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September 8, 2016

DBS Attorney Cal Stein Collaborates On Article About Scientific Research Misconduct

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Lexis Nexis has published an article co-written by Donoghue Barrett & Singal's Cal Stein and Penningtons Manches' Jim Kinnier-Wilson reviewing the legal aspects of scientific research misconduct. The article is published in full below.


This article was first published on Lexis®PSL IP & IT on 22 August 2016. Click for a free trial of Lexis®PSL

Scientific research misconduct

22/08/2016

IP & IT analysis: In this transatlantic article, we take a look at the legal aspects relating to scientific misconduct, both here in the UK and across the pond in the US. Jim Kinnier-Wilson of Penningtons Manches considers the position in the UK and Callan Stein of Donoghue Barrett & Singal outlines the state of play in the US.

Under what circumstances could scientific misconduct constitute a civil or criminal wrong?

Jim Kinnier-Wilson (JKW): In the UK, there is no specific wrong-doing of scientific misconduct. Essentially it is up to each employer to set out the ethical and professional standards that it expects its scientists to adhere to. Nevertheless there are attempts to provide a unified, albeit voluntary, approach through mechanisms such as the Concordat to Support Research Integrity from Universities UK, and the Policy and Guidelines on Governance of Good Research Conduct from the Research Councils of the UK (RCUK).

Within these frameworks, research misconduct has no single definition, but can be thought of to include at least:

  • fabrication
  • falsification
  • plagiarism
  • misrepresentation
  • failure to follow established protocols and ethics standards

The potential for civil or criminal liability obviously depends on the misconduct that has taken place. For instance, plagiarism may give rise to a tortious liability for copyright infringement, although there is no criminal offence for such acts. Likewise, a failure to follow established protocols might give rise to a claim of negligence or of breach of duty of care in tort, or perhaps a breach of contract brought by an employer, but is unlikely to result in criminal sanctions.

The misconduct that results in the greatest amount of negative publicity, and possible harm, are those of fabrication, falsification and misrepresentation. These, individually and collectively, could amount to fraud, which has serious consequences both in terms of the sanctions that can be imposed and manner in which such claims need to be brought.

In a widely-reported matter originating in 1998, Dr Wakefield linked the MMR vaccine to autism and bowel disease in children. The General Medical Council (the UK's official medical regulator) found that Dr Wakefield's methods of research did not have ethical approval, nor did he have the relevant qualifications for the tests he carried out. Therefore he broke medical guidelines and committed a tort. However, there is much debate as to whether his actions amounted to fraud.

Civil fraud is broadly defined and generally means the torts of fraudulent misrepresentation or deceit. It can also include the breach of an academic or professional code of conduct. As allegations of fraud can have a serious negative impact on the innocent, there is a heightened obligation on a claimant in relation to asserting fraud. To succeed in an action for deceit, it has to be established that:

  • the defendant made a statement of fact
  • the statement was false
  • at the time of making the statement, the defendant's state of mind was dishonest (there was no belief as to the truth of the statement)
  • the defendant intended the claimant to rely on the statement
  • the claimant did in fact rely on the statement, and
  • the claimant thereby suffered financial loss
    As this is a high burden, actions for deceit are rare--but the circumstances which might give rise to such a cause of action are regrettably common if one looks at reports in the scientific press.

Criminal liability for research misconduct will also depend upon the nature of the research and the employment of the researcher. In addition to potential prosecution under the Fraud Act 2006 (FA 2006), a researcher might face prosecution for criminal acts under any law or regulations that apply to the conduct of the research, such as the Good Laboratory Practice Regulations 1999, SI 1999/3106 (the Laboratory Practice Regulations).

Under FA 2006, a researcher might face prosecution for:

  • a false representation (FA 2006, s 2), or
  • failing to disclose information the researcher is under a duty to disclose (FA 2006, s 3)
    As with other criminal acts in the UK, both of these offences require dishonesty. The person involved must know that the representation is false or that the information given does not honestly disclose the relevant information.

In relation to the specific laws and regulations, in 2013 the first prosecution under the Laboratory Practice Regulations was pursued. It came about following the self-reporting by Aptuit (a clinical research organisation subject to the Laboratory Practice Regulations) of irregularities in pre-clinical data following an audit. The Medicines and Healthcare products Regulatory Agency (MHRA) conducted a far-reaching inquiry, and decided to prosecute one individual, although it seems that others were also implicated in the activities. The prosecution resulted in a three-month prison sentence for Steven Eaton, a former employee of Aptuit. He was found to have falsified and selectively reported pre-clinical trial data, with the aim of securing funding for Aptuit from its customers to perform further clinical trials.

Callan Stein (CS): In the US there is no statute that specifically criminalises scientific misconduct. Thus, the government can only prosecute scientific misconduct criminally where the misconduct violates some other criminal statute. Historically, this has occurred only in the most severe cases. In the past thirty years there have only been a handful of criminal prosecutions for scientific misconduct, and in virtually every case the government's theory of criminal liability has been grounded in the federal statute making it a crime to make false statements to the government.

In the US, the federal false statements statute is typically used to prosecute individuals for perjury, obstruction of justice, or fraud on the government, and has been used to obtain numerous high profile convictions including recently against Martha Stewart and Bernie Madoff. In the context of scientific misconduct, a researcher can violate the false statements statute by knowingly submitting a grant application or progress report to a federal granting agency--usually the National Institute of Health (NIH)--that contains falsified, fabricated, or plagiarised data. Although such false statement prosecutions are rare, if the scientific misconduct is egregious enough a researcher convicted under the state can be sentenced to serve jail time. For example, as recently as February 2015 a scientist who pleaded guilty to two felony violations of the false statements statute for submitting falsified and fabricated data in HIV vaccine trials to NIH was sentenced to serve 57 months in prison and to pay $7.2m in restitution.

With respect to civil liability, under certain circumstances scientific misconduct can implicate any of a host of civil claims including:

  • common law fraud (eg where the researcher presents or publishes falsified or fabricated data and another person or entity justifiably relies on it)
  • breach of contract (eg where the scientific misconduct violates one or more contractual obligations owed by the researcher, usually in an employment contract to act ethically or to present only true data), or
  • common law theft (eg where the researcher's scientific misconduct involves stealing another researcher's data)
    However, notwithstanding the number of potentially available legal claims, civil lawsuits in the US involving scientific misconduct remain rare and difficult to pursue, largely because of the general reluctance of civil court judges to insert themselves into complex scientific disputes or second guess a researcher's scientific judgment.

In complicated areas of research, how would scientific misconduct be discovered?

JKW: The scientific community has a peer review system to spot anomalies and irregularities in reported data during collection and also once research reaches the publication stage. However, there are potential issues with junior colleagues being asked to peer review their senior colleagues as they may not feel they are in a position to raise any concerns they may have. For example, in a case we are aware of, it has been seen that colleague collusion is a problem which can subvert this system.

Potentially the most effective, but currently under-utilised, method of spotting misconduct is to encourage whistleblowing among colleagues. In the matter mentioned above, concerns were initially raised by fellow research staff, although these were not fully realised until a routine audit was conducted. Similar concerns were clearly present in the Aptuit case as well.

Regular audits can be useful to spot irregularities and to prevent misconduct. For pharmaceutical and other regulated research, regulators also make routine inspections to check that their guidelines are being followed.

It can sometimes be difficult to show whether an identified data anomaly is factual error or fraud. The Aptuit case resulted in proceedings in the US over the liability of Aptuit's insurer to cover losses suffered by Aptuit's customers. In those proceedings, Aptuit argued that certain claims could have resulted from genuine factual errors rather than fraudulent conduct. Indeed, although it was recognised in the District Court judgment that Steven Eaton was unlikely to have been alone in his fraudulent activities, because of this uncertainty, it was not known if other individuals could be implicated in the misconduct or not.

CS: Frequently, scientific misconduct is discovered and reported by individuals working in the research community. In the US, competition for scarce federal grant money can be very fierce among individual researchers operating in a specific scientific field. This competition can create lucrative incentives for competitors to scrutinise published research and report any perceived data inaccuracies or misconduct. Additionally, there are many cases where individuals who actually collaborated on the research later filed reports of possible scientific misconduct. Indeed, it is not uncommon to see a scientific misconduct case initiated against a principal investigator based on allegations by a disgruntled graduate student or postdoctoral fellow, nor is it uncommon for a principal investigator to uncover mistakes in published data and then blame it on the misconduct of one of their subordinates.

In recent years, the prevalence of this type of post-publication peer review of research data has spawned a number of online anonymous whistleblower groups that have led to an increase in the number of reports of possible scientific misconduct. For example, the website PubPeer (which allows users to anonymously discuss and review published scientific research) has highlighted a number of deficiencies and potential misconduct in several high profile papers. There are many other individuals who have taken to anonymously emailing allegations of possible scientific misconduct directly to scientific journals, including, most notoriously, those who do so using the pseudonym 'Clare Francis'. While there has been some criticism of these types of anonymous allegations (and the methods they often employ to uncover what they perceive to be misconduct), allegations on PubPeer and from anonymous emailers have led to retractions and the initiation of scientific misconduct proceedings.

In the case of scientific misconduct, who is the victim?

JKW: There are many possible victims. The Aptuit case highlights that patients can be put at risk by unscrupulous researchers. The MHRA stated that as a result of Steven Eaton's actions, several new medicines had been significantly delayed due to the burden of checking all of the data he had been involved in. Patients, customers and employers could each suffer losses and have a cause of action against the wrongdoer but, unless the losses are financial, a researcher whose research is subject to misconduct would be unlikely to face a fraud claim.

Patients can also be put at direct risk, as seen with the case of the MMR scandal. Due to the publication of Dr Wakefield's study, many children were not vaccinated and the country saw a sharp spike in the number of measles cases, including a number of fatalities.

If it has not been complicit in the misconduct, the company or institution for whom the researcher works can also be a victim in these types of cases. They will need to provide resources for investigations and the outcomes of experiments will not be able to be relied on. Affected experiments will have to be either re-commissioned or the work abandoned. In extreme cases, where misconduct has not been identified until a product has been placed on the market, the products may also have to be pulled from the market.

However, if the work delegated to the dishonest researcher was the kind of work that might normally be delegated, which more often than not it will be, then the employer becomes vicariously liable for the actions of its employee, thus making the employer potentially liable for its employees' actions, and so potentially both victim and defendant.

The profession as a whole can also be damaged by reporting of scientific misconduct. The public as a whole may lose confidence in the processes of scientific research, which could have currently unknown consequences for the profession and the industry.

CS: As is often the case with violations that involve fraud of some sort, there are many potential victims and the degree of 'victimhood' depends on who you ask. For example, in any case of scientific misconduct, the grantor--ie the individual or entity that paid for the fraudulent research or issued a grant based on fraudulent data--would likely consider itself the primary, or perhaps only, victim. In countries where a significant portion of scientific research is funded by the government, this could mean that, in addition to the granting agency, the nation's taxpayers are also victims when scientific misconduct occurs.

But there are also other potential victims to consider beyond those who have a financial stake in the falsified research. Competitors of a researcher who commits scientific misconduct could become victims if, for example, grant money that would have gone to them on the basis of their truthful research was instead given to the offender on the basis of their falsified or fabricated research. Similarly, collaborators of a researcher who commits scientific misconduct could become victims if, when developing their own experimental programs and research priorities, they rely on published data that has been falsified or fabricated without their knowledge.

Finally, the list of possible victims of scientific misconduct might also include anyone caught up in the collateral damage a scientific misconduct scandal often leaves in its wake. Such collateral damage usually takes the form of reputational damage to:

  • the institution at which the fraudulent research was conducted
  • collaborators who knew nothing of the misconduct but whose names appear on a paper that is ultimately retracted
    or irrevocably tainted, and
  • the scientific journal that unknowingly publishes and then is forced to retract the falsified research

Could a university or research institute conceivably sue the scientist if the discovery of scientific misconduct led to loss of earning or damage to reputation?

JKW: In short, yes, but any claim will likely depend on its facts and the seriousness of the misconduct. In a recent case involving the falsification of results, three main civil causes of action were pursued or considered, namely:

  • breach of contract and code of conduct
  • professional negligence due to a breach of the researcher's duty to act with the skill and care expected of a
    professional scientist, and
  • breach of the fiduciary duty owed to employer (duty to deal honestly with the company, to handle its property (including, in particular, its data) responsibly and with proper regard for the company's reputation and resources, and not to act dishonestly (whatever the motivation may have been) by manipulating or causing or permitting the company's data to become corrupted or manipulated)

However, identifying and quantifying loss is difficult--particularly when it comes to loss of the company's/institution's reputation and/or damage to its goodwill. A company could claim for delay to its research programme and the cost of rerunning experiments, loss of income from the loss of workload from employees and directors, a threat to the company's reputation, and legal advice.

CS: From a legal perspective it is absolutely conceivable that an institution could sue a scientist for damages relating to their scientific misconduct. As noted earlier, scientific misconduct can implicate a host of potential civil claims that could be utilised by a scorned institution. Indeed, the possibility of an institution initiating a civil lawsuit against a researcher guilty of scientific misconduct could be particularly attractive where the institution can establish a tangible loss of earnings or demonstrable damage to its reputation, as both types of losses usually constitute proper measures of damages in a civil lawsuit.

However, despite the apparent availability of the legal process to research institutions in such circumstances, civil lawsuits against researchers guilty of scientific misconduct are still rare in the US. When faced with the possibility of suing a scientist, more often than not institutions choose to exercise discretion on the basis that the potential benefits of the litigation will be greatly outweighed by its costs for several reasons.

First, scientific misconduct typically does not directly cause significant lost earnings for an institution. This means that in most cases the bulk of an institution's damages will be to its reputation. Proving reputational damage at trial is notoriously difficult and this difficulty often deters institutions from incurring the significant legal fees necessary to file and effectively pursue a civil lawsuits.

Second, even if an institution successfully proves significant monetary damages at trial the amount of that judgment will only be as valuable as the institution's ability to recover it. Thus, if the institution knows the researcher does not have the financial resources to compensate it for the lost earnings and reputational damage it does prove (as will often be the case, especially where the misconduct is committed by a graduate student or postdoctoral fellow) the institution may well decide pursuing what will likely be ultimately fruitless litigation is not worthwhile.

Finally, even in cases where the institution can prove and recover the full amount of a significant judgment in its favour, the institution may make the business decision that the additional public relations damage it would incur from widely publicising a scientific misconduct dispute in a civil lawsuit would greatly outweigh the monetary benefit and, thus, the more prudent course of action is to forgo even winnable litigation altogether.

What action can be taken to prevent scientific misconduct? Are there calls for some sort of regulatory/criminal oversight of academia?

JKW: As mentioned at the start of this interview, the issue of research integrity is a matter for national concern. Not only have the major public research organisations within the UK signed up to detailed policies and guidelines, some of this work is being supervised by third parties. The UK Research Integrity Office (UKRIO), an independent charity, provides advice, education and training for these issues, and also direct involvement and support in any investigation.

Further demonstrating the importance of this topic, a forum was arranged, chaired by members of the House of Lords' Science and Technology Committee, to debate these issues. This forum was aimed at identifying and considering strategies for protecting the integrity and rigour of UK research, and supporting the quality of the UK research base. The panel of speakers and delegates included representatives from all walks of the UK research base.

One suggestion is that the global scientific community should police itself. To a certain extent this already occurs, with institutions publishing a professional code of conduct for researchers to follow which sets the boundaries of good practice. However, many believe that governance must be internationally agreed and adopted to ensure that allegations of misconduct are adequately investigated.

For criminal liability, while there are no calls at present for a greater oversight of academic research, in the Aptuit case, due to the potential impact on patients, the court felt that the sentencing powers allowed under the Laboratory Practice Regulations were inadequate. It would therefore seem that there is an appetite for increased criminal oversight with possibly stronger powers of determent.

CS: In the US there is already very significant oversight of government-funded research, albeit in a regulatory and not criminal capacity. Research institutions are required by law to institute and comply with minimum procedures for investigating allegations of scientific misconduct set by the government. Furthermore, when scientific misconduct allegations concern government-funded research, the institutions are required to report their investigational findings to the federal government's Office of Research Integrity so that offenders can be punished, often with serious sanctions up to and including debarments from receiving or using government research funds.

In this sense, the US Government has put the onus on the individual research institutions to ferret out and prevent scientific misconduct. In fact, very recently a US court in Washington DC issued a decision holding that when a research institution conducts a legally-mandated inquiry or investigation into allegations of research misconduct, it is performing an 'official function' that has been delegated by the US Government. As a result of this relationship, the court held that during the course of its research misconduct proceedings the private research institution, essentially, stood in the shoes of the government and was, thus, immune from civil tort liability for conduct arising therefrom just as the government would be. The name of this case, that was decided on 31 March 2016, is Kumar v George Washington University.

In performing these 'official functions', private research institutions are required to comply with the minimum procedural standards set forth in US Government regulations. However, the institutions are permitted, and indeed encouraged, to exceed those minimum standards and put additional safeguards in place. Some institutions have done so by implementing additional protocols and requirements aimed at preventing scientific misconduct, including requiring additional training for their researchers and/or encouraging mentoring, monitoring, or formal peer-review relationships among its researchers.

With respect to criminal oversight of academia, there are some who have called for the implementation of a statute criminalising scientific misconduct. However, to date such efforts have not gained significant traction. Opponents of a criminal scientific misconduct statute point to factors such as the difficulty and cost of prosecuting complex scientific misconduct case in courts and before judges not equipped or trained to handle them, as well as the 'chilling effect' such regulation could have on scientific research as reasons why such legislation would not be appropriate. In addition, the manner by which US courts have dealt with (or, more accurately, declined to deal with) scientific misconduct in the limited circumstances that have arisen to date strongly suggests that the criminalisation of scientific misconduct would be fraught with practical difficulties. In their limited involvement in scientific misconduct cases, judges in US courts have repeatedly stated their extreme reluctance for becoming involved in such highly technical and complex cases that would oftentimes require them to second-guess the scientific judgment of seasoned researchers. The criminalisation of scientific misconduct would require them to do precisely that and more.

Jim Kinnier Wilson is a partner and the head of the life sciences group at Penningtons Manches in the UK. He has a first degree in Biochemistry and a Masters in Biochemical Engineering. Jim advises clients at all stages of the company lifecycle including those listed on Nasdaq and the ASX. He deals with commercial contracts and disputes, with a strong IP bias, mainly for businesses involved in life sciences, clean tech or engineering. He focuses on commercial agreements from research and collaboration, clinical trial/assessment agreements, manufacturing, supply and marketing issues, as well as regulatory support in the pharmaceutical, medical devices and biotech spheres. He handles complex science and engineering disputes, mainly those relating to patents, industrial designs and related copyright or confidentiality issues.

Cal Stein is an attorney in the litigation department of Donoghue Barrett & Singal, P.C. located in Boston, Massachusetts. He regularly represents researchers accused of scientific misconduct in proceedings before their institution and before the US Government's Office of Research Integrity and the Department of Health and Human Services. Callan also regularly represents clients in other civil and white collar criminal defense litigation. He can be reached via email at cstein@dbslawfirm.com or you can visit his bio on his firm's website.

About the Author

Callan Stein

Callan Stein is an associate in Donoghue Barrett & Singal’s Boston office. He regularly represents small and large businesses in litigation and general corporate matters. You can follow him on Twitter at @CallanSteinEsq

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