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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Embedding clinical research as part of routine healthcare: Managing the potential for competing interests.0

 

Nik Zeps
AHRECS Consultant

 

Clinical trials are widely accepted as the best method for understanding whether any particular medical intervention is safe, efficacious, acceptable to patients and cost-effective. Almost every Health Service in Australia runs clinical trials of one sort or another. Enrolment of patients (in this instance they are all patients and not healthy volunteers) into clinical trials through health services operates as a separate activity to routine health care delivery and is managed through its own governance processes rather than as a part of clinical governance. This is widely recognised to be necessary but is unfortunately inefficient, duplicative in many instances, has a lack of objectivity and as a result of poor resourcing and training, is often slow and regarded as problematic by the research community. Sadly, there is a fairly widespread view amongst researchers that Research Governance is a bureaucratic hurdle rather than a means to ensure their research will be safe, quality work, be well managed and have significant impact.

One of the problems with the current system is that it treats all clinical trials as a single category rather than recognising the profound differences between trials that are seeking to establish new evidence for experimental therapeutics and those that are comparing existing therapeutic interventions (so-called Comparative Effectiveness Trials-CETs). It is clear that the risks of being enrolled in a CET are likely to be less than if being enrolled in a trial involving an unapproved therapeutic. Indeed many patients expect clinicians to deliver evidence based care, rather than practice variation, which can only elicited from high quality CETs  However, it is also true that if a person is randomised into the standard-of-care control arm of a trial of an unapproved therapeutic is at no greater risk than if they were not in the trial. Indeed, there is a broad range of evidence that participation in trials has an overall benefit in terms of safety and outcomes even for the control arms so one could argue that being in trial is by and large better than not being in a trial. It is also widely believed that the act of randomisation, the key feature underlying the power of clinical trials, is in itself risky and lifts any trial into a category that requires careful management. The National Statement does not make any such comment about risk related to randomisation and this view is one of subjective convention rather than one based on any proper assessment of risk.

Another feature of managing clinical trials is ensuring that potential participants are given appropriate information free of any coercion or inducements so that they can make a completely autonomous and sufficiently informed decision to participate or not. To ensure this a great deal of time and attention is paid to reviewing increasingly lengthy and complicated Participant Information Sheets and Consent forms (PICFs). In contrast almost no meaningful time is spent on evaluating the skills of the team in providing the information and being able to answer questions in a manner that ensures there is no coercive or inducive behaviour. Moreover, to my knowledge, no HREC has ever sent observers to audit how a participant is recruited, whether consumer input was sought in the development of the enrolment strategy or to evaluate notes taken as part of the consent process. This would appear to be the more important component of understanding whether the ethical issues arising from enrolling participants in a trial are being met.

Another area of research governance in need of an overhaul is a proper evaluation of the competing interests involved in running clinical trials in the first place. The term ‘conflict of interest’ is problematic in itself because it inherently assumes a negative position rather than recognising that instead there are legitimate instances of competing interests that have to be balanced and that it is not a black and white scenario. The NHMRC National Ethics Conference held in 2005 had this topic as it’s central theme and attendees discussed the need to take a more nuanced approach that included a broader consideration of competing rather than conflicting interests. These competing interests apply to participants themselves, the health professionals running the trials, the institutions responsible for operating the site where the trials are being done and finally the funders of the trials who may also be the ‘sponsor’ in the definition adopted by the TGA, that is, those with a direct vested interest in proving an unapproved therapeutic is better than existing practice so they can market their product for profit. Frameworks for managing these competing interests are often little more than answering ‘conflict of interest’ questions in the ethics application forms or on institutional declaration forms and stating that any institutional policy is being followed. This is clearly inadequate for a variety of reasons. Firstly, in my view after having worked in public and private institutions for 20 years, is that there is a check box mentality to managing potential competing interests with no resources deployed to either teaching staff about it or exploring the more subtle elements as opposed to simply addressing the blatantly obvious ones such as a direct financial conflicts. Secondly,

Given the earlier statements about the potential benefits of being enrolled in trials, and also the fact that for a subset of people the trial may be the only way to access a potentially life-saving treatment, participants themselves may have a profound self interest in participation. At the end of the day who are we doing research for if not the end-users, therefore system generated research barriers inadvertently have a direct impact on patients and members of the public.

It is also possible that participation in the trial leads to funding of components of care that would otherwise be a cost to the person. Some hold the view that people on trials should not experience any out-of-pocket expenses, even where those expenses would occur if they were not on the study. Arguments presented by investigators and sponsors that people should still have to pay any out-of-pocket expenses for standard-of-care components of a trial have been met with opposition by HRECs and institutions in some instances.

Health services are encouraged to run clinical trials for a variety of reasons that include being seen to be a centre of innovation and learning as well as providing access to cutting edge treatments. The reputational benefits are a discrete interest of the organisation that may, if connected to revenue from increased referrals, also be regarded as a potential marketing tool.  In addition, some have argued that government funders or health funds should not have to pay for treatments provided during any part of a clinical trial and therefore enrolment in trials is a means to offset some of the expenses associated with providing care to people in the health service. Some also argue that to promote clinical trial activity health services should have enrolment of patients in trials as a Key Performance Indicator (KPI) despite the obvious issues arising from simply working in ways that focus on meeting this that may not align with the best interests of participants. Indeed, whilst setting KPIs may seem like a good idea they create perverse incentives that are difficult to manage in the existing framework.

A topic that is rarely adequately discussed is the conflicts of interest of the institution that is both the site of the research, enjoying some of financial and reputation benefit from doing so, having a degree of duty of care for the participant, plus conducting the ethical and governance review. Commercially sponsored studies bring in revenue which is used to offset the costs of managing a clinical trial infrastructure. Ironically, making HRECs and Research Governance Offices dependent on revenue from commercial sponsors through fees is a major potential risk for conflicts of interest to arise, particularly where pressure is put to streamline approvals which could compromise more thorough evaluation of risks. Clearly a need to balance efficiency with due process is needed, but the dependence on fees that are not linked in any way to actual work done in terms of proportionate fee structures creates a clear conflict of interest within organisations. There is also a significant issue with using clinical trial revenue from commercially sponsored studies to subsidise the costs of Investigator led studies which do not otherwise enjoy such financial support. Whilst highly attractive to cash-strapped organisation unwilling to invest in such trials, the dependence on such revenue is far from ideal, and in some instances means that these trials cannot be opened as they may compete for recruitment of the same patient population and revenue generating trials will take precedence. I have observed this on several occasions at my own and other institutions, so it is far from a hypothetical risk.

Finally, investigators themselves may have competing interests with respect to enrolling people into trials and there have been arguments against permitting doctors who are both a chief investigator and the primary care provider for a patient from being involved in enrolling a person into a study. This is a fundamentally flawed argument and not one supported in the National Statement. Health Professionals have a primary responsibility to ensure the safety of those in their care and this is enshrined in a legal framework that could result in them losing their status as a health provider for any serious transgressions. Health Professionals should be in true equipoise regarding whether a person participates in a study or not and only suggest it if it would not be against their interests. Those paid to do research (study coordinators and Research Nurses) have competing interests to enrol people with no such equipoise and penalty for failing to exercise good judgement about whether a person should or should not participate. For this reason for medical interventions only doctors should decide whether a person should be invited to participate and should provide independent advice regarding the risks and benefits. Recognising where competing interests to enrol a person exist are managed well on the whole although I have also experienced instances in which obliviousness to the actual conflict of interest of being an investigator and having a financial interest in a product were not identified by doctors as being a direct conflict despite filling in forms that asked them to identify these. Therefore, it is not enough to simply write policies and ask people to fill in forms and appropriate training and the development of a culture that supports people to think about what they are doing is needed.

With our thanks to Nicola Straiton for her helpful comments on an earlier draft.

It is perhaps worthwhile for institutions implementing the Australian Clinical Trial Governance Framework overseen by the Australian Commission for Safety and Quality in Health Care (ACSQHC) to incorporate key parts of managing competing interests used in clinical governance for research activities as these likely overlap. A reasonable question can be asked: Do potential participants appreciate the conflicts of the parties they might assume are supposed to safeguard their welfare and interests? What is therefore needed is more than simply listing financial interests or relationships in ethics and governance applications. Instead a systematic and sophisticated approach is required that weighs up the risks and benefits of running research at a strategic level that is deployed as a core part of the culture of an organisation rather than as check box approach in research applications.
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This post may be cited as:

Zeps, N. (29 June 2020) Embedding clinical research as part of routine healthcare: Managing the potential for competing interests. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/embedding-clinical-research-as-part-of-routine-healthcare-managing-the-potential-for-competing-interests

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

When Research is the treatment: why the research/clinical care divide doesn’t always work0

 

Nik Zeps
AHRECS Consultant

Health services are often operated by people who strive to improve the way they deliver care. In the public imagination improvements arise from ‘breakthroughs’ such as the discovery of new disease mechanisms and drugs or devices to address these. However, it is not just novel treatments that lead to better outcomes. Sadly, it is not widely recognised that eliminating sub-optimal practices or variations in healthcare practices play a major role in improving clinical outcomes. Indeed, I don’t recall a headline announcing an increase in operational efficiency in any health service as this is hardly exciting news regardless of its value. Funders of healthcare are interested though, and in a report entitled Exploring HealthCare Variation in Australia: Analyses resulting from an OECD Study, published by the Australian Commission on Safety and Quality in Health Care in 2014, the authors stated that:

Unwarranted variation may also mean that scarce health resources are not being put to best use. As countries face increasing pressure on health budgets, there is growing interest in reducing unwarranted variation in order to improve equity of access to appropriate services, the health outcomes of populations, and the value derived from investment in health care.

All consumers of health care should therefore be interested in this and support those working toward improving health services. Unfortunately doing this work is difficult and often unrewarding. The ethical imperative to do this work is also often thwarted by the ‘ethics’ and governance framework that too often encumbers those doing it {Clay-Williams, 2018 #516}. It is also largely left to the NHMRC to fund Health Services Research (HSR) and the Comparative Effectiveness Research (CER) studies that generate evidence to reduce wasteful practice. In contrast, very little funding from health services themselves go to these activities despite them being the direct beneficiaries of the research.[1] Importantly, those engaged in HSR and CER are becoming an increasingly larger proportion of the total medical research endeavour in Australia, and by classification constituted almost one third of NHMRC competitive funding in 2019[2]. This is despite the fact that the studies undertaken often take several years to complete and therefore the number of publications is smaller than for life sciences. For HSR, publication is rarely in the ‘higher impact’ journals, whereas for some CER Trials the outcomes are so profound that they are of international significance and will be published in widely read international journals. Pleasingly this suggests that the criteria for assessment do not necessarily disadvantage such research in terms of competitiveness for funding, but also reflects the fact that clinical trial funding from the NHMRC supports a great deal of CER studies.

Those doing HSR and CER are also often involved in working in health services as clinicians which reduces the amount of time they can devote to academic research and to build a competitive personal research portfolio. The NHMRC has implemented a “Relative to opportunity” process in an attempt to address the almost impossible task of taking into account personal circumstances, but I doubt anyone is truly comfortable in applying it across the breadth of candidates and disciplines. Indeed, it could be argued that it is a surprisingly unscientific and subjective approach to use in schemes that are rewarding the quality of scientific approaches to address major societal issues. In 2019, only 7% of investigator grants went to applicants identified as HSR researchers.

It is difficult to think of what could replace this system across all areas of scientific endeavour but there is a possibility of rethinking how we fund and manage HSR and CER clinical trials. In both types of activity the end points are focussed on providing evidence to inform changes to clinical practice and health service delivery. As such the end users are health care providers and their funders. It would therefore seem much more appropriate that the end users play a much greater role in judging what kind of research should be done as well as the value of the outcomes of existing projects. The problem with this is that Health Services do not have the internal infrastructure and capability to manage research and have no incentive or means to do so.

What is particularly important to reflect on here is that publication metrics and university-based career milestones are largely irrelevant to the health services and arguably should not be the drivers of why the work is done. It would be more appropriate to have a regular employment relationship between the health services researchers and the health services in a manner that does not differ to clinical safety and quality activities. Sadly, health services have not seen the need to invest in this out of their operating budget and one can see why they would not if universities will do so. The problem though is that health service managers inevitably regard them as academic exercises with no direct relevance to routine health practice and when budgets are tight any support rapidly evaporates.

Like other industries that are reliant on R&D, it could be argued that a defined proportion of all health funding should go to HSR and CER that is conducted and run within the health services themselves. In the UK the National Institute for Health Research (NIHR) was established in 2016 with £1 billion to do just this, representing just under 1% of the total National Health Service Budget at the time (£126 billion[3]). The current public expenditure on health in Australia is $81.8 billion AUD, however, the total health spend, including private and personal (out of pocket) expenditure was $185 billion in 2017/2018[4]. The combined NHMRC and MRFF expenditure on all HSR and clinical research is estimated to be around $800million in 2019, less than 0.5% of the total health expenditure. The difference with the UK is that the Australian funding is largely administered through universities and not by the health services as in the UK.

I would propose that researchers engaged in HSR and CER should be employed by the health services themselves and be regarded as intrinsic to the operations of the health service. In addition, I propose that these staff would not publish papers under their own names but instead publish under the health service banners, either singly or as collaborations of organisations. In this way individual career progression would be based upon demonstration of outcomes in the same way that other activities in the health service are evaluated. Staff who do their job well would continue in their employment and be eligible for ongoing employment. Career progression would be through building a demonstrated portfolio of achievement that is attested to by their employers in a similar way that professional references are provided. Success for individuals would therefore be entirely based on being able to show how they had contributed to productive activity within the organisation.

If this major change to operating this type of research was made then it might also change one of the other major barriers that currently exists, the disproportionately burdensome ethical and governance requirements for such ‘research’ which is mostly treated as having the same risk profile as novel interventional studies. The aims of research are stated to differ from those of providing clinical care to patients, and this is at the heart of the Declaration of Helsinki’s ethical principles as well as those known as The Belmont Report published in 1979. In the Australian National Statement on Ethical Conduct in Human Research, such a distinction between clinical care and research is no longer identified and not commented on so explicitly.

For HSR and CER the distinction between what is routine practice and what is research is extremely blurred, particularly within the context of a self-improving/self-learning healthcare system in which a constant cycle of analysis of the current status of clinical activity informs the delivery of healthcare into the future. The robust methodologies employed to do the analysis and to test potential alternative practices aimed at improving care are indistinguishable to those used for researching novel and potentially more risky interventions. However, the risk profile is completely different, particularly where the research involves one or more practices already in widespread use. A more embedded framework that ensures that ethical issues are addressed at a systemic level rather than through the existing ethics and governance system that treats such work as ‘other’ is needed. The 2019 draft Clinical Trial Governance Framework developed by the ACSQHC goes some way toward creating a culture in which this can be delivered although it will likely require significant cultural change at most health services engaged in research.

We need a system that values those doing this work as core employees and is directly vested in the outcomes of the work and their implementation into improved practice as the prime demonstration of productivity. Such a cultural change will provide the drive to streamline the overly burdensome regulatory framework that currently exists. Such a framework would deliver its own efficiency dividends in a positive cycle enabling more of this work to be done and an acceleration in avoiding wasteful practice and generation of data that brings real improvements to people’s lives. It would seem that this is the very definition of an ethical outcome.

[1] ACSQHC/ACTA report on clinical trial benefits https://www.safetyandquality.gov.au/publications-and-resources/resource-library/economic-evaluation-investigator-initiated-clinical-trials-conducted-networks-final-report

[2] https://www.nhmrc.gov.au/file/14808/download?token=GAkwLHj0

[3] https://fullfact.org/health/spending-english-nhs/

[4] https://www.aihw.gov.au/reports/health-welfare-expenditure/health-expenditure-australia-2017-18/contents/summary

This post may be cited as:

Zeps, N. (04 June 2020) HWhen Research is the treatment: why the research/clinical care divide doesn’t always work Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/when-research-is-the-treatment-why-the-research-clinical-care-divide-doesnt-always-work

COVID 19, human research and human research ethics review1

 

Prof. Colin Thomson AM
AHRECS Senior Consultant

We at AHRECS, like all our friends, colleagues and clients, are becoming more and more aware of the immediate and probably long-lasting impact of this pandemic on almost every part of our lives. It has compelled researchers to vary methodologies adopted for both ongoing and planned human research. It has also been forcing institutions to adapt human research ethics review processes to enable responsible social distancing.

In this brief item, we are opening a conversation to offer assistance, ideas, successes and strategies to achieve these changes while maintaining the ethics and quality of human research and ethics review.
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Human research ethics review

A number of our clients have long been conducting ethics review meetings online because of geographical necessity. Australia’s regional universities have led these innovations and acquired considerable experience in managing to achieve effective, efficient and quality ethics review. They use different online platforms and have experience of the strengths and weaknesses of several of these in running both synchronous meetings and asynchronous review processes.

They also have experience of assisting those committee members who have been reluctant to review digital applications. The current crisis may compel further limitations on such assistance; for instance, institutions may be unable to print and dispatch agenda papers and members may be less willing to receive them. Experience in enabling less IT-savvy members to adopt online processes with comfort could be a value now to other institutions making these changes.

There may also be substantive issues in addition to these ones of process.  For example, how does COVID-19 change our perceptions of merit; what if it shifts the balance in an unfavourable direction after a project has been approved?

We have asked some of our clients who have these experiences to respond to this item and encourage others to either offer or seek assistance, not necessarily through AHRECS, but directly. This may be the time in which the development of broader community of human research ethics review practice will be more needed than ever.
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Human research

For researchers, particularly those with approved projects that involve interaction with participants, the new restrictions on physical distancing and self-isolation are likely to present significant difficulties in continuing and completing their projects. They will need to change the manner of that interaction and the ways they collect the data they need so as to limit risks to participants and to themselves.

In normal circumstances, such changes would require prior ethics approval to conform to the conditions of approval that the National Statement requires (National Statement 5.5.6 (c)). However, the consequences for researchers of seeking prior approval may have a greater impact on the continuity and completion of their work and, in busy research institutions, lead to a significant workload increase in approval requests for urgent project variations.  In addition, those alterations to data collection will involve, in due course, changes in the manner in which data are stored, used and either retained or destroyed, all of which would, in normal circumstances, require consent from participants.

Other issues that researchers may face include:

  1. Identifying and fulfilling the responsibilities that arise when they have to close down their research, e.g. can they use data already collected? Do they inform participants and, if so, how?
  2. What obligations they may have to participants who are distressed by the current situation, especially when relevant to the research, as it is entirely foreseeable?
  3. How do they continue to engage in consultations to which they are committed, whether with communities or with all stakeholders?

In the situation that now presents itself, new strategies will need to be devised and it is likely these will depend more than ever on the ethics reviewers’ trust of researchers. For example, an institution could permit researchers to make urgent changes themselves to data collection methods in order to protect participants and meet COVID-19 limitations on condition that they notify the ethics reviewers as soon as practicable following the implementation of the change. That later application could also include a request for approval of changes to data use, management and retention or destruction.
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Guidance for researchers

Australian governments at Commonwealth, State and Territory level have provided combined guidance for researchers, especially those conducting clinical trials and other institutions have combined to offer practical advice for researchers on how to negotiate needed changes and ethics review.
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Research about COVID-19

The COVID-19 situation will generate research initiatives, not only in relation to the immediate medical needs such as vaccines, but also about the impact on health professionals, researchers, and families of those victims of infection, serious illness or death, as well as about the social impact of information, social distancing and self-isolation.

In vaccine projects, issues of justice in inclusion of participants are likely to be difficult to resolve: should all be included or only those capable of a voluntary consent.  And achieving an ethically sound consent will be complicated by the need to provide sufficient information, counter the possibility of social pressure to participate or the heightened influence of health professionals.  As Haaser says, “It is not easy to say no to a hero.”
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An invitation

In this brief note, these are but early suggestions. We invite our readers to respond to these thoughts with ideas and experience of strategies that they, as researchers or ethics reviewers, have adopted to address the new needs.

Further, and more importantly, this invitation is to encourage institutions, ethics review administrators, ethics review committees and researchers to exchange their ideas and their experiences.  It may be ironic that one of the effects of the COVID-19 crisis is to promote a wider community of good ethical human research practice – but it would nonetheless be a very good outcome.

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This post may be cited as:
Thomson, C. (18 April 2020) COVID 19, human research and human research ethics review Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/covid-19-human-research-and-human-research-ethics-review

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