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Griffith University’s implementation of the Australian Code (2018)0

 

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.
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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.
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APPROACH TO THE AUSTRALIAN CODE (2018)

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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:

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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.
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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.
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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.
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The above work is underway and progressing well.
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In the event new institutional guidance is required, it will be included in the updated RIRS series.
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UPDATED RESEARCH INTEGRITY RESOURCE SHEETS

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The following resource sheets are being produced:
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  1. Introduction to research integrity at Griffith University
  2. Moving to the 2018 version of the Australian Code
  3. Planning and conducting a project responsibly
  4. Responsible research outputs
  5. Responsible data management
  6. Collaborative research: Hints and tips
  7. The responsible supervisor
  8. The responsible candidate
  9. Conflicts of interest
  10. Tips for peer review
  11. Disputes between researchers
  12. Investigations of alleged breaches of the Australian Code for the Responsible Conduct of Research
  13. Alleged breaches: Tips for complainants
  14. Alleged breaches: Tips for respondents
  15. Research Misconduct

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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.
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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.
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COMMUNICATION PLAN

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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.
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AWARENESS AND PROFESSIONAL DEVELOPMENT PLAN
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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.
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Amanda is happy to be contacted with any questions or suggestions about this work.
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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
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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.

 

Justice in Human Research Ethics: A Conceptual and Practical Guide0

 

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.

Contributors:
Ian Pieper, AHRECS Consultant, Ian’s AHRECS profile
Colin Thomson AM, AHRECS Senior Consultant, colin.thomson@ahrecs.com | Colin’s AHRECS profile

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.

 

It’s not (just) about the money0

 

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:

  1. $10,000 towards a research project related to one of the company’s drugs.
  2. Being chosen as a Keynote Speaker to present at a prestigious conference, with no honorarium.
  3. 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.

References

Australian Public Service Commission (2017) Values and code of conduct in practice.Australian Government. Available from: https://www.apsc.gov.au/aps-values-and-code-conduct-practice

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

Komesaroff, P., Kerridge, I. & Lipworth, W. (2012) Don’t show me the money: the dangers of non-financial conflicts. The Conversation. March 30. Available from: https://theconversation.com/dont-show-me-the-money-the-dangers-of-non-financial-conflicts-5013

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

Subramanian, S. (2017) Worse than Tuskegee. Slate26. Available from: http://www.slate.com/articles/health_and_science/cover_story/2017/02/guatemala_syphilis_experiments_worse_than_tuskegee.html

Toy, S. (2017) 45 years ago, the nation learned about the Tuskegee Syphilis Study. Its repercussions are still felt today. USA Today. Available from: https://www.usatoday.com/story/news/2017/07/25/tuskegee-syphilis-study-its-repercussions-still-felt-today/506507001/

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.

Contributors
Miriam Wiersma, Ian Kerridge and Wendy Lipworth

This post may be cited as:
Wiersma, M., Kerridge, I. and Lipworth, W. (22  August 2018) It’s not (just) about the money. Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/its-not-just-about-the-money

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.

Contextualising Merit and Integrity within Human Research: A Summary0

 

Pieper, I and Thomson, CJH (2011) Contextualising Merit and Integrity within Human Research, Monash Bioethics Review,Volume 29, Number 4, pp 15.1 – 15.10 https://link.springer.com/article/10.1007/BF03351329

A Series on the Four Principles of the Australian National Statement on Ethics Conduct in Human Research

In this and succeeding issues of the Research Ethics MonthlyIan Pieper and Colin Thomson will present 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.
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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 make each of the four articles available through SharedIt links which will be listed in each of the REM summaries. This month, we start with research merit and integrity.

The scientific merit of a project is an ethical issue because in our culture and society, participation in research is not obligatory. Accordingly, when people choose to offer themselves as research participants, they do so out of a sense of altruism.  We agree with the argument that this choice should be based on sufficient information about and belief in the purpose of the research.  Central to this is that the research has merit: that it is of value.

For any research to realise that value, it must be designed so that the results are recognised as being true or meaningful: that is, that the research has validity. The validity of research rests on the principles and processes of scientific, academic and disciplinary traditions relevant to the project and researchers need to show ethics review bodies that their project conforms to them.

Although ethics review bodies are not scientific review bodies, they do need to be satisfied that the research that they approve has merit so that involvement of human participants is ethically justified.

Judging the value and validity of a project, and being satisfied that the research has value and validity are two different exercises. When, in the review of a proposed project, formal scientific or disciplinary peer review processes are relied on, the distinction is clear. In this situation, the human research ethics review proceeds on the premise that the research has merit – that is, has value and validity.

The Australian National Statement lists six components of research merit that can be summarized as:

  1. Potential benefit,
  2. Methods appropriate to the project aims and discipline,
  3. Scientific basis,
  4. No compromise of respect for the participants,
  5. Adequately experienced, qualified and competent researchers and
  6. Appropriate facilities and resources.

The National Statement lists four components of research integrity:

      1. Searching for knowledge and understanding means that research is conducted openly and consistently with, or builds on, established principles and so provides rigour.
    An activity sheet about research ethics committees and the evaluation of scientific merit 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.
  1. Following recognised principles of research conduct, so that researchers need to show that the proposed methods are recognized by the relevant discipline, are suitable and that the researchers competent in their use.
  2. Conducting research honestly, so that researchers are transparent about their aims and motivations. Otherwise, for example where a financial motive is concealed, recruitment would fail to fully inform participants, removing their ability to provide informed consent.
  3. Disseminating and communicating results is necessary because when findings are not published, participants’ contributions are devalued. Accordingly, human research ethics review bodies should insist on suitable disclosure of findings. What constitutes suitable disclosure should, in part, be determined by the need to respect the contribution made by participants.

Researchers can satisfy these requirements by fulfilling their primary responsibility (National Statement 5.2.5) for showing that their research has merit, not only by providing scientific and methodological discussion about the project, but also explaining the value of the project and its worth.

Ethics review bodies need to be assured that research has merit. Accordingly, researchers can make their lives easier by taking time to understand the evidence that will satisfy an ethics review body as to that merit and providing that evidence clearly, concisely, and accurately.

Contributors:
Ian Pieper, AHRECS Consultant, Ian’s AHRECS profile
Colin Thomson AM, AHRECS Senior Consultant, colin.thomson@ahrecs.com | Colin’s AHRECS profile

This post may be cited as:
Pieper, I & Thomson C. (22  August 2018) Research Ethics in Australia: A Story. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/contextualising-merit-and-integrity-within-human-research-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.