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. .
JC Gaillard School of Environment, The University of Auckland, New Zealand Unit for Environmental Sciences and Management, North-West University, South Africa Profile | jc.gaillard@auckland.ac.nz
Lori Peek Department of Sociology and Natural Hazards Center, University of Colorado Boulder, USA Profile | Lori.Peek@colorado.edu
. We recently called for a code of conduct in disaster research. This call is rooted in our respect for the research process itself and our care for affected people and the researchers who do this work. To be clear, we are calling for a cross-disciplinary conversation to advance a shared set of moral and ethical principles to help guide what we study, who we study, how we conduct studies, and who is involved in the research process itself. We are not arguing for another layer of bureaucratic or regulatory oversight such as those required in some countries by internal review boards and ethics committees. Our hope is that such a discussion will launch first within focused academic and policy meetings, before it can be scaled up to the regional and eventually international levels.
Our intent is to prompt further reflection and conversation around the following three possibilities for ensuring that disaster scholarship is relevant, fair, and ethically sound.
First, it is essential that research has a clear purpose that is rooted in present knowledge gaps and emergent context-specific research priorities in the disaster aftermath. The collaborative work that happens before disaster and in the immediate aftermath can help clarify the focus of research studies and ensure that the knowledge generated is locally-relevant and hence more likely to effectively inform response, recovery and future disaster risk reduction efforts.
Second, ensuring that research is filling relevant knowledge gaps requires that local voices be put at the forefront of the research effort. Local voices may include a range of perspectives, including those of local researchers and those who hail from elsewhere but hold deep knowledge of the places and people affected by disasters. They also comprise those voices of the survivors whose ability to deal with the event and contribute to the recovery effort is central to rebuilding damaged physical infrastructure as well as people’s lives and livelihoods. Ensuring that local researchers and survivors are in the driving seat does not exclude outside researchers when prompted by local colleagues. In many instances, outside scholars have access to a wide range of resources (e.g., equipment, funding, time) that may be unavailable locally in times of collective hardship. Crucial, though, is that local researchers have the opportunity to lead efforts associated with research design, data collection and analysis, and ultimately the sharing of findings.
Third, it is crucial that research agendas and projects launched in the disaster aftermath be ethically coordinated and involve locals and outsiders. This means that local researchers need to be identified quickly after disaster—the National Science Foundation-supported Extreme Events Research and Reconnaissance networks have already jump-started these efforts. There are many other organizations and networks globally that have advanced new methods for identifying researchers and communicating creatively in the disaster aftermath through virtual forums and virtual reconnaissance efforts that allow for a wider range of researchers to connect, communicate, and ultimately collaborate.
Engaging with the three aforementioned areas of possibility is crucial given the rising number of disasters and disaster studies. It is clear that disasters stir the interest of researchers, as evidenced by the growing number of academic publications on the topic. Most of these researchers are driven by a genuine desire to contribute to reducing suffering, but researching disasters can be difficult and there is not a clear ethical playbook for how to proceed.
This becomes especially pressing because researching disasters entails navigating a complex and sensitive environment where survivors may struggle with both the consequences of the event and the task of recovering. Meanwhile, local and outside responders try to support the relief and recovery effort. To fully grasp the complexity of the situation, researchers need to be equipped with an appropriate ethical toolkit that goes beyond the requirements of the research ethics committees of universities and other research institutions. It entails a nuanced understanding of the cultural, social, economic and political context wherein disasters unfold. For scholars who choose to work in new contexts following disasters, this sort of competence is difficult to acquire ad-hoc and in a short span of time.
With these challenges in mind, it remains a dominant pattern after major disasters that outside researchers converge and lead studies conducted in locations beyond their familiar cultural environment. In fact, disaster studies are often driven by scholars located in Northern America, Europe, East Asia, and Australasia. A review of publications on disasters over the past four decades shows that there are fewer researchers publishing studies from Africa, South and Southeast Asia, the Pacific, and Latin America although these regions of the world are those where disasters claim more lives and occur more frequently.
Such unequal power relationships in terms of who leads, conducts, and communicates research on disasters influences how disaster scholarship is framed and approached on the ground. Disaster studies are largely informed by Western ontologies and epistemologies that do not necessarily reflect local worldviews and ways of generating knowledge, which means that implications for policy and practice may be misleading.
Identifying these gaps opens up the possibility for reconsidering some of the fundamental assumptions about how research is conducted and ultimately how knowledge is generated and shared. Our call for a code of conduct is about ensuring that ethical concerns have the same primacy as our research questions. We look forward to continuing the conversation.
In our careers to date, we have had many formal conversations with members of HRECs across different institutions regarding human research ethics applications and amendments. We have also had many informal conversations with members of HRECs regarding standard operating procedures in the labs we have worked in. In this article, we share our experience engaging with our HREC in a different context, specifically, formal negotiations with our HREC following an adverse incident that occurred during our data collection for one of our projects.
To provide some context, our research often uses non-invasive brain stimulation techniques including transcranial magnetic stimulation (TMS). TMS has been commonly used in research since the mid-1980s, and is considered safe, non-invasive, and painless. TMS involves a brief, high-current electrical pulse delivered through a handheld coil placed over the scalp, which induces a magnetic field that passes through the scalp and skull with little attenuation. The magnetic field induces current flow in the underlying brain tissue, and if the stimulation is sufficiently intense, it will activate the underlying brain cells providing a measure of brain excitability [1, 2]. There are published international guidelines for the safe use of TMS [3, 4] that are used to design the experiments and screen for contraindications to TMS (for example it is routine to exclude any persons who have a history of epilepsy, metal implants in the skull, or cardiac pacemakers). Nonetheless, research using TMS involves a small but finite risk. Occasionally, research participants experience a mild and temporary headache, nausea, muscular problems, dizziness, or fainting during or after TMS.
In a 12-month period in 2017, we experienced three adverse incidents: three participants in our research projects using TMS fainted#. As mentioned above, TMS studies involve a small but known risk of fainting. There have been some reports of syncope in the literature [5-7]. It is proposed that anxiety and exposure to a novel stimulus are likely responsible for fainting in the context of TMS [3, 5-7], however it is not possible to determine whether fainting or syncope is a secondary effect of an emotional response or a direct effect of the TMS on the nervous system.
It was following the reporting of these adverse events that we found ourselves in formal conversations with our HREC as well as informal interactions with several members of the HREC. There were two key steps involved in these conversations worth outlining. First, we invited the members of the HREC to visit the lab and attend a lab meeting in which we were discussing the adverse events. This engagement with the members of the HREC in our lab environment was a mutually beneficial exercise: it helped researchers to fully understand the concerns of the HREC and helped the members of the HREC to better understand our research procedures and aims, and observe our commitment to minimizing the risks associated with our research.
Second, we scrutinised our standard operating procedures to determine what changes we could make to minimize the risk of another adverse event. As outlined above, fainting during a TMS experiment is highly likely to be related to a psycho-physical response, although we cannot rule out the possibility that it is due to a direct effect of TMS on the nervous system. Following the adverse incidents, we have made several changes to our procedures. First, and perhaps most importantly, we send our potential participants a short video so they can see a typical experiment before they enter the lab. Second, when participants come into the lab we ask them if they have had any substantial change to their routine (for example sleep pattern, medication) feel stressed by factors independent of the research, and if they have had food and water in the preceding few hours (we have snacks and water in the lab if participants haven’t eaten). Third, we made changes to our lab setting such as moving to a modern, clinical testing room which was larger and brighter than the old testing room. Fourth, we take time to explain all of the equipment in the lab, not just the equipment being used in that particular experimental session.
Since the implementation of the changes to our standard operating procedures, we have not experienced an adverse event. The entire process of conversing both formally and informally with the HREC has led to improved written communication of our research to potential participants and HREC in the form of new project applications. Additionally, the process led to the development of resources for members of the lab, such as evolving standard operating procedures and a formal (compulsory) lab induction, and resources for potential participants, such as the communication of study information via a combination of written, video, and photo formats. Importantly, the implemention of revised procedures not only improved the safety profile of our experiments, but also it brought us in a better position to conduct high-quality research by enriching our resources in training lab members, communications with participants, and experience in engaging with HRECs. So, what did we learn from our conversation with an HREC? The processes of conversing with the HREC in the context of an adverse event is beneficial and needn’t wait for an adverse event to occur!
#In a 12-month period in 2017”, note that these are the only fainting incidents that we experienced since we have started our role at MU in 2015
References:
1. Barker AT, Jalinous R and Freeston IL, Non-invasive magnetic stimulation of human motor cortex. Lancet, 1985. 1(8437): p. 1106-7.
2. Hallett M, Transcranial magnetic stimulation: a primer. Neuron, 2007. 55(2): p. 187-99.
3. Rossi S, Hallett M, Rossini PM and Pascual-Leone A, Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol, 2009. 120(12): p. 2008-39.
4. Rossi S, Hallett M, Rossini PM and Pascual-Leone A, Screening questionnaire before TMS: An update. Clinical Neurophysiology, 2011. 122(8): p. 1686-1686.
5. Kirton A, Deveber G, Gunraj C and Chen R, Neurocardiogenic syncope complicating pediatric transcranial magnetic stimulation. Pediatr Neurol, 2008. 39(3): p. 196-7.
6. Kesar TM, McDonald HS, Eicholtz SP and Borich MR, Case report of syncope during a single pulse transcranial magnetic stimulation experiment in a healthy adult participant. Brain stimulation, 2016. 9(3): p. 471.
7. Gillick BT, Rich T, Chen M and Meekins GD, Case report of vasovagal syncope associated with single pulse transcranial magnetic stimulation in a healthy adult participant. BMC neurology, 2015. 15(1): p. 248.
Dr Yvonne Haigh Chair, HREC, Murdoch University. Perth Western Australian
. In 2015, Murdoch University’s HREC received increasing numbers of applications that covered innovative approaches to cognitive neuroscience with a specific focus on TMS (Transcranial Magnetic Stimulation). The topic area covered was very new with significant levels of technical and neuroscience language. While the methods of data collection were relatively unfamiliar for the committee members, several members did undertake some broad reading in order to establish greater familiarity and understanding. However, the applications did refer to different forms of TMS which further exacerbated the committee’s hesitation. In order to establish good rapport between the researchers and the committee, we invited the researchers to present on the topic – TMS. The aim of the presenting was to provide an overview of the variations of the technology, any side effects, international benchmarks and so forth. The committee was certainly reassured with the researchers’ level of experience and expertise. Moreover, it was also apparent the researchers had a sound approach to safety and participants’ wellbeing. .
However, over the ensuing years a range of adverse incidents occurred which involved dizzy spells and fainting in a few cases. The researchers informed the committee and put in place a range of options. The committee was invited to the laboratory to observe and experience the methods. This was particularly helpful and reassuring for the members who attended and enabled a broader discussion with those committee members who could not attend the laboratory. The Manager, Research Ethics & Integrity was also invited to attend a laboratory team meeting where the incidents were discussed, safety procedures revised, and student researchers reminded of their roles and obligations. This meeting enabled a confident report back to the HREC which was aligned with the adverse incident reports and made the committee’s task of reviewing the incidents significantly clearer. .
These conversations and visits resulted in updated procedures (including safety) from the research leaders. This has led to clearer exclusion criteria and additional questions incorporated into the consent process to ensure any known risks are minimised. While adverse incidents are difficult, the outcome in this instance has led to building increased trust between the committee and the research team and a proactive approach from both sides to ensure that new emerging issues are discussed and resolved. .
One of the very clear outcomes of this process has been an increased level of quality in these ethics applications which take less committee time and effort to approve. While the technology is always evolving, and research in the area is ‘cutting edge’, the possibility that this research may change the lives of participants in these projects is evident in the researchers’ applications. From the committee’s perspective, it has been the open and respectful communication between all parties that has generated both a solid working relationship and enabled high level ethical research. The HREC’s response to a more recent ethics application reviewed since the adverse incidents described begins with the words: “The committee were impressed by the quality of this application and the careful attention to detail. The committee thank the researchers for their ongoing efforts to incorporate suggestions and advice in the collaborative effort to attain ethically strong research and positive outcomes for the community”.
Clinical trials have enormous value to society as they provide the most robust means of working out whether or not particular treatments used to improve the health of our population work or not. Governments have a stated objective to increase participation in clinical trials based upon a series of assumptions that extend beyond their utility as a means to derive the highest level of reliable evidence about the efficacy and safety of interventions. One of these is that those people who are included derive a tangible benefit from doing so. Whilst this may not be true in all cases, after all up to 50% of people may receive an inferior treatment by definition, there is the potential for people to derive individual benefit, and it is often stated that those involved in a trial receive a higher standard of care than those not included. Certainly, the additional testing and closer scrutiny of people on a trial may equate in some instances to better care, but this should not be seen as a major driver as it could be argued that equitable care should be available as a universal right. A less discussed benefit is the connectedness and satisfaction that people may derive from making a tangible contribution to society through participation in clinical research. Furthermore, there may be indeterminate peer group benefits even if an individual does not benefit.
In an Australian study Smith et al (1) found that CALD people whose preferred language was not-English (PLNE) had the lowest participation rates in clinical trials. Whilst CALD people whose preferred language was English (PLE) had greater levels of enrollment than the PLNE group, they were still underrepresented by population. This has been described across the world and is identified as a pressing concern (2). Understanding why this is the case is important for a number of reasons. In multiculturally diverse countries like Australia, testing interventions where a significant proportion of the population are not included could result in evidence that is not applicable to those people. This spans across biological differences which may be relevant to drug efficacy or toxicity through to interventions such as screening that may fail to be useful in those populations. Where there is evidence that participation in a clinical trial may present specific advantages there is also the issue of injustice through exclusion of a particular group or groups of persons. Certainly, from an implementation perspective, not including a diverse group of participants and analyzing for cultural and behavioral acceptability may mean that even if an intervention has merit it fails to be taken up.
The reasons for non-inclusion are likely more complex than those of language barriers, although having protocols for clinical trials that specifically exclude people who don’t have higher levels of proficiency in English do not help. It would seem that the language barrier could be soluble through providing greater resources to enable translation services, particular in areas with a clear need for this. Certainly, multi-national trials already have PICFs in multiple languages and these could be readily deployed through use of innovative technologies including eConsent processes.[1] Funders of clinical trials could make it a requirement for such inclusivity and back it up through provision of specific funding for this in any grants they award. Legal means to enforce this, whilst possible, are unlikely to drive systemic change and could have the unintended consequence of making it harder to do any trials at all in an environment already subject to extreme financial pressures.
However, a major reason for low levels of participation in clinical trials may be attributed to equity of access to clinical services in the first place. It is hard to recruit people from the general population into clinical trials, but even harder if specific members of the population don’t come to the health service in the first place. There is relatively little research on this topic and it would seem logical to do this as a priority in parallel with examining why people fail to participate in clinical trials due to language barriers. Perhaps clinical trials are simply the canary alerting us to broader inequities that need greater research and investment. Research into solutions to these inequities is accordingly a priority and may solve clinical trial participation rates as a consequence.
References
Smith A, Agar M, Delaney G, Descallar J, Dobell-Brown K, Grand M, et al. Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers. Asia Pac J Clin Oncol. 2018;14(1):52-60.
Clark LT, Watkins L, Pina IL, Elmer M, Akinboboye O, Gorham M, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol. 2019;44(5):148-72.
Nik Zeps participated in the CCV forum at the COSA ASM. A full report of the workshop and research by the CCV and MCCabe centre is forthcoming.
The senior consultants started AHRECS in 2007. We were looking for a way of responding to requests for advice on research ethics and integrity from the government, health and education sectors read more...
Comments’ rules
We decided to include comment functionality in the Blog because we want to encourage the Research Integrity and Human Research Ethics communities to contribute to public discourse about resourcing and improving practice. read more...
Random image from the AHRECS library. These were all purchased from iStockPhoto. These are images we use in our workshops and Dr Allen used in the GUREM. Less
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