ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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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.

 

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.

 

New resources coming soon from AHRECS0

 

AHRECS has always had two primary missions: to provide relevant and up-to-date information services on human research ethics and research integrity and to provide expert consultancy services in those areas. We have developed and maintain free services – the Research Ethics Monthly and the Resources Library – that feedback shows are increasingly used and valued. We actively maintain these by regular surveying relevant literature to identify items of interest and value. We have attracted a regular community of readers and user of our services.

We have come to the view that, in order to ensure that these are maintained, a subscriber or patronage arrangement is needed. This patrons’ area will provide additional online services and resources.

We plan to establish such a subscription/patron’s area on 1 July. Our aim is to make available to subscribers material that supplements what we continue to offer at no charge and so rewards those who commit to this way of supporting us.

There will be different financial levels of patronage, starting at 1USD a month. For research institutions, our expectation is that one (for example, the ethics manager) or two (the HREC Chair as well) would become patrons, but we would of course be delighted if members of the research ethics committees and researchers (from all disciplines and across career stages) who are an important intended audience for this new material, decide to become AHRECS patrons.

The kinds of things that will be available are:

(i) Vignettes on human research ethics/research integrity topics;

(ii) Commentaries (about 300 words) on breaking news and significant research outputs;

(iii) A few times a year a group Q&A session with one of the AHRECS consultants;

(iv) Booklets and resource papers; and

(v) Periodic webinars on topics nominated by patrons.

The information and resources will be shared on a non-commercial creative commons basis.

On the more fun side of things, patrons will be able to download images AHRECS have commissioned for use in professional development workshops and receive free mugs/desktop mice pads.

The base level of subscription will grant access to an exclusive behind the scenes feed from the AHRECS team.

The monthly payments will be via Patreon and Paypal and can be discontinued or modified at any time without losing the right to use already downloaded material.

We’re excited by this new way to engage with the human research ethics and research integrity communities.

Rest assured the Resource Library and Research Ethics Monthly will continue and remain free.

The Contributors
Gary Allen, Mark Israel and Colin Thomson – senior consultants AHRECS

This post may be cited as:
Allen G., Israel M. and Thomson C. (22 June 2018) New resources coming soon from AHRECS. Research Ethics Monthly. Retrieved from: https://ahrecs.com/ahrecs-admin/new-resources-coming-soon-from-ahrecs

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.

Australian Code 2018: What institutions should do next1

 

Gary Allen, Mark Israel and Colin Thomson

At first glance, there is much to be pleased about the new version of the Australian Code that was released on 14th June. A short, clear document that is based upon principles and an overt focus on research culture is a positive move away from the tight rules that threatened researchers and research offices alike for deviation from standards that might not be appropriate or even workable in all contexts.

The 2007 Code was rightly criticized on several grounds. First, weighing a system down with detailed rules burdened the vast majority with unneeded compliance for the recklessness and shady intentions of a very small minority. Second, there was reason to suspect the detailed rules did not stop the ‘bad apples’. Third, those detailed rules probably did not inspire early career researchers to engage with research integrity and embrace and embed better practice into their research activity. Finally, the Code did little to create an overall system able to undertake continuous improvement.

But, before we start to celebrate any improvements, we need to work through what has changed and what institutions and researchers need to do about it. And, then, maybe a quiet celebration might be in order.

Researchers have some fairly basic needs when it comes to research integrity. They need to know what they should do: first, as researchers and research supervisors in order to engage in good practice; second, if they encounter poor practice by another researcher; and, third, if other people complain about their practices.

The 2007 Australian Code offered some help with each of these. In some cases, this ‘help’ was structured as a requirement and over time was found wanting. The 2018 version appreciated that these questions might be basic but that the answers were often complex. The second and third questions are partly answered by the accompanying Guide to Managing and Investigating Potential Breaches of the Code (the Investigation Guide) and we’ll return to this. The answer to the first question is brief.

The Code begins to address responsibilities around research integrity through a set of eight principles that apply to researchers as well as their institutions: honesty; rigour; transparency; fairness; respect; recognition of the rights of Indigenous peoples to be engaged in research; accountability, and promotion of responsible research practices. Explicit recognition of the need to respect the rights of Aboriginal and Torres Strait Islander peoples did not appear in the 2007 version. There are 13 responsibilities specific to institutions. There are 16 responsibilities, specific to researchers, that relate to compliance with legal and ethical responsibilities, require researchers to ensure that they support a responsible culture of research, undertake appropriate training, provide mentoring, use appropriate methodology and reach conclusions that are justified by the results, retain records, disseminate findings, disclose and manage of conflicts of interest, acknowledge research contributions appropriately, participate in peer review and report breaches of research integrity.

In only a few cases might a researcher read these parts of the Code and conclude that the requirements are inappropriate. It would be a little like disagreeing with the Singapore Statement (the one on research integrity, not the recent Trump-Kim output). Mostly, the use of words like ‘appropriate’ within the Code (it appears three times in the Principles, twice in the responsibilities of institutions and five times in responsibilities of researchers) limit the potential for particular responsibilities to be over-generalised from one discipline and inappropriately transferred to others.

There are some exceptions, and some researchers may find it difficult to ‘disseminate research findings responsibly, accurately and broadly’, particularly if they are subject to commercial-in-confidence restrictions or public sector limitations, and we know that there are significant pressures on researchers to shape the list of authors in ways that may have little to do with ‘substantial contribution’.

For researchers, the Code becomes problematic if they go to it seeking advice on how they ought to behave in particular contexts. The answers, whether they were good or bad in the 2007 Code, are no longer there. So, a researcher seeking to discover how to identify and manage a conflict of interest or what criteria ought to determine authorship will need to look elsewhere. And, institutions will need to broker access to this information either by developing it themselves or by pointing to good sectoral advice from professional associations, international bodies such as the Committee for Publication Ethics, or the Guides that the NHMRC has indicated that it will publish.

We are told that the Australian Code Better Practice Guides Working Group will produce guides on authorship and data management towards the end of 2018 (so hopefully at least six months before the deadline of 1 July 2019 for institutions to implement the updated Australian Code). However, we do not know which other guides will be produced, who will contribute to their development nor, in the end, how useful they will be in informing researcher practice. We would hope that the Working Group is well progressed with the further suite if it is to be able to collect feedback and respond to that before that deadline.

There are at least eight areas where attention will be required. We need:

  1. A national standard data retention period for research data and materials.
  2. Specified requirements about data storage, security, confidentiality and privacy.
  3. Specified requirements about the supervision and mentoring of research trainees.
  4. A national standard on publication ethics, including such matters as republication of a research output.
  5. National criteria to inform whether a contributor to a research project could or should not be listed as an author of a research output.
  6. Other national standards on authorship matters.
  7. Specified requirements about a conflicts of interest policy.
  8. Prompts for research collaborations between institutions.

For each of those policy areas the following matters should be considered:

1. Do our researchers need more than the principle that appears in the 2018 Australian Code?

2. If yes, is there existing material upon which an institution’s guidance material can be based?

3. Who will write, consider and endorse the guidance material at a national or institutional level?

Many institutions will conclude it is prudent to wait until late 2018 to see whether the next two good practice guides are released and discover how much they cover. Even if they do so, institutions will also need to transform these materials into resources that can be used in teaching and learning at the levels of the discipline and do so in a way that builds the commitment to responsible conduct and the ethical imaginations of researchers rather than testing them on their knowledge of compliance matters.

Managing and Investigating Potential Breaches

The Code is accompanied by a Guide to Managing and Investigating Potential Breaches of the Code (the Investigation Guide). The main function of this Guide is to provide a model process for managing and investigating complaints or concerns about research conduct. However, before examining how to adopt that model, institutions need to make several important preliminary decisions.

First, to be consistent with the Code, the Guide states that institutions should promote a culture that fosters and values responsible conduct of research generally and develop, disseminate, implement and review institutional practices that promote adherence to the Code. Both of these will necessitate the identification of existing structures and processes and a thorough assessment to determine any changes that are needed to ensure that they fulfil these responsibilities.

This means that institutions must assess how their processes conform to the principles of procedural fairness and the listed characteristics of such processes. The procedural fairness principles are described as:

  • the hearing rule – the opportunity to be heard
  • the rule against bias – decisionmakers have no personal bias in the outcome
  • ‘the evidence rule – that decisions are based on evidence.

The characteristics require that an institution’s processes are: proportional; fair; impartial; timely; transparent, and confidential. A thorough review and, where necessary, revision of current practices will be necessary to show conformity to the Guide.

Second, when planning how to adopt the model, institutions need to consider the legal context as the Guide notes that enterprise bargaining agreements and student disciplinary processes may prevail over the Guide.

Third, the model depends on the identification of six key personnel with distinct functions. Some care needs to be taken to match the designated roles with the appropriate personnel, even if their titles differ from those in the model, in an institution’s research management structure. The six personnel are:

  • a responsible executive officer, who has final responsibility for receiving report and deciding on actions;
  • a designated officer, appointed to receive complaints and oversee their management;
  • an assessment officer or officers, who conduct preliminary assessments of complaints;
  • research integrity advisers, who have knowledge of, and promote adherence to, the Code and offer advice to those with concerns or complaints;
  • research integrity office, staff who are responsible for managing research integrity;
  • review officer, who has responsibility to receive requests for procedural review of an investigation.

Last, institutions must decide whether to use the term ‘research misconduct’ at all and, if so, what meaning to give to it. Some guidance is offered in a recommended definition of the term but, as noted above, this will need to be considered in the legal contexts of EBAs and student disciplinary arrangements.

Conclusion

The update to the Code provides a welcome opportunity to reflect on a range of key matters to promote responsible research. The use of principles and responsibilities and the style of the document offers a great deal of flexibility that permits institutions to develop their own thoughtful arrangements. However, this freedom and flexibility comes with a reciprocal obligation on institutions to establish arrangements that are in the public interest rather than ‘just’ complying with a detailed rule. We have traded inflexibility for uncertainty; what comes next is up to all of us.

Click here to read about the AHRECS Australian Code 2018 services

The Contributors
Gary Allen, Mark Israel and Colin Thomson – senior consultants AHRECS

This post may be cited as:
Allen G., Israel M. and Thomson C. (21 June 2018) Australian Code 2018: What institutions should do next. Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/australian-code-2018-what-institutions-should-do-next

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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