ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Resource Library

Research Ethics MonthlyAbout Us

Research Ethics Committees

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Update on the new subscribers’ area0

 

We are currently expecting the new service to go live prior to us sending the July 2019 edition of the Research Ethics Monthly.

It is being built by some talented designers and coders we are excited to be working with.

The service will be located at AHRECS.vip, will be far more easily browsed and used, with an annual subscription of $360 (Plus GST and a 2% charge if you pay by credit card).

We will have more about this new service in the next edition.  Email VIP@ahrecs.com if you have any questions.

Is it something I said (or the way I said it)?0

Posted by Admin in Human Research Ethics on May 29, 2019 / Keywords: ,
 

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

Reflecting on review feedback

Feedback from the research ethics review of a project is often one of the first interactions between a researcher and a research ethics committee. It helps define, and can permanently tarnish, the relationship between an institution’s committee and research community – for good, or for bad. So, it’s centrally important to an effective ethics research culture.

Unfortunately, typically, it only receives cursory attention in national human research ethics arrangements and institutional policy. It does not feature highly in review body member training, standard operating procedures or the orientation of secretaries and chairpersons.

Having worked with many review bodies during the last few decades, we thought it might be helpful to share some ideas and experiences.

1 NATIONAL ARRANGEMENTS– review feedback should be based clearly upon the relevant national arrangements: these provide the justification for the feedback and establish a neutral ground on which to resolve differences. For example, in Australia it should be located in and cite a provision of the National Statement (see Common Missteps 6).

Feedback on revision should make its ethical consideration explicit if it is not based on national or institutional policies. (Dr Gan Zhen-Rong, Human Research Ethics Committee, National Cheng Kung University, Taiwan)

2 INSTUTIONAL ARRANGEMENTS– when the host institution’s policy or procedures discuss a matter relevant to the project being reviewed, the review feedback should be located in and cite those arrangements.

3 GUIDANCE MATERIAL– A valuable role can be played by guidance material, such as suggesting ways a national/institutional policy can be applied in a situation, or how a researcher might justify an alternative. The Griffith University Research Ethics Manual (GUREM) is one such document, which Griffith University has licensed[1] so other institutions can copy and modify its booklets to create its own resource manual.

4 FACILITATION AS A CORE OBJECTIVE– A central objective of research ethics review is facilitating the ethical conduct of research. This can be promoted by constructive feedback with clear explanations and prompts (for what is needed to satisfy the committee) and how the matter can be resolved.

Research regulators in general, including HRECs, have not only a responsibility to uphold the principles of the regulatory ‘ecosystem’, but must ensure and enable a ‘growth mindset’ that fundamentally has the research participant at its core… fostering and nurturing novice researchers as well as redirecting and upskilling seasoned researchers is vital. To this end, removing a punitive viewpoint and replacing it with an opportunity to educate and highlight the principles of the framework is required.  Not only will it foster a strong collaborative research culture, after all we are all on it for the participants’ benefit, but such an approach will assist in removing the ‘us’ versus ‘them’ mindset that currently pits researchers against research administrators. (Sonia Hancock, Manager, Research Integrity and Compliance, Metro South Health Research, Queensland)

We do this at CQU (Chair chats [with researchers about specific items in their proposal]), it promotes a collegial interaction between HREC and researchers and actually reduces workload for the committee as applications don’t bounce around. (Prof. Tania Signal, Chair, Central Queensland University Human Research Ethics Committee)

It’s really important to have a review process that models the respect that the committee would want the applicants to show to participants in the research. (Lindsey Te Ata o Tu MacDonald, University of Canterbury Human Ethics Committee, New Zealand).

— COMMON MISSTEPS —

5 ‘BECAUSE WE ALWAYS INSIST ON THIS’ – When crafting review feedback, a  review body should be wary of matters that do not adhere to one of the above, but are consistently included in the review body’s feedback to applicants, primarily because the committee always insists upon it. Ignoring the circular logic, if there is no other basis for the feedback item (see above), it is almost certainly time to change that habit.

Too often committees can lose sight of the differences in context, participant populations and the myriad other variables that make it difficult to apply precedents. The principles and values of committee members (within the context of applicable regulations and legislation) should drive review. (Lindsey Te Ata o Tu MacDonald, University of Canterbury Human Ethics Committee, New Zealand

Some review bodies still insist on participants signing a consent form (see Wynn and Israel, 2018). Fetishising such standards is dismissive of the agency of potential participants, is excessively paternalistic and may also create a barrier to participation for some demographic groups. There may be circumstances where such practices are warranted, but it should not be an automatic requirement. And don’t get us started on insisting on witness signatures on consent forms.

Discussion of what the National Statement actually requires can also be used to show how familiarity with, rather than prescriptive use of, the National Statement can avoid unnecessarily constraining ethical research.  References to such passages as paragraph 2.2.4 and this paragraph on p.11 of the National Statement speaks to this idea:

These ethical guidelines are not simply a set of rules. Their application should not be mechanical. It always requires, from each individual, deliberation on the values and principles, exercise of judgement, and an appreciation of context.

6 FIXATING ON ONE PROVISION RATHER THAN THE WIDER MESSAGE– In circumstances when a review body is working from a detailed set of arrangements (such as the National Statement (2007 updated 2018) in Australia) there is a danger the review body will focus on one provision, while missing the wider intention of a section. This bad habit can easily become a standard requirement of the review body (see 5). For example, some well-meaning review bodies can insist recruitment material and consent material are depersonalised, written in the passive so that friendly courtesy is removed even from interaction involving peers.  Review bodies may believe in so doing they are faithfully applying NS item 2.2.1 (consent needs to be voluntary) and avoiding language that might be seen as persuasive and therefore in some way manipulative. In doing so they are ignoring NS 2.2.3 and 5.2.17 (be relevant to the participants’ circumstances). Some review bodies still insist on participants signing a consent form (see Wynn and Israel, 2018). Fetishising such standards is dismissive of the agency of potential participants, is excessively paternalistic and may also create a barrier to participation for some demographic groups. There may be circumstances where such practices are warranted, but it should not be an automatic requirement.

7 PROOFREADING– A review body should not spend more than a few moments of meeting time/words in the review feedback proofreading recruitment/consent material or a data collection instrument. Instead the review body should indicate proofreading is required, provide some examples and indicate there are more requiring attention. Consideration of the revised material should be delegated and handled outside a later meeting.

8 MANY WAYS TO SOLVE A PROBLEM– There is rarely only one solution to an ethical challenge (so there can be difference of view between researchers and reviewers). In addition to project-specific matters such as conventions of the (sub)discipline, methodology, potential participant pool and contextual considerations, there can be more than one ethically acceptable solution. Consequently, a feedback item should not imply there is only one way to tackle a problem.

Committees need to be genuinely open to rebuttal or alternate approaches from researchers if that argument is couched within the framework of the National Statement. (Prof. Tania Signal, Chair, Central Queensland University Human Research Ethics Committee)

Too often committees can lose sight of the differences in context, participant populations and the myriad other variables that make it difficult to apply precedents. The principles and values of committee members (within the context of applicable regulations and legislation) should drive review. (Lindsey MacDonald, University of Canterbury Human Ethics Committee)

9 RISK-AVERSE– The review body should take care to ensure (and reflect on over time) its decisions to ensure they aren’t overly risk-averse or conservative.

— TIPS —

10 POSITIVE FEEDBACK– Learn from the broader literature on effective feedback and identify a component of the proposed project to compliment, such as the importance of the research question, the care and thought demonstrated by the approach to a problem, the described respectful approach to a participant cohort, or perhaps thoroughly addressing a matter that was missed by the applicants in earlier proposals.

Common courtesies go a long way within ethics processes. Thank applicants for applying for review committee, start most requests with ‘please… (comment/consider/explain)’, and rephrase demands as questions. In my experience adding those phrases help to soften even harsh criticism of applications, so that productive – not defensive – relationships thrive between the committee and researchers. Encouraging researchers to ring the Chair as soon as they have a problem with a committee’s feedback was the single most important time-saving device for my time as chair  – a minute or two on the phone is so much more constructive than emails. (Lindsey Te Ata o Tu MacDonald, University of Canterbury Human Ethics Committee, New Zealand)

11 NOT A CONDITION OF APPROVAL– If a review body is aware a matter is beyond its remit but could impact upon the project’s chances of success, its quality or impact, it could be framed in the following way, ‘The following is not a condition of ethics approval, but the reviewers noted… Have the applicants considered this?’.

12 LIMITS OF ETHICS APPROVAL– In some cases, a review body might only feel able to grant approval because of the involvement of a specific individual team member or support service. The implication is that if her/his involvement ends, or the service is no longer available, the project must be paused until alternative arrangements can be made. Similarly, the review body might not want the ethics approval of the project to be seen as a precedent where similar projects without the involvement of that experienced person, or service, will also be approved. In such circumstances, the reasons/limits of the approval should be specified in the review feedback.

13 INVITE REFLECTION– Assuming an applicant has missed a matter or is indifferent to a problem might not only be incorrect, it might make the review process more adversarial. A more positive approach could be: ‘Given the experience of the applicants, <review body> would be interested to hear how you have previously handled… and the degree to which you feel that would be useful in this case.’

14 REAs– If your institution has established a network of collegiate Research Ethics Advisers and the review body is concerned applicants have not understood their responsibilities and/or the review feedback will require considerable explanatory text, the review body could direct the applicants to consult their REA before resubmitting. The Chair (or nominee) could speak with the REA to explain the situation.  If your institution does not have such a network, face to face conversations with researchers, the Chair and/or some committee members can usually achieve agreed resolutions.

15 PILOT TESTING– In circumstances where a review body is uncertain about the described risks/proposed risk mitigation strategy, the review body might suggest a limited pilot test. Such a test might involve a smaller number of participants for a specified period of time, with a view to the researchers reporting back on the actual experience of those matters. The ethics approval could either be converted a full approval or the project modified on the basis of the experienced.

16 CONTINUE TO BUILD YOUR EXPERTISE – No research ethics committee can be experts in everything. Once a committee accepts this, there are various strategies that it can adopt. First, it can engage in collective professional development making sure it receives regular briefings on new methods, disciplines, groups of participants or regulations. In some cases, these can be provided by researchers (either individuals or groups); in others, the committee may need to bring in external expertise. Second, it might increase the size of the committee to add expertise but look for more flexible ways of deploying that membership.

…if a research team is about to begin utilising a new technique/procedure/machine that beeps etc. consider inviting them to provide a short briefing presentation to the HREC ahead of any submissions. This allows a two-way conversation, HREC can highlight issues that will need further consideration and researchers can address misconceptions. (Prof. Tania Signal, Chair, Central Queensland University Human Research Ethics Committee)

17 PROPORTIONAL CONSIDERATION– If the practice of your review committee is that all researcher responses are considered at the next meeting of the review body, consider delegating this task to administrative review, executive review or to a small panel of the review body depending on the level of the review that might be required for any particular case. Perhaps the response should only go back to the review body in the most sensitive of circumstances. Nevertheless, those delegated bodies should be able to escalate the consideration to a higher pathway.

Distinguish between the problems of submitted proposals to see if they reflect substantial ethical issues or just raise minor matters such as failure to provide sufficient information, demonstrate a lack of submission experience or careless editing. If the latter, consider delegating this task to administrative or executive review.(Dr Gan Zhen-Rong, Human Research Ethics Committee, National Cheng Kung University, Taiwan)

Acknowledgements

We want REM to start conversations among its readers. In this issue, we are grateful to Dr Gan Zhen-Rong (National Cheng Kung University, Taiwan), Prof. Tania Signal (Chair of HREC, Central Queensland University), Dr Lindsey Te Ata o Tu MacDonald (University of Canterbury) and Sonia Hancock (Metro South Health, Queensland) for providing comments (at short notice) on this article.

Bibliography

Wynn, LL and Israel, M (2018) The Fetishes of Consent: Signatures, Paper and Writing in Research Ethics Review. American Anthropologist120(4) pp795–806.

[1]Dr Gary Allen is the principal author of the GUREM and receives a proportion of all sales, so AHRECS acknowledges the conflicts of interest in mentioning the manual.

This post may be cited as:
Allen, G., Israel, M. & Thomson, C. (29  May 2019) Is it something I said (or the way I said it)? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/is-it-something-i-said-or-the-way-i-said-it

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

 

Adrian Barnett, Queensland University of Technology

.
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

Monitoring research is too important to be optional and too resource intensive to be manual0

 

Dr Gary Allen, Senior consultant AHRECS | Profile | gary.allen@ahrecs.com

The National Statement specifies researchers submitting self-completed ethical conduct reports as the minimum acceptable institutional monitoring of approved human research projects (NS 5.5.5).  This reflects the importance of institutions monitoring the research conducted under its auspices and highlights the ethical responsibilities of researchers, and the host institution, continue beyond the research ethics review of a project.

.

Send an email to blueprint@ahrecs.com if you would like to discuss AHRECS conducting a Desktop Audit of your institution’s human research ethics and producing a blueprint for constructive change

.

Researchers providing annual self-reporting really isn’t an onerous requirement.  Except it seems it is.

Since 2008, AHRECS has been formally conducting consultancy work with research institutions.  This often includes a desktop audit of the institution’s human research ethics arrangements and then a blueprint for constructive change.  Pretty much in every case, Australian research institutions are struggling with the following challenges:

  • Many researchers are recalcitrant in their annual reporting.
  • The process of reminding researchers to provide an annual report and chasing overdue reports is time-consuming.
  • Providing reports to the HREC wastes precious meeting time, wastes paper and often doesn’t produce anything substantive.
  • The associated data entry, note taking and printing are significant burdens on an already stretched committee secretary and administrative support.

This image (without the watermark) can be download by our USD3/month subscribers – https://www.patreon.com/posts/27006486

Such observations echo what we have seen in our practice over the decades.

To summarise the recommendations we have made in those blueprints1 2:

  1. The institution’s research management system (ethics module) should at a simple click send reminders to researchers via email.
  2. Researchers should complete and submit their ethical conduct reports online with some fields automatically completed for them and validation on their response to some questions (e.g. minimum word count).
  3. Report should be considered proportionate to certain criteria administratively, executively, by a panel of the HREC, and only a small proportion of reports considered at a committee meeting.
  4. The phrasing of the automated reminders should be based upon escalating terseness depending on whether the email is the initial reminder, a 30 days overdue notice, 60 days overdue or 90 days overdue that might be considered a breach of the institution’s human research ethics arrangements (]and so a breach of the Australian Code (2018).
  5. Online reporting to the heads of department listing researchers who have ethical conduct reports due, overdue, late or very late.
  6. The institution’s research management system (ethics module) should produce automated committee papers
  7. One of the labour savings of this approach is that it is the researchers who do the data entry(rather than it being rekeyed by the research office).This burden on researchers is offset by the convenience of the online system.

In an earlier post Prof. Colin Thomson AM discusses some areas of reported HREC activity that illustrate that some institutions are failing to adhere to the requirements of the National Statement– which are arguably perhaps too lenient.l

1Our blueprints include more detailed text about ethical conduct reports including the conduct of proportional reviews and criteria for the different pathways.

2 Included here is an image that summarises this approach. Inside the subscribers’ area is a version that isn’t watermarked.

In the subscribers’ area is a rough outline for an ethical conduct report.  Clients who engage AHRECS to produce blueprint are provided the full ethical conduct report (including help text) and AHRECS can liaise with your system administrators on its deployment.  Send an email to blueprint@ahrecs.com to discuss further.

.
References

Thomson C. (2017, 22 March 2018) “More what you’d call guidelines”. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/more-what-youd-call-guidelines

National Health and Medical Research Council (NHMRC) 2007 updated 2018, National Statement on Ethical Conduct in Human Research.Available at: https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

National Health and Medical Research Council (NHMRC) 2018, Australian Code for the Responsible Conduct of Research.Available at: https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018

This post may be cited as:
Allen, G. (21  May 2019) Monitoring research is too important to be optional and too resource intensive to be manual. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/monitoring-research-is-too-important-to-be-optional-and-too-resource-intensive-to-be-manual

0