Research Misconduct and Its Federal Regulation: The Origin and History of the Office of Research Integrity—With Personal Views by ORI's Former Associate Director for Investigative Oversight

Misconduct in science and research became the subject of significant public attention and Congressional scrutiny beginning in the 1970s and 1980s, which led to public statements, policies, and finally formal federal regulations being promulgated by Government agency officials. The Office of Research Integrity (ORI) in the Department of Health and Human Services was a major and very visible component of this process. This article provides a detailed history of the first two decades of federal research misconduct regulations and of ORI's history (under extremely difficult and unfair challenges), including personal views by the former ORI chief investigator and associate director.     

Commentary: Perverse Incentives or Rotten Apples?

Around 2% of the investigators admit to have falsified or fabricated data at least once. Also, 34% report to have been guilty to one or more questionable research practices, such as doing many statistical analyses and to publish only what fits their theoretical framework. Prevention of questionable research practices is very important. Universities should ensure that the training is in order and the research culture is adequate, and they should critically look at perverse incentives, such as a too high publication pressure, but also by ensuring proper guidelines, and by having a fair and transparent procedure for suspected violations of scientific integrity.     

Evaluating U.S. Medical Schools' Efforts to Educate Faculty Researchers on Research Integrity and Research Misconduct Policies and Procedures

This paper examines how well U.S. medical school institutions are doing to promote research integrity. It is an important question to ask in order to determine whether there are sufficient and adequate protections in place to protect the U.S. Public Health Service's (PHS) resources devoted to medical research. This paper focuses on 5,100 medical school researchers' knowledge of what constitutes research misconduct as well as their willingness to report it to the research integrity officer (RIO) and educate their Ph.D. trainees. We learned that 5.6% of researchers could correctly distinguish seven or more of the nine scenarios that depicted likely research misconduct, as defined by the PHS regulations, from scenarios describing other ethical issues. Instead, researchers had expansive definitions and often inappropriately identified infractions such as conflicts of interest, Institutional Review Board (IRB) violations, and other breaches in ethical standards to be research misconduct. In addition, researchers who correctly identified four instances of likely research misconduct in the test items were highly unlikely to report their observations to a RIO. Researchers also provided insight on the factors they believe influence their decision making process of whether to report research misconduct. In addition, this paper also reports on the guidance that faculty said they provided their trainees on research misconduct issues. We conclude with a discussion and recommendations on what institutional leaders might consider doing in order to enhance their research integrity efforts and protect their institution's reputation.     

知识诚信与知识产权:学术不端法律调整的理论思考

学术不端的行为主体——知识创造和传播主体应享受的学术自由和学术领域的自治要求使得法律调整学术不端时只能限制于程序领域而不能判断具体学术问题,否则便是干涉了学术自由。学术不端与知识产权侵权没有必然联系表明知识产权法虽然能够调整部分学术不端行为,但是受到很大局限。通过分析知识诚信与知识产权的联系与区别,揭示了法律不能有效调整学术不端行为的根源。     

论法官惩戒之事由

英美法系国家或大陆法系国家的法官惩戒事由主要包括司法内不当行为和司法外不当行为两个部分,而我国司法实践中,法官惩戒事由除上述两个方面的内容外,还包括＂错案追究＂和＂业绩考核＂。为完善我国法官惩戒制度,未来应当在逐渐扩大司法外不当行为的范围、为法官惩戒设置禁区、消除业绩考核和错案追究制度给法官带来的消极影响等几个方面努力,使法官惩戒逐渐从＂行为、结果混合主义＂转向＂行为主义＂。     

基于实证的学术不端成因分析及对基金管理的启示

科研诚信缺失是现在学术界研究和政府关注的热点问题.首先梳理了科研诚信缺失行为的概念内涵,然后探讨了影响科研诚信缺失行为的影响要素,最后对这些要素进行了实证检验和结构方程模型分析.研究发现:科研工作者周围的诚信环境、竞争压力、科研收益、资金规范状况及科研能力将显著影响其科研诚信行为.     

Data-Intensive Science and Research Integrity

In this commentary, we consider questions related to research integrity in data-intensive science and argue that there is no need to create a distinct category of misconduct that applies to deception related to processing, analyzing, or interpreting data. The best way to promote integrity in data-intensive science is to maintain a firm commitment to epistemological and ethical values, such as honesty, openness, transparency, and objectivity, which apply to all types of research, and to promote education, policy development, and scholarly debate concerning appropriate uses of statistics.     

Corporate corruption of medical literature: Asbestos studies concealed by W. R. Grace & Co.∗

In 1959, an X‐ray survey of 130 mine workers in Libby, Montana found that 48 had evidence of asbestos‐related lung disease. The ore they were mining contained up to 30% tremolite, an asbestiform mineral. In 1963, W.R. Grace acquired the mine and employee health problems at the mine became known to W.R. Grace executives and to Grace's insurance company, Maryland Casualty. In 1976, in response to tighter federal regulation of asbestos and asbestos‐containing products, W.R. Grace funded an animal study of tremolite toxicity. They hoped to prove that tremolite did not cause mesothelioma, the cancer uniquely associated with asbestos exposure. However, the study showed that tremolite did cause mesothelioma. W.R. Grace never disclosed the results of this animal study, nor did they disclose their knowledge of lung disease in the Libby workers, either to the workers themselves or to regulatory agencies. These actions were intentional, and were motivated by Grace's conscious decision to prioritize corporate profit over human health.     

Risk scientists and government regulation of ethical behavior: A comparative analysis of opponents and proponents

A mail survey instrument was sent to almost 1,500 members of three professional organizations whose participants study health and environmental risk. Members were asked their opinions about the effectiveness of government auditing of data, research designs, and facilities. Respondents who thought auditing would be effective were outnumbered 6 to 1 by those who thought it would be ineffective. Supporters tended to be less experienced than opponents. They disproportionately had earned baccalaureate or masters degrees as their terminal degree, not doctoral degrees. Supporters had jobs that required data for regulatory purposes, and they perceived that incompetence and pressure lead to misconduct.     

What the sciences can learn about ethics from business and the professions

Because the sciences are only now beginning to do what businesses and the professions have been doing for some time, scientific laboratories can learn a good deal from business and the professions about how to maintain an ethical environment, both about what doesn't work (benign neglect, role models, sermons, the iron fist, one‐shot programs, and legalism) and about what does work (a systematic multi‐pronged long‐term program).