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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Worried your researchers might not be treating human research ethics as a core component of good research practice? Concerned they are not seeing it as their responsibility?0

 

All of us might be part of the problem.

Dr Gary Allen
AHRECS Senior Consultant

Consider a hypothetical problem:

You find a partially submerged car bobbing in the local harbour. 

A big problem

So, you rush out to hire a crane and pay an operator to lift it out of there.

 

It’s working perfectly.  Soon the pesky vehicle will be out of everyone’s way and normal life can resume.

Except…

 

Except you hadn’t allowed for the weight of the car and water, and you hadn’t factored in the leverage effect of the degree to which the car was below the crane.

WOOSH, ARGH! SPLASH

So now you have both a crane and car blocking the harbour.

And by the way you might now also have a crane operator who is badly injured.

 

This latest development really isn’t a problem because you rush out to get an even bigger crane to lift out the first crane with the attached pesky car.

All is going well.

Until it isn’t.

 

Most of these images record a costly sequence of blunders in Galway, Ireland (which apparently was initiated by a parking accident).

At the risk of undermining my metaphor, the last image is a photoshop fake.

For human research ethics, the big problem is that researchers might not be seeing human research ethics as a vital component of doing research well, and researchers might not perceive ethics as their responsibility.  A related problem is ensuring the ethical design and conduct of research might not be perceived as also institutional responsibility.

The usual response has been to

  1. grab research ethics review as a governance weapon to be wielded with ardent fervour.
  2. slam submitted applications we perceive as being incomplete or ill-advised,
  3. respond with scores of directive conditions. And
  4. use enforcement and sanctions procedures to punish the researchers who dare to resist.

But in attempting to solve this problem, have we created a worse one?

Reflections on the limitations of our current approach

  • The international approach was created as a response to some egregious biomedical and psychology scandals. Safeguarding against such incidents has driven our implementation and the continue evolution of the arrangements.
  • The approach is wedded to a compliance and enforcement way of seeing any problem.
  • The approach tends to treat the 99+% harshly because of the misbehaviour of <1%.
  • It also assumes it is possible and helpful to try to direct the complex behaviour of professionals across a vast array of (sub)disciplines, methods, topics, populations and contexts.

Reflecting back on the time, effort and the resources we have expended over the last 60 years, we find ourselves confronted with an uncomfortable question: Does this approach catch the dangerous minority? I would suggest it does not.

Symptoms of the problem

  • Institutions that almost exclusively focus their human research ethics efforts on ethics review.
  • The institution’s executive is anxious about institutional risk exposure.
  • There is a crippling workload for reviewers and administrators.
  • It is not uncommon to hear researchers ask each other, “Have you done ethics yet?”
  • Too many researchers outsource their ethical responsibility to the research ethics committee.
  • There is evidence of unthinking or grudging compliance, avoidance and misrepresentation.
  • Ethics training at the institution has been reduced to better form filling.

The National Statement (2007 updated 2018)

  • The National Statement is not the problem, though it has its limitations.
  • Are we trapped by past practice? “This is the way it has always been done.”
  • Both the National Statement and the Australian Code stress institutional responsibility for research culture and research training.
  • We recognise the challenges and flexibility that are open to us by the framing of the national arrangements (by way of example, the Australian National Statement on Ethical Conduct in Human Research (2007 updated 2018) allows for great diversity in the selection of a consent strategy, even though there are committees that treat an information sheet and consent form as the preferred consent strategy).
  • Having excellent policies, processes and forms aren’t enough for us to claim we are promoting a culture of ethical and appropriate conduct.
  • Could we actually be encouraging researchers not to be reflective? Could we actually be making things worse?

 

 But there is a better way: resourcing reflective practice

  • Stressing personal, rather than outsourced, ethical responsibility.
  • Encouraging ethical thinking before commencing an ethics application.
  • Seeing an approval certificate as a step, not the end of thinking about human research ethics.
  • Continued reflection on: merit and integrity matters (such as non-financial conflicts of interest); beneficence (such as public goods and community harms); respect for persons (such as a communal approach to consent); and justice (such as ensuring an otherwise disenfranchised voice is not lost).
  • Developing skills to monitor ethical conduct throughout the lifecycle of a project.
  • Responsibilities continue through analysis, write up, reporting/publication, and management of data/material after a project is completed.
  • Regarding research ethics as a design, conduct, quality and professional responsibility – not ‘just’ a matter of compliance and bureaucratic concern.
  • Recognising a reciprocal obligation for those of us who participate in and/or administer research ethics reviews, to approach the review as facilitating research, not policing it.

Strategies to resource reflective practice

  • Shift institutional ethos – from relying solely on HREC review as a demonstration that the institution is serious about ethical conduct – to an ethical research culture.
  • Ethics review to advise and inform, rather than to clear/approve/police.
  • Ethics administrators empowered to work with both researchers and reviewers.
  • The institution having resource materials rather than rules.
  • Use of mentors and collegiate advisors, such as a network of Research Ethics Advisors.
  • An ongoing commitment to upskilling ethics reviewers.
  • Training, training, training – professional development focused upon principles, strategies to apply the principles to challenges, not just form filling.
  • Top down (institutional and discipline leaders) and bottom up (HDR and supervisor training, new staff and experienced staff).
  • Inviting two-way communication – welcoming innovation, praising thoughtful and elegant strategies, inviting feedback, and supporting creative problem solving.
  • Continuous improvement and striving towards a learning institutional approach, where complaints and negative feedback are opportunities to improve.

No cranes were harmed in the drafting of this post

See also

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. pp 285-316. http://www.utppublishing.com/The-Ethics-Rupture-Exploring-Alternatives-to-Formal-Research-Ethics-Review.html

Israel, M, Allen, G & Thomson, C (2016) Whiteboard: resourcing reflective practice.
https://ahrecs.com/previous-projects/whiteboard-resourcing-reflective-practice

This post may be cited as:

Allen, G. (19 June 2020) Worried your researchers might not be treating human research ethics as a core component of good research practice? Concerned they are not seeing it as their responsibility? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/worried-your-researchers-might-not-be-treating-human-research-ethics-as-a-core-component-of-good-research-practice-concerned-they-are-not-seeing-it-as-their-responsibility

How we interpret the words ‘proportional review’0

 

Dr Gary Allen
AHRECS Senior Consultant

Over the last decade, AHRECS has worked with institutions of various types, size and maturity.  The project brief often refers to fixing or implementing proportional review.  When you drill down, the work item will generally owe its origins to calls from researchers, the research ethics review body, the research office and the institution’s executive.  They might all use the words proportional review or perhaps expedited review, but are they really talking about the same thing?

A casual glance at the NHMRC’s annual activity report shows many institutions are conducting reviews outside their HREC.  So why are researchers still calling for change?

While cases like the Racist bus driver, Laughing at the Disabled and the Sexual health survey cases do raise questions about the (mis)use of triggers for review outside an HREC, there remains an apparent tension between the meanings that different stake-holders have of proportional review.

For institutions, proportional review is often understood to include:

  • From the date of application, how long does it take to get a review outcome to the applicants.
  • that the length of the application form is determined by the specifics of an individual project.
  • the review process allows the review body to move quickly through ‘low risk’ and ‘low ethical sensitivity’ projects leaving more time for more contentious work.

Within that frame proportional review can be achieved by committees meeting relatively often, everyone using a smart form and a good structuring of the research ethics committee’s business.

But for researchers the term ‘proportional review’ often means:

  • Not having a form with questions they struggle to relate to their research design.
  • The review body including members who understand their (sub)discipline and methodology.
  • The reviewers being aware of relevant good practice
  • The objective of the review is to provide useful and constructive feedback.

What we understand researchers look for in proportional review arrangements are the following:

  • A short and tight form where answers can be as expansive as necessary, guided by clear and useful help text.
  • The reviewers are different from the main committee and include persons with a background in qualitative, participatory and iterative designs that are relevant to their research.
  • The triggers between different review pathways, e.g. previously reviewed projects, not more than negligible risk, not more than low risk should be clear, predictable, transparent and consistently applied.

Within this frame, a researcher is unlikely to be satisfied with the review of their research by the ordinary committee or the use of the same form as for full HREC reviews.  In such circumstances, they are likely to perceive (even if that perception is inaccurate) that they are being forced to use a process intended for higher risk biomedical research.

One of the advantages of a discernibly separate process is that it is easier to stress to reviewers to adopt a proportional approach to their reflections and that an important part of their role is the facilitation of ethically sound research.

This post may be cited as:
Allen, G. (03 June 2020) How we interpret the words ‘proportional review’ Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/how-we-interpret-the-words-proportional-review

A checklist to assist a supervisor to check a candidate’s research ethics review application0

 

“Regulations don’t solve things. Supervision solves things”
Wilbur Ross 2015

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

HDR supervisors should, and often do, play an important role in the formulation of a candidate’s research ethics review application. If you talk to an experienced busy research ethics committee member, they will tell you they’ve seen too many applications where there wasn’t any indication the supervisor even saw the application prior to its submission.

Many institutions consider the supervisor to be the lead investigator for candidate research. Even those that don’t usually will expect the supervisor to be a key adviser and mentor for the candidate’s passage through the research ethics review process.

A supervisor not taking an active role in a candidate’s review application can reflect a worrying attitude: “I don’t have time to know about research ethics in detail. The candidate should submit what they have, the experts on the committee can tell them what they need to fix and how they want it changed.”

Such thinking is irresponsible and concerning at numerous levels, not least because research ethics is a fundamental component of the quality design of research.

Being able to think and write about ethical challenges is an essential component of the research training of new researchers.

A supervisor or a research school that isn’t systematically engaged in a candidate’s ethical capacity-building and professional development is failing them.

But a not unreasonable question is “What should I be looking for, when I read an HDR candidate’s application?” A reader of the Research Ethics Monthly asked for a tool she could use.

Attached here is the start of such a tool. The Research Ethics Monthly community includes some very experienced research ethics reviewers. It would be deeply appreciated if you could comment on what we have drafted and suggest other elements for the tool.

This post may be cited as:
Allen, G., Thomson, C. & Israel, M. (24 May 2020) A checklist to assist supervisor to check a candidate’s research ethics review application Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/a-checklist-to-assist-supervisor-to-check-a-candidates-research-ethics-review-application

AHRECS and COVID-190

 

To date, we are delighted to report the extended team is virus-free. Our best wishes go out to any member of the Human Research Ethics/Research Integrity community who are currently battling the awful pandemic. To the first responders, clinical staff on the frontlines and researchers working on a vaccine, thank you for your service.

Like the majority of small businesses in Australasia, AHRECS has taken a bit of a hit financially. Please consider becoming a subscriber, whether institutional ($350/yr) or individually (from USD1/month). Your support during this difficult time would be hugely appreciated.

Send any enquiries to enquiry@ahrecs.com.

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