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GIVEN the nexus between published research, medical practice and public health policy, the veracity of published medical research is vital.
Melbourne newspaper The Age recently reported on an “explosion of medical research fraud”, and an editorial in this week’s issue of the MJA examines a specific incident of fraud.
Trust in the ethical behaviour of researchers is the cornerstone of medical science and publication. The Guideline for Good Clinical Practice, to which Australia adheres, provides some regulation but not enough to protect against fraud.
It is up to medical journals to take a primary role in the prevention of research fraud, and many already have policies in place. These include requirements for ethics approval and registration of all trials before publication will even be considered.
Authors should state their contribution to the study and manuscript and must declare all financial conflicts of interest. Finally, articles must be skilfully peer reviewed before publication.
Despite all this, as described in the MJA editorial, it is clear that current policies are inadequate and we must ask — what else can be done?
The role of thorough audits is well established to improve regulation by funding bodies and ethics committees.
There is a push to make raw trial data available to reviewers and readers.Already, some agencies such as the US Food and Drug Administration mandate that raw data be made available to them for their own independent analysis.
In principle, making raw datasets available at or before the time of publication has many potential advantages, with deterrence of fraud being only one important benefit.
Facilitating data sharing among researchers, allowing other researchers and peer reviewers to test published conclusions, testing of secondary hypotheses, simplifying data acquisition for meta-analyses, and preventing selective reporting are all important advantages. It may even reduce unnecessary research duplication and facilitate research progress.
In comparison, the case against the publication of raw datasets seems flimsy.
Issues of confidentiality are easily overcome, and issues of data dredging and invalid analyses are no different to those already confronted by ethics committees and the peer-review process.
However, the practical difficulties of data sharing cannot be understated.
The vast quantity of data collected in large clinical trials would require the provision of the data dictionary and statistical code to make the data intelligible. Further, it is unlikely that peer reviewers would be able to make sense of the data in a timely way.
But practical issues are not the only obstacle. Clearly, there is resistance to the publication of raw data; researchers have a natural tendency to view the collected data as their own.
However, there is a compelling argument to maximise the utility of data collected when research has been funded by the public purse. The Wellcome Trust has already stated its aspiration to share data.
For now, however, to prevent research fraud, we need to ensure that we seek out smart, proactive peer reviewers, and the research community needs to ensure that audits are carried out so that history does not repeat itself and researchers are called to account early in their careers.
Change is inevitable, but what shape it takes is yet to be defined.
Dr Annette Katelaris is the editor of the MJA
This article is reproduced from the MJA with permission.
Posted 20 June 2011
I am in full agreement with the comments by Dianna Kenny—these research frauds have been going on for years, so where and when and how does anyone start?
Sharing data and making datasets available to reviewers might sound like feasible solutions to the problem of research fraud, but they also present significant challenges. The first is the legal minefield of intellectual property. Most researchers will not agree to submitting their raw data to a journal or reviewers unless there are legal protections in place for their intellectual property. This would involve the drawing up of Memoranda of Understanding (MOU) by the institutions to which the researchers belong. This can take months, if not longer and seriously delay the publication of research. Secondly, not all reviewers are experts in the statistical analysis of data. Many are contacted to review work in their substantive area of medical or scientific expertise and decline to comment on the complexities of the statistical analyses undertaken. Some journals now have specialist statistical reviewers to comment on the adequacy of the methodology and statistical analyses before it goes for content review. Thirdly, we have learnt from bitter experience that peer review is a flawed method of ensuring ethical or professional conduct within a professional community. We cannot count on any community of scholars or professionals to self-monitor without fear or favour. There are too many impediments against the exposure of fraudulent practices. A great deal of thinking and debate about this issue is needed – we need to hasten slowly.