© by Journal of the History of Ideas. Federico Commandino can be considered the personification of the renaissance of mathematics in sixteenth-century Italy. Previous scholars have generally reduced the philosophy of mathematics developed by Commandino in the preface to his translation of Euclid’s Elements to a superficial synthesis of Neoplatonic and Aristotelian elements. Until now, no attention has been paid to Commandino’s use of the sixth-century commentary on Aristotle’s De Anima by John Philoponus. In his article I will argue that, (...) in depicting imagination as a mental drawing board for geometrical figures, Commandino directly relies on Philoponus’s concept of mathematical imagination. (shrink)

Over the past 20 years or so, a small but growing literature has emerged with the aim of modeling agents who are unaware of certain things. In this paper we compare two different approaches to modeling unawareness: the object-based approach of Board and Chung (Object-based unawareness: theory and applications. University of Minnesota, Mimeo, 2008) and the subjective-state-space approach of Heifetz et al. (J Econ Theory 130: 78-94,2006). In particular, we show that subjectivestate-space models (henceforth HMS structures) can be embedded (...) within object-based models (henceforth OBU structures), demonstrating that the latter are at least as expressive. As long as certain restrictions are imposed on the form of the OBU structure, the embedding can also go the other way. A generalization of HMS structures (relaxing the partitional properties of knowledge) gives us a full converse. (shrink)

In this article, we examine the link between board composition and an enterprise strategy outcome, stakeholder relations. Because a firm’s enterprise strategy is set at the highest level of the organization, we expect the presence of stakeholder directors (suppliers, customers, employees, and community representatives) to be positively associated with stakeholder performance.Results from an analysis of 3,268 board members representing 250 firms are discussed in the context of both corporate governance and stakeholder management literatures.

The study aimed to identify the role of administrative procedures and systems in enhancing the performance of the educational institutions in the Islamic University in Gaza. To achieve the research objectives, the researchers used the analytical descriptive approach to collect information. The researchers used the questionnaire distributed to three categories of employees at the Islamic University (senior management, faculty members, their assistants and members of the administrative board). A random sample of 314 employees was selected and 276 questionnaires were (...) retrieved with a recovery rate of 88.1%. The Statistical Analysis Program (SPSS) was used to enter process and analyze data. The results of the research showed a positive role for the administrative procedures and systems in enhancing the performance of the Islamic University from the point of view of the members (senior management, teaching staff and their assistants and the administrative body), where the relative weight of all the paragraphs (73.728%). The analysis of the results revealed that the administrative procedures at the Islamic University in Gaza are used to an acceptable degree. The relative weight of all the paragraphs is 70%. This indicates a relationship between administrative procedures and regulations and the performance of the Islamic University in the Gaza Strip. The study found that there was a good degree of approval from the sample regarding the administrative procedures and their relationship to the job performance. There exist a sufficient degree of powers to the deans and department managers to carry out their tasks, with the use of plans as control tools. And that there are rules and procedures provided for decision-making in the University Council. It also has full powers to manage the university to improve the teaching and learning environment. The researchers also recommended a number of recommendations, including the need to follow up on the procedures and systems of management and update them continuously in the light of changes that may occur and to ensure the existence of a strong system of electronic information systems within the university. There is a need to provide mechanisms for obtaining information about the surrounding external environment, and effective mechanisms to provide managers with the necessary information in a timely manner. The importance of providing channels of communication that enables staff to communicate information about any violations and breaches. The study also recommended the follow-up, review, procedures and administrative systems, and work to modify them in line with the mission of the university and the objectives that the university seeks to reach. (shrink)

This study examines how heightened expectations of board responsibility and accountability affect the socio-cognitive decision-making of boards and their collective task performance. Using data from the directors of 60 boards who served before and after the enactment of Sarbanes–Oxley, this study provides insight into the potential negative impact that this tightened accountability environment can have on a board’s task performance. Examining several socio-cognitive elements of board decision-making, board authority is found to have a positive main effect (...) on board task performance, while relative CEO power and affective conflict have curvilinear relationships with board task performance. Cohesiveness also moderates the relationship between a board’s perceived uncertainty and affective conflict with board task performance. In sum, the model shows how a new era of director accountability can affect the social cognitions of board decision-making that underlie board task performance. (shrink)

The study aimed to identify the relationship between correcting the deviations in the measurement of performance and achieving the objectives of control and the performance of the job at the Islamic University in the Gaza Strip. To achieve the objectives of the research, the researchers used the descriptive analytical approach to collect information. The questionnaire consisted of (20) statements distributed to three categories of employees of the Islamic University (senior management, faculty members, their assistants and members of the administrative (...) class='Hi'>board). A random sample of 314 employees was selected and 276 responses were retrieved with a recovery rate of 88.1%. The Statistical Analysis Program (SPSS) was used to enter, process, and analyze the data. The results of the study showed a positive relationship between correcting deviations in performance measurement and achieving the control objectives represented by the functional performance in the Islamic University from the point of view of the members (senior management, faculty and their assistants, and the administrative board), where the relative weight of all the paragraphs was (74.25%). The study recommended the need to ensure that the actual performance of the planned performance is matched and decisions are taken to correct the serious deviations and take the necessary measures in terms of retraining and change in regulations, wages and bonuses and punishment of the culprit, neglect and negligence by mistake. (shrink)

Boarding school is a major educational option for many students (e.g., students living in remote areas, or whose parents are working interstate or overseas, etc.). This study explored the motivation, engagement, and achievement of boarding and day students who are educated in the same classrooms and receive the same syllabus and instruction from the same teachers (thus a powerful research design to enable unique comparisons). Among 2,803 students (boardingn= 481; dayn= 2,322) from 6 Australian high schools and controlling for background (...) attributes and personality, we found predominant parity between boarding and day students in their motivation, engagement, and achievement. We also found that classroom-average motivation, engagement, and achievement was not significantly affected by the number of boarders (relative to day students) in the classroom. In addition, the effects of boarding were generally not moderated by students’ background or personality attributes. We conclude that boarders have academic opportunities and outcomes that are comparable to their day student counterparts. Implications for students, teachers, and parents are discussed. (shrink)

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related (...) risks, as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants. (shrink)

Background:Surveillance technology such as tag and tracking systems and video surveillance could increase the freedom of movement and consequently autonomy of clients in long-term residential care settings, but is also perceived as an intrusion on autonomy including privacy.Objective:To explore how clients in residential care experience surveillance technology in order to assess how surveillance technology might influence autonomy.Setting:Two long-term residential care facilities: a nursing home for people with dementia and a care facility for people with intellectual disabilities.Methods:Ethnographic field study.Ethical considerations:The boards (...) representing clients and relatives/proxies of the clients were informed of the study and gave their written consent. The clients’ assent was sought through a special information leaflet. At any time clients and/or proxy were given the option to withdraw from the study. The research protocol was also reviewed by a medical ethics committee.Findings:Our findings show a pattern of two themes: (1) coping with new spaces which entailed clients: wandering around, getting lost, being triggered, and retreating to new spaces and (2) resisting the surveillance technology measure because clients feel stigmatized, missed the company, and do not like being “watched.”Conclusion:Client experiences of surveillance technology appear to entail a certain ambivalence. This is in part due to the variety in surveillance technology devices, with each device bringing its own connotations and experiences. But it also lies in the devices’ presupposition of an ideal user, which is at odds with the actual user who is inherently vulnerable. Surveillance technology can contribute to the autonomy of clients in long-term care, but only if it is set in a truly person-centered approach. (shrink)

Anesthesiology training programs are tasked with equipping trainees with the skills to become medically and ethically competent in the practice of anesthesia and to be prepared to obtain board certification, yet there is currently no standardized ethics curriculum within anesthesia training programs in the United States. To bridge this gap, and to provide a validated ethics curriculum to meet the aforementioned needs, in July 2021, a survey was sent to anesthesia scholars in the field of biomedical ethics to identify (...) key areas that should be included in such an ethics curriculum. The responses were rated on a Likert scale and ranked. This paper identifies the top ten topics identified as high priority for inclusion in an anesthesiology training program and consequently deemed most relevant to meet the educational needs of graduates of an anesthesiology residency: (1) capacity to consent; (2) capacity to refuse elective versus lifesaving treatment; (3) application of surrogate decisionmaking; (4) approach to do not resuscitate (DNR) status in the operating room; (5) patient autonomy and advance directives; (6) navigating patient beliefs that may impair care; (7) “futility” in end-of-life care: when to withdraw life support; (8) disclosure of medical errors; (9) clinical criteria for “brain death” and consequences of this definition; and (10) the impaired anesthesiologist. (shrink)

The study aimed to identify the role of measuring and evaluating performance in achieving the objectives of control and the performance of the job at the Islamic University in Gaza Strip. To achieve the objectives of the research, the researchers used the descriptive analytical approach to collect information which is the questionnaire that consisted of (22) phrases were distributed to three categories of employees of the Islamic University (Faculty Members and Their Assistants, Members of the Administrative Board, Senior Management). (...) A random sample of (314) employees was selected and 276 responses were retrieved with a recovery rate of 88.1%. The Statistical Analysis Program (SPSS) was used to enter process and analyze the data. The results of the research showed a positive role between measuring and evaluating the performance and achieving the objectives of the control of performance in the Islamic University from the point of view of the members (senior management, faculty and their assistants, and members of administrative board). The researchers also recommended a number of recommendations, most notably the provision of an appropriate level of the elements of the control systems today through the modernization and continuous development of performance measures and the need to provide the physical and financial resources necessary to continue the development and achievement within the university, to expand the development of technology in the various activities of the university through the construction of a complete and integrated system to support supervision systems in the university to suit the size of the university. The researchers also recommended following up and reviewing the performance measures and work to modify them in line with the mission and the goals of the university that it seeks to reach. (shrink)

The author is the recipient of the Herman Halperin Electric Transmission and Distribution Award, IEEE; United States Activities Board Professional Leadership Award, IEEE; United States Activities Board Citation of Honor, IEEE; Philip Sporn Award, Cigré; Atwood Associate, Cigré. J.A. Casazza has established the Peter Cooper Fund for Advancing Government Technical Competitions at Cooper Union.

Board composition, insider participation on compensation committees, and director compensation practices can potentially cause conflicts of interest between directors and shareholders. If these corporate governance structures result in situations where actions beneficial to directors do not also benefit shareholders, then shareholders may suffer.Corporate ethics programs usually address conflicts of interest that may arise in the firm''s activities. Some boards of directors take active roles in their firms'' ethics programs by actively overseeing the programs. This paper empirically examines the relationship (...) between ethics programs and potential conflicts of interest and the relationship between board involvement in a firm''s ethics program and potential conflicts of interest. (shrink)

This study empirically examines the association between certain director characteristics and the extent of voluntary audit committee disclosure in annual reports. Results suggest that Singapore's publicly traded firms are more likely to voluntarily disclose audit committee related information as: the number of board members increases; different individuals occupy the roles of CEO and board chairperson; and the proportion of independent directors serving on the board increases. Findings, however, fail to show any association between the amount of voluntary (...) audit committee disclosure and the percentage of executive directors' ownership. Documented findings are of interest and benefit to various parties including regulators, corporate governance reformists, and corporate management. For instance, findings imply that a positive by-product of implementing major corporate governance reforms currently championed by corporate governance reformists will be an increase in audit committee disclosures. As a result, there will be less pressure on regulators to develop, introduce, and enforce mandatory audit committee disclosures that may be potentially intrusive to a firm's management. (shrink)

This book is a small handbook designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient. The chapters of this book are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee (...) meetings. (shrink)

This study examined the relationship between the proportion of women serving on firms' boards of directors and the extent to which these same firms engaged in charitable giving activities. Using a sample of 185 Fortune 500 firms for the 1991-1994 time period, the results provide strong support for the notion that firms having a higher proportion of women serving on their boards do engage in charitable giving to a greater extent than firms having a lower proportion of women serving on (...) their boards. Further, the results suggest a link between the percentage of women on boards and firm philanthropy in the areas of community service and the arts, but found no link between women boardmembers and firm giving to support education or public policy issues. The implications of the findings and some areas for future research are discussed. (shrink)

OBJECTIVES: To compare 2005 and 1995 ethics guidelines from journal editors to authors regarding requirements for institutional review board (IRB) approval and conflict-of-interest (COI) disclosure. DESIGN: A descriptive study of the ethics guidelines published in 103 English-language biomedical journals listed in the Abridged Index Medicus in 1995 and 2005. Each journal was reviewed by the principal author and one of four independent reviewers. RESULTS: During the period, the proportion of journals requiring IRB approval increased from 42% (95% CI 32.2% (...) to 51.2%, p<0.001) to 76% (95% CI 66.4% to 83.1%, p<0.001). In 2005, an additional 9% referred to the Declaration of Helsinki or the International Committee of Medical Journal Editors' Uniform requirements for ethical guidelines; 15% (95% CI 8.5% to 22.5%, p<0.01) provided ambiguous or no requirements. The proportion of journals requiring COI disclosure increased from 75% (95% CI 66.6% to 83.3%, p<0.05) to 94% (95% CI 89.4% to 98.6%, p<0.05); 41% had comprehensive requirements, while some addressed only funding source (6%), were vague (10%) or both (14%). Criteria for authorship rose from 40% (95% CI 30.5% to 49.5%, p<0.05) to 72% (95% CI 63.3% to 80.7%, p<0.05). Journals with higher impact factors were more likely to require IRB approval (p<0.01). Journals in anaesthesia and radiology all required IRB approval; requirements in other disciplines varied. CONCLUSIONS: Instructions to authors regarding ethical standards have improved. Some remain incomplete, especially regarding the scope of disclosure of COI. The ethical guidelines presented to authors need further clarification and standardisation. (shrink)

The use of Internet to aid research practice has become more popular in the recent years. In fact, some believe that Internet surveying and electronic data collection may revolutionize many disciplines by allowing for easier data collection, larger samples, and therefore more representative data. However, others are skeptical of its usability as well as its practical value. The paper highlights both positive and negative outcomes experienced in a number of e-research projects, focusing on several common mistakes and difficulties experienced by (...) the authors. The discussion focuses on ethics and review board issues, recruitment and sampling techniques, technological issues and errors, and data collection, cleaning, and analysis. (shrink)

This paper describes a one-day workshop format for introducing ethics into the engineering curriculum prepared at the University of Puerto Rico at Mayagüez (UPRM). It responds to the ethics criteria newly integrated into the accreditation process by the Accreditation Board of Engineering and Technology (ABET). It also employs an ethics across the curriculum (EAC) approach; engineers identify the ethical issues, write cases that dramatize these issues, and then develop exercises making use of these cases that are specially tailored to (...) mainstream engineering classes. The different activities and strategies employed in this workshop are set forth. Specific references are made to the cases and exercises developed as a result of these workshops. The paper ends by summarizing the different assessments made of the workshop by addressing the following questions: how did it contribute to the overall ABET effort at UPRM; could other universities benefit from a similar activity; and how did the participants evaluate the workshop? (shrink)

Background:Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives, setting, and nature of the nurse–participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary nursing responsibility. Little is known about whether research nurses experience unique ethical challenges distinct from those experienced (...) by nurses in traditional patient-care settings.Research objectives:The purpose of the study was to describe the nature of ethical challenges experienced by clinical research nurses within the context of their practice.Research design:The study utilized a qualitative descriptive design with individual interviews.Participants and research context:Participating nurses self-identified as having experienced ethical challenges during screening. The majority were Caucasian, female, and worked in outpatient settings. Approximately 50% had > 10 years of research experience.Ethical considerations:The human subjects review board approved the study. Written informed consent was obtained.Findings:Predominant themes were revealed: the inability to provide a probable good, or/do no harm, and dual obligations. The following patterns and subthemes emerged: conflicted allegiances between protocol implementation, needs of the participant, desire to advance science, and tension between the nurse–patient therapeutic relationship versus the research relationship.Discussion:Participants described ethical challenges specific to the research role. The issues are central to the nurse–participant relationship, patient advocacy, the nurse’s role in implementing protocols, and/or advancing science.Conclusion:Ethical challenges related to the specialized role of clinical research nurses were identified. More research is warranted to fully understand their nature and frequency and to identify support systems for resolution. (shrink)

In Canada, all research conducted by individuals associated with universities must be subjected to review by research ethics boards (REB). Unfortunately, decisions reached by REBs may seriously compromise the integrity of university-based research. In this paper attention will focus on how requirements of REBs and a legal department in four Canadian universities affected response rates to a survey of domestic and international students. It will be shown that in universities in which students were sent a legalistic cover letter to a (...) mail survey, or were required to sign a consent form, lower response rates were achieved than in universities in which students were sent a relatively friendly letter. In turn, lower response rates resulted in: sample characteristics that deviated from population characteristics; a reduction in the possibility of testing research hypotheses; and increased survey costs. As a consequence, it is argued that the unreasonable demands of REBs are seriously compromising the quality of research that can be carried out on Canadian university students. (shrink)

Next SectionBackground: Publication bias and discrimination are increasingly recognised in medicine. A survey was conducted to determine if medical journals were more likely to publish research reports from members of their own than a rival journal’s editorial board. Methods: A retrospective review was conducted of all research reports published in 2006 in the four competing medical journals within five medical specialties. Only three journals were willing to divulge the authorship of reports that had been rejected. Results: Overall, 4460 research (...) reports were published in 2006 by the 20 journals from five subspecialties (mean 223 (SD = 164) reports per journal; median 176; interquartile range 108–238). On average, 17.2 (7.7%) reports were from a journal’s own editorial board (SD = 10.7; median 15; interquartile range 10–23; n = 20), and 6.3 (2.8%) reports were from a member of the editorial board of one of the three rival journals within the specialty (SD = 7.3; median 3.5; interquartile range 1–8; n = 60). There was a statistically significant excess of publications from the journal’s own editorial board in 14 of the 20 journals (p<0.05). Journals were almost three times more likely to publish reports from their own editorial board than from one of the three rivals within their subspecialty (p<0.0001; median difference 11; Mann–Whitney U test; power for 5% significance >99.99%). Conclusions: There was a significant excess of publications from medical journals’ own editorial boards, although it is not possible to determine whether this is due to bias in the peer review process or selective submission by editors. (shrink)

As part of a larger research study, we present model language for disclosing financial interests in clinical research to potential research participants, and we describe the empirical basis and theoretical assumptions used in developing the language. The empirical process for creating appropriate disclosure language resulted in a generic disclosure statement for cases in which no risk to participants’ welfare or the scientific integrity of the research is expected, and nine more specific disclosure statements for cases in which some risk is (...) expected. The disclosure statements are not meant to be canonical, but were instead designed to reflect the typical situations in which disclosure of financial interest might be considered by an institutional review board or conflict of interest committee. Individual institutions could modify key phrases to suit their purposes, and others could use the language in future empirical work on informed consent to better refine the options for disclosing financial interests in clinical research. (shrink)

We examined differences in the knowledge and beliefs that exist among nurse researchers in the USA (n = 119) regarding informed consent and the use of data from patients’ medical records. Using a mail survey, two domains of ethical knowledge and beliefs were assessed: the legal right to privacy and the moral right to privacy. More than half of the participants were very confident in their knowledge of institutional review board procedures, research ethics, informed consent, the legal right to (...) privacy, and the moral right to privacy. In contrast, most rated themselves as uncertain about US federal research regulations and there was wide variation in knowledge about current federal guidelines. Those who were more confident in their knowledge of or had more practical experience with research ethics, were no more likely to answer correctly a question about current federal guidelines regulating the use of patient data from medical records than those who reported less confidence or experience. (shrink)

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a (...) panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB). (shrink)

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...) a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas. (shrink)

Distributed Leadership (DL) is a feature of education in many jurisdictions. Similarly, in Ireland the principles of DL have been adopted as part of a quality framework to underpin a system that provides high quality student care, learning and teaching. This model necessitates an alignment of senior leaders (SLs) and middle leaders (MLs) whose actions are informed by the needs and priorities of their particular school. The traditional notion of the ML position as a management position is changing. The evolution (...) requires a reconceptualisation, a transformation of the role and how we support and develop it to ensure that MLs are an integral part of the leadership structure of the school. This pragmatic research explored the PD needs of MLs in Irish, Education and Training Board (ETB) post-primary schools. It involved a mixed-methods, exploratory sequential study. Stage one involved a set of five semi structured interviews with AP I post holders. These were used as an instrument to develop the online surveys. Stage two involved quantitative research. Online surveys were distributed to all ETB schools in the republic of Ireland. In stage three a summary of the findings of the survey were shared with ten AP Is who were subsequently interviewed to gain further insights. The study illustrated that the development of MLs requires the support of SLs, skills development, a supportive school culture and combined training for senior and middle leaders which should be facilitated by an independent person. (shrink)

This research reports the results of a study of women serving on boards of directors of Canadian private and public sector organizations. These women (N = 278) were an impressive and talented group (eduction, professional designations). In addition, they brought a variety of backgrounds and expertise to their director responsibilities. Most were nominated as a result of recommendations from current board members, CEOs, or someone who knew board members or CEOs. Thus personal relationships (the old boy's network) as (...) well as track records and appropriate expertise were important factors in board nominations. Women directors thought they had some influence on women's issues with their boards and board companies. A majority believed that board members should be more diverse, including more women and fewer male CEOs. However they indicated several barriers faced by women in being selected and nominated for board appointments. (shrink)

Objective: To examine how research ethics boards review research projects in emerging disciplines such as functional neuroimaging.Design: To compare the criteria applied and the decisions reached by REBs that reviewed the same mock research protocol in functional neuroimaging.Participants: 44 Canadian biomedical REBs, mostly working in public university or hospital settings.Main measurements: The mock research protocol “The Neurobiology of Social Behavior” included several ethical issues operating at all three levels: personal, institutional and social. Data consisting of responses to closed questions were (...) analysed quantitatively. Qualitative analysis of open-question responses used mixed classification.Results: Similar criteria were used by most participating REBs. Yet the project was unconditionally approved by 3 REBs, approved conditionally by 10 and rejected by 30.Conclusions: The results point to the difficulty for REBs of reviewing all kinds of research projects, regardless of field, by relying on international and national norms framed in general terms and a possible variation between REBs in the interpretation of their mandate for the protection of research subjects. (shrink)

The American Society for Microbiology addresses issues of research integrity in several ways. There is a Code of Ethics for Society members and an Ethics Committee, a Publications Board has editorial oversight of ethical issues involved in Society journals and other publications, and the Public and Scientific Affairs Board is involved in ethical issues and scientific policies at the national level. In addition, the Society uses meetings and publications to inform and educate members about research integrity.

This study empirically investigates the dismissal of U.S. CEOs following negative media coverage of environmental, social, and governance (ESG) practices. Extending related literature on the media, ESG, and CEO dismissal, I develop a theoretical framework that considers the media as an influential third party that forms and reflects public opinion about ESG issues. In this role, the media reduces information asymmetry by providing cues on their relative salience and prompting corporate directors to attribute firm-level ESG issues to the CEO, regardless (...) of their involvement in the misconduct. Findings confirm this framework and particularly suggest that coverage of issues in prominent media sources is more likely to result in CEO dismissal. Further, companies that have made public commitments to ESG oversight and those with stronger monitoring are more likely to dismiss the CEO following negative coverage of ESG issues. Overall, this study builds an understanding of how contemporary boards approach the uncertain CEO dismissal decision amidst media coverage of ESG- related misconduct and reflects a shifting norm towards ESG integration at the board-level. (shrink)

The concepts of informed consent and surveillance of human research designed to protect human subjects is commendable. The regulations of the Institutional Review Board are having a major impact on clinical cancer research. There is greater administrative time needed of the investigator, the mechanisms of patient care have become cumbersome and some patients reject optional medical management that could be life saving. IRB regulations must be flexible to meet the needs of human subjects as well as those of the (...) clinical investigator. (shrink)

Clinical biobanks processing data of participants in the European Union fall under the scope of the General Data Protection Regulation, which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party —an EU advisory body currently known as the European Data Protection Board. Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines suggest (...) that additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a “one size fits all” approach to all clinical biobanks. Rather, differences between clinical biobanks—especially regarding the scientific aims and patient populations—make the case for context-relative norms that determine the appropriate type of consent. (shrink)

Data Safety and Monitoring Boards have been referred to as a “growth industry,” and this trend continues to be fueled by recent FDA guidance and the NIH's requirement that DSMBs be employed in virtually all phase III clinical trials. The widening role of DSMBs has been sporadically questioned on ethical grounds, but growth has continued, despite the fact that many of the questions endure, unanswered, save for repeated references to safeguarding the scientific integrity of trials. This may be about to (...) change. The recently appointed director of the Office for Human Research Protections , Jerry Menikoff, is on record as regarding current practices — where consent forms often promise what the DSMB has been assembled to specifically not provide — as constituting fraudulent behavior. That is, a subject may inherently rely on, to their detriment, information that has been misrepresented in the consent document. In this paper, we assemble some of the enduring questions and top them off with Menikoff's tour de force to present what we hope will be a compelling argument to require that consent forms fairly represent what the DSMB will do — and not do — with trial data as they accumulate. We argue that DSMBs should be used only in rare circumstances, and question the practice of precluding principal investigators from DSMB membership, but our main thrust is to ensure that DSMBs, when used at all, are properly described in trial consent forms. (shrink)