Inequitable Conduct and Invalidation of Patents Related to Food and Drug Administration-Regulated Products.

This study examines the frequency of drug patent invalidations based on inequitable conduct.

Should the Regulation of Research Misconduct Be Integrated with the Ethics Framework Promulgated in The Belmont Report?

The federal research misconduct regulations finalized in 2005 did not incorporate important principles regarding human subjects protections articulated in The Belmont Report, yet research misconduct can involve harms to research subjects and to subsequent patients whose treatments are based on false research findings. Consistency with the Belmont principles would require assuring regular monitoring to detect research misconduct, tracing effects of research misconduct on trial participants and informing them of these effects, and assuring timely correction of published reports of research findings if research misconduct related to the study was subsequently discovered. Research misconduct has historically been viewed as a matter for the scientific community to manage; it is actually a threat to the welfare of human subjects and ethically ought to be treated as such.

The Legal Consequences of Research Misconduct: False Investigators and Grant Proposals.

In a survey on research misconduct, roughly 20% of the respondents admitted that they have submitted federal grant proposals that include scholars as research participants even though those scholars were not expected to contribute to the research effort. This manuscript argues that adding such false investigators is illegal, violating multiple federal statutes including the False Statements Act (18 U.S.C. §1001), the False Claims Act (31 U.S.C. §3729), and False, Fictitious, or Fraudulent Claims (18 U.S.C. §287). Moreover, it is not only the offending academics and the false investigators that face civil and criminal penalties because administrators may also be liable if they sign off on proposals and are in a position to know that false investigators might be included. Policy recommendations that should reduce the use of false investigators include changing institutional cultures, better training and oversight of the responsible conduct of research, and, most importantly, making all grant reviews double blind.

Toward global standardization of conducting fair investigations of allegations of research misconduct.

In the United States, through nation-wide discussions, the procedures for handling allegations of research misconduct are now well established. Procedures are geared toward carefully treating both complainants and respondents fairly in accordance with the US framework. Other countries, which have their own cultural and legal framework, also need fair and legally compatible procedures for conducting investigations of allegations of research misconduct. Given the rapid growth of international collaboration in research, it is desirable to have a global standard, or common ground, for misconduct investigations. Institutions need clear guidance on important subjects such as what information should be included in the investigation reports, how the investigation committee should be organized once research misconduct allegation has been received, how to conduct the investigation, how the data and information obtained should be taken as evidence for vs. against misconduct, and what policies the investigation committee should follow. We explore these issues from the viewpoint of members of committees investigating accusations of research misconduct (hereafter referred to as "investigation committees") as well as persons overseeing the committees in Japan. We hope to engender productive discussions among experts in misconduct investigations, leading to a formulation of international standards for such investigation.