Perceptions concerning research integrity and the practice of data audit in the biotechnology industry

A survey was conducted in order to evaluate the responses of biotechnology executives concerning their perceptions of the frequency of questionable R & D studies performed in their companies and to assess the extent to which their companies voluntarily conducted data audits. Data audit was found to be commonly practiced on a voluntary basis by biotechnology companies, in contrast to its almost lack of practice by universities. However, public companies were more likely to practice data auditing than privately held companies. Moreover, the likelihood that managers suspected or detected questionable studies in their companies was significantly increased if the company practiced data auditing.     

Clarifying the concept of the “Social” in risk assessments for human subjects research

International guidelines for the conduct of research with human participants, such as those put forth by the Council for International Organizations of Medical Sciences (CIOMS, 2002), recommend that research review committees account for social risk and benefits to society in their review of proposed research. What do the concepts of the “social” and “society” mean in the context of the review of human participants research? Here we analyze concepts of social and society to define the terms: social harm, social risk, social benefit, and benefits to society. We argue that use of these terms invite more questions than answers and beg for difficult empirical research to determine the nature, likelihood, and magnitude of this category of risk and benefit. Until more research is done and these questions are answered, we advise reviewers to adopt an attitude of provisionalism and caution in their review of specifically “social” risks and benefits and “benefits to society.”     

论内部审计实施的法律要件

《中华人民共和国审计法》和《审计署关于内部审计工作的规定》是法定单位进行内部审计的法律依据;同时亦是内部审计实施的法律要件的法源。内部审计实施的四大法律要件之间关系紧密,对确保法定单位顺利地实施内部审计具有决定性意义。     

Management of quality assurance in clinical trials

Good Clinical Practices (GCP) were first established by the FDA and are now actively implemented by different countries. This becomes necessary as multinational large clinical programs are more complex, involving a large diversity of personnel and locations, with different practices of medicine and local regulatory requirements.

The responsibility of an independent Quality Assurance (QA) organization is to oversee the quality and integrity of research activities, and to assure compliance with company's regulatory requirements, and ethical considerations in order to facilitate worldwide registration of new compounds. The goal of a Clinical QA group is to provide continuous assistance to monitoring teams and investigators to ascertain authentic and reliable clinical trials. The Clinical QA programs must be flexible, calling for active communication and good understanding of quality requirements.

Clinical auditing is one of the instruments of Clinical QA. Study audit activities begin with the protocol, encompass all facets of the clinical trial and end with the final study report.

The focus of the presentation is geared towards auditing activities at investigator's site, purpose of which is to ensure that data gathered in the final clinical study report reflects the raw data collected at the source.     

Auditing biochemical research data: A case study

There is little documentation in the literature of how to conduct a data audit of laboratory research. The purpose of such an audit is to verify the extent to which the published data agree with the corresponding laboratory notebook data and whether the data thus examined appear to be sufficient to justify the published conclusions. A case study is presented, which demonstrates a step by step approach towards conducting a data audit of a published research study.     

中国明清古村落建筑艺术研究——以皖南、晋东南古村落为例

随着近代工业文明的发展，那些散布各地的明清古村落正在衰退甚至消失。中国现存的明清古村落在村庄整体布局上浸透了中国传统文化中“天人合一”的哲学理念，在建筑雕刻方面处处透露着“尽精微、致广大”的艺术审美理念，在建筑色彩上遵循道家哲学中的朴素为美的美学观点，朴素、大气、恢弘，灵动中透露着严谨，古朴中透露着奢华，具有独特的艺术美感以及较高的审美价值和文化价值。皖南古村落和晋东南古村落是中国境内尚存的明清古村落，具有独特的审美价值和研究价值。     

On the potential cost effectiveness of scientific audits

The rationale for the routine performance of scientific audits has been previously discussed, and it has been proposed that independent professionals audit scientific data just as certified public accountants in independent public accounting firms audit financial data (1–4). Scientific audits would typically require the examination of data in laboratory notebooks and other work sheets, upon which research publications are based. Examples of such audits have been publicized recently, although these represent audits which have been conducted relatively inefficiently, over periods of several years per audit, and which have only been conducted due to the persistence of whistleblowers suspecting scientific fraud (5, 6). A detailed report has also appeared on the results of an audit of the research activities of a particular individual, where the audit was limited solely to an examination of the research publications themselves for errors and discrepancies (7). It should be emphasized that the purpose of conducting scientific audits is not only to detect fabrication of experimental results but also to monitor presumably more prevalent, non‐fraudulent, inappropriate practices, such as misrepresentation of data, inaccurate reporting, and departure from institutional guidelines for handling hazardous materials, working with human subjects, etc.

Two concerns which have been raised concerning the performance of scientific audits relate to cost. What would they cost, and who would pay for them? These questions, however, may be turned around. What does it cost not to conduct such audits, and who pays for that? An assumption often made is that science is self‐correcting, that sooner or later the truth will be revealed because of the need to replicate experiments of others for independent verification of novel findings (8). Testimony recently presented at a U.S. congressional hearing suggests that the self‐correcting manner in which science advances represents a very slow and inefficient process for uncovering scientific fraud (5, 6, 9). Data from a survey of university scientists was also presented, indicating “. . . a reluctance to take prompt, corrective action not only when an investigator suspects another of misconduct but also should the investigator discover flaws in his or her own published reports‐whether the flaws were the result of honest error or fraud”; (10).

The uncritical acceptance by established scientists that the self‐correcting process works compounds the problem. The Editor of Science has written that”;. . . 99.9999 percent of reports are accurate and truthful. . .”; (8). If indeed only 0.0001% of published reports were inaccurate or untruthful, there would be little justification for scientific audits. However, congressional testimony from the National Institutes of Health (NIH) revealed that”;. . . the NIH Director's office has handled an average of 15–20 allegations and reports of misconduct annually in its extramural programs, which supports the work of approximately 50,000 scientists”; (11). As I shall attempt to demonstrate, since NIH alone receives fraud‐related complaints concerning the work of at least 0.03% of scientists it supports in other institutions, and since evidence indicates that the incidence of fraud is considerably greater than 0.03% (10, 12), the need to audit data is justifiable on the basis of being cost effective.     

Comprehensive audits for use in evaluating scientific research

Calls for new arrangements to deal with problems involving the integrity of results reported from scientific research have generally taken the form of investigations into data quality and the research methods utilized. Alternatives to proposed government regulation of scientific research have included suggestions for using accounting type audits of the kind used for attesting to the representations of management in corporate financial reports. Here a different type of audit is suggested for the advantages it offers in dealing with the situations in science—which are much less structured and not restricted to situations like those to which financial accounting audits are directed. A broadening from “accounting”; to “accountability”; is thereby achieved. Experimentation with the use of such audits is suggested which can simultaneously help to improve scientific processes and accommodate the interests of the public in responding to the results of scientific research. A beginning is also suggested in the form of “GAO type”; (U.S. General Accounting Office) audits of research activities undertaken (or to be undertaken) at laboratories such as Los Alamos, Livermore and Sandia as they are being redirected from military to civilian type research. It is also suggested that GAO type audits be extended from audits of management activities to examination and evaluation of the validity and significance of the research that has been, or is to be, undertaken.     

The office of scientific integrity investigations: The importance of data analysis

Certified Public Accountants serve as independent auditors of financial statements. They perform information‐integrity testing for the economy and society, adding creditability to financial statements prepared by organizations’ management. Investors, creditors, and others rely on these financial statements and the audit report to make business decisions. Auditing work involves gathering evidence (research) and forming an opinion (reporting results) about the “fairness”; of financial statements according to regulatory, legal, and professional rules. As researchers, auditors are subject to a complex network of mechanisms to promote accountability in their work. These mechanisms exist at environmental, professional, and audit‐firm levels. They combine to influence the judgments of individual auditors.     

Genocide Reconsidered: A Pragmatist Approach

The recent literature on genocide shows signs of taking what might be called a “processual turn,” with genocide increasingly understood as a contingent process rather than a singular event. But while this second generation's turn may be clear to those within the literature, the theory guiding the change is insufficiently specified. The theory regarding process and contingency is implicit, and, as such, genocide theory does not realize its full generative potential. The primary goal of this article is to provide a more robust theoretical framework for making sense of the continually evolving dimensions of genocide. It builds on the literature's existing foundations, most notably Mann's (2005) notion of “contingent escalations.” In the spirit of the recent revival of American Pragmatism in sociology, it draws on the work of Dewey, Mills, Follett, and Addams (among others) as part of a theoretical reconstruction using pragmatist concepts such as rupture, perplexity, vocabularies of motive, and experimentation to consider examples from the Rwandan genocide and show how we might explore the potential for non‐teleological intentionality on the part of genocidal actors. The result is an enhanced theoretical framework that offers “fresh eyes” for considering one of the worst (and most under‐theorized) social problems.     

Social Representations Theory: A Progressive Research Programme for Social Psychology

The study “Psychoanalysis—its image and its public” intimates that common sense is increasingly informed by science. But common sense asserts its autonomy and, in turn, may affect the trajectory of science. This is a process that leads to many differentiations—in common sense, in scientific innovation and in political and regulatory structures. Bauer and Gaskell's toblerone model of triangles of mediation provided a distillation of their reading of “La Psychanalyse.” Here it was argued that representations are multi‐modal phenomena necessitating the use of multiple methodologies (comparative and longitudinal; qualitative and quantitative). In this paper we briefly summarise these arguments and elaborate ways in which social representation theory can be considered a progressive research programme. “Progressive” because as the theory has developed it has extended the range and depth of its conceptual basis; it provides a new synthesis for the social scientific understanding of the phenomena of common sense and of representation; it acts as an antidote to the reductionism of public opinion and, finally, it is a stimulus to depart from disciplinary silos. However, there remain unresolved issues: how to segment the relevant social milieus and how to close the feedback loop from common sense to science?     

The Social Composition of China's Private Entrepreneurs: Class and Cohort Differences*

On the basis of survey data on Chinese private enterprises over the years, we try to respond to the classic subject of “the social composition of private entrepreneurs (siyingqiyezhu 私营企业主).” In nearly forty years of development, the overall composition of private entrepreneurs has undergone major changes. The group contains a growing proportion of people who have a market background and higher education and are non-political CPCs. On further classifying the occupational mobility of private entrepreneurs into categories such as “xiahai 下海” (jump into business), “gaizhi 改制” (restructuring), “kuajie 跨界” (crossover), “tiaoban 跳板” (springboard) and “caogen 草 根” (grassroots), we find there are significant differences in the occupational mobility of entrepreneurs in large, medium, and small enterprises in terms of what they did before they founded their businesses. In particular, entrepreneurs in large enterprises are more likely to have “jumped into business” from inside the government system or after restructuring, while most small and medium entrepreneurs develop outside the system. Multiple regression and coefficient clustering analysis shows that education level and political status have varying effects on the occupational mobility of entrepreneurs in terms of class and cohort.     

A theory of “popular political legitimation”: A dual-process model approach to legitimation and political socialization

How do everyday people—or actors who do not occupy positions of political authority—legitimate political systems? Responding to this question, I use work from sociology, political science, and cognitive science to build a theory of “Popular Political Legitimation” (PPL)—defined as everyday people's legitimation of a political system. To answer how PPL happens, we must answer two sub-questions that address legitimacy as a normative phenomenon: 1) What are the processes of socialization through which individuals learn the norms, widely held beliefs, and values that legitimate a political system? 2) How do individuals subsequently use these norms, widely held beliefs, and/or values in their own legitimations of a political system? Thus, we see that a model of socialization is central to understanding how PPL happens. I proceed in four steps. First, I review the literature on political legitimation. Next, I review the literature on political socialization. Third, to address gaps in the two aforementioned literatures concerning a model of socialization that explains legitimation, I turn to neuroscience (for reviews see Greene, 2017; Cushman, 2020) and psychology to review models of socialization and rationalization. Finally, I synthesize these literatures to develop a theory of political socialization and how it generates PPL.     

The Myth of “Security Moms” and “NASCAR Dads”: Parenthood,Political Stereotypes,and the 2004 Election*

Objective. The objective of this article is to explore the impact of being a parent on political views and to test the accuracy of the “Security Mom” and “NASCAR Dad” labels that were pervasively applied in the context of the 2004 presidential election. Methods. The methods we employed consist of using data primarily from the 2004 National Election Study to determine whether parents differ from nonparents in terms of their political attitudes on a wide range of issues. We argue that parenthood affects women and men differently, so we analyze the sexes separately. Results. Mothers have important political distinctions from women without children, mostly in the case of social welfare issues. They do not, however, appear to be “Security Moms” in the post‐9/11 world. As for fathers, for the most part it makes little sense to talk about dads as a distinct voting bloc, as in very few cases do their political attitudes differ from men without children. Conclusions. The media's use of the labels “NASCAR Dad” and Security Mom” promoted an inaccurate understanding of the political preferences of parents. Beyond debunking these media myths, our results provide one of the first comprehensive looks at the impact of parenthood on political attitudes, an overlooked area in the adult socialization literature.     

Methodological naturalism,saturation, and Psychology's failure to save the phenomena

Many scientists and philosophers of science have argued that metaphysical naturalism and methodological naturalism represent distinct and separable philosophical commitments. This claim is true in the sense that metaphysics and epistemology reflect different philosophical projects. The major question of interest to psychologists, however, is whether at the pragmatic level of research designed to discover the psychological sphere in which we live our lives, the metaphysical and the methodological realms are so tightly interwoven that some important aspects of our humanity cannot be faithfully revealed without distortion, or even missed altogether. This paper argues that, in light of its intellectual origins, methodological naturalism is informed by metaphysical naturalism at the level of its formulation, and, thereby, is by its nature more apt to reveal phenomena of certain ontological types and less apt to faithfully reveal phenomena of other ontological types. In this sense, metaphysical naturalism cannot help but subtly shape psychological investigation and thus insert itself to some degree into our understanding of many important psychological phenomena. The work of the French phenomenologist Jean-Luc Marion, particularly his concept of “saturated phenomena,” is briefly discussed by way of a call for greater methodological openness in psychological research – an openness that will permit psychological scientists to better “save the phenomena” in their accounts of human experience.     

Names and naming in adoption: Birth heritage and family‐making

In this article, we consider the significance and practices of names and naming in adoption to develop understanding of the issue amongst scholars, policymakers, adoption practitioners, and adoption communities. Research on the topic of names and adoption is scarce and focused mostly on international and domestic adoptions in the United States. We draw on the research literature to critically explore names and naming in adoption through two recurrent and related themes. The first is “birth heritage,” where names, forenames especially, are shown to be important in the approach taken by adopters to their child's birth family and cultural identity. The second theme is “family‐making,” where namesaking and homogeneity of surname emerge, amongst others, as strategies to create, sustain, and display “family.” In gathering together for the first time an otherwise scattered, disparate body of research, our article showcases names and naming as illuminating distillations of key contemporary challenges experienced by families formed through adoption. We conclude our article by considering emergent gaps in existing knowledge and understanding about names, naming, and adoption that might usefully be addressed, to inform professional advice and familial decisions about names, and enhance outcomes for adoptees and their families.     

Thirty years of the Three Worlds of Welfare Capitalism: A review of reviews

In the 30 or so years since the publication of Gosta Esping-Andersenapos;s Three Worlds of Welfare Capitalism a number of rival welfare state typologies have emerged. This article has two broad aims. First, we review the reviews of welfare state typologies, pointing to issues of often unclear case selection and a wide range of concepts, variables, and methods, resulting in a variety of worlds of welfare and their constituent nations. We show that there is a great variety in the welfare modelling business at two different levels. Reviews vary significantly in terms of the number and composition of included studies, which has made it difficult to sum up the “state of the art.” Individual studies included in the reviews also vary significantly in terms of issues such as aims, concepts, variables, and methods. Second, we produce a new review, which adds value as it is based on a clearer search strategy, and includes more recent material that was not available in earlier reviews. This finds that there is a great variety in terms of process (concepts, variables, methods, and number of countries) and findings (the number and composition of “worlds”). We argue that the country classification seems to show less consensus that previous reviews, with fewer “pure” nations (i.e., agreement between studies). We suggest that in order to provide a clear point of engagement, future reviews need to pay more attention to a clear and explicit search strategy, including issues such as inclusion criteria.     

Xun Zi Holds That Human Nature Is Simple and Uncarved,Not Evil

For more than two thousand years, the chapter of the Xunzi titled “Man’s Nature Is Evil” has labeled Xun Zi as a representative of the doctrine that human nature is originally evil. In fact, Xun Zi holds to a belief in human nature as originally simple and “uncarved.” The ideas of human nature in that chapter conflict with those in the other chapters including “Discourse on Ritual Principles,” “An Exhortation to Learning,” “Discourse on Nature,” “On the Correct Use of Names” and “Of Honor and Disgrace.” According to these chapters, human nature is not evil, but simple and uncarved; its good or evil is undetermined, it may become either good or evil, etc. Furthermore, we can find other evidence, such as the sayings of Xun Zi’s disciples, the Records of the Grand Historian, the doctrines of human nature in the Western Han dynasty, and so on, for the statement that Xun Zi holds that human nature is simple and uncarved.