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Restoring confidence in research integrity
Editorial
On July 1, 2015, a US federal judge handed down a 4·5 year prison sentence and a US $7·2 million fine to laboratory manager, Dong-Pyou Han, for falsifying HIV research data. Han admitted that, while a researcher at Iowa State University (Ames, IA, USA), he added human antibodies to blood from rabbits that had been injected with an experimental vaccine, which gave the impression that the vaccine worked. Collaborators attempting to replicate these results uncovered the fraud, and a federal investigation was launched. This episode comes at a time when issues surrounding ethical behaviour have never been more acute. But what can be done to restore trust in research integrity? One suggestion is that the global scientific community should police itself. The rise of online commentary and social media in particular has to some extent succeeded in this aim by increasing transparency. Such self-monitoring is especially valuable in cases where the reproducibility of findings is in question. For example, in 2014, independent bloggers were key to reporting the inability of researchers to reproduce published data that purported to show that somatic cells could be reverted to a pluripotent state with simple cellular stress-inducing agents such as an acid bath. As a result, several papers were retracted, and the researchers involved at the RIKEN Center for Developmental Biology (Kobe, Japan) were charged and found guilty of misconduct. Given the potential for a bias towards the reporting of positive results, post-publication debate in online fora can provide much needed balance. However, online commentary can be prone to sensationalism and undisclosed bias, due to lack of coordination, overarching policies, and readily available context. At the institutional level, research integrity is monitored by funding bodies and research institutions, with policies and practices as divergent as the countries they reside in. In the USA, several funding agencies have their own inspectors who have varying levels of power to examine allegations of research misconduct. For example, the US National Science Foundation has a single inspector who can initiate investigations, issue bans, and refer cases to the Department of Justice.
www.thelancet.com/oncology Vol 16 August 2015
By contrast, the Office of Research Integrity (ORI) can only oversee investigations initiated by institutions that employ researchers funded by the National Institutes of Health (NIH), but it cannot directly investigate them. If misconduct is found, the ORI can rescind NIH funds or refer the case to the Department of Justice. To be effective, this style of oversight requires the cooperation of the research institute and the absence of bias at the institutional level. Recent events in the case of Duke University (Durham, NC, USA) researcher Anil Potti, have shown that this dependence on robust institutional oversight is essential. Potti falsified data used to create personalised cancer genomic models that resulted in patients being inappropriately treated. Subsequent revelations, such as Potti’s falsification of his credentials, and retraction of several publications, resulted in the broadening of initial investigations of his conduct into a full misconduct review. The Duke University review into the Potti case is still ongoing and the full report of the investigation has not yet been released, nearly 5 years after it began. In addition to variations in the approaches taken by institutions and funding bodies within a country, different countries handle misconduct in a variety of ways. These differences have been addressed by several bodies issuing global guidelines for research integrity, but the enforcement of these guidelines remains uneven and difficult to implement or monitor. Given the current global nature of scientific research, one possible option could be the establishment of an international body to issue universal guidance for adoption worldwide. Moreover, such a body could also act as an ombudsman in complex cases. Whether Han’s punishment is proportionate to his crime, and acts as the hoped-for deterrent, remains to be seen. It is clear, however, that major changes are required in how research misconduct is handled. Governance must be internationally agreed and adopted to ensure that allegations of misconduct are adequately investigated. Together with the many other solutions currently being debated, these steps will help restore faith in research integrity. ■ The Lancet Oncology
AP Photo/Charlie Neibergall
Restoring confidence in research integrity
For more on recent issues surrounding ethical behaviour see Comment Lancet Oncol 2015; 16: 752–54 and Editorial Lancet 2015; 385: 2121 For more on the Potti case see Comment Lancet Oncol 2011; 12: 116
871
On July 1, 2015, a US federal judge handed down a 4·5 year prison sentence and a US $7·2 million fine to laboratory manager, Dong-Pyou Han, for falsifying HIV research data. Han admitted that, while a researcher at Iowa State University (Ames, IA, USA), he added human antibodies to blood from rabbits that had been injected with an experimental vaccine, which gave the impression that the vaccine worked. Collaborators attempting to replicate these results uncovered the fraud, and a federal investigation was launched. This episode comes at a time when issues surrounding ethical behaviour have never been more acute. But what can be done to restore trust in research integrity? One suggestion is that the global scientific community should police itself. The rise of online commentary and social media in particular has to some extent succeeded in this aim by increasing transparency. Such self-monitoring is especially valuable in cases where the reproducibility of findings is in question. For example, in 2014, independent bloggers were key to reporting the inability of researchers to reproduce published data that purported to show that somatic cells could be reverted to a pluripotent state with simple cellular stress-inducing agents such as an acid bath. As a result, several papers were retracted, and the researchers involved at the RIKEN Center for Developmental Biology (Kobe, Japan) were charged and found guilty of misconduct. Given the potential for a bias towards the reporting of positive results, post-publication debate in online fora can provide much needed balance. However, online commentary can be prone to sensationalism and undisclosed bias, due to lack of coordination, overarching policies, and readily available context. At the institutional level, research integrity is monitored by funding bodies and research institutions, with policies and practices as divergent as the countries they reside in. In the USA, several funding agencies have their own inspectors who have varying levels of power to examine allegations of research misconduct. For example, the US National Science Foundation has a single inspector who can initiate investigations, issue bans, and refer cases to the Department of Justice.
www.thelancet.com/oncology Vol 16 August 2015
By contrast, the Office of Research Integrity (ORI) can only oversee investigations initiated by institutions that employ researchers funded by the National Institutes of Health (NIH), but it cannot directly investigate them. If misconduct is found, the ORI can rescind NIH funds or refer the case to the Department of Justice. To be effective, this style of oversight requires the cooperation of the research institute and the absence of bias at the institutional level. Recent events in the case of Duke University (Durham, NC, USA) researcher Anil Potti, have shown that this dependence on robust institutional oversight is essential. Potti falsified data used to create personalised cancer genomic models that resulted in patients being inappropriately treated. Subsequent revelations, such as Potti’s falsification of his credentials, and retraction of several publications, resulted in the broadening of initial investigations of his conduct into a full misconduct review. The Duke University review into the Potti case is still ongoing and the full report of the investigation has not yet been released, nearly 5 years after it began. In addition to variations in the approaches taken by institutions and funding bodies within a country, different countries handle misconduct in a variety of ways. These differences have been addressed by several bodies issuing global guidelines for research integrity, but the enforcement of these guidelines remains uneven and difficult to implement or monitor. Given the current global nature of scientific research, one possible option could be the establishment of an international body to issue universal guidance for adoption worldwide. Moreover, such a body could also act as an ombudsman in complex cases. Whether Han’s punishment is proportionate to his crime, and acts as the hoped-for deterrent, remains to be seen. It is clear, however, that major changes are required in how research misconduct is handled. Governance must be internationally agreed and adopted to ensure that allegations of misconduct are adequately investigated. Together with the many other solutions currently being debated, these steps will help restore faith in research integrity. ■ The Lancet Oncology
AP Photo/Charlie Neibergall
Restoring confidence in research integrity
For more on recent issues surrounding ethical behaviour see Comment Lancet Oncol 2015; 16: 752–54 and Editorial Lancet 2015; 385: 2121 For more on the Potti case see Comment Lancet Oncol 2011; 12: 116
871