A new book, Doctored: Fraud, Arrogance and Tragedy in the Quest to Cure Alzheimer’s by Charles Piller is a deeply dispiriting story. Dispiriting in particular, as it yet again tells a story of harmful unchecked research misconduct.

Piller is an investigative journalist with the respected academic journal, Science. In Doctored he tells the story of how fraudulent research and corrupt and dishonest conduct by some research leaders and biotech and start-up companies went undetected for years. He argues that Alzheimer’s research funding decisions were dominated by a powerful group of researchers, to the detriment of other theories and potential therapies.

Piller describes many systems failures that contributed but it was flagrant research misconduct (better called research fraud) that was the initial trigger to this unfortunate story. Regrettably, it took nearly two decades and the work of a determined young researcher, Matthew Schrag, who overcame many barriers, before this story became public.

The system failures were manifold and included the relative impotence and tardiness of the key US regulatory agencies (the Food and Drug Administration and the Office of Research Integrity) and the research funding agency (the National Institutes of Health), the sluggishness of medical journal editors in responding to requests for retraction of questionable publications, the conflicts of interest that marred universities’ investigation of their own staff, and how the pursuit of share market success led some researchers astray. Piller argues that effective therapies for Alzheimer’s disease were delayed as a result of the fraudulent research and dominance of the powerful research group.

Research misconduct is deeply resented by the vast majority of medical researchers who adhere to the core values of research (objectivity, honesty, openness, accountability, fairness and stewardship). So what systems can best identify and deal with those who publish fraudulent research? This is a big topic and, as in health itself, prevention should be key. But are the systems for preventing, deterring, detecting, investigating and penalising research misconduct adequate in Australia? We believe that the answer, unfortunately, is no. That more than 500 Australian academic publications have been retracted in the last 20 years is evidence of its inadequacy.

In Australia, the standards demanded of researchers are set out in the Australian Code for the Responsible Conduct of Research. The two major research funding agencies, the NHMRC and the ARC, require that researchers adhere to the Code. However, investigations of alleged research misconduct are devolved to employing universities and research institutes with no public reporting requirements. A frequent criticism of such a system, a system common to most countries, is that universities and institutes may be motivated to conceal, minimise or dismiss instances of misconduct to protect their reputations. This is not to suggest that Australia’s institutions frequently fail in this manner, though in the absence of open and mandatory reporting one cannot know. Examples of strong institutional leadership do exist.

NHMRC and ARC bolstered the system in 2011 by establishing the Australian Research Integrity Committee. However, ARIC is limited to reviewing the processes followed by a research institution. Without statutory powers, ARIC cannot require institutions to report, cannot independently open inquiries into institutional investigations and cannot make its findings public. In the absence of public reporting, we cannot know the extent of research misconduct nor the consequences for the perpetrators of the misconduct.

What then should be done?

Some Australian researchers advocate for a legislated body like the US Office of Research Integrity but it too depends on local institutionally-based investigations and is restricted to federally funded research (and did not perform well in the case described by Piller). Notable exceptions to sole reliance on institutional processes are Sweden and Denmark. In 2020, Sweden established a single national agency to investigate allegations of research misconduct, the Swedish National Board for Assessment of Research Misconduct  while Denmark has had its national Board on Research Misconduct for longer.

These calls for Australia to adopt a single national agency with powers to investigate all allegations of research misconduct seem unlikely to be set up. Based on our past experience of seeking to strengthen the Code for the Responsible Conduct of Research, such a scheme will be resisted by universities and other research institutions (resistance well-documented in Doctored), and by higher education unions. Given the size of our country, running such a national agency to investigate all allegations would be expensive and, unlike Sweden and Denmark, legal complexity would arise from being a federation.

But something does need to be done. We recommend building on what is already in place. As a first step, all Commonwealth research funding should be subject to a reformed and more empowered Australian Research Integrity Committee (renamed the Australian Research Integrity Office), with the authority and resources to:

• Be the central repository of all allegations of research misconduct received by our universities, research institutes and hospitals, with obligatory reporting.
• Monitor the outcomes of these allegations, receive complaints about the processes, and re-investigate if it is deemed that the processes were not in compliance with the Australian Code for the Responsible Conduct of Research. (One crucial revision needed for this Code is that institutions must appoint external members with no conflicts of interest when establishing inquiry panels.)
• Publish in real-time, and in accord with privacy laws, the outcomes of inquiries into allegations of research misconduct.

Commonwealth agencies such as the NHMRC and ARC should be authorised by the government to impose penalties recommended by ARIO.

Such an ARIO will likely be resisted too, but could be quickly put in place by a decision of the Commonwealth Government. We believe that this would be welcomed by the overwhelming majority of researchers.

Health and medical researchers need protection from the small minority who tarnish medical research’s reputation through research misconduct. The community needs protection too so that clinical and public health advice is based on honest, trustworthy research, and so that its taxes are well spent.

The views expressed in this article may or may not reflect those of Pearls and Irritations..