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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

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

Working flexibly through the Coronavirus: Continuing professional development in research integrity or human research ethics?0

 

Research ethics and research integrity professional development works best as a long-term commitment to building the capacity of the current and next generation of researchers. As universities extend their online capacity to educate coursework students in the face of the Coronavirus (COVID-19) and place restrictions on staff travel, there is little reason to close down all professional development for staff and research students.

We think there are a number of compelling reasons to conduct these workshops online.  Online workshops offer an opportunity to trigger research conversations among staff working remotely; their timing can be readily adjusted to meet availabilities and they can also be captured and reused in the institution over the next couple of years.

Using Zoom,[1] AHRECS can deliver online workshops for any number of HDR candidates, supervisors and early career researchers. The workshops would be tailored to your institution and your needs. We have run such workshops across Australia, New Zealand and the broader region.

The basic type of workshop lasts for 55 minutes and works best for up to 20 participants. This workshop costs $2000. https://www.ahrecs.vip subscribers receive a 10% discount. Such a workshop might be a 101 introduction or more advanced and practical. AHRECS can also run longer, more interactive workshops and run sessions for larger groups, on request.

Send an email to emquiry@ahrecs.com to discuss further.

[1] Zoom has the advantage of being free for the user and being accessible via computer, tablet and smartphone.  It also supports connection via phone. Sessions can be recorded.

Lost time may never be found again but is it time to talk about the duration of ethics approvals?0

 

“To everything there is a season, and a time to every purpose” a time to report on ethical conduct, a time to renew an approval, or a time to face misconduct proceedings.

Dr Gary Allen

What is the length of ethics approvals that your HREC grants?  In this article, I will discuss this question and some of the reasons for choosing approval periods.

A related question is, under what circumstances should an ethics approval be withdrawn?  Can/should research ethics review bodies withdraw approval because of extended/repeated failure by a researcher to provide an ethical conduct report?

Australia is unlike the US where the conventional interpretation of the Common Rule is that ethics approvals are of one year.  Accordingly, US researchers must provide annual ethical conduct reports to maintain ethics approval and avoid needing to make a fresh application.

In Australia, the duration of approval is not specified by the National Statement and the only clear Australia-wide external requirement to provide reports in a certain time is paragraph 5.5.5 of the National Statement which provides that researchers should report to ethics review bodies at least annually.  As a result, approval duration is likely to be dictated by institutional policy and some have adopted maximum duration periods.  A short (e.g. 12 months) approval period and renewal requirement is one lever committees can use to compel researcher compliance to provide evidence that the needs for approval periods are being met.

There are, I suggest, four such needs that are served by a choice of duration of an ethics approval, namely:

  • Compelling a report from a researcher and allowing a review body to confirm that –
    1. a project is being conducted as per the approval, and
    2. the welfare and interests of participants are still being adequately provided for.
  • Providing an opportunity to reflect on any changes to national standards or institutional policies or pertinent cases that warrant a rethink of approvals.

Researchers can typically seek a long duration ethics approval because:

  • The design calls for repeated data collection across an extended period, such as a longitudinal ethnographic study;
  • The work is a component of a program of work focussed on a cure for a chronic condition; or
  • The work intends to compile an archive of biospecimens, data, document samples, audio-visual material or other items of historical/cultural significance.

The maximum duration of a research ethics approval would also appear to be connected to how long an HREC has operated and the amount of work the committee is undertaking. In Australia, institutional decisions on the matter can also be associated with changes in national ethics review requirements that occurred in 1999, 2007 and 2018 (and beyond).

Like other aspects of human research ethics practice in Australia, the approach to duration has reflected practice in the United States.  While Australia does not have the same kind of regulatory framework as the US where failing to maintain ethics approval can have consequences for institutions, the use of single year approvals is probably used as a way to promote adherence to the institution’s ethical conduct reporting requirement.

While understandable, such short-term approvals can punish conscientious researchers because of an institutional response to recalcitrant researchers.

However, early in a research ethics committee’s operation, it is not uncommon for it to grant approvals with durations of between one and three years.

This can reflect the committee’s confidence:

  1. in its role and decisions;
  2. and trust that researchers understand their responsibilities and will abide within the scope of the ethics approval; and
  3. that projects will progress as per applications or researchers will contact the institution’s research office if the unexpected occurs.

A low workload of a committee can serve as an incentive for short duration approvals and longer duration/longitudinal work is chunked out into two or more applications. Increasing the number of approvals may not allow the committee and research team to develop expertise before the committee commits to an extended period of research. Alternatively, a committee might be tempted to inflate its number of approvals artificially to attract either resources or credibility.

Conversely, when a research ethics committee is very busy, there may be more incentive to grant longer approvals to minimise the number of times the committee needs to review renewals of long duration projects.

Given, the National Statement (2007 updated 2018) is currently silent on the issue of the duration of ethics approvals, it might appear the Australian national framework should not impact on approvals. However, there is both a predictable impact and a real reason to rethink our current approach to the duration of approvals.

At this stage an update to Section 4 of the National Statement might be released in the next six months and an update to Section 5 will move out of the planning stage shortly.

Some institutions and committees tie the duration of ethics approvals and forced renewal around the timeframe during which the national arrangements might change (and perhaps inter alia institutional policy).  In Australia this might equate to around a five year approval duration.

The changed approach to updates to the National Statement means that such a cycle might not be especially helpful.

Suggested change to duration and monitoring procedures

We recommend institutions and HRECs do the following:

  1. Adopt a policy setting that the conduct of human research without prior ethics approval may be considered a breach of the Australian Code for the Responsible Conduct of Research (2018) and of the institution’s research integrity arrangements. This would be consistent with the Investigation good practice guide.
  2. Adopt a policy setting that any proposed change to a project must be submitted for prior review, otherwise the conduct of a project in a manner not in adherence to its ethics approval may be considered in breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  3. Adopt the practice of reminding researchers of their responsibility –
    1. to consider and safeguard the welfare of research participants
    2. to remain reflective of whether the risks of a project are justified by its benefits
    3. to remain reflective of the degree to which the project addresses the core ethical principles of the National Statement
    4. notify the HREC of any changes with regard to 3a-c.
    5. Notify the HREC if any participant raises a concern about the ethical design or conduct of a project. Including notifying the HREC if any participants withdraw consent because of a concern about ethical matters.
  4. Adopt a policy that a researcher who fails to meet the responsibilities described at 3 may be considered in breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  5. Adopt a policy that an ethics approval can be approved for the planned duration of a project.
  6. Adopt a policy that researchers must submit an ethical conduct report every 12 months during the currency of an ethics approval. Extended/repeated failure to do so may be considered a breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  7. Adopt a practice of timed reminders to researchers to provide overdue ethical conduct reports, culminating in breach proceedings[1].
  8. Adopt a policy and practice that every five years a clearance is active the research office/HREC assess whether there are circumstances that require a new ethics review of a project.

In most cases, a new review should not be required, but a standardised, clear checklist should be used to determine whether a new review is required. Subscribers to https://www.ahrecs.vip or https://www.patreon.com/ahrecs will find a suggested checklist for conducting such a check.

On this basis, I suggest research ethics review bodies/research offices can and should withdraw approval because of extended/repeated failure by a researcher to provide an ethical conduct report.  This however must be based upon documented policy and procedure.  It must also be foreshadowed in ethics approval notifications, report reminders and resource material.

[1] The approach here might be constrained by the research management system the institution is using.  This includes usefully tracking correspondence between the researchers and the research office.

This post may be cited as:
Allen, G. (3 March 2020) Lost time may never be found again but is it time to talk about the duration of ethics approvals?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/lost-time-may-never-be-found-again-but-is-it-time-to-talk-about-the-duration-of-ethics-approvals

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