“Regulations don’t solve things. Supervision solves things” Wilbur Ross 2015
Dr Gary Allen, Prof. Colin Thomson AM and Prof Mark Israel AHRECS Senior Consultants
HDR supervisors should, and often do, play an important role in the formulation of a candidate’s research ethics review application. If you talk to an experienced busy research ethics committee member, they will tell you they’ve seen too many applications where there wasn’t any indication the supervisor even saw the application prior to its submission.
Many institutions consider the supervisor to be the lead investigator for candidate research. Even those that don’t usually will expect the supervisor to be a key adviser and mentor for the candidate’s passage through the research ethics review process.
A supervisor not taking an active role in a candidate’s review application can reflect a worrying attitude: “I don’t have time to know about research ethics in detail. The candidate should submit what they have, the experts on the committee can tell them what they need to fix and how they want it changed.”
Such thinking is irresponsible and concerning at numerous levels, not least because research ethics is a fundamental component of the quality design of research.
Being able to think and write about ethical challenges is an essential component of the research training of new researchers.
A supervisor or a research school that isn’t systematically engaged in a candidate’s ethical capacity-building and professional development is failing them.
But a not unreasonable question is “What should I be looking for, when I read an HDR candidate’s application?” A reader of the Research Ethics Monthly asked for a tool she could use.
Attached here is the start of such a tool. The Research Ethics Monthly community includes some very experienced research ethics reviewers. It would be deeply appreciated if you could comment on what we have drafted and suggest other elements for the tool.
Dr Amanda Fernie, Manager Research Ethics & Integrity, Griffith University Dr Gary Allen, Senior Policy Officer, Griffith University
AUSTRALIAN CODE (2007)
At Griffith University, the implementation, operation, investigations and related professional development of/for the 2007 edition of the Australian Code for the Responsible Conduct of Research is the responsibility of the Research Ethics & Integrity team in the Office for Research.
The Griffith University Code for the Responsible Conduct of Research was the University’s policy implementation of the Australian Code (2007) and it was supplemented by the Research Integrity Resource Sheet (RIRS) series. The Griffith University Code was largely a direct repeat of the Australian Code into Griffith University policy. The RIRS is a series of short (most are four pages) guidance documents that provide practical tips related to the University’s implementation of Part A and Part B of Australian Code (2007).
IMPLEMENTING THE AUSTRALIAN CODE (2018)
This is the first post in the series about institutions implementing the Australian Code (2018). We’d love to hear about your instution’s progress and story. Email us at IntegrityStory@ahrecs.com to discuss logistics.
At the outset, Griffith University decided to give its Research Integrity Adviser (RIA) network a more collegiate advisory role, and while RIAs were made available to advise complainants and respondents, or parties in a dispute, their primary role was providing advice and suggestions. . Professional development workshops on research integrity for new HDR candidates were conducted a few times a year (as part of the orientation) and were co-facilitated by the Office for Research and the Griffith Graduate Research School. Workshops on research integrity were also conducted for new HDR Supervisors as part of their accreditation. Since 2007, professional development workshops in Schools, Departments, Research Centres, Administrative units and Groups have been co-facilitated by the relevant RIA and a member of the Research Ethics & Integrity team. .
APPROACH TO THE AUSTRALIAN CODE (2018)
. Griffith University aims to have fully implemented the Australian Code (2018) by the end of March 2019. Griffith’s Research Committee has recommended to the Academic Committee that the redundant detail of the Griffith University Code be replaced by the Griffith University Responsible Conduct of Research policy. This policy articulates the University’s implementation of the principles and responsibilities of the Australian Code (2018), the role of the University’s collegiate RIAs, and the existence and role of the resource material that will be produced by the Office for Research. Our Office for Research is currently liaising with the relevant parts of the University to determine who has control of:
.
Level 1 – Documents that refer to or link to the Australian Code, where a simple change to the reference/URL is required. Example: HDR candidate supervision policy. . Level 2 – Documents that derive authority from the Australian Code, where it will need to be determined if the Australian Code (2018) still directly provides that authority or if any changes are required. Example: Publication ethics standards. . Level 3 – Documents that copy, refer to or use a component of the Australian Code (2007), where it will need to be determined if the Australian Code (2018) still provides that component or if it needs to be replaced by institutional guidance. .
The above work is underway and progressing well. . In the event new institutional guidance is required, it will be included in the updated RIRS series. .
UPDATED RESEARCH INTEGRITY RESOURCE SHEETS
. The following resource sheets are being produced: .
Introduction to research integrity at Griffith University
Moving to the 2018 version of the Australian Code
Planning and conducting a project responsibly
Responsible research outputs
Responsible data management
Collaborative research: Hints and tips
The responsible supervisor
The responsible candidate
Conflicts of interest
Tips for peer review
Disputes between researchers
Investigations of alleged breaches of the Australian Code for the Responsible Conduct of Research
Alleged breaches: Tips for complainants
Alleged breaches: Tips for respondents
Research Misconduct
. Initially any ‘new’ guidance material will use text from Part A of the Australian Code for the Responsible Conduct of Research (2007), but the intention is to refine the material based on (sub)discipline and methodological feedback from the University’s research community, drawing from useful ideas from the Committee on Publication Ethics (COPE), International Committee of Medical Journal Editors (ICMJE), US Office of Research Integrity (ORI) and the UK Research Integrity Office. . As new good practice guides are released the relevant RIRS will be reviewed and updated as required. Griffith University is taking a ‘learning institution’ approach to this material, where it is refined and improved over time based on user feedback and suggestions, institutional and (inter)national experience/events and changes in needs. . COMMUNICATION PLAN
. The Office for Research is currently finalising a communication plan, in addition to regular updates to Research Committee, the RIA network and the areas of the University identified for the consultation above. This will include briefings for the Group Research Committees. .
AWARENESS AND PROFESSIONAL DEVELOPMENT PLAN . Early in 2019, the Office for Research and RIAs will commence professional development activities to raise awareness and understanding of the national and international changes. .
Contributors Amanda Fernie, Griffith University | a.fernie@griffith.edu.au & Gary Allen, Griffith University
This post may be cited as: Fernie, A. & Allen, G. (26 November 2018) Griffith University’s implementation of the Australian Code (2018). Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/griffith-universitys-implementation-of-the-australian-code-2018 . 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.
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:
Dates
A description of the event/episode
Sources, references, urls,
Any multimedia material (images, video or audio files…) that might be used for teaching or presentations
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.
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.
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.
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.”
The senior consultants started AHRECS in 2007. We were looking for a way of responding to requests for advice on research ethics and integrity from the government, health and education sectors read more...
Comments’ rules
We decided to include comment functionality in the Blog because we want to encourage the Research Integrity and Human Research Ethics communities to contribute to public discourse about resourcing and improving practice. read more...
Random image from the AHRECS library. These were all purchased from iStockPhoto. These are images we use in our workshops and Dr Allen used in the GUREM. Less
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