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.

3. 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.

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