion’ (NHMRC, 2007 p 81). This wording has carried across to the current revision. (NHMRC, 2018 p 87).

What, then, is it that Category D members of HRECs bring to meetings? What is pastoral care? Finding a simple definition is somewhat challenging but Grove (2004, p. 34) defines it as ‘all measures to assist an individual person or a community reach their full potential, success and happiness in coming to a deeper understanding of their own humanness’. Pastoral carers are not therapists, but they do come into contact with human beings at high and low points of their lives. Often, however, they see more every-day lows than those that typically cause people to make appointments with therapists – and very few people will pay a therapist to share joys. They do, however, come to congregational clergy and Aboriginal elders to share the joy of the birth of a child and to mark other rites of passage within the life of their communities. Pastoral carers thus have insights into how people make meaning in their lives that many other people are not privileged to share. They can therefore offer broader perspectives on how participants might respond to some kinds of research than can many other HREC members.

Second, ‘the Church’ does not have a uniform perspective on biomedical ethical issues. While some denominations have specific stances on abortion, contraception, euthanasia, stem-cell research and so on, others do not. In my own denomination, most forms of contraception are widely accepted although some, such as the ‘morning after pill’ would divide members and clergy alike. Abortion, euthanasia and stem-cell research are all controversial, with Uniting Church members and clergy holding a range of opinions very close to the spread found in the wider community. It is therefore not possible to assume that any given Christian minister of religion will be against this kind of research as a matter of principle. This would also be true for pastoral carers from other world religions. Further, it is my experience as someone who has worked in a multicultural and multifaith university environment for several decades that while the things that divide religions are the things we notice most, we have far more in common than things that divide us. A fundamental part of most religions is an attempt to help people to understand what it means to be human, so someone with pastoral care experience from within a religious context can offer valuable insights into the human condition that are not bound by the teachings of her or his religion. They may well, for instance, have supported people making difficult decisions about biomedical ethical issues and have a better insight into whether the researchers have put appropriate measures in place for support of participants.

In addition, ministers of religion are not the only people on HRECs whose perspectives are shaped by religion. I have certainly known people serving in other roles on HRECs whose faith positions affect how they view some of the applications we are considering. The religious perspectives of Category D members are more likely to be overt, but any member of a HREC should declare a conflict of interest if s/he holds a faith/moral position that would not allow her/him to approve particular research no matter how well it complied with the National Statement. It is also quite likely that ministers of religion have studied ethics at a tertiary level as part of their ministry training.

Thus, I would argue that people with experience in providing pastoral care bring a unique and valuable perspective to the deliberations of HRECs, as long as they are selected with a little care. If you are responsible for recruiting members and biomedical research involving abortion, euthanasia, contraception or stem cell research and/or research around human sexuality and sexual orientation come up regularly in your business, you need to address the issues in your recruitment of Category D members. Although members of some religious groups are more likely to have problems with these issues, you cannot predict how a particular pastoral carer might react based on his or her religious group’s official policy. If you are replacing a Category D appointee or recruiting an extra one, the current one may be able to suggest colleagues that s/he thinks might be suitable. If you are setting up a new committee, the Category D appointees on nearby committees might have some ideas about suitable people. Some pastoral carers might even be willing to belong to more than one committee as long as the agendas are not too long and the meeting dates do not clash. In the end, however, you need to inform potential appointees about the kinds of issues you regularly deal with and ask them if they see any problem about their being able to assess these kinds of applications objectively. You also need to ensure that they understand that they are being recruited for their pastoral care experience not to provide a religious perspective. Taking these two steps should see your committee well served by your Category D appointments as they offer their particular perspectives on the applications before you.

We would like to build upon Judith’s excellent post about the pastoral position in future editions with similar commentaries about other positions.  Please contact us on HREC_members@ahrecs.com to discuss.

References

Grove, M. (2004). The Three R’s of Pastoral Care: Relationships, Respect and Responsibility. Pastoral Care in Education, 22(2), 34-38. doi:10.1111/j.0264-3944.2004.00261.x.

National Health and Medical Research Council (Australia) (1982). First Report By NHMRC Working Party on Ethics In Medical Research: Research in Humans. National Health and Medical Research Council, Canberra, ACT.

National Health and Medical Research Council (Australia) (1999). National Statement on Ethical Conduct in Research involving Humans. National Health and Medical Research Council, Canberra, ACT.

National Health and Medical Research Council (Australia) (2007). National Statement on Ethical Conduct in Human Research. National Health and Medical Research Council, Canberra, ACT.

National Health and Medical Research Council (Australia) (2018). National Statement on Ethical Conduct in Human Research, updated 2018. National Health and Medical Research Council, Canberra, ACT.

Contributor
Rev Dr Judith C S Redman, Chaplaincy Coordinator, Charles Sturt and La Trobe Universities, Albury-Wodonga Campuses | jredman@csu.edu.au

This post may be cited as:
Redman, JCS (27 March 2019) Why do we need Category D appointments on HRECs and how should we find suitable people? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/why-do-we-need-category-d-appointments-on-hrecs-and-how-should-we-find-suitable-people

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