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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Are you attending the ‘Constructive voices’ panel discussions in November about the 2018 changes to the Australian Code and National Statement on Ethical Conduct in Human Research?0

 

Just a reminder these online discussions are free, but you will need to RSVP. Details below. Recordings of the sessions will be available from our subscribers are (https://www.patreon.com/ahrecs).


Australian Code (2018) – 8 November 2018
https://www.nhmrc.gov.au/guidelines-publications/r41

New South Wales Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
Western Australia  Thursday, 8 November at 11:30:00 am AWST UTC+8 hours
Australian Capital Territory Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
Queensland Thursday, 8 November at 1:30:00 pm AEST UTC+10 hours
South Australia Thursday, 8 November at 2:00:00 pm ACDT UTC+10:30 hours
Northern Territory Thursday, 8 November at 1:00:00 pm ACST UTC+9:30 hours
Victoria  Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
New Zealand  Thursday, 8 November at 4:30:00 pm NZDT UTC+13 hours

Moderator: Prof. Mark Israel
Guests: Jillian Barr (NHMRC) and Kandy White (Expert Working Committee and Director, Research Ethics and Integrity, Macquarie University)
Voices: Prof. Colin Thomson AM
Rapporteur: Dr Gary Allen

To RSVP:
Yes.AC_081118@ahrecs.com



National Statement (Updated 2018) – 22 November 2018

https://www.nhmrc.gov.au/_files_nhmrc/file/publications/national-statement-2018.pdf

New South Wales Thursday, 22 November at 2:30:00 pm AEDT UTC+11 hours
Western Australia  Thursday, 22 November at 11:30:00 am AWST UTC+8 hours
Australian Capital Territory Thursday, 22 November at 2:30:00 pm AEDT UTC+11 hours
Queensland Thursday, 22 November at 1:30:00 pm AEST UTC+10 hours
South Australia Thursday, 22 November at 2:00:00 pm ACDT UTC+10:30 hours
Northern Territory  Thursday, 22 November at 1:00:00 pm ACST UTC+9:30 hours
Victoria  Thursday, 22 November at 2:30:00 pm AEDT UTC+11 hours
New Zealand  Thursday, 22 November at 4:30:00 pm NZDT UTC+13 hours

Moderator: Prof. Colin Thomson AM
Guests: Jeremy Kenner (NHMRC), Professor Wendy Rogers (Chair National Statement Review Working Group, Macquarie University) and Associate Professor Pamela Henry (Newly appointed Chair of the ECU, Human Research Ethics Committee)
Voices: Dr Gary Allen

To RSVP:
Yes.NS_221118@ahrecs.com



PROFILES:

Dr Gary Allen (AHRECS)

Gary is a member of the National Statement Review Working Group and chaired the committee that drafted the revision to NS Chapter 3.1. He is the Managing Director of, and a Senior Consultant with, AHRECS. Gary has worked in the human research ethics and research integrity spheres since 1997. He was formerly a member of the NHMRC’s Australian Health Ethics Committee. Gary holds a social science doctorate and a bachelor of education.
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Jillian Barr (NHMRC)

Jillian Barr is the Director of Ethics and Integrity NHMRC. Jillian’s work involves developing a range of ethics guidelines and research standards including the recently released 2018 Australian Code for the Responsible Conduct of Research, the National Statement on Ethical conduct in Human Research and animal ethics guidelines. Jillian’s team is responsible for providing policy and guidance for Human Research Ethics Committees in Australia and for supporting the Australian Health Ethics Committee. Jillian is also responsible for research integrity matters that relate to research involving NHMRC funding.
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Associate Professor Pamela Henry

Associate Professor Pamela Henry is the Director of the Sellenger Centre for Research in Law, Justice and Social Change at ECU. She is also a newly appointed Chair of the ECU, Human Research Ethics Committee. Her role as the Director of the Sellenger Centre has seen her develop an extensive body of research in policing focused on integrity, use of information management systems, human source recruitment and management, use of force, policing those experiencing mental illness, and other programs of research examining the effectiveness of police operational deployment models. She also holds a PhD in Psychology.
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Professor Mark Israel (AHRECS)

Mark provides advice to higher education institutions, research agencies, government and non-government organisations in Australia, Hong Kong, New Zealand, Taiwan, the United Kingdom and acts as an ethics reviewer and rapporteur for the European Research Council

As an Executive Director of and Senior Consultant with Australasian Human Research Ethics Consultancy Services, he works on institutional policy and practice in relation to research ethics and research integrity. Mark was a member of the Australian National Health and Medical Research Council’s Working Party responsible for revision of Section 3 of the National Statement. He was professor of law and criminology at Flinders University and University of Western Australia

He has a degree in law and postgraduate qualifications in sociology, criminology and education from Oxford (DPhil), Cambridge (MA, MPhil) and Flinders Universities (MEdStudies) respectively. He has over 90 publications in the areas of criminology and socio-legal studies, higher education policy and practice, and research ethics and integrity. His recent books include Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance (Sage, 2015).
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Jeremy Kenner (NHMRC)

Jeremy is Expert Advisor for Ethics at NHMRC. At NHMRC, he contributes to the development of guidelines and advice on matters related to health and research ethics, research integrity and governance and clinical trials. Jeremy’s experience includes ethics administration at Peter Maccallum Cancer Centre, multiple roles in education and law practice. His various loyalties extend to Melbourne, Tasmania, Canada and the U.S
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Professor Wendy Rogers (Professor of Clinical Ethics, Macquarie University)

Wendy Rogers is Professor of Clinical Ethics at Macquarie University and Deputy Director of the Macquarie University Research Centre on Agency, Values and Ethics, with strong interests in healthcare policy and practice. During her first term on the Australian Health Ethics Committee she served on the working party responsible for the 2007 revision of the National Statement. Since 2010, she has been Chair of the working party on the current rolling revision of the National Statement. Her research interests include over diagnosis, ethics of surgical practice and research, transplant abuse and vulnerability.
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Professor Colin Thomson AM (AHRECS)

Colin Thomson AM is a senior consultant with Australasian Human Research Ethics Consultancy Services Pty. Ltd. (AHRECS) and a former Professor in Health Law and Ethics in Graduate Medicine, University of Wollongong and positions in law faculties at the Australian National University and the University of Wollongong.

He was a member of the Medical Research Ethics Committee of the National Health and Medical Research Council (NHMRC), a member and chair of the Australian Health Ethics Committee and Consultant in Health Ethics to the NHMRC.

As a consultant, he conducted training for human research ethics committees (HRECs) in State Health departments in Queensland, NSW, Victoria and Tasmania and in universities in all States and territories; certification assessments for the NHMRC National Certification Scheme and advised government departments in the Commonwealth, NSW and Victoria.

He has been a member and chair of multiple HRECs in universities, local health districts, government departments and public sector agencies.

In 2018, he was made a Member of the Order of Australia for services to medical research and research ethics.
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Dr Karolyn (Kandy) White

Kandy is the Director, Research Ethics and Integrity at Macquarie University. Kandy has taught research ethics to undergraduate and postgraduate student both in Australia and overseas as well as to ethics committee members. She Chairs a Social Science and Humanities Human Research Ethics Committee. Kandy has been the Chair of the AEN Advisory Group, co-convenor of ARMS Research Ethics and Integrity SIG, a member of the national Code Review Committee established to revise the Australian Code and Chair of the Better Practice Guides (BPG) working group responsible for developing the Investigation Guide.
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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.

 

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