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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

“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

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