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. .
Dr Amanda Fernie, Manager Research Ethics & Integrity, Griffith University Dr Gary Allen, Senior Policy Officer, Griffith University
AUSTRALIAN CODE (2007)
At Griffith University, the implementation, operation, investigations and related professional development of/for the 2007 edition of the Australian Code for the Responsible Conduct of Research is the responsibility of the Research Ethics & Integrity team in the Office for Research.
The Griffith University Code for the Responsible Conduct of Research was the University’s policy implementation of the Australian Code (2007) and it was supplemented by the Research Integrity Resource Sheet (RIRS) series. The Griffith University Code was largely a direct repeat of the Australian Code into Griffith University policy. The RIRS is a series of short (most are four pages) guidance documents that provide practical tips related to the University’s implementation of Part A and Part B of Australian Code (2007).
IMPLEMENTING THE AUSTRALIAN CODE (2018)
This is the first post in the series about institutions implementing the Australian Code (2018). We’d love to hear about your instution’s progress and story. Email us at IntegrityStory@ahrecs.com to discuss logistics.
At the outset, Griffith University decided to give its Research Integrity Adviser (RIA) network a more collegiate advisory role, and while RIAs were made available to advise complainants and respondents, or parties in a dispute, their primary role was providing advice and suggestions. . Professional development workshops on research integrity for new HDR candidates were conducted a few times a year (as part of the orientation) and were co-facilitated by the Office for Research and the Griffith Graduate Research School. Workshops on research integrity were also conducted for new HDR Supervisors as part of their accreditation. Since 2007, professional development workshops in Schools, Departments, Research Centres, Administrative units and Groups have been co-facilitated by the relevant RIA and a member of the Research Ethics & Integrity team. .
APPROACH TO THE AUSTRALIAN CODE (2018)
. Griffith University aims to have fully implemented the Australian Code (2018) by the end of March 2019. Griffith’s Research Committee has recommended to the Academic Committee that the redundant detail of the Griffith University Code be replaced by the Griffith University Responsible Conduct of Research policy. This policy articulates the University’s implementation of the principles and responsibilities of the Australian Code (2018), the role of the University’s collegiate RIAs, and the existence and role of the resource material that will be produced by the Office for Research. Our Office for Research is currently liaising with the relevant parts of the University to determine who has control of:
.
Level 1 – Documents that refer to or link to the Australian Code, where a simple change to the reference/URL is required. Example: HDR candidate supervision policy. . Level 2 – Documents that derive authority from the Australian Code, where it will need to be determined if the Australian Code (2018) still directly provides that authority or if any changes are required. Example: Publication ethics standards. . Level 3 – Documents that copy, refer to or use a component of the Australian Code (2007), where it will need to be determined if the Australian Code (2018) still provides that component or if it needs to be replaced by institutional guidance. .
The above work is underway and progressing well. . In the event new institutional guidance is required, it will be included in the updated RIRS series. .
UPDATED RESEARCH INTEGRITY RESOURCE SHEETS
. The following resource sheets are being produced: .
Introduction to research integrity at Griffith University
Moving to the 2018 version of the Australian Code
Planning and conducting a project responsibly
Responsible research outputs
Responsible data management
Collaborative research: Hints and tips
The responsible supervisor
The responsible candidate
Conflicts of interest
Tips for peer review
Disputes between researchers
Investigations of alleged breaches of the Australian Code for the Responsible Conduct of Research
Alleged breaches: Tips for complainants
Alleged breaches: Tips for respondents
Research Misconduct
. Initially any ‘new’ guidance material will use text from Part A of the Australian Code for the Responsible Conduct of Research (2007), but the intention is to refine the material based on (sub)discipline and methodological feedback from the University’s research community, drawing from useful ideas from the Committee on Publication Ethics (COPE), International Committee of Medical Journal Editors (ICMJE), US Office of Research Integrity (ORI) and the UK Research Integrity Office. . As new good practice guides are released the relevant RIRS will be reviewed and updated as required. Griffith University is taking a ‘learning institution’ approach to this material, where it is refined and improved over time based on user feedback and suggestions, institutional and (inter)national experience/events and changes in needs. . COMMUNICATION PLAN
. The Office for Research is currently finalising a communication plan, in addition to regular updates to Research Committee, the RIA network and the areas of the University identified for the consultation above. This will include briefings for the Group Research Committees. .
AWARENESS AND PROFESSIONAL DEVELOPMENT PLAN . Early in 2019, the Office for Research and RIAs will commence professional development activities to raise awareness and understanding of the national and international changes. .
Contributors Amanda Fernie, Griffith University | a.fernie@griffith.edu.au & Gary Allen, Griffith University
This post may be cited as: Fernie, A. & Allen, G. (26 November 2018) Griffith University’s implementation of the Australian Code (2018). Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/griffith-universitys-implementation-of-the-australian-code-2018 . We invite debate on issues raised by items we publish. However, we will only publish debate about the issues that the items raise and expect that all contributors model ethical and respectful practice.
Pieper, I. & Thomson, C.J.H. Justice in Human Research Ethics: A Conceptual and Practical Guide, Monash Bioethics Review I Volume 31, Number 1, 2013 pp 99-116: https://link.springer.com/article/10.1007/BF03351345
A Series on the Four Principles of the Australian National Statement on Ethics Conduct in Human Research
In this issues of the Research Ethics Monthly, Ian Pieper and Colin Thomson continue their series of short summaries of each of their four co-authored articles on the principles that underpin the Australian National Statement, namely, research merit and integrity, justice, beneficence and respect.
The articles were originally published in the Monash Bioethics Review and remain available to subscription holders to that journal. The publisher, Springer, has generously agreed to place each of the four articles on Free Access for one month after the corresponding short summary is published in the Research Ethics Monthly. Last month they revisited the paper on Contextualising Merit and Integrity within Human Research. This month they revisit the paper on the principle of justice as it applies to human research. The full paper can be found here.
Researchers are required under the National Statement to demonstrate to ethics review bodies that their proposed human research projects are just. Members of ethics review bodies are responsible for determining whether or not proposals for human research demonstrate the principle of justice. This paper explores the historical development of the concept of justice within human research ethics and how it came to be one of the four basic values on which the National Statement is based.
Justice is now accepted as one of the core values to be applied in a review of the ethics of human research. However, justice is a multi-facetted concept and not easily defined. Justice means different things to different people depending on the context and circumstances. In paragraphs 1.4 and 1.5 the National Statement describes justice using examples such as; fairness in relation to the distribution of burdens and benefits, and guarding against the exploitation of participants. Throughout the document, the National Statement revisits the concept of justice to provide guidance on how it might be demonstrated in particular contexts.
The inclusion of justice as a requirement in the ethical review of human research largely stems from the Belmont Report. It was there that particular cohorts of participants first began to be identified as being exploited by researchers. Its utility as a principle was highlighted during the debates arising from the conduct of international biomedical research in the late 1990s, especially in their collection of research data from lower or middle income countries and use or the benefit of the populations of higher income countries. Given its relatively recent addition to the human research ethics discussion, what constitutes just research is still an evolving concept.
An activity sheet about research ethics committees and the evaluation of justice has been added to the AHRECS subscribers’ area. It includes notes for presenters. By becoming a patron you will get access to all the subscription material (with new items added every month). The material is posted on a creative commons basis so it can be loaded onto your institution’s servers for use in your in-house professional development activities. A subscription of USD15 per month (approx AUD20) grants access to all material. Subscribers can make requests for the topics for future activity sheets. AHRECS can provide a statement for paid subscriptions (for your accounting purposes). To subscribe visit https://www.patreon.com/ahrecs.
In this paper, the origins and recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished and the manner in which they can be applied meaningfully in the ethical review all human research is identified.
Justice is not only a consideration for researchers, but also for the integrity of the conduct of the evaluation process. Questions of justice can be seen as subjective. The concept of justice – whether distributive or commutative – and what counts as a just distribution or exchange – are given different weight and meanings by different people. Decisions need to be seen to be even handed, transparent, comparable, and inline with both community expectations and the guidance material. In this the National Statement acts as the common lexicon for these discussions. This paper explores and explains the specific paragraphs relating to justice throughout the National Statement.
Throughout the document, the National Statement highlights areas to be considered during the review of applications in relation to the justice aspects. It also provides guidance to researchers as to how they can demonstrate that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes so that paragraphs 1.4 and 1.5 of the National Statement are satisfied. This paper provides practical guidance to researchers on how to articulate issues of justice so that it is evident in the design of their research project.
This post may be cited as: Pieper, I & Thomson C. (24 September 2018) Justice in Human Research Ethics: A Conceptual and Practical Guide. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/justice-a-summary
We invite debate on issues raised by items we publish. However, we will only publish debate about the issues that the items raise and expect that all contributors model ethical and respectful practice.
Let’s imagine for a moment that you are a mid-career university researcher with growing expertise in a particular field. A pharmaceutical company contacts you and says that it would like to recognise the important work you are doing in this area, and has asked you to choose among the following forms of recognition:
$10,000 towards a research project related to one of the company’s drugs.
Being chosen as a Keynote Speaker to present at a prestigious conference, with no honorarium.
Being invited to join an international advisory board.
What would you choose? Would you choose the money? Or is there something appealing about the acknowledgement of your expertise in Option B, or impressive status associated with Option C?
Perhaps simply contemplating these questions makes you feel uncomfortable. After all, as medical researchers, questioning what motivates our behaviour or actions beyond the pursuit of scientific knowledge is not exactly pleasant. We like to think that we act in a way that is free from bias – and that while other researchers may have conflicts of interest, we certainly do not. Or not at least conflicts of interest that matter. Which begs the question – what types of things create conflicts of interest (COI)? Is it only when money enters the equation, or are there other forces at play?
It would appear, from the emphasis placed on financial COIs by medical journals, conference organisers and professional societies, that only money matters (Komesaroff et al. (2012), JAMA (2017). The COI disclosure forms that we dutifully complete tend to focus on financial COI and are comparatively vague when it comes to the declaration of non-financial COI (if indeed such declaration is required at all). Similarly, the disclosure statements made by speakers at conferences tend to take the form of ‘Dr X received $$$ from Company Y, $$ from Company Z’ and on the list goes.
But we believe that this exclusive emphasis on money overlooks many other non-financial interests that can create significant COI. These may stem from personal or religious beliefs – for example, Christian views about the moral status of the embryo held by legislators and scientists undoubtedly played a major role in the securing the prohibition of public funding of embryonic stem cell research.
Non-financial COI may also arise from a researcher’s desire for status or respect. As the case study illustrates, pharmaceutical companies may utilise both financial and non-financial incentives to encourage industry collaboration and promote industry agendas.
Personal circumstances and relationships also have the potential to give rise to non-financial COI – for example, if a member of a drug regulatory agency had a close relative who could benefit from the subsidisation of a drug under consideration this would constitute an obvious non-financial COI. Interests such as these have long been recognised in other contexts, including in the public sector (Australian Public Service Commission (2017), OECD (2003)). The OECD Managing conflicts of interest in the public service guidelines state that any ‘forward looking’ policy should describe non-financial sources of COI – including non-financial personal interests and relationships (OECD). The Australian Public Service Commission also specifies that social relationships and personal interests should be declared by employees.
We argue that to overlook non-financial COIs is problematic for several reasons (Wiersma et al. (2018a), Wiersma et al. (2018b). Most importantly, disregarding non-financial COI ignores the fact that serious harm may arise from such conflicts. We need look no further than the notorious Tuskegee scandal (Toy (2017) or Guatemalan ‘research’ (Subramanian (2017) to see that the drive to satisfy scientific curiosity can not only cloud researchers’ judgement, but can also cause significant harm to (unwilling or unknowing) participants.
Furthermore, ignoring non-financial COI also fails to take into account the fact that financial and non-financial COI are frequently entwined. For example, recognition by the pharmaceutical industry as a ‘Key Opinion Leader’ is not only associated with financial remuneration (for example, speaker’s fees), but also status and prestige.
We have also argued that non-financial COI can be managed using similar strategies to those used to manage financial COI (Wiersma et al. (2018a) There is no reason, for example, that a person on a drug regulatory committee could not disclose that they have a relative with a medical condition that may benefit from the drug under consideration and recuse themselves from voting in relation to that particular drug.
Of course, given the highly personal nature of some non-financial interests, it is important that declaration should only be required when evidence indicates that these may lead to a non-financial COI. Here we can draw from the Australian Public Service Commission guidelines which state that a personal interest does not lead to a conflict of interest unless there is ‘real or sensible’ (not merely theoretical) possibility of conflict.It is also crucial that declarations are handled with discretion.
None of this is to disregard the difficulties in determining what precisely constitutes a conflict of interest in medicine and how these should be managed. Medical researchers and practitioners have long grappled with these questions, and heated debate as to what should or should not be considered a ‘COI’ and what types of COI should be managed continues to this day (Bero 2017, Wiersma et al. (2018b).
However, we believe that acknowledging the importance of non-financial COI may be the starting point for a more sophisticated approach to managing both financial and non-financial COI in health and biomedicine. Perhaps most importantly, by acknowledging that we are all conflicted in certain ways, and that having a COI is not necessarily ‘bad,’ we may be able to take some of the ‘sting’ out of the label. And this may, in turn, encourage open discussion and disclosure of both financial and non-financial COI, enhance our understanding of COIs in general, and help us develop and refine a more nuanced approach to all forms of COI.
Bero, L. (2017) Addressing bias and conflict of interest among biomedical researchers. JAMA: The Journal of the American Medical Association, 317(17): 1723-4.
JAMA: The Journal of the American Medical Association (2017) Conflict of interest theme issue. JAMA: The Journal of the American Medical Association, 317 (17):1707-1812. Available from: https://jamanetwork.com/journals/jama/issue/317/17
OECD (2003) Managing conflict of interest in the public service. OECD guidelines and country experiences. Organisation for Economic Co-operation and Development. Available from: http://www.oecd.org/governance/ethics/48994419.pdf
Wiersma, M., Kerridge I. & Lipworth, W. (2018a) Dangers of neglecting non-financial conflicts of interest in health and medicine. Journal of Medical Ethics, 44: 319-322. Available from: https://jme.bmj.com/content/44/5/319
Wiersma, M., Kerridge I. Lipworth, W. & Rodwin, M. (2018b) Should we try and manage non-financial interests? British Medical Journal, 361: k1240. Available from: https://www.bmj.com/content/361/bmj.k1240
Conflicts of interest: All authors had financial support from the National Health & Medical Research Council (NHMRC, grant number APP1059732) for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
We invite debate on issues raised by items we publish. However, we will only publish debate about the issues that the items raise and expect that all contributors model ethical and respectful practice.
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
Before you send your plan please ensure you have read the frequently asked questions. Below are terms and conditions that you must accept before you can submit your research plan.
TERMS AND CONDITIONS – RESEARCHERS
Questions about these terms and conditions and/or the warranties should be directed to gary.allen@ahrecs.com. Allegations of any breaches or disputes should also be directed to gary.allen@ahrecs.com.
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The following resource sheets are being produced: