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

Resource Library

Research Ethics MonthlyAbout Us

Australia

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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.
.
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.

 

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.

.
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.

.

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.

Research Ethics in Australia: A Story0

 

Have you ever needed to find a history of human research ethics, whether for personal study or for use in professional development work with human research ethics committee members or researchers?

Motivated perhaps by George Santayana’s often paraphrased ‘those who cannot remember the past are condemned to repeat it’, we at AHRECS have often needed to refer to the history of the emergence of ethics in human research but have found repeatedly that the readily available histories focus on international, European and (predominantly) United States events. Conventionally, they begin in the 18th century and recount a litany of unethical research and, apparently consequential, increases in regulation, whether in the form of revised and strengthened guidelines, additional review processes or even legislation.

A typical pattern is to begin with Edward Jenner’s smallpox work in the late 18th century, Claude Bernard’s early 19th-century cautions about avoiding harm, Walter Reid’s yellow fever study in Havana in the early 1900s, the start of the Tuskegee syphilis study in the early 1930s, the Nuremberg experiments and the Code (and the mere lip-service paid to it in the US Army’s atomic energy studies in the 1950s) and, sometimes, the Japanese Unit 731 biological and chemical warfare studies in the 1940s. Then, in the 1960s, Henry Beecher’s New England Journal of Medicine article, Maurice Papworth’s human guinea pigs article and book, what Martin Tolich referred to as the ‘unholy trinity’ of Stanley Milgram’s authority study, Laud Humphrey’s tearoom trade study and Philip Zimbardo’s Stanford prison experiment, and the Declaration of Helsinki.  Then the 1970s brings disclosure and cessation of the Tuskegee syphilis study, the US National Research Act, the first common rule regulations, the President’s Commission and the Belmont Report.  Sentinel events in the 1990s include the Pfizer Trovan study in Nigeria, the clinical trial deaths of Jesse Gelsinger and, since 2000, the death of Ellen Roche, the Northwick Park TGN 1412 study and the disclosure of the Guatemalan sexually transmitted disease studies, and controversy over Napoleon Chagnon’s Amazon bioprospecting and the US military’s Human Terrain System.  There are of course other US and international events that could be added, but, in our experience the ones mentioned tend to recur most.

There are a number of difficulties with this ‘schooled by scandal’ history. First, the implicit (and simplistic) assumption of causality between examples of unethical (as seen with the benefit of hindsight) research and the subsequent tightening of regulations, guidelines or standards. Second, the unrepresentative importance accorded to the “scandals” can conceal the fact that most human research at the time was ethically acceptable.  Nonetheless, we accept that the so-called scandals are important at least in the fact that they reveal points of time at which the ethical and social acceptability of prevailing practices in human research was being questioned from new perspectives whose sources are historically and socially complex.  Third, the assumption that regulations have evolved and that all changes in regulation have benefited both research and research participants. Finally, the most important difficulty is that the history is simply not representative of our part of the world.

Australia has its own story to tell.  It is likely that this story has been influenced at identifiable points by events in other parts of the world but it is equally important to recognise that those influences find an Australian expression. We at AHRECS think that we do need to know – and tell – our own story.

An Australian account could include

Date Event Source Material/urls
1920s and 1930s early physiological research conducted in South Australia with Aboriginal men
1930s to the 1950s vaccine studies on children in orphanages in Queensland and Victoria
1950s to the 1970s secret strontium 90 pathology studies of bones
1950s atomic energy experiments at Maralinga
1950s early confrontation between Aboriginal mission administrators and researchers at Haast’s Bluff
1966 the first statement on human experimentation from the NHMRC (on which the influence of the 1964 Declaration of Helsinki is likely)
1970s repetition of Stanley Milgram’s authority study at Latrobe University
1976 to 1999 ongoing revision of and additions to the statement on human experimentation
1986 the confrontational conference on Aboriginal and Torres Strait Islander health research in Alice Springs
1991 NHMRC Interim guidelines on Aboriginal and Torres Strait Islander health research
1987 development by the Australian Research Council of a discussion paper on human research ethics
1992 radical revision of ethical review and approval of clinical trials
1994 to 1996 ministerial review of human research ethics system
1997-99 development the first National Statement, including joint working party of ARC, UA & scholarly academies
2002-03 guidelines on Aboriginal and Torres Strait Islander research from the Australian Institute of Aboriginal and Torres Strait Islander Studies in and from the NHMRC
2002 defamation litigation about a Sydney doctor’s clinical trial approval and conduct practices
2006 public disclosure of the Latrobe University lifestyle study
2006 development of a national approach to shared ethical review
2007 revision of the National Statement
2007 to date rolling revision of the National Statement
2007 public controversy about a study entitled ‘laughing at disabled’
2013 the Brisbane bus driver racial discrimination study

Accordingly, there is, in our view sufficient material from Australia to constitute a local, well documented story that is as valuable for study and professional development purposes as any of the conventional international and American accounts.

However, we are aware that stories of this kind are rarely complete. Accordingly, with this article, we are commencing the Research Ethics in Australia: A Story Project as a process of developing a more comprehensive Australian account which we propose to make available to AHRECS subscribers in formats that can be readily deployed for presentations or study resources.

A next step in that process is to invite our readers to add events that will fill out that history.  Please send us at australianstoryproject@ahrecs.com any publicly available resources, documented anecdotes or other material that can be used to fill out the emerging story.  The tabular format in which we have listed Australian events would be a suitable form in which to do this, accordingly please provide:

  1. Dates
  2. A description of the event/episode
  3. Sources, references, urls,
  4. Any multimedia material (images, video or audio files…) that might be used for teaching or presentations
  5. First-hand accounts if you were part of the story and are free to share that account#.

# If you are free, legally and ethically, to do so, let us know if you have any personal accounts of any item.  Don’t send us the account yet, we’ll seek ethics approval before asking you about your experience.

We would especially welcome accounts of the achievements of ethical human research in Australia.  This could address the second difficulty, referred to above, with typical histories and inform a balanced and fairer Australian story of human research ethics

A final version will be in the form of a resource, suitable for presentation, supported with links to the sources of the events and accompanied by notes and advice on its use.  Consistent with our mission, we firmly encourage the use of these past events in a constructive manner – how knowledge and understanding of them can inform better design, review and conduct of human research.

As you will be aware, we are delighted to have New Zealand colleagues among our consultants and know that that country has its own human research ethics story.  Indeed, our colleagues, Martin Tolich and Barry Smith, have started telling the history of New Zealand research ethics. We are interested in developing a parallel New Zealand account and will invite contributions to this as well later on.

Our proposed final resource will include both narrative and presentation formats that embed links to source materials about events, procedures or documents. We will offer guidance about using the resource constructively, consistent with AHRECS’ mission, so that the underlying message is how to design, review and conduct human research well.

Contributor
Prof. Colin Thomson
Senior Consultant, AHRECS
AHRECS profile | colin.thomson@ahrecs.com

This post may be cited as:
Thomson C. (30 July 2018) Research Ethics in Australia: A Story. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/research-ethics-in-australia-a-story

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

0