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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:

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

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.

Ian Pieper, AHRECS Consultant, Ian’s AHRECS profile
Colin Thomson AM, AHRECS Senior Consultant, | 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:

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.


Save the Date (please)0

Posted by Admin in AHRECS Admin, Human Research Ethics, Research Integrity on August 27, 2018

Constructive Voices: Implementing the 2018 updates to the National Statement and Australian Code
Get answers to your questions and hear essential implementation tips

The 2018 changes to the Australian Code for the Responsible Conduct of Research and the National Statement on Ethical Conduct in Human Research are significant. However, identifying and meeting new requirements by their respective due dates – Australian Code (30 June 2019) and National Statement (31 December 2018) – can seem daunting. In addition, a focus just on compliance may make it harder to take advantage of the opportunities for constructive changes to policies and processes that might enhance ethical conduct and responsible research practice.

Your research office staff, HREC Chairs and members, Research Ethics Advisers/Research Integrity Advisers and research community may have ideas for implementing the two documents, but are they sound and how will they compare to better practices elsewhere in the Australian sector?
In November 2018, AHRECS is hosting two panel discussions to help answer those questions and consider how best to implement changes.\

Australian Code panel discussion: 8 November at 14:30 (ADST)
National Statement panel discussion: 22 November at 14:30 (ADST)

The three-person panel discussions will be moderated by Mark Israel (Australian Code discussion) and Colin Thomson (National Statement discussion), will include senior nominees of the NHMRC and experienced HREC Chairs/research office staff (the final panel members will be confirmed in October).

People considering attending are asked to send a blank email to:

Attendees are invited to provide in advance the questions they would like discussed by the panel and there will be facility to type questions to the panel.

The events will use Zoom’s webinar function (which attendees will need to install on their computer/device prior to the event) and will be recorded. Attending the webinars is free, and a copy of the recordings will be available from the AHRECS Subscribers’ area.

Please send any questions about these events to

PDF copy of this date claimer.

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.


Australian Public Service Commission (2017) Values and code of conduct in practice.Australian Government. Available from:

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:

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:

OECD (2003) Managing conflict of interest in the public service. OECD guidelines and country experiences. Organisation for Economic Co-operation and Development. Available from:

Subramanian, S. (2017) Worse than Tuskegee. Slate26. Available from:

Toy, S. (2017) 45 years ago, the nation learned about the Tuskegee Syphilis Study. Its repercussions are still felt today. USA Today. Available from:

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:

Wiersma, M., Kerridge I. Lipworth, W. & Rodwin, M. (2018b) Should we try and manage non-financial interests? British Medical Journal, 361: k1240. Available from:

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.

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:

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.

How do we ‘do’ consent?0


This blog post expands on ideas from our recent publication: McWhirter, R. E., & Eckstein, L. (2018). Moving Forward on Consent Practices in Australia. Journal of Bioethical Inquiry, 1-15.

Recently I participated in a research study. With the research nurse sitting opposite me expectantly, I moved quickly to sign in the appropriate place.

Hang on a minute. I’m a researcher, and an HREC member. I’ve published papers on informed consent, for goodness’ sake. I know better than this. Dutifully, I went back to the information sheet to read it properly.

After a couple of lines, I got bored and started scanning for key phrases. What will they do with my data? Which HREC approved this? Am I signing myself into eternal servitude?

Oh, who am I kidding, I thought. I’ve already made my decision. So, I just signed it, the research nurse smiled, and we got on with it.

Research suggests that I am not alone in my reaction to consent forms. They are boring, sometimes bordering on impenetrable. HRECs blame researchers for not writing in plain English. Researchers blame HRECs for being too inflexible and demanding a ridiculously long list of things to be included in a rigid format. There’s probably some truth on both sides, as well as some misunderstanding. And so, we end up with long, boring and ultimately unhelpful consent documents.

This is not to suggest that everyone is doing consent badly. There are lots of examples of research groups working with communities – whose members are usually potentially vulnerable in some way – to develop consent materials or processes that actually meet the needs of participants. Sometimes the solutions are technological– involving multimedia tools to overcome literacy or language barriers – and sometimes structural – such as by undertaking consent over several visits, so that individuals can decline to participate either by saying no or by avoiding the researchers, which can be an important option in communities where this is considered a more culturally acceptable method for refusal.

So, consent doesn’t have to be boring.

But what of the other problem indicated by my experience above? I had already made up my mind to participate before I’d been given the information sheet. Those with experience in study recruitment will know that I’m not unusual in this respect either. Depending on how the recruitment is undertaken, first contact might be a phone call, an email or letter, or a face to face conversation. In most cases, there will be some kind of blurb that precedes a participant’s reading of the consent documents and this is largely what people are basing their decision on.

These initial contacts are difficult to standardize (and it’s not necessarily desirable to do so) and difficult for HRECs to review, especially if they are verbal. A lot depends upon the character of the person doing the recruiting (usually a research nurse or research assistant rather than a principal investigator).

For one study in remote Aboriginal communities that I was involved in, I undertook several months of community consultation prior to commencing recruitment. I worked with community members to develop the study design and consent materials, employed local research assistants, and was helped enormously by senior women from each community. The relationships we developed meant that the study better met the needs of the communities, was more ethically sound (complying with both the National Statement and Values and Ethics) and resulted in a wider range of benefits than would otherwise have arisen.

These relationships also created trust between us. And that no doubt had an effect on our recruitment. The women liked me and wanted to help me. I had the support of influential elders. And by the time we got to use our carefully designed audio books, with information recorded in multiple dialects and with culturally relevant illustrations, most participants had already heard about the study, either from the community meetings during the consultation phase or through word of mouth. Although I stressed that participation was voluntary, and they were welcome to say no, everyone I invited agreed to participate.

So, what was the point of informed consent here? Well, it’s still polite to ask. The process of consultation that preceded it was effectively a form of community consent. And although individual decisions were probably influenced by their relationship with me and other study team members, these participants arguably had a greater understanding of the study than many participants in studies using more traditional methods.

I’m not sure there is a perfect way to ‘do’ consent. But it helps to be aware that the process is wider than just the consent documents. Providing training and ongoing team-based reflection for recruiters would help to address concerns over the quality of the less formal elements of consent. And it would be useful for HRECs to recognize the value of community consultation and consumer engagement in the study design phase, and to be open to non-traditional approaches to undertaking consent, rather than focusing unduly on the precise wording of consent forms.

We can’t ‘protect’ participants from researchers through mandating lists of information to be conveyed through formal documents, but we can encourage a culture of ethical research that better addresses community interests by reflecting on what we’re actually doing when we ‘do’ consent.

Rebekah McWhirter
Centre for Law and Genetics, Faculty of Law, University of Tasmania

This post may be cited as:
McWhirter R. (26  August 2018) How do we ‘do’ consent?. Research Ethics Monthly. Retrieved from:

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.