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Ethical review

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Smarter proportional research ethics review0

 

Rushing toward a faster review decision should not mean relaxing standards or playing chicken with stricter central control

Gary Allen, Mark Israel and Colin Thomson

Too often, there is a danger that ‘expedited ethical review’ (a term not used in the National Statement since 1999) might equate to an approach that abridges the review process to the point where it’s little more than a friendly exchange between peers or a nod to seniority. We won’t call out the well-reported cases where it is hard to fathom how they were granted ethics approval. Such cases should make us uncomfortable, because they are invitations to replace institutional self-regulation with something hasher and unsympathetic.

Don’t get us wrong, we’ve spoken often and enthusiastically about the value of well-designed proportional review arrangements. We have assisted many clients, large and small, to design and implement such arrangements and believe that they form part of a well-conceived review system.

A proportional review arrangement can deliver a review outcome much faster than consideration by a human research ethics committee, but instead of a ‘Claytons’ or mock-review, it should have the following features:

  1. While there can, and should, be a mechanism to do an automated quick self-assessment of whether a proposed project qualifies for ethics review other than by a research ethics committee, the process should:
    1. not rely on questions along the lines of “Is this a low risk research project?”
    2. draw on, reference and link to guidance material.
    3. when using trigger questions, ensure they are nuanced, with probing sub-questions.
    4. include confirmation of a quick assessment by an experienced ethics officer or chairperson.
    5. retain an applicant’s responses, both as a record of what they said about the project, and for future evaluation of whether the arrangement is correctly assessing new projects and guiding applications along the correct review pathway.
  2. The process should preferably be online, easily (re)configurable, easily auditable, with information entered by applicants and ‘triaged’ by an ethics officer.
  3. A quality online system will populate committee papers and reports, will issue reminders and will populate with known information.
  4. While many projects may be reviewed outside of the human research ethics committee, the reviews should be conducted by experienced persons, who participate in annual professional development and who can draw upon internal and external policy and resource material.

In Australia, an institution’s proportional review arrangements might include the following pathways:

  1. Prior review– Research that has already been reviewed by another HREC, appropriately delegated review body, or an international body equivalent to an Australian research ethics review body.
  2. Scope checker– A test to confirm whether a proposed project is in fact human research.
  3. Exemption test– A test to determine whether the proposed research is a type an institution could exempt from ethics review as per the National Statement.
  4. HREC review required test– A test to confirm whether the research project is of a type the National Statement specifies must be reviewed by a HREC.
  5. Institutional exemption test– Many institutionsexempt some categories of human research from research ethics review (e.g. universities often exempt course evaluations and practical activities for a teaching-learning purpose).
  6. Negligible risk research– Subject to qualifying criteria an institution might establish a negligible risk review pathway in which applications are considered administratively.
  7. Low-risk, and minimal ethical issue research– Subject to qualifying criteria, proposed projects that are low risk and have minimal ethical sensitivity could be reviewed by the chair of the research ethics committee.
  8. Low-risk, some ethical issue research– Again subject to qualifying criteria, proposed projects that are low risk but have some ethical sensitivity could be reviewed by a small panel of the research ethics committee (including external member of the committee).
  9. HREC review – Only human research (see 2), that has not previously been reviewed (see 1) that is not exempt (see 3 and 4) and has not been classified as negligible risk (see 6) or low risk (see 7 and 8) needs to be reviewed by HREC.

An arrangement with the features listed above would allow for review that is proportional, timely, efficient and justifiable. Reviews that are merely expedited or fast places us all at risk. The increasing examples of “how could that have been approved?” makes it feel as though some institutions are gambling that a desire to meet researchers’ calls for quick, if superficial, review won’t be exposed by unethical practice. Perhaps they are correct, but every new reported review misstep makes us more nervous. Realistically, establishing a nationally administered reliable, robust and agile proportional review process requires substantial investment of time and other resources so is unlikely to happen.  But, what poor review processes could do is invite far more detailed direction on how institutions can design, conduct and monitor processes outside of a HREC. In our experience, there are greater and longer-lasting benefits that can accrue from an institution having a high quality approach to proportional review.

The above is a summary of the discussion we typically include in blueprint documents about establishing a robust proportional review arrangement. We have included some further notes on this topic on our https://www.ahrecs.vip and Patreon pages.

Please contact us at proportional@ahrecs.com if you would like to discuss how we might assist your institution.

This post may be cited as:
Allen, G., Israel, M. & Thomson, C. (26 August 2019) Smarter proportional research ethics review.  Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/smarter-proportional-research-ethics-review

Proportional processes can sometimes be the answer to a few (apparently competing) problems0

 

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.

  1. 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.

Figure 1 This image (without the watermark) is available to USD3+ Patrons https://www.patreon.com/posts/27638074

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

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

“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
  
   .

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

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