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Abstract

Three cases of research misconduct, none conceded by their appropriate approving IRB/HREC. Without international transparency, nothing can be trusted.
Research Governance in Australia: exposing empirical deception
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A case series of three ethical breaches within research institutions
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The replacement of genuine moral reflection by procedures and protocols finally paralyses people’s
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capacity for moral reflection... Padmasiri De Silva
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Geoff Kirwood, kirwoods@tpg.com.au
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Abstract
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A case series of three ethical breaches within research institutions. The absence of audit for
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purposes of Quality Control, so as to curtail undue industry influence or investigator deceit, damages
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confidence in the medical evidence base. A history of research misconduct scandals exposed in the
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Australian media is unfortunate recourse to redress deceptions, and publicly disparaging to a field of
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mostly altruistic and dedicated scientists.
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Method. Ethical failures by Victorian researchers, uncovered in the course of Clinical Research
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studies, were investigated between 2015 and 2017. No recourse is made to privileged information,
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but reliance is wholly upon published incriminatory facts. Three institutional and three government
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regulatory governance bodies were tested for integrity per declared responsibilities, in three cases
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for concern. Correspondence was sought from authors, their affiliated institution, and then
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misconduct allegations escalated to funding bodies and finally, governmental regulators.
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Results. A journal publisher declined to comment on a fabricated report; research Sponsors were
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satisfied with progress of a study despite nothing having been published two and a half years
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subsequent to final data collection; Federal Ministers were unconcerned by misappropriated grants;
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and the only Institution conceding prima facie case for misconduct did so under cover of
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Confidentiality. This concealment also applies to Australian Research Integrity Committee reporting
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of that and all other cases.
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Conclusion. Minimal evidence of accountability in Australian research was apparent in six regulatory
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bodies’ ethical failures. Published statements as to ‘doing the right thing’ aside, the performance
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record of both the institutional ethical governance and the national integrity authorities should be
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reported upon. This would forewarn potential whistleblowers of not only career jeopardy, but also
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the impossibility of redressing wrongdoing. Further investigation as to the extent of fraudulent,
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fabricated or buried study reports is required before policy redress is undertaken.
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Introduction
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A well-publicised exposé through national Australian Broadcasting Corporation (ABC) radio and TV
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documentary of allegations over two years of ongoing scientific misconduct, fraud and fabricated
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studies at University of New South Wales (UNSW) resulted in a finding by Vice-Chancellor Rory
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Hume of errors of judgement warranting censure (Van Der Weyden (2004). Charges against Bruce
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Hall, who is still a research Professor at UNSW, had been found proven by external inquiry under Sir
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Gerard Brennan, onetime High Court Chief Justice. Hume resigned two years into his five year
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tenure, and backed independent St James Ethics Centre inquiry’s recommendation (News, 2005) for
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a US-style Office of Research Integrity (ORI), so as to remove responsibility for investigating research
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misconduct from the funding bodies.
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A decade later, again consequent to ABC coverage (Scott, 2013), UNSW’s failure to twice adequately
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address allegations against Levon Khachigian of manipulated cancer cell images, caused National
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Health & Medical Research Council (NHMRC) to withdraw $AUD8.4m in funding to the team,
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pending an investigation. The resultant internal review stopped short of using the descriptor
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‘misconduct’, but conceded that their Code of Conduct had been breached albeit apparently
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inadvertently. Professor Khachigian was reinstated, and funding resumed, but the whistleblower Dr
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Ying Morgan was not re-employed (Scott, 2013; UNSW, 2015; Israel and Drenth, 2016). This followed
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UNSW’s confidentially twice dismissing allegations at both a preliminary and a subsequent review by
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external panel insisted upon by Dr Morgan. The histology expertise of Prof David Vaux helped to air
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the matter, and his subsequent article (Vaux, 2016) considers the spectrum of misconduct from
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error through to intentional falsehood - putting not only trial participants at risk but, by inference,
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including future iatrogenic harm through a corrupted evidence base. Repercussions of convicted US
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felon Scott Reuben’s fabricated trials weren’t redressed by retraction alone, since there’s 21
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systematic reviews to amend, and clinical protocols that may never be rewritten (Marret et al.,
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2009).
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The Australian Research Integrity Committee (ARIC) would appear to function as an ORI equal to
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those of the US or UK, but lacking statutory powers. Their charter is to “Review the process by which
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a nominated institution has managed an allegation of research misconduct
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(AustralianResearchCouncil, 2011) and inform the appropriate CEO of either NHMRC or translational
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science funding body, the Aust Research Council. ARIC discloses their activity as a paragraph in the
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parent body annual report. These past five years consistently report a de-identified finding of:
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“…several weaknesses in an institution’s investigative process. The NHMRC CEO subsequently
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communicated with the institution on the matter(Brent, 2014). There are no mentions of retraction
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or other repercussion.
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Methods and Rationale
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Testing of institutions is poorly tolerated in academia, making this report novel. Quality
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Management in organisations is prescribed by ISO9001, which follows a ‘Plan, Do, Check, Act’ model.
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Quality Assurance establishes process frameworks, then Quality Control checks upon their success,
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and acts appropriately. However research institutions wholly focus on guidelines as preventative of
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ethical failure, and lack precedents for robust methods of detection or remedial action.
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The following examples of hitherto unreported misconduct detailed were encountered in the course
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of studies at Deakin and Monash Universities. None meet the definition of ‘whistleblow’ in that
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privileged information isn’t leaked, rather the allegations are reliant upon facts which are publicly
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available. The concern is that there was no forum available to dispute research conduct. The three
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exemplified situations involved repeated institutional Human Research Ethics Committee (HREC)
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apathy to complaints from this non-faculty member author. These tests of integrity were further
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applied to three regulatory authorities.
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Allegations of an ethical breach were raised to, first the designated corresponding author (p.o.c) and
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Principal Investigator (PI), then second the institutional ethics approvers, and third multiple
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independent bodies grant funding and/or government regulators, or journal editors and/or
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ethicists at contributing author’s universities.
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1. Relationship Between Mental Health and Foot Pain
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NHMRC funded a cohort study on obesity and osteoarthritic knee pain (Berry et al., 2010), data from
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which and with additional support from Royal Australasian College of Physicians (RACP) resulted in
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this offshoot study (Butterworth et al., 2014) published in journal Arthritis Care and Research
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(AC&R). The authors comprised rheumatologists, podiatrists, and bariatric physicians. The above title
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and Conclusion: “Mental health is associated with changes in foot pain” are at odds with data
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presented. Table 1 of the article reveals a non-significant p=0.08 association between chronic pain
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non-improvers and poor mental health. However, the significant association of Vitality as measured
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by SF-36 with the outcome (p=0.02) is overlooked. Both PI , p.o.c. in Monash School of Public Health
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& Preventative Medicine (SPHPM), and her NHMRC rheumatology grants Assigner co-author
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declined to acknowledge the complaint, and subsequent NHMRC trial funded by grant 1083664 of a
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TriCyclic Antidepressant to treat pain sensitisation in that population concluded in 2018 and awaits
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report. This matter was brought to the attention of an ARIC member and onetime NHMRC
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Commissioner of Unanswered complaints who co-presented at SPHPM seminar ‘Why very few
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patients benefit from the drugs they take and why many are harmed by them, on 6th Feb 2015 and
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again on 8th Jun.
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NHMRC Director of Grants repeated their response deferring accountability to Monash HREC on 17th
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April, stating: To reiterate, we would anticipate that the institution would manage the allegation of
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research misconduct in accordance with Part B of the Code [Australian Code for the Responsible
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Conduct of Research (NHMRC, 2007a)] … If you are not satisfied with the liaison you have had with
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the institution… One option is lodging your complaint with the Commonwealth Ombudsman.
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A complaint was made to the Commonwealth Ombudsman, whose reply conceded systemic faults:
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“… the NHMRC's response of 12 May 2015 to your complaint, indicated that the NHMRC referred you
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to other bodies to pursue your complaint, in particular the researcher's institution. In my view this
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was not an unreasonable response. I am aware, however, that your approaches to other bodies,
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including the researcher's university, have been unsuccessful to date(Baragry, 2015). The editor of
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AC&R was contacted 24th April 2015, as were publishers American College of Rheumatology, but
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without reply. SPHPM Research Governance Officer was contacted on 19th May, with this third
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instance complaining of ethical breaches within the department, but only the two matters previous
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were acknowledged even if not pursued. Monash HREC was then notified on 21st May, and
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acknowledged on 29th October 2015, but took no action and stopped corresponding. Complaint
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made to Manager of Research at RACP Foundation was answered 4th Aug with “… the College does
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no enter into correspondence regarding its decisions(Winne, 2015).
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2. PT056 Pharmacological Restoration of Mood In Heart Failure (Pro-Heart): Rationale
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And Design(Hare et al., 2014)
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PRO-HEART enrolled the first participant in the 6-month trial of anti-depressant escitalopram in Oct
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2010, the same year that the manufacturer pleaded guilty to allegations of “off-label promotion of
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the drugs and various forms of illegal remuneration for doctors, including cash payments disguised as
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grants or consulting fees, preceptorships, speaking fees, expensive meals and lavish entertainment
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and other valuable goods and services(Office-PublicAffairs, 2010). The study p.o.c. and PI both
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declined to answer a concern raised on 3rd June 2014, and sent again on 9th July 2015, regarding the
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worsened risk of hyponatremia in the studied population, an association which was later proven
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(Leth-Møller et al., 2016).
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A German trial’s finding against the use of escitalopram in heart failure (Angermann et al., 2016)
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should have been raised by the team with their Ethics Committee per Section 12.8(e) of NHMRC
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guidelines (NHMRC, 2007b), but Austin Health refused a formal Freedom of Information Act request
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of 19th July 2017 as to whether this adverse event was envisaged or ever communicated. Their
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grounds given being (Stephens, 2017) under Trade Secrets and Information Communicated in
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Confidence where “Disclosure may impair our ability to acquire such information in the future”. This
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commercial confidentiality was despite funding having come from two public charities.
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The sponsors forecast a completion year of 2014 (BeyondBlue, 2007) and final data was collected
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Feb 2018. The CEO of BeyondBlue stated on 18th August 2017 that she was satisfied with its
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progress, and chair Julia Gillard declined to comment to absence of a report two and a half years
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later. Funding partner Heart Foundation’s manager of executive services responded 9th July 2015 on
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behalf of the CEO, to advise that “Safe-guarding the rights and welfare of human subjects involved in
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research during the tenure of Heart Foundation funded research is the responsibility of the awardee
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and of the institution in which the award is held". Another author on the protocol (Hare et al., 2014)
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was approached, answering on 4th September 2017 of: Im not involved in this trial. If you have any
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problems with this trial please direct your inquiries to Austin Health ethics committee. Austin Health
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Research manager ignored the latest challenge to buried results, in July 2020, having declined a 2018
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offered right-of-reply to this article’s draft.
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3. The Feasibility of Embedding Data Collection into the Routine Service Delivery of a
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Multi-Component Program for High-Risk Young People (Knight et al., 2017)
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A UNSW Professor was serving on the NHMRC GRANTS committee when $AUD386,771 was awarded
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to his brother’s business BackTrack, for a trial proposing to provide cognitive based therapy to
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teenage abusers of alcohol (Shakeshaft, 2015). The BackTrack manager’s prior experience was as a
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dogcatcher (Meldrum-Hanna, 2011), and there are no skills in delivery of psychotherapy among the
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staff. Indeed, operations as documented in an observational PhD includes physical abuse, and the
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manager has been caught Driving Under the Influence of alcohol (Pastor, 2015). The published
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report (Knight et al., 2017) contains only survey data, and neither the PI, Bernie Shakeshaft, nor
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p.o.c. (lead author, qualification being BA and Bach Business) responded to a request for details of
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the claimed intervention. BackTrack runs a residential farm, offering inmates free board and
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(unaccredited) farm skills training in return for labour to neighbouring properties. Both Indigenous
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and white juvenile (14-17yo) miscreants are recruited when presenting at Armidale Magistrates
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Court, when custodial sentencing appears to be the only option due to prior record. The first three
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principles of the Code’ (NHMRC, 2007a) are violated, being: respect the rights of those affected;
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manage conflicts of interest; and adopt methods appropriate for proposal aims.
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NHMRC Ethics and Governance memo of 17th May 2017 advised: “Your allegations of misconduct
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would need to be addressed by raising your concerns with the research institution through which the
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research was conducted. NHMRC has no remit to independently investigate allegations of research
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misconduct or breaches of the Code”. Director of Integrity at UNSW had acknowledged the complaint
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sent 5th May 2017, and committed to respond to the alleged conflict of interest within three weeks.
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A reminder was sent when this lapsed, along with assertion of criminal fraud in that money was
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claimed for works not performed. UNSW advised on 29th Jun 2017 that another week was needed
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for answering very serious and complex concerns, and two years later on 14th Feb 2019 sent a
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Strictly Confidential letter finding a prima facie case of Research Code breach, but not one of
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Research Misconduct owing to not being ‘multiple and continuous’.
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Australian Federal Police disclaimed jurisdiction: “Under the Australian Government Investigations
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Standards, Commonwealth entities have their own anti-fraud or investigative components, and have
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the primary responsibility for investigating fraud involving their agencies(Witchard, 2017). Of the
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two AFP suggested agencies, the Fraud Section in Dept of Prime Minister & Cabinet didn’t reply, and
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the Ombudsman sent a case closure letter (Hill, 2017) stating: ”I suggest that you raise this matter
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with the UNSW again. On 13th Aug 2017 a formal Request for Review form was submitted to ARIC,
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and four days later notification received that a response should be had within three weeks. A status
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request was answered on 19th Oct with an update from the ARIC Chair of “still under investigation
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by UNSW (Brent, 2017).
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Discussion
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77 American Institutional Research Integrity Officers were interviewed for a report on process,
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where it was found that 23% of complaints were lodged by post-doc level or below, and 71% by
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Scientist or Professor (Bonito et al., 2012). This could indicate that seniority imbued greater
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confidence to break rank, even when given statutory protection. That is one of several factors, along
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with institutional supportiveness, mooted as being predictive of complaint effectiveness (Malek,
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2010). Risk vs benefit steers the moral compass for most placed in such a dilemma. The Dalai Lama’s
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call for moral responsibility despite the presence of dirty business and dirty science is described as
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‘muscular compassion’ (Goleman, 2015), and reliant upon an inner strength outside of any
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framework’s support.
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The US independent ORI is envisaged, on the basis of researcher survey, to handle 2300 cases p.a.,
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yet receives at most a hundred allegations (Bonito et al., 2012). The scale of the problem is
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perceived as being two dozen times bigger than the effort to expose it. Over the last decade
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misconduct findings by ORI have averaged 11 p.a., and twice as many more complaints were not
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pursued or lacked evidence (Partin, 2017).
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The ARIC and SPHPM member to whom complaint was made of the false mental health and pain
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conclusion has opined that whistleblowers are undervalued and lack support, while auditing was
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overly costly (Breen, 2016). He’d earlier authored a chapter with mention of the Hall affair: The
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Code places an onus on institutions to ensure that researchers are trained in research ethics and
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research practices according to the Code, the National Statement on Ethical Conduct in Human
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Research and related documents, and places an onus on researchers to make themselves familiar
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with these documents. One study of the staff of a large research institute suggested that clinician
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researchers were the group least informed about these documents(Breen, 2010), entrusting
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guideline compliance to a self-regulatory model and putting blame on clinicians for ignorance (Babl
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and Sharwood, 2008). On the one hand organisational stonewalling blocks individuals making an
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ethical stance, yet on the other reform is being suggested from the bottom upwards.
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A Medical Journal of Australia editorial (Van Der Weyden, 2004) on UNSW’s Prof Hall itemised these
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needs: External inquiry upfront; Statutory powers; Panel expertise; Transparency rather than
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confidentiality; Universal process; and Prevention rather than detection. Two years later the current
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Monash SPHPM Governance Officer and Head of School co-authored a document endorsing their
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internal audit process (Poustie et al., 2006), citing the MJA editorial but mentioning neither these six
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lessons nor the merit of an ORI.
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Postscript
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As of Feb 2017 a substantially revised 2010 ‘NHMRC policy on actions to be taken in response to
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misconduct involving NHMRC funding’ came into effect, having grown from 6 to 23 pages (Director,
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2016). A major amendment was mandatory notification to NHMRC by the institution of any
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investigation exceeding 56 days. Disregard of this timeframe by UNSW demonstrates the weakness
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of guidelines alone. A concurrent revision to ‘the Code’ (NHMRC, 2007a), approved in 2018, was
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circulated for feedback to both institutions and the largely independent Association of Australian
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Medical Research Industries, with the latter submitting that (if adopted) the administrative burden
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of “adhering to multiple legislative and policy instruments” would be lessened (Hilton, 2015).
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Introduction to part B ‘Breaches of the Code and misconduct in research’ acknowledges calls for
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holding of investigations in independent statutory tribunals, but considers the Federal Constitution
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to be among the legal obstacles. A further impediment to justice came from Workplace Agreements
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in academia (Van Der Weyden, 2004), so a legal Commission of Inquiry could be requisite to
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improved conduct.
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Conclusion
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Integrity means doing the right thing in a reliable way. Much is written about ethics, but the lack of
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cohesion between words and actions strengthens the claim made: there is no accountability in these
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institutions medical research governance. Three of the universities are members of the Group of
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Eight, a coalition of leading Australian research universities in receipt of 60% of the NHMRC
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$AUD800m budget, ostensibly robust institutions.
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A global review of national Ethics Committees performance would be a merit-worthy study, one
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that compared the record of misconduct allegations with investigational outcomes. This report
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recorded failures due to stonewalling from four institutional HRECs, and two regulators i.e.
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Commonwealth Ombudsman and NHMRC Ethics & Integrity. This consistent result gives confidence
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to the declaration that governance in Australian research is not assured, and hence contamination of
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the global evidence base is to an indeterminate degree. The prevailing attitude in Australia seems to
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be that ‘what happens in the department, stays in the institution’.
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Empty suggestions of further templates for best practice, or ongoing research into misconduct’s
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roots, both continue the unhealthy situation of unchecked breaches. It’s been postulated that extant
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mandatory training, and diligent mentoring are sufficient (Kornfeld and Titus, 2017). But without
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international registries for reporting against complaints, it’s impossible to tell if the Australian
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context is unique.
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Limitations
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Institutional process documents are written on the assumption that a staff member is intending to
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whistleblow, yet the three cases were submitted by a postgrad student.
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Acknowledgements and Declaration
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Thanks to Prof Brian Martin, University of Wollongong, whose assistance through writing critique
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was greatly appreciated. The author has no conflicts-of-interest to declare, and is self-funded. This
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report does not reuse any material published elsewhere.
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Introduction: More than 20% of chronic heart failure (CHF) patients are depressed and have an increased mortality risk, poor medication adherence and poor quality of life. There is currently no evidence that depressed CHF patients respond to anti-depressant medications. The Pharmacological Restoration of mOod in HEART failure (PRO-HEART) trial (www.anzctr.org.au/ACTRN12610000223033.aspx) is an investigator initiated, double- blind, randomized, placebo-controlled, parallel group, multi-centre study run by Austin Health with collaborative funding from the Heart Foundation of Australia and beyondblue. Objectives: The primary aim of PRO-HEART is to assess the efficacy of the selective serotonin re-uptake inhibitor, escitalopram, to reduce depression symptoms in CHF patients using the Hamilton Depression Rating Scale (HAM-D) and the Cardiac Depression Scale (CDS). Secondary aims are to examine the association between change in depression scores and autonomic function, psychosocial functioning, and gene polymorphisms. Methods: Systolic CHF patients receiving optimal heart failure pharmacotherapy, with documented LVEF < 0.40 and screening positive for depression confirmed by psychiatric interview are eligible for enrolment. Power calculations on the primary end-point require randomisation of 124 patients, stratified according to investigational site and depression severity. Escitalopram or matching placebo will be up-titrated from 5mg to 10mg after 1 week, followed by depression-severity guided up-titration to 20mg at 2 months. Patients will receive allocated, blinded treatment for 6 months, followed by a 6 month open label phase for the active treatment group. Results: Treatment efficacy will be evaluated from baseline to 6 months on the CDS and 17-item HAM-D scores for combined Major and Minor Depression using Analysis of Covariance (ANCOVA), with the effects of escitalopram on depression, autonomic and psychosocial functioning adjusted for age, gender and baseline psychological functioning. Hierarchical multiple regression will be used to examine the association between change in depression and change in intermediate cardiac end points, such as autonomic functioning, and social support. Conclusion: PRO-HEART should inform and contribute to international management guidelines for depression in CHF patients.
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