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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.

What’s been going on at AHRECS0

 

We’re thrilled by how the AHRECS team has been growing and the expertise Sarah, Barry and Nik have brought to the team and the new services we can now provide. We hope in the coming weeks to announce some more additions to the team. The central ethos of resourcing reflective practice remains unchanged and we still strive to be a voice for constructive change.

You may have noticed a few refinements of the AHRECS web site have been happening quietly:

  • The Resource Library ahrecs.com/resources: the search functionality has improved (but still needs some work), and there’s now related materials with a link to other items in the Resource Library.
  • The blog pages ahrecs.com/blog: a form to subscribe to the Research Ethics Monthly; pdf copies of earlier editions, and within stories there will be links to related blog items and related Resource Library items.
  • The Our Services pages https://ahrecs.com/our-services  describes our various service.
  • The Research Ethics Adviser Platform https://ahrecs.com/about-this-service can now be used to obtain expert and independent advice on a research ethics review application prior to its submission to a research ethics committee. A quick advisory costs AUD50 and can be returned in less than 14 days.
  • The AHRECS home page has links to the COPE site (AHRECS is an associate member of COPE) and Retraction Watch (we’re proud to support their work).

The Research Ethics Monthly and Resource Library will remain free, but work is underway to:

  • Provide downloadable vignettes and discussion activities.
  • Short articles reflecting on recent news in the human research ethics/research integrity spheres.
  • An AHRECS app for smartphones.
  • A human research ethics game.
  • A research integrity game.
  • An online Q&A clinic.
  • Hosted webinars
  • And much more.

We hope that strikes you as useful, because we’re excited to be working on them.

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