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Should you be worried about paying children to take part in research?0

Posted by Admin in Human Research Ethics on July 30, 2019
 

Associate Professor Stephanie Taplin, Institute of Child Protection Studies, Australian Catholic University

 

The commentary below the article is by Virginia Morrow, Visiting Professor, University College London 

Decision-making about children’s participation in research requires consideration of factors such as the risk or sensitivity of the study, payments, study methods and the potential benefits for participants (NHMRC, 2007: Ch: 4.2). Although these issues are generally weighed up by adult decision-makers, including ethics committees, organisational gatekeepers and parents, it is important that children and young people are given the opportunity to make their own decisions about participating in research about issues that affect them (NHMRC, 2007: Ch: 4.2).

In Australia and other developed countries, it is common to provide payments to adult research participants as compensation or reimbursement. However, research payments for children are more contentious, even when research involves low or negligible risk. The general principle is that payments must not be offered at such a level that they become an inducement that is likely to encourage participants to take risks they would not be willing to accept with smaller payments (NHMRC, 2007: Ch: 2.2; Appelbaum, Lidz, & Klitzman, 2009; Wendler, Rackoff, Emanuel, & Grady, 2002; Spriggs, 2010; Singer & Couper, 2008). However, a lack of specific guidance has led some ethics committees to refuse research payments for children (Bagley et al., 2007), which may in turn reduce the likelihood of children participating in research about issues that affect them.

The Managing Ethical Studies on Sensitive Issues (MESSI) study used online surveys to present children and decision-makers with hypothetical scenarios of varying risk (or sensitivity) and payments, and tested their influence on participation.

The scenarios ranged from relatively benign or lower risk to highly sensitive or risky. For the lower risk scenario, we used an internet safety scenario, which asked about their views and the strategies they use in relation to internet safety. For the higher risk scenario, participants were asked about their experiences of sexting (defined as a sexual or sexually suggestive message, photo or video) and for copies be provided to the researchers.

To test the influence of payment amounts on the children and young people’s agreement to the different hypothetical scenarios, each respondent was presented with a range of payments from no payment through to A$30 (an amount commonly used by the research team), A$100 (a high payment unlikely to be approved for research with children) and a high ($200) prize draw entry.

Children and young people were also asked if they had had a “bad experience with this topic” that would affect their decision to participate.

The responses of 151 young people (aged 15-17 years) and 43 children (aged 12-14 years) who completed both the lower risk scenario and the high-risk scenario are reported in the article:

Taplin, S., Chalmers, J., Hoban, B., McArthur, M., Moore, T. & Graham, A. (2019) Children in social research: Do higher payments encourage participation in riskier studies? Journal of Empirical Research on Human Research Ethics. 14(2), 126-140.  https://doi.org/10.1177/1556264619826796

We found that:

  • Children were able to identify the higher risk studies and respond accordingly. They were more likely to participate in the lower risk study than in the higher risk study.
  • Significant numbers of children and young people who were invited to participate in a study will do so for no payment.
  • Paying children increased the likelihood that they would agree to participate in the studies and, in general, the higher the payments the higher the likelihood of their participating.
  • No evidence of undue influence from payment was detected.
  • Children and young people of lower socio-economic status were more likely to participate in research, regardless of whether they were paid, and were no more influenced by higher payments than were those of higher socio-economic status.
  • Children with adverse experiences in the research area still generally wanted to participate, and should be given the opportunity to contribute their views and experiences.

In conclusion, the MESSI study has found that payments can be used to increase the participation of children and young people in research without concerns about undue influence.  However, the overriding consideration should always be the level of risk to the children and young people if they participate in the study, as is integral to undertaking such research ethically.

Further papers from the MESSI study on the HREC, organisational decision-maker and parent responses to the hypothetical scenarios are in development.

See also:

Powell, M., McArthur, M., Chalmers, J., Graham, A., Moore, T., Spriggs, M. & Taplin, S. (2018) Sensitive topics in social research involving children. International Journal of Social Research Methodology.21:6, 647-660. https://doi.org/10.1080/13645579.2018.1462882

Powell, M.A., Graham, A., McArthur, M., Moore, T., Chalmers, J. & Taplin, S. (2019, in press). Children’s participation in research on sensitive topics: addressing concerns of decision-makers, Children’s Geographies. https://doi.org/10.1080/14733285.2019.1639623

References:

Appelbaum, P. S., Lidz, C. W., & Klitzman, R. (2009). Voluntariness of consent to research: A Conceptual Model. Hastings Center Report, 39(1), 30-39. doi:10.1353/hcr.0.0103

Bagley, S. J., Reynolds, W. W., & Nelson, R. M. (2007). Is a “Wage-Payment” Model for Research Participation Appropriate for Children? Pediatrics, 119(1), 46-51. doi:10.1542/peds.2006-1813

NHMRC (2007, updated 2018) National Statement on Ethical Conduct in Human Research 2007. file:///C:/Users/sttaplin/Downloads/national-statement-2018-updated%20(1).pdf

Singer, E., & Couper, M. P. (2008). Do Incentives Exert Undue Influence on Survey Participation? Experimental Evidence. Journal of Empirical Research on Human Research Ethics, 3(3), 49-56. doi: doi:10.1525/jer.2008.3.3.49

Spriggs, M. (2010). Understanding consent in research involving children: The ethical issues. A handbook for human research ethics committees and researchers. Melbourne: Children’s Bioethics Centre.

Wendler, D., Rackoff, J. E., Emanuel, E. J., & Grady, C. (2002). The ethics of paying for children’s participation in research. J Pediatr, 141(2), 166-171. doi: 10.1067/mpd.2002.124381

Funding and Team:

The MESSI study was funded by an Australian Research Council Discovery Grant (DP150100864).

Chief Investigators: Prof Morag McArthur (ACU); A/Prof Stephanie Taplin (ACU); Dr Jenny Chalmers (UNSW); Prof Anne Graham (SCU); A/Prof Tim Moore (ACU/Uni SA)

Project Managers: Dr Bianca Hoban & Dr Mary Ann Powell.

. Comments on ‘Should you be worried about paying children to take part in research?’
……Virginia Morrow, Visiting Professor, University College London
.
Paying anyone to take part in research risks being seen as ‘undue influence’ and contrary to the principle that consent should be ‘freely given’. Adult concerns about protecting children usually mean that research ethics committees tend to err on the side of caution – while reimbursement of expenses or provision of snacks and beverages is seen as acceptable, paying children cash, or even saying thank you with gift vouchers, are highly contested..
.

Whether or not children should be paid is rarely discussed in the research literature, so it is very welcome to see this systematic attempt by Stephanie Taplin and colleagues to explore children’s opinions about whether or not payment influences their participation in low- or high-risk research..
.
The findings are useful and reassuring for researchers wanting to undertake research with children. It is notable that children and young people say they will participate in research for no payment, which demonstrates their altruism. Also interesting is that children and young people of lower socio-economic status were more generally likely to participate in research, regardless of whether they were paid. The findings about children’s altruism and reasonableness about participation in research reflect the results of a consultation on involving children in clinical research undertaken for Nuffield Council on Bioethics in UK (Spencer et al. 2015). This found that children themselves wanted their contributions to research to be valued and respected, to be thanked for their time, rather than induced to participate via ‘bribery’. Children and young people said that expressions of gratitude included providing information about what happens as a result of the research and how their contributions have been taken up more broadly in policy and practice..
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Stephanie’s research (reported in full in Taplin et al. 2019) did raise a couple of questions that I think warrant further discussion. First, I wondered about using online surveys as a way to gather data from children – a good way to reach a lot of children quickly but limited in the depth to which the research can go. The questions of payment for research participation would be interesting to explore too in qualitative research, and perhaps a useful topic for group discussions..
.Second, the authors used a cash prize draw/lottery to attract children to participate in the online survey for the research, with a prize of A$200. This in itself raises questions, again rarely discussed in the research literature – one question being a perennial one for online research with children about proof of age, another question being, how much is too much?  These questions are for ethics committees to discuss, and Taplin et al.’s paper will be helpful for research ethics committee members. However, online cash draws are also often used by NGO researchers, with no recourse to ethics support. I once advised a researcher from a large NGO that had used a prize draw to encourage children to complete an online survey about mental well-being; the survey had not indicated a lower age limit and the researchers did not know what to do when seven-year-olds had entered sensitive data..
.Third, discussions about payments, compensation, reciprocity and reimbursement for children and young people (and indeed adults) in low and middle-income countries also merit much more systematic attention from the research community than they have received to date. Looking forward to reading more about this on the pages of Research Ethics Monthly in due course.
.

Spencer, G., Boddy, J. and Rees, R. (2015) “What we think about what adults think”: Children and young people’s perspectives on ethics review of clinical research with children. Nuffield Council on Bioethics. http://nuffieldbioethics.org/wp-content/uploads/Report_young_peoples_perspectives_on_ethics_review.pdfwww.nuffieldbioethics/org

This post may be cited as:
Taplin, S. (30 July 2019) Should you be worried about paying children to take part in research?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/should-you-be-worried-about-paying-children-to-take-part-in-research

Proportional processes can sometimes be the answer to a few (apparently competing) problems0

 

But they shouldn’t equate to abridged consideration

Dr Gary Allen | AHRECS senior consultant | Profile
Professor Mark Israel 
| AHRECS senior consultant | Profile
Professor Colin Thomson AM
 | AHRECS senior consultant | Profile

 

There are three things that we have consistently found when we have conducted desktop audits of human research ethics arrangements:

  1. Researchers believe the manner in which their interactions with their institution’s human research ethics arrangements are being treated is disproportional to the real risks and ethical sensitivity of their work. Symptoms include delays waiting for the next meeting of the research ethics committee and lengthy forms, which seem excessive for a project that might be following the well-established practice in a discipline. For busy researchers, this seems to confirm their suspicion that the research ethics committee is indifferent to the nature and value of the project and the process is about policing their conduct and catching them in wrongdoing. This perception can be especially acute in disciplines other than those in health sciences and clinical trials and is particularly prevalent for participant-directed designs. We have written about the dangers of this adversarial climate (Israel et al., 2016), and as consultants have advised many research institutions on how to tackle it.
  2. Research ethics committees(and research office staff) talk of being overwhelmed with work (and sometimes paper), struggling to find time to focus properly on the most risky and ethically challenging projects, and being left with insufficient resources to conduct professional development or other constructive activities that could improve ethical practice (design, review, conduct or reporting). One of the common complaints of review bodies who are overwhelmed by their workload is that matters would be improved if more researchers were more familiar with and understood the requirements and submitted better applications.

Reviewers and researchers commonly point to the other as the source of the problem and insist only change to the other party’s attitudes will fix the ‘ethics problem’.

The irony is that a suite of related strategies can fix both these behaviours. Rather than one party changing and the other ‘prevailing’, if both change cooperatively and the functioning of human research ethics arrangements shifts to a more positive approach, the process can facilitate research and achieve the objective of resourcing reflective practice.

This article is not about a proportional research ethics review arrangement (a piece on that will be in the Research Ethics Monthlyincluding discussion about constructive review feedback). Instead, this piece is about proportional processes, which complement research ethics review. And, this is linked with our third finding.

  1. Institutional risk concerns appear to be associated with any delegation of these matters to a process outside of the research ethics committee.

Those processes relate to the consideration of:

  1. applicant responses to review feedback,
  2. ethical conduct reports, and
  3. variation requests.

Figure 1 This image (without the watermark) is available to USD3+ Patrons https://www.patreon.com/posts/27638074

The default position for consideration on those matters should be processing outside the research ethics committee, such as panel review (a small group of committee members via email), executive review (by the Chairperson or Deputy Chairperson) or administrative review. Full research ethics committee review should be reserved for the most risky and ethically sensitive of projects.

In our experience, it is common for institutions to include these items on the research ethics committee agenda. The purpose of this can be unclear: is it for ratification or notification? And are all committee members expected to consider these? In our view, this is often impractical: these matters typically need to be considered in the context of the whole project, a context that committee members cannot be expected to retain or revisit. Provided adequate records of the panel or executive consideration are kept, committee agendas may need to include these items only when the ethics consideration merits committee consideration.

AHRECS has been able to assist clients to define triggers for the processing pathways, stage transition towards the ultimate delegated review and establish the required record keeping. We have also assisted small/early journey institutions to set thresholds (soft and hard) that would trigger transitioning from the point at which all matters are considered by the research ethics committee to the implementation of delegated processing. In this way, change is proactive and stays ahead of the predictable rise in workload.

In the AHRECS subscribers’ area, USD10+ Patrons can access suggested criteria for the delegated processing of (b) and (c) from the list above.

If implemented correctly, this approach should help:

  1. Researchersperceive the process as far more relevant, reasonable and client focussed. They also should have a clearer appreciation of the triggers for higher review.
  2. Research ethics committees have more time and capacity to concentrate on genuinely risky cases, to be involved in professional development and to formulate policies and resources.
  3. Institutional risk concerns are alleviated by having transparent criteria for escalated consideration and reduced reasons for researchers to avoid the processes.

Reference

Israel, M, Allen, G & Thomson, C (2016) Australian Research Ethics Governance: Plotting the Demise of the Adversarial Culture. In van den Hoonaard, W & Hamilton, A (eds) The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review. Toronto: University of Toronto Press. pp285-316.ISBN 9781442626089 http://www.utppublishing.com/The-Ethics-Rupture-Exploring-Alternatives-to-Formal-Research-Ethics-Review.html

Commentary

Dr Mark Bahr, Chair of Bond University Human Research Ethics and Assistant Professor Psychology

Communication is the key to much of what we do in any part of our lives. Much of the time what is said and what is heard are very different things… communication and a shared understanding of our roles in reviewing and conducting research is vital, and as indicated often misunderstood through the lens of our role. There is a clear need to establish trust at the three levels indicated in the article. Where there is a reasonable understanding of the role of each group, institutional risk managers, research ethics committees and researchers there is plenty of scope for alternate models of review for certain types of low-risk review. For example, where research methods are being taught using authentic assessment methods with clearly defined limits there is scope for flexible review especially when a process is in place for escalation to a greater level of scrutiny when called for.

One difficulty with all review is the evaluation of risk, it is clear that we each appreciate risk differently. Appreciation of risk in the study and indeed the benefit of the study varies with the beholder. There is no intrinsic issue with proportional approaches but the setting of thresholds is an important consideration. One of the concerns I would have in perhaps the intermediate-term is that what starts off as a flexible framework with responsive settings, over time tends to drift towards rigidity. We need to be vigilant that we don’t drift in that direction.

Shara Close, Manager, Research Integrity & Ethics, Charles Darwin University

Broadly from my experience over the last five-plus years working in the research integrity and ethics space – both pre- and post-implementation of proportional review – the introduction of expedited review processes and streamlining of the administrative functions associated with HREC review has drastically shifted attitudes and the ‘adversarial climate’ associated with ethics review at the University. Colleagues joining the University post-implementation have commented on how peculiar it is to find such positive attitudes towards ethics review. We now find ourselves focusing on more nuanced issues regarding improving engagement with researchers and improving applications in an effort to increase the number of high-quality applications that are ‘approved first go’ or with only very minor adjustments.

Laura Thorncraft, Research Ethics Coordinator, Charles Darwin University

Our proportional process gives researchers a sense of choice and control over the review of their proposals. The researcher nominates the risk level and justifies the risks, so they make a case for proportional review that is treated seriously by research admin staff. It’s relatively rare that proposals are escalated. I think this feeds into the article’s first point about perceptions and adversarial relationships, and something that we do quite well.

This post may be cited as:
Allen, G., Israel, M. & Thomson,  C. (23 July 2019) Proportional processes can sometimes be the answer to a few (apparently competing) problems. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/proportional-processes-can-sometimes-be-the-answer-to-a-few-apparently-competing-problems

Research Ethics Review as a Box-Ticking Exercise0

 

Associate Professor Angela Romano | Faculty Research Ethics Adviser, Creative Industries Faculty, Queensland University of Technology

 

My role as a university Research Ethics Advisor involves an interesting range of activities, although sadly there is less actual advising than I would like. As Faculty Research Ethics Advisor (FREA) for the Queensland University of Technology’s Creative Industries Faculty, I review ethics applications for a wide variety of projects, ranging from negligible risk to high risk; manage a team of six Research Ethics Advisors, who review applications for projects with negligible to low risk; conduct training workshops and drop-in sessions for researchers to seeking advice research ethics; and answer queries about multitudinous ethics-related issues.

In practice, however, most of my work relates to checking ethics applications that are submitted in order to ensure that they are ready for review, then overseeing the review process and completing the associated paperwork. Since I commenced the FREA’s role almost a year ago, I have tried to increase the number and depth of conversations with colleagues and research students about broader issues of ethics, rather than simply how to complete an application. I see the culture changing, but most discussion continues to be initiated by an onus to complete ethics applications and focuses on application requirements.

A long-held critique voiced by Western scholars about the review of human research ethics is that the process is excessively focussed on box ticking and bureaucratic compliance rather than meaningful deliberation about ethical issues (Floyd & Arthur, 2012; Johnsson et al., 2014; Schrag, 2011). Sociology and law professor Gresham Sykes forecast this problem more than 50 years ago when he noted: ‘There is the danger that an institutional review committee might become a mere rubber stamp, giving the appearance of a solution, rather than the substance, for a serious problem of growing complexity which requires continuing discussion’ (Sykes, 1967, p. 11).

Many contemporary research articles about human research ethics boards and review processes decry this so-called box ticking or rubber stamp mentality, but usually these articles discuss review boards or processes without considering the mindset of researchers themselves. As a FREA at a major Australian university, I see substantive numbers of researchers who would actually welcome a more rudimentary ‘tick and flick’ process, with short, simple forms that would promptly grant them a rubber stamp of institutional endorsement.

I have witnessed this attitude in many research teams in which research assistants, project managers or research students are given primary or sole responsibility for research ethics and the writing of ethics applications, with little to no input or oversight from team supervisors or leaders. Such conduct would not be tolerated in any other area of research activity. Those same research team leaders would never request their research assistant to write an application for a major research grant, ask their project manager to draft an article for a respected journal, or instruct one of their master’s or doctoral students to submit a report for Confirmation of Candidature or other major study milestone without a senior team member providing major input and checking the text prior to submission. Ethics applications are not directly attached to any KPIs, so these researchers simply do not see the writing of an ethics application as warranting the same level of attention.

At an institutional level, there is substantial variation among research leaders and administrators in their grasp of the principles of research ethics and their fondness for a box ticking approach. In my discussions with staff from different universities, I have heard numerous research leaders argue research ethics advisors and reviewers should ‘stick to ethics and stop providing feedback about methods’. The head of one research centre leader told me in all seriousness that ethics committees should not request amendments in an ethics application if their review processes reveal that ‘the project sucks’ as long as there were no ‘ethical problems’ such as risk of harm to participants.

One academic who held one of the most senior research leadership positions in his university was surprised when I explained to him that researchers could not simply state what methodology they were using , such as focus groups, then be given a checklist of the ethical risks that applied to that particular methodology. He told me that he had not realised the ethics committees needed to know details about the exact methods being used, nor had he previously considered that the risks relating to each element of the project might change according to numerous contextual factors, such as the topic being studied, the location of research, the nature of recruitment, and the age, education levels, employment and cultures of participants.

Such comments indicate a perspective about research ethics that is fundamentally at odds with the approach that is outlined in the National Statement on Ethical Conduct in Human Research(2018), which sets standards for human research in Australia. The National Statement is based on the premise that research ethics and methods are inextricably linked. Itdefines ‘merit and integrity’ as essential components of ethical research (Section 1). For a research project to have merit and integrity, it must be designed ‘using methods appropriate for achieving the aims of the proposal’; be conducted by researchers with ‘experience, qualifications and competence that are appropriate for the research’; and be supported by ‘facilities and resources appropriate for the research’ (Section 1.1). Section 3.1 outlines ethical issues in seven overlapping phases that occur in most human research, these being ‘Recruitment’, ‘Consent’, ‘Collection, Use and Management of Data and Information’, ‘Communication of Research Findings or Results to Participants’, ‘Dissemination of Research Outputs and Outcomes’ and ‘After the Project’.

It is hard to see how any research leader who is familiar with the National Statementcould define human research that ‘sucks’ or has manifest methodological problems as ‘ethical’, yet I have encountered this mindset surprisingly often. From my observation, scholars who believe that there is only a limited connection between research methods and ethics will also often express simplified notions about ethics assurance and demonstrate a fondness for ticking boxes and using cut-and-paste responses.

A number of scholars have argued that rather than rely on box ticking and a culture of enforcement through form filling, research institutions should build reflective practice about research integrity by developing resources and supporting professional development (Allen & Israel, 2018; Israel & Drenth, 2016). I agree with that perspective, but believe those researchers who favour a box ticking approach will have no impetus to change until their employers and funding institutions demonstrate that they value and reward a reflective approach to ethics in the same way that they show they value and reward successful grant applications, research publications or research student completions.

REFERENCES

Allen, G., & Israel, M. (2018). Moving Beyond Regulatory Compliance: Building Institutional Support for Ethical Reflection in Research. In R. Iphofen & M. Tolich (eds). The SAGE Handbook of Qualitative Research Ethics (pp. 276-289). London: Sage.

Floyd, A., & Arthur, L. (2012). Researching from within: External and internal ethical engagement. International Journal of Research & Method in Education, 35(2), 171-180. doi: 10.1080/1743727X.2012.670481

Israel, M., & Drenth, P. (2016). Research Integrity: Perspectives from Australia and Netherlands. Handbook of Academic Integrity, 789-808.

Johnsson, L., Eriksson, S., Helgesson, G., & Hansson, M. G. (2014). Making researchers moral: Why trustworthiness requires more than ethics guidelines and review. Research Ethics, 10(1), 29-46. doi: 10.1177/1747016113504778

National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). The National Health and Medical Research Council, the Australian Research Council and Universities Australia. Commonwealth of Australia, Canberra.

Schrag, Z. (2011). The case against ethics review in the social sciences. Research Ethics, 7, 120-131. doi: 10.1177/174701611100700402

Sykes, G.M. (1967). Feeling our way: A report on a conference on ethical issues in the social sciences. American Behavioral Scientist, 10(10), 8-11.

This post may be cited as:
Romano, A. (22 June 2019) Research Ethics Review as a Box-Ticking Exercise Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/research-ethics-review-as-a-box-ticking-exercise

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

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