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Release of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) – With interview0

 

The revised National Statement on Ethical Conduct in Human Research 2007 (updated 2018) was released on 9 July 2018.

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Content of the updated National Statement

The National Statement consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992 and is subject to rolling review. This means that parts of the National Statement are updated as needed, in accordance with strategic planning, or in response to user feedback or national or international developments in research or ethics.

Since 2007, Section 3 of the National Statement has addressed ethical considerations specific to research methods or fields. The 2018 revision provides a new structure for Section 3, based on the elements of a research project (from conception to post-completion). The revised Section 3 begins with a chapter that addresses ethical issues in all research, followed by specialised guidance for research involving human biospecimens, genomics and xenotransplantation.

This approach emphasises that researchers, Human Research Ethics Committees (HRECs) and other users of the National Statement must take account of the principles and major themes in research ethics addressed in Sections 1 and 2 of the document as the foundation of the guidance in Section 3 and then, in turn, consider the guidance provided in Chapter 3.1 as a base for the guidance provided in the other chapters included in this section.

While significant changes have been made to all aspects of the guidance provided in Section 3, we note, in particular, the additional guidance that has been provided in relation to collection, use and management of data and information and to management of the findings or results arising from genomic research.

As part of this update, changes have also been made to Chapters 5.1, 5.2 and 5.5 in Section 5, the Glossary and the Index as a consequence of the revisions to Section 3.

Revisions to the National Statement were informed by working committees and through public consultation in accordance with requirements of the National Health and Medical Research Council Act 1992.

Currency and effective date

All users of the National Statement, including HRECs, research offices and researchers are expected to ensure that the current version of the National Statement is being used in developing research proposals, making submissions for ethics review and undertaking ethics review. However, as a consequence of the scope of the revisions to Section 3, we expect that users of the National Statement will gradually integrate these revisions into their proposals, submissions and review over the period from July to December 2018, with full implementation expected by 1 January 2019.

This timeline is intended to give researchers and HRECs an opportunity to familiarise themselves with the new guidance prior to the revocation of the version of the National Statement updated, most recently, in 2015. To facilitate this transition, both the current version of the National Statement and the updated version are available on the NHMRC website at http://nhmrc.gov.au/guidelines/publications/e72.

Use of the National Statement is also linked to the Human Research Ethics Application (HREA), released in December 2016 to replace the National Ethics Application Form.

To coincide with the release of the revised National Statement, questions in the HREA will require revision and users of the HREA will be advised when the revised HREA is online.

Institutions and HRECs are encouraged to allow a transition period for researchers while the revisions to the HREA take effect. The provision of a transition period, how it will be managed and its timeframe are at the discretion of individual Institutions/HRECs.

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Context

Australia’s research integrity framework is underpinned by three national standards developed by NHMRC and its co-authors, the Australian Research Council (ARC) and Universities Australia (UA). Together these three standards provide guidance on responsible and ethical research conduct for both humans and animals.

The overarching document is the Australian Code for the Responsible Conduct of Research, 2018. The Code is the leading reference for researchers and institutions across all disciplines about the expectations for responsible research conduct and the handling of investigations into research misconduct. After 10 years in operation, the Code has been reviewed and the 2018 edition was released in June 2018. The other two documents are the National Statement and the Australian code for the care and use of animals for scientific purposes (also endorsed by CSIRO).


INTERVIEW

AHRECS (While we know it predated the recent work on s3) What drove the decision to conduct a rolling review, rather than a review of the entire document?

NHMRC During the revision of the National Statement that was completed in 2007, it was determined that a more flexible, more efficient approach to revising the document would be a good innovation. We wanted to be able to both respond to the needs of users for more limited changes – from a word, to a paragraph, to a single chapter – without having to review the whole document and to be able to integrate or modify the content in response to changes nationally or internationally in research, research ethics or government regulation. Review of the 1999 National Statement took three years from start to finish and we thought we could improve on that timeline! We have found that this approach has, in practice, enabled us to make both minor changes and significant changes to single chapters of the document, as well as to review one of the five sections of the document, as we have just done.

AHRECS Are there downsides to that approach?

NHMRC Yes, there are. The major downside is that the document is ‘of a piece’ and changes to any one part of the document invariably require consideration of changes to the other parts, not just in terms of cross-referencing, but in terms of the content itself. This issue of ‘consequential effect’ manifests itself in the need to ensure consistency in our guidance and to consider the impact on the whole document of more philosophical or conceptual changes that have been introduced by the changes. An example in the most recent revision of Section 3 is that our approach to interventional research in Section 3 had a ‘flow on’ effect to Section 5 in terms of where certain guidance belonged, how that guidance should reflect changes in the clinical research sector since 2007 and how it should reflect other guidance documents (e.g. related to safety reporting) that NHMRC has published in the last 12 months.

AHRECS What were you hoping to accomplish with the changes to section 3 (and Section 5 + the Glossary)? Was it achieved?

NHMRC Principally, we were hoping to facilitate a re-thinking on the part of users (researchers and HRECs, primarily) regarding how they conceptualise and address ethical issues in the design, review and conduct of the research. We began with a decision to abandon the idea of ‘categories’ or ‘types’ of research as the main way to package this guidance and to focus on the reality that most ethics guidance applies to ALL research, thereby requiring ALL researchers to consider it, rather than just going to their specialised chapter of the document and, potentially, ignoring the broader issues. We then settled on the ‘life cycle’ of a research project as the best structure – that is, from conception to post-completion stages of a research project. This also enabled us to see more clearly what was not general guidance and encapsulate that extra guidance in separate, specialised chapters that each required consideration of the general guidance as a prerequisite to fully understanding and implementing the specialised guidance content.

The changes that we made to Section 5 and the Glossary were a direct consequence of the revision of Section 3 and we purposefully did not introduce changes to those parts of the document that were independent of the Section 3 revision, even though it was pretty tempting to do so sometimes.

We do think that we achieved our objectives and we are very satisfied with the results of the review process.

AHRECS If you could say just one thing about the work to date what it be?

NHMRC Review of the National Statement, while challenging, involves very stimulating and satisfying dialogue with lots of researchers, reviewers and other users of the document. We are so committed to it that we are almost immediately taking on the review of Section 4 and Section 5 – so, watch this space!

AHRECS When someone says they would have liked examples to better illustrate the new concepts in the update how do you respond?

NHMRC A weaselly response would be: it depends on which new concepts you are talking about; but, to use one example, a good look at Chapter 3.3: Genomic research and the Decision tree for the management of findings in genomic research and health care that we included (on page 52) to address this complex issue provides just such an attempt to illustrate by example. The main impediment to using examples or case studies to illustrate concepts is the difficulty of deciding which concepts to illustrate and with how many examples, as well as potentially expanding the size of the document exponentially in order to do the examples justice.

AHRECS When will a html version be available online?

At present, the 2007 version of the National Statement (updated May 2015) is available in both PDF and HTML format; whereas the version updated 2018 is only available in PDF. We are not 100% sure when the HTML version of the National Statement (updated 2018) will be available, but we anticipate within the next two to three months. Please also note that the current address (https://beta.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#block-views-block-file-attachments-content-block-1) is only temporary, which means that you’ll need to update your bookmarks/links again when the final version of the new NHMRC website is released in late August or early September.


 

This post may be cited as:
NHMRC (31 July 2018) Release of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018). Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/release-of-the-national-statement-on-ethical-conduct-in-human-research-2007-updated-2018-with-interview

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.

The complex art of benefit-sharing0

 

In community-based participatory action programs (programs which have a research component but which are also focussed on community development and empowerment), it might be possible to identify a link between a research project and a benefit to the participating community. Over and above conducting the study, in research on domestic violence, studies have provided emotional and practical support for victims, offering information about, and organizing access to, formal and informal services, providing feedback to the study community and relevant agencies, and supporting or engaging in advocacy on behalf of abused (Usdin et al. 2000). Work on victims of state violence has also advocated for broader political change (Stanley 2012).

However, in other circumstances it may be far more likely that participants may contribute to research but gain very little direct or even no benefit from it. The lack of reciprocity may be particularly problematic if participants are drawn from vulnerable groups.

For example, members of poorer communities have a right to feel aggrieved if research undertaken in their communities is only likely to be of benefit to wealthier societies. This is most obviously the case where multinational pharmaceutical corporations trial drugs or procedures in the Global South that are in the end likely to be priced out of the reach of participant communities or which were never relevant to their needs. Not surprisingly, therefore, the concept of benefit-sharing has been most widely developed in discussions of health and genetic research.

In response, international agreements and statements related to biomedical research such as the Declaration of Helsinki (from 2000 onwards) and non-human genetic and bioprospecting research such as the legally-binding Convention on Biological Diversity (1992), formalised in the Nagoya Protocol (Convention on Biological Diversity, 2010), instituted obligations relating to benefit-sharing for projects that fell within their jurisdiction. These agreements recognised that:

Those who contribute to developments in science and technology ought to share in the benefits, so if those benefits are not shared with the contributors to scientific advancement, that advancement is exploitative. (Arnason and Schroeder, 2013, p. 21)

As a result, the Nagoya Protocol pointed to the principle that research projects should offer benefits to participants. Non-financial benefits might include: sharing research results; collaboration, cooperation and contribution in research and development programmes, education and training; institutional capacity-building; contributions to the local economy; research directed towards priority needs of the participating community; institutional and professional relationships that can arise from an access and benefit-sharing agreement and subsequent collaborative activities; livelihood security benefits; and, social recognition. It is easy to imagine how such benefits, in the context of biomedical research, can be applied to social research; or, at least, it would be if social researchers were funded at the same level as biomedical researchers.

Unfortunately, the art of benefit-sharing has proved to be complex.

First, it might not be straightforward to identify what constitutes a benefit, particularly at the beginning of a researcher’s engagement with a new community. In her recent critique of transnational Feminist researchers, Rajan (2018) portrayed some external attempts at intervening in support of women’s rights in the Global South as ‘unfairly patronizing, or alternatively… ill-advised and characterized by a lack of sufficient knowledge of local context and concerns’ (p.271).

Second, it may not always be easy to work out what a particular community might regard as a fair way of sharing benefits. Even those projects that have sought to implement formal benefit-sharing arrangements have struggled to achieve a just and equitable distribution of benefits. For example, there is evidence that women have been marginalized in the negotiation and implementation of benefit-sharing arrangements, despite (and indeed because of) their additional susceptibility to exploitation within vulnerable communities. In addition, it is possible that some benefits aimed at individual participants might undermine commitments to respond to injustice at a macro-level and might even cause intra-community conflict. For instance, providing a participant family with additional food in a village where food is scarce may cause resentment among neighbours.

Third, some disciplines are less likely than others to generate tangible benefits and, even if they can, researchers may not be able to assure that the intended benefits of a research project will flow to participants. They may be particularly powerless in the face of powerful institutions whose job it is to restrict the freedom of participants. Zion et al. (2010), for example, argued that researchers seeking to work on projects on self-harm by asylum seekers funded by the Australian Commonwealth government were likely to be compromised. As asylum seekers are subjected to indefinite mandatory detention in Australia, Zion and her colleagues concluded that even projects aimed at improving the mental wellbeing of detainees risk legitimizing a detention regime that inevitably breached human rights.

Finally, acceptance of the importance of benefit-sharing arrangements is not universal. In 2008, the United States effectively opted out of the provisions of the Declaration of Helsinki that relate to ensuring that research participants must be allowed access to tested clinical interventions that were found to be successful and that research in low and lower middle-income countries must be designed to benefit local communities. Even before that time, there was little evidence that Institutional Review Boards in the US were taking the requirement seriously (Macklin, 2004).

So, benefit-sharing offers a way of directing both the outcomes and the process of research towards the pursuit of global and social justice. Unfortunately, a broader range of disciplines need to do more to develop and share strategies of benefit-sharing before we can have confidence that it has found a place in across our research programs.

Acknowledgements:

This article further develops an argument that will appear in Israel, M. & Fozdar, F. (in press) The ethics of the study of ‘Social Problems’ . In Treviño, J. & Marvasti, A. (eds) Researching Social Problems. New York: Routledge.

Bibliography

Arnason, G. and Schroeder, D. (2013) Exploring Central Philosophical Concepts in Benefit Sharing: Vulnerability, Exploitation and Undue Inducement. In Schroeder, D. and Lucas, J.C. (eds.) Benefit Sharing: From Biodiversity to Human Genetics. Springer. pp.9-31

Convention on Biological Diversity (2010) Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. http://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf

Macklin, R. (2004) Double Standards in Medical Research in Developing Countries. Cambridge: Cambridge University Press.

Rajan, H. (2018) ‘The Ethics of Transnational Feminist Research and Activism: An Argument for a More Comprehensive View’, Signs: Journal of Women in Culture and Society 43(2): 269-300.

Stanley, E. (2012) ‘Interviewing Victims of State Violence’ in Gadd, D., Karstedt, S. and Messner, S.F. (eds) The Sage Handbook of Criminological Research Methods. Sage: London. DOI: http://dx.doi.org/10.4135/9781446268285.n15

Usdin, S., Christfides, N., Malepe, L. and Aadielah, M. (2000) ‘The value of advocacy in promoting social change: implementing the new Domestic Violence Act in South Africa’, Reproductive Health Matters, 8(16): 55–65.

Zion, D., Briskman L. and Loff, B. (2010) ‘Returning to History: The Ethics of Researching Asylum Seeker Health in Australia’, The American Journal of Bioethics, 10(2): 48-56. DOI: 10.1080/15265160903469310

Contributor
Prof. Mark Israel
Senior consultant AHRECS – AHRECS Profile | mark.israel@ahrecs.com

This post may be cited as:
Israel M. (24 July 2018) The complex art of benefit-sharing. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/the-complex-art-of-benefit-sharing

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.

Vigilance versus vigilantism in science: Are ethics no longer important?25

 

Michael James PhD, Senior Researcher, Rheumatology Unit, Royal Adelaide Hospital
Les Cleland AM MBBS MD FRACP, Head of Rheumatology (1982-2015), Royal Adelaide Hospital

In July 2016, the University of Adelaide received an allegation of research misconduct involving the PhD thesis work of a graduate student. We were her supervisors.

We first heard about the allegation not from the University but from a journalist working for ABC TV Australia. It was alleged to have occurred in our laboratory over 15 years ago.

The ABC journalist was in possession of confidential emails between the complainant and the University of Adelaide and the journalist was persistent in attempts to obtain our comments. Although the University process was confidential, it appeared that the complainant was working with the journalist to run a story on unsubstantiated claims before an investigation had commenced.

The claim was made against one of our former students, Dr Maryanne Demasi, who had been awarded her PhD in 2004. Since then, Dr Demasi has worked for the SA Government as a Ministerial advisor and most recently, as a science journalist for ABC TV’s Catalyst program. In 2016 she produced and presented a program covering the scientific debate on the possible health effects of the electromagnetic radiation from Wi-Fi-enabled devices like mobile phones. This attracted criticism from the Telco industry and the ABC imposed a three-month suspension on her duties. Dr Demasi defended her program (Demasi, 2016). However, shortly after her high-profile suspension, the allegation of research misconduct arose.

The complainant’s identity was not known to us but the emails we received from the ABC journalist described the person as a ‘leading Australian scientist’ from the prestigious Walter and Eliza Hall Institute (WEHI). The journalist’s specific mention of WEHI as the employer of the complainant served to give gravitas to the allegations. They appeared to have the imprimatur of WEHI.

The complaint was made in the form of several images of Northern and Western blots with arrows and annotations and alleged that Dr Demasi had duplicated some images in her PhD thesis. The experiments had been done 15-16 years earlier and the thesis was submitted 14 years ago. The topic of her thesis relates to the effect of hypoxia on expression and activity of cyclooxygenase 2 (COX-2), a pro-inflammatory enzyme. There was no context to the complaint such as whether the allegations could have affected the conclusions drawn from the impugned figures or the conclusions of each thesis chapter or the overall conclusions of the thesis. Also, there had been no suggestions of any issue with the research findings in the 15-16 year interim.

The process for managing allegations of research misconduct was specified in the Australian Code for the Responsible Conduct of Research (National Health and Medical Research Council, 2007a). After an initial internal investigation, which took 11 months, the University convened an independent panel, external to the University, to examine the allegations. This was in accord with the Australian Code.

The Chair was the Honourable John Sulan QC, a former Justice of the Supreme Court of SA. There were three other panel members who were all academic experts. The panel took testimony from expert witnesses, from ourselves as the supervisors of Dr Demasi’s PhD studies, and from Dr Demasi. Witnesses, including ourselves, had previously provided written sworn statements and were questioned on these by legal counsel assisting the panel and by Dr Demasi’s legal team.

The hearing was held in Sydney. It commenced in March 2018, approximately 21 months after the University received the allegations, and ran over four days. At the time of our attendance at the hearing, we learned that the complainant had declined a request to attend the hearing to speak to the allegations under the panel’s rules of procedural fairness in place for all witnesses. The complainant chose not to provide a sworn statement presenting the evidence or context for the allegations.

The process placed the entire burden of proof on Dr Demasi. Most of the original documents from the experiments conducted in the years 2001-03 had been discarded years before, especially as our laboratory had closed prior to the building, in which it was housed, being decommissioned for the move to the new Royal Adelaide Hospital. The allegations were based on highly processed images that had been generated on a scanner and computer technology dating back to the 1990s.

In response to three allegations, there had been duplication and this was intended. They represented the ‘baseline’ value for time course experiments and they were intended to indicate there is only one baseline for both the normoxia and hypoxia treatments. The expert witnesses and the panel agreed this was acceptable practice at the time, circa 2002, and did not constitute a breach in any code. The panel found no evidence of duplication for the remainder of the specific allegations where the respondent had denied duplication. The panel ruled that it could not substantiate any of the allegations made by the complainant (University of Adelaide, 2018).

Within 24 hours of the panel findings appearing on the University website, the online Post Publication Peer Review (PPPR) site ‘Retraction Watch’ posted the headline ‘Controversial Australian science journalist admits to duplication in her PhD thesis’. This headline thus began by branding Dr Demasi as controversial and then misrepresented the findings of the panel (Anonymous – Retraction Watch, 2018).

Motive for vigilantism has raised considerable discussion in the PPPR environment. The Editor-in-Chief of the journal Plant Physiology is critical of the anonymous aspect of online comments on the PPPR site, PubPeer, saying, ‘The overwhelming majority of posts on PubPeer are negative and occasionally malicious.’ He further states, ‘What of the bulk of comments posted on PubPeer? These relate to small errors and oversights, not the stuff of misconduct nor likely to arouse any but the most obsessive of temperaments’ (Blatt, 2015).

By contrast, PPPR sites are supported in the article ‘Science Needs Vigilantes’ which argues that the motive for making an accusation is not relevant – ‘are the vigilantes really doing something that requires explanation?’ (Neuroskeptic, 2013).

In the present case, the complainant had made allegations about thesis work conducted 15-17 years earlier for which there had been no previous suspicion of misconduct. If the motive of any science vigilante must be to correct the scientific record, there was no apparent reasonable motive for the complainant to trawl through this old thesis. Further, because the complainant worked with a journalist to run a story on unsubstantiated claims, it is presumed the motive was other than to correct the scientific record. The collaboration with the journalist overrides the requirement of procedural fairness, also described as natural justice, as required by Section 12 of the Australian Code.

In our view, the argument that the motives of vigilantes are irrelevant fails to recognise that their activities can preclude conformity with the standards for investigation of allegations and, consequently, the protections that those standards accord to participants.

The investigations were conducted according to the Australian Code (2007a). This stipulates that research misconduct has several mandatory elements, one of which is that it must have ‘serious consequences’. Therefore, an allegation of research misconduct requires content and context. However, this was absent in the allegations presented to the University by the complainant and to us by the ABC journalist. There was no suggestion that the alleged image manipulation could allow the student to make a claim or conclude anything different from that which was already in the thesis. Nevertheless, the process lasted for 21 months at great financial cost to the accused and at great cost to the health and wellbeing of the accused. It was a process that required no input from the complainant after the initial allegation.

The Code states ‘A person who makes an allegation must also be treated fairly and according to any legislative provisions for whistleblowers during and following investigation of the allegations.’ The standards for taking a complaint seriously are low, presumably to protect the vulnerable whistle blower. However, the standards for refuting even a mischievous complaint are high and onerous. Once the accused is shown to have no case to answer, the mischievous complainant should have a case to answer. The 2007 Australian Code is unbalanced and failed to protect the falsely accused.

The 2018 revision of the Australian Code devotes more space to dealing with a complaint that is made in ‘bad faith or is vexatious’ and states that ‘action to address this with the complainant should be taken under appropriate institutional processes’ (NHMRC 2018). However, such action will necessarily be limited or will be non-existent when the complainant is not an employee of the institution as in the present case.

This revision of the Australian Code and the Guide to Managing and Investigating Potential Breaches of the Code (the Investigation Guide) published in 2018 together provide a manual for dealing with allegations of research misconduct while allowing scope for subjective judgements. The Guide does contain a list of “principles of procedural fairness” that institutions are “expected” to incorporate in their investigation processes. However, for these to clearly address circumstances such as those in the current case, it would benefit greatly from specifying ethics principles to be used in making judgements. Respect for persons, beneficence/non-maleficence, and justice are ethics principles that are adopted across medicine and human research (National Health and Medical Research Council, 2007b). The current case demonstrates unethical behaviour when measured against these principles. It can be argued that a complainant is not obliged to observe these ethics principles when making an allegation under the Australian Code because they are not explicit in the Australian Code. However, such an argument does not pass a reasonable person test nor would it prevent an institution requiring a complainant to observe the fairness principles that are now specified in the Guide.

Research Ethics Monthly invites 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.

References

Anonymous (2018) Retraction Watch. May 9. [cited 2018 June 5] Available from: https://retractionwatch.com/2018/05/09/controversial-australian-science-journalist-admits-to-duplication-in-her-phd-thesis/

Blatt M.R. (2015) Vigilante science. Plant Physiology 169: 907-9.

Demasi M. (2016) Sometimes asking questions provides you with answers that may be uncomfortable. Huffington Post. Feb 19. [cited 2018 June 5] Available from: https://www.huffingtonpost.com.au/maryanne-demasi/sometimes-asking-questions-provides-you-with-answers-that-may-be-uncomfortable_b_9267642.html

National Health and Medical Research Council (2007a) The Australian Code for the Responsible Conduct of Research. Available from: https://www.nhmrc.gov.au/guidelines-publications/r39

National Health and Medical Research Council (2007b) The National Statement on Ethical Conduct in Human Research. Available from: https://www.nhmrc.gov.au/guidelines-publications/e72

National Health and Medical Research Council (2018) Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research. Available from: https://www.nhmrc.gov.au/_files_nhmrc/file/publications/17653_nhmrc_-_guide_to_managing_and_investigating_potential_breaches_-_v1-3-accessiblefinal_0.pdf

Neuroskeptic (2013) Science needs vigilantes. Discover magazine. Dec 31. [cited 2018 June 5] Available from: http://blogs.discovermagazine.com/neuroskeptic/2013/12/31/publish-damned/#.WwEm-iDhXct

University of Adelaide (2018) May 9 [cited 2018 June 13] Available from: https://www.adelaide.edu.au/research-services/oreci/integrity/inquiries/docs/summary-panel-report-for-publication-9-may-2018.pdf

Contributors
Michael James, Senior Researcher, RAH – Profile (see below#) | contactmjjames@gmail.com

Les ClelandHead of Rheumatology Unit, RAH – Profile (see below*)

# “Research activity in the Rheumatology Unit at the Royal Adelaide Hospital (RAH) from 1988 – 2016 involved laboratory based studies on lipid inflammatory mediators and their metabolic enzymes and also included clinical trials with omega-3 fatty acids in cardiac and rheumatoid arthritis patients. I was an Adjunct Professor in the Dept of Medicine at the Univ of Adelaide until 2018. I was Chair of the Royal Adelaide Hospital HREC for 14 years from 1995 to 2009 and have been Chair of a Bellberry HREC since 2009.”

* “Research interests have included production and regulation of lipid mediators of inflammation, clinical effects of dietary omega-3 fatty acids, early intensive treatment of rheumatoid arthritis and the role of T cells in  experimentally-induced arthritis. Member of Institute of Medical & Veterinary Science Ethics of Animal Research Committee 1984-2001.”

This post may be cited as:
James M. and Cleland L. (22 June 2018) Vigilance versus vigilantism in science: Are ethics no longer important?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/vigilance-versus-vigilantism-in-science-are-ethics-no-longer-important

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

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