What is Recklessness in Scientific Research? The Frank Sauer Case.

On May 22, 2017, administrative law Judge Leslie Rogall of the Department of Health and Human Services' Departmental Appeals Board, Civil Remedies Division, ruled in favor of the Office of Research Integrity (ORI) concerning its decision to charge former University of California at Riverside biochemistry professor Frank Sauer with research misconduct for fabricating or falsifying digital image data included in three papers and seven grant applications submitted to the National Institutes of Health. More specifically, Sauer was deemed responsible for manipulating, reusing, and falsely labeling images of autoradiograms and gels in his research in epigenetics. One month after this decision, ORI announced its final ruling concerning Sauer, which barred him from serving in any advisory capacity to the Public Health Services and required him to retract affected papers. The case raises some interesting and important questions concerning research integrity because it focused on the legal issue of what constitutes recklessness in scientific research.

Incarceration, restitution, and lifetime debarment: legal consequences of scientific misconduct in the Eric Poehlman case: Commentary on: "Scientific forensics: how the office of research integrity can assist institutional investigations of research misconduct during oversight review".

Following its determination of a finding of scientific misconduct the Office of Research Integrity (ORI) will seek redress for any injury sustained. Several remedies both administrative and statutory may be available depending on the strength of the evidentiary findings of the misconduct investigation. Pursuant to federal regulations administrative remedies are primarily remedial in nature and designed to protect the integrity of the affected research program, whereas statutory remedies including civil fines and criminal penalties are designed to deter and punish wrongdoers. This commentary discusses the available administrative and statutory remedies in the context of a specific case, that of former University of Vermont nutrition researcher Eric Poehlman, and supplies a possible rationale for the legal result.

Scientific forensics: how the Office of Research Integrity can assist institutional investigations of research misconduct during oversight review.

The Division of Investigative Oversight within the U.S. Office of Research Integrity (ORI) is responsible for conducting oversight review of institutional inquiries and investigations of possible research misconduct. It is also responsible for determining whether Public Health Service findings of research misconduct are warranted. Although ORI findings rely primarily on the scope and quality of the institution's analyses and determinations, ORI often has been able to strengthen the original findings by employing a variety of analytical methods, often computer based. Although ORI does not conduct inquiries or investigations, it has broad authority to provide assistance to institutions at all stages of their reviews of allegations. This assistance can range from providing advice on best practices, to legal assistance, to suggestions for how best to investigate specific allegations. When asked, ORI can also conduct certain forensic analyses, such as a statistical examination of questioned digits or a simple examination of a questioned figure in Photoshop. ORI will not provide opinions or render judgment on such analyses while the institution is still conducting its investigation. Such analyses can be done without knowing much else about the case.

Scientific misconduct and research integrity for the bench scientist.

This paper describes the role of the Office of Research Integrity (ORI), a component of the Public Health Service (PHS), in defining scientific misconduct in research supported with PHS funds and in establishing standards for responding to allegations of misconduct. The principal methods by which ORI exercises its responsibilities in this area are defining what types of behaviors undertaken by research investigators constitute misconduct, overseeing institutional efforts to investigate and report misconduct, and recommending to the Assistant Secretary for Health (ASH) PHS administrative actions when misconduct is identified. ORI also takes affirmative steps to promote research integrity through education, training, and other initiatives. The role of the research institution in responding to misconduct and promoting research integrity is complementary and overlapping with ORI's efforts but, as the employer of research investigators and front-line manager of the research, the institution has a greater opportunity to promote the highest standards of integrity in the day-to-day conduct of research. Finally, legal precedent established through civil litigation has played an important role in defining the standards that apply in determining when a breach of research integrity has occurred.

Office of Research Integrity: a reflection of disputes and misunderstandings.

Each year, the U.S. Public Health Service (PHS) provides billions of dollars to support over 30,000 extramural research grants to more than 2,000 institutions in the U.S. and other countries. The Office of Research Integrity (ORI) is responsible for protecting the integrity of the research supported by the grants awarded for the PHS extramural research program. One of its responsibilities includes monitoring investigations into alleged or suspected scientific misconduct by institutions that receive the PHS funds. However, not all of the alleged or suspected scientific misconduct meet the the PHS definition of scientific misconduct. Among the wide range of allegations that the ORI receives are those that are ultimately determined to be authorship disputes. This article will report on ORI's functions and review some of the commonly reported allegations that do not constitute scientific misconduct according to the PHS definition.