We are pleased to present an excerpt from Trust in Medical Research, a freely available new book by Warwick P. Anderson, emeritus professor of physiology and biomedical sciences at Monash University in Victoria, Australia.
It has always been difficult for me to admit that we have a genuine and substantial problem of fraud and rubbish science in medical research. I suspect this is true for most scientists. We want to think of science as being free from half-truths and fake news. We hope that the high moral purpose of medical research will guard against wrongdoing, that it will weigh on our minds so heavily that we all take care to work and publish honestly and competently.
We know that scientists sometimes make unintentional mistakes due to ignorance, but we also know in our hearts that some people are so ambitious that they push the envelope, stretch the truth and take shortcuts. We know, too, that a few others go further and get carried away by the prospects of scientific and financial rewards and so cheat, commit fraud and lie in publications. This is what some humans do in all walks of life.
We know all this, but it is fair to say that we generally do not want to face up to it. Jennifer Byrne at the University of Sydney put it well when she wrote that we tend to overlook the research fraud issue “because the scientific community has been unwilling to have frank and open discussions about it”:
Fraud departs from community norms, so scientists do not want to think about it, let alone talk about it … This becomes a vicious cycle: because fraud is not discussed, people don’t learn about it, so they don’t consider it, or they think it’s so rare that it’s unlikely to affect them, and so papers are less likely to come under scrutiny. Thinking and talking about systematic fraud is essential to solving this problem.
When challenged about the incidence of fraud in medical research, many scientists tend to take defensive positions. We might contend that the usual self-correcting methods of science, replication of experiments and peer review will solve the problem. But we know that peer review is not honed to detect fraud reliably (though it can do), that replication of experiments is something that most of us are not very interested in doing (and it rarely gets supported by funders anyhow) and that a negative result from replication research will struggle to get published. All medical researchers should talk more about research misconduct because it is we who have most at stake: our reputations, the reputation of medical research itself, and our time and resources when we spend months or years on a project based on what turns out to have been fraudulent research.
So, what should we do as scientists to better own the problem and guard medical research? One way, I contend, is for medical research to become a true profession.
Medical research is not a profession, even though it demands a high level of professionalism. Anyone can call themselves a medical researcher. There are no processes that affirm an individual has reached some agreed level of expertise, proficiency and reliability. There is no specific training and no accreditation program. There is no requirement to learn a designated set of skills and knowledge, such as the proper use of statistics, what good research practices are or what the ethical obligations are. There is no equivalent of the Australian Health Practitioner Regulation Agency and the national- and state-based medical boards. There is no need for registration and demonstration of training. There is not even a set of stated principles that we expect every medical researcher to share.
Other groups of people who train to be expert, whose jobs involve individual responsibilities and can be hazardous to others, have professional bodies that manage accreditation or are accredited by government. Such fields have training and competency entry requirements, and they usually require ongoing training and education. They have formal ways to withdraw recognition and accreditation when their members act in ways that harm their customers or patients and tarnish the reputation of the profession itself. Why should medical research be different to doctors, dentists, physiotherapists and vets? Why don’t we have a professional certification system in medical research that requires achievement and maintenance of competency and ethical standards and could remove accreditation when misconduct is proven?
I have written this chapter with some trepidation. Some of my colleagues fear that any internal criticism of the methods and procedures of medical research will be seized upon by critics, especially politicians, to attack scientists and medical research itself and potentially even take control of funding.
I understand this concern, but the bigger risk in the medium to long term is to not address the problems ourselves. After all, if scientific training teaches us anything, it is how to critically examine everything – methodology, results, applications for funding, proposed publications, PhD theses, seminars and conference presentations – and then to find solutions.
The danger signs are already flashing. Richard Smith, a previous editor of The BMJ, wrote recently about clinical trials: “We have now reached a point where those doing systematic reviews must start by assuming that a study is fraudulent until they can have some evidence to the contrary.” When someone as experienced as Smith makes such a statement, it is past time for us to put our house in order.
Warwick Anderson is emeritus professor at Monash University. He was chief executive officer of the National Health and Medical Research Council of Australia (2006-2015) and secretary general of the International Human Frontier Science Program Organization (2015-2021). He chairs the Global Biodata Coalition.
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