After years of debate over the importance of ethical conduct in organizations, the federal government has decided to institutionalize ethics as a buffer to prevent legal violations in organizations. The key requirements of the Federal Sentencing Guidelines (FSG) are outlined, and suggested actions managers should adopt to improve ethical compliance are presented. An effective compliance program is more a process and commitment than a specific blueprint for conduct. The organization has the responsibility to create an organizational (...) climate to reduce misconduct. The adoption of a FSG compliance program has the potential to substantially lessen organizational penalties if there is due diligence to prevent misconduct. Federal courts determine the effectiveness of an FSG program after a violation occurs. (shrink)

In November, 1991, the U.S. Congress enacted the U.S. Federal Sentencing Guidelines legislation which had a dramatic impact on corporate America. Can the Guidelines be used as a model or framework by other countries? Could other countries in the world benefit from adopting a similar piece of legislation? Are there any limitations to consider? In addressing these issues, the authors make the argument that the time has arrived for other countries to consider the development of legislation (...) similar to the Guidelines in order to improve organizational ethics. (shrink)

Although Business Ethics has become a topic of wide discussion in both academia and the corporate world, questions remain as how to present ethical issues in a manner that will effectively influence the decisions and behavior of business employees. In this paper we argue that the Federal Sentencing Guidelines (FSG) offer a unique opportunity for bridging the gap between the theory and practice of business ethics. We first explain what the FSG are and how they apply to (...) organizations. We then show how discussions of the FSG might be used in business ethics courses in a way that is both theoretically sound and practically applicable. Finally, we show how the requirements of the FSG can be used by companies to develop effective ethical compliance programs. As such, we maintain that the FSG provide a powerful heuristic tool for the teaching and training of business ethics. (shrink)

On May 16, 2012, RAND brought together a group of public company directors and executives, chief ethics and compliance officers, and stakeholders from the government, academic, and nonprofit sectors for a series of conversations about organizational culture, as well as to explore the business and policy ramifications of efforts to build better ethical cultures in corporations.

This is an essay about the philosophical and practical problems associated with the concept of punishment for corporations that have grievously broken the law. It is specifically an essay about the special incentives that the U.S. Government has put in place to encourage American corporations to create comprehensive ethics programs and observe them faithfully. First, I will look at the sorts of obstacles to effective punishment of recalcitrant corporations that eventually prompted extraordinary measures by the U.S. Government. Then I will (...) present a detailed description of the Federal Sentencing Guidelines which took effect on November 1, 1991, describe what they entail, examine what purposes for which they were intended and question how likely they will be to accomplish their objectives. Finally, we will raise the question whether such policies will help further corporate social responsibility and ethical conduct in the workplace. (shrink)

In the process of implementing an ethical code of conduct, a business organization uses formal methods. Of these, training, courses and means of enforcement are common and are also suitable for self-regulation. The USA is encouraging business corporations to self regulate with the Federal Sentencing Guidelines (FSG). The Guidelines prescribe similar formal methods and specify that, unless such methods are used, the process of implementation will be considered ineffective, and the business will therefore not be considered (...) to have complied with the guidelines. Business organizations invest enormous funds on formal methods. However, recent events indicate that these are not, by themselves, yielding the desired results. Our study, based on a sample of 812 employees and conducted in an Israeli subsidiary of a leading multinational High-Tech corporation headquartered in the US, indicates that, of the methods used in the process of implementation, one of the informal methods (namely, the social norms of the organization) is perceived by employees to have the most influence on their conduct. This result, when examined against employee tenure, remains relatively stable over the years, and stands in contradistinction to the formalistic approach embedded in the FSG. We indirectly measure the effectiveness of the percieved most influential implementation process methods by analyzing their impact on employee attitudes (namely, personal ethical commitment and employees'' commitment to organizational values). Our results indicate that the informal methods (manager sets an example or social norms of the organization) are likely to yield greater commitment with respect to both employee attitudes than the formal method (training and courses on the subject of ethics). The personal control method (my own personal values) differs significantly from all the other methods in that it yields the highest degree of personal ethical commitment and the lowest degree of employees'' commitment to organizational values. (shrink)

ON DECEMBER 10, 1991 Charles Shonubi, a Nigerian citizen but a resident of the USA, was arrested at John F. Kennedy International Airport for the importation of heroin into the United States.1 Shonubi's modus operandi was ``balloon swallowing.'' That is, heroin was mixed with another substance to form a paste and this paste was sealed in balloons which were then swallowed. The idea was that once the illegal substance was safely inside the USA, the smuggler would pass the balloons and (...) recover the heroin. On the date of his arrest, Shonubi was found to have swallowed 103 balloons containing a total of 427.4 grams of heroin. There was little doubt about Shonubi's guilt. In fact, there was considerable evidence that he had made at least seven prior heroin-smuggling trips to the USA (although he was not tried for these). In October 1992 Shonubi was convicted in a United States District Court for possessing and importing heroin. Although the conviction was only for crimes associated with Shonubi's arrest date of December 10, 1991, the sentencing judge, Jack B. Weinstein, also made a ®nding that Shonubi had indeed made seven prior drug-smuggling trips to the USA. The interesting part of this case was in the sentencing. According to the federal sentencing guidelines, the sentence in cases such as this should depend on the total quantity of heroin involved. This instruction was interpreted rather broadly.. (shrink)

Abstract:The literature contains many recommendations, both explicit and implicit, that suggest how an ethics program ought to be designed. While we recognize the contributions of these works, we also note that these recommendations are typically based on either social scientific theory or data and as a result they tend to discount the moral aspects of ethics programs. To contrast and complement these approaches, we refer to a theory of the right to identify the characteristics of an effective ethics program. We (...) draw from Kant’s ethical theory to identify three guiding principles of a moral ethics program and then apply those principles to the specific components of ethics programs as discussed in the Federal Sentencing Guidelines. Doing so provides insights as to how an ethics program ought to be designed from a moral point of view and sparks discussion of the moral aspects of ethics programs. (shrink)

Abstract:The literature contains many recommendations, both explicit and implicit, that suggest how an ethics program ought to be designed. While we recognize the contributions of these works, we also note that these recommendations are typically based on either social scientific theory or data and as a result they tend to discount the moral aspects of ethics programs. To contrast and complement these approaches, we refer to a theory of the right to identify the characteristics of an effective ethics program. We (...) draw from Kant’s ethical theory to identify three guiding principles of a moral ethics program and then apply those principles to the specific components of ethics programs as discussed in the Federal Sentencing Guidelines. Doing so provides insights as to how an ethics program ought to be designed from a moral point of view and sparks discussion of the moral aspects of ethics programs. (shrink)

In 2004, the United States Sentencing Commission amended the Federal Sentencing Guidelines to allow firms that create “effective compliance and ethics programs” to receive better treatment if prosecuted for fraud. Effective compliance and ethics, however, appear to be limited to activities focused on complying with the firms’ internal legal and ethical standards. We explored a potential connection between the firms’ external corporate social responsibility (CSR) behaviors and internal compliance: Is there an organizationally valid relationship between these (...) two firm activities? That is, when organizations demonstrate CSR with behaviors external to the firm, such as employee volunteerism, are their employees more likely to demonstrate uncompromised legal and ethical compliance behavior internally? We collected data from 164 working professionals enrolled in a top-tier MBA program in the southeastern United States regarding their employer-sponsored volunteer activities and their intentions to comply in various organizational compliance vignettes. We found that employer-sponsored volunteerism is associated with uncompromised compliance choices in one of the three vignettes. This finding indicates preliminary support for further inquiry into the relationship within the firm between external CSR behaviors and policies regarding organizational compliance. Post hoc analyses suggest that employer-sponsored volunteerism is strongly associated with a positive organizational identity, but organizational identity is not associated with the significant compliance vignette. This evidence suggests that the underlying mechanism that connects external CSR behaviors and internal compliance intentions is complex and requires future study. (shrink)

The corporate meltdowns of this and the previous decade in the US - WorldCom, Enron, Tyco, and in Australia - FAI, HIH and AWB being among the many examples - have resulted in the governments of those two countries introducing legislation and policy guidelines aimed at minimising future corporate misbehaviour. -/- The US has introduced the Sarbanes Oxley Act, with requirements on corporate accountants and auditors, as well as its whistleblowing provisions. It has revised the Federal Sentencing (...) Guidelines for Organizations. New rules for the NYSE and NASDAQ have also been introduced. In addition, the U.S. Securities and Exchange Commission and U.S. Department of Justice have further strengthened the Foreign Corrupt Practices Act 1977, last revised in 1997. -/- Australia has revised the Corporations Act to include whistleblower protection clauses as well as adopted the ASX Corporate Governance guidelines. Standards Australia has issued its handbook on corporate governance. Although not a business issue, the Australian government has also announced that it will introduce whistleblower protection legislation for the public sector by the end of its first term in office. This legislation will likely influence whatever the private sector does in this respect. The inclusion of whistleblower protection in both Sarbanes–Oxley and the Corporations Act reflects a growing body of research that finds that people internal to an organisation are the most effective way to identify corporate wrongs. The Commonwealth Treasury has recently issued an options paper, stating that the Corporations Act has been ineffectual. It has sought submissions on revisions to the legislation that the Australian Government could take. This paper examines the policies advocated by over 20 organisations and academics concerned with whistleblowing issues. It draws the conclusion that on current indications, even after further reform, Australian legislation and policies are still likely to be less effectual than overseas practices. -/- --------------------------------- . (shrink)

Since the mid-1980s, internal corporate investigations have become commonplace in the U. S., with an upsurge occurring as a result of the corporate scandals of 2001-02 involving Adelphi Communications Corporation, Enron, Merck & Company, Riggs Bank, and other companies accused of financial malfeasance. After an introduction, this article first presents the U. S. public policy framework (as implemented through the U. S. Sentencing Commission, the U. S. Department of Justice, and the Securities and Exchange Commission) encouraging the use of (...) corporate internal investigations and self-reporting of these results to federal authorities; second, evaluates this framework, identifying the public policy issues inhibiting companies from using corporate internal investigations and self-reporting significant results; third, proposes a policy incentive regime which attempts to ameliorate these outstanding issues; and fourth, offer policy recommendations and suggestions for further research on this topic, including increasing the maximum deduction in the Organizational Sentencing Guidelines Culpability Score available to a firm for development of an Effective Compliance and Ethics Program (from 3 to 5 points), and self-reporting the results of an internal investigation (from 5 to 7 points); evaluating the effectiveness of these enhancements in legal incentives over a period of 5-7 years after implementation; instituting a formal federal government effort to educate the American business community on the corporate reputation (and financial) benefits of an effective compliance program; and protecting attorney-client privilege and work product protection, through legislative action, to encourage company executives and directors to utilize independent, outside attorneys to conduct fair, comprehensive, and impartial internal investigations. (shrink)

The key concept in Business Ethics has changed from ‘corporate social responsibility’ to ‘integrated risk‐management’. This change, first wrought by American laws, has been extended to other countries through globalization. The most important laws concern corruption, anti‐trust, consumer safety, environmental protection and insider‐trading. The ‘Federal Corporate Sentencing Guidelines’ have particularly been helpful in identifying and valuing business risks. The author proposes a ‘next‐generation’ Business Ethics integrating personal, professional and organizational ethics in the context of an institutionalized, country‐sensitive (...) ‘corporate culture’. (shrink)

This article presents an overview of traditional legal and regulatory incentives directed at achieving lawful corporate behavior, together with examples of more recent governmental incentives aimed at encouraging self regulation activities by corporations. These incentives have been differentiated into positive incentives that benefit corporations for actions that encourage or assist lawful behavior, and punitive incentives that only punish corporations for violations of legal or regulatory standards. This analysis indicates that traditional legal and regulatory incentives for lawful corporate behavior are overwhelmingly (...) punitive in their intended effects, while more recent governmental incentives to encourage voluntary corporate self regulation are much more positive in their intended effects.A prototype private compliance system containing typical features specified in governmental incentives for corporate self regulation was then analyzed applying the same positive/punitive analysis that was performed with the governmental incentives. This analysis suggests that corporate compliance programs that are structured to comply with Department of Defense regulations for defense contractors or the new Federal Organizational Sentencing Guidelines will reflect the same overwhelmingly punitive balance of incentives for lawful and ethical employee conduct as do the traditional legal and regulatory incentive systems for lawful corporate behavior. (shrink)

In the face of a perceived lack of widespread understanding of the theoretical issues underlying the development, dissemination and implementation of clinical guidelines, the Royal College of General Practitioners Guidelines Group developed a 2-day course aimed at teaching the theory in these areas. The course was targeted at potential opinion formers and ran on six occasions. Postal questionnaire assessment of the course revealed high levels of satisfaction with all aspects of the course and high levels of reported use (...) of the knowledge gained. Further developments of the course are discussed. (shrink)

The United States Sentencing Commission’s guidelines for the sentencing of organizations found guilty of violating federal laws recently became effective. Dramatically increased penalties are possible under these gudelines, but so too is a substantial reduction in the penalties imposed on organizations that have an effective program in place to prevent and detect violations. This provides corporations with a tremendous new incentive in inaugurate organizational ethics audits both to avoid violations in the first instance and to reduce (...) the penalty imposed in the event that a violation occurs. We argue, however, that there have always been very good reasons for organizations to conduct such audits, which emphasize the identification of the organizational factors that create incentives for unethical behavior. Corporate ethics programs initiated without reference to such factors cannot reasonably be expected to be effective in improving a company’s internal ethical environment. (shrink)

(1994). Purposes of punishment under the Minnesota sentencing guidelines. Criminal Justice Ethics: Vol. 13, No. 1, pp. 11-20. doi: 10.1080/0731129X.1994.9991956.

A number of philosophers, linguists and psychologists have made the dual claim that metaphor is cognitively significant and that metaphorical utterances have a meaning not reducible to literal paraphrase. Such a position requires support from an account of metaphorical meaning that can render metaphors cognitively meaningful without the reduction to literal statement. It therefore requires a theory of meaning that can integrate metaphor within its sematics, yet specify why it is not reducible to literal paraphrase. I introduce the idea of (...) a "second-order meaning", of which metaphor is but one instance, that is a function on literal-conventional, i.e., first-order meaning, and outline a linguistic framework designed to provide a representation of linguistic meaning for both. This framework is designed to represent linguistic units ranging from a single word to an entire text since I argue that the by-now familiar position that the sentence is the appropriate unit for metaphor has mislead us into asking the wrong questions about metaphorical meaning. With this apparatus, we can specify the conditions under which an utterance may transcend the constraints on first-order meaning (transgressions not always apparent on the sentential level), without thereby being "meaningless". Conversely, we can specify the conditions that may render apparently odd utterances first-order meaningful rather than metaphorical. In this way we see how metaphorical language differs both from deviant language and from specialized language such as technical language, fanciful and fantastical language (in fairy tales, science fiction, etc.). (shrink)

This paper analyses the ethical performance of foreign-investment enterprises operating in China in comparison to that of the indigenous state-owned enterprises, collectives and private enterprises. It uses both the deontological approach and the utilitarian approach in conceptualization, and applies quantitative and econometric techniques to ethical evaluations of empirical evidences. It shows that according to various ethical performance indicators, foreign-investment enterprises have fared well in comparison with local firms. This paper also tries to unravel the effect of a difference in business (...) culture and competitive market forces on ethical performance by comparing the behavior of foreign-investment enterprises with that of the indigenous state-owned enterprises and collectives on the one hand, and with that of the indigenous private enterprises on the other. (shrink)

This paper reports on recent regulations and guidelines in the Federal Republic of Germany bearing on perinatal medical ethics, embryo research and trophoblast biopsy. Some of the regulations are defensive responses to new moral opportunities. In contrast, this paper calls for a more aggressive moral cost-benefit assessment of high technology medicine, which would include large-scale research on embryos prior to the fiftieth day post-menstruation. Keywords: abortion, embryo research, moral triage, prenatal diagnosis, withholding treatment CiteULike Connotea Del.icio.us What's this?

The aim of this article is to articulate and critically discuss different answers to the following question: How should decision-makers deal with conflicts that arise when the values usually entailed in ethical guidelines – such as accuracy, privacy, non-discrimination and transparency – for the use of Artificial Intelligence clash with one another? To begin with, I focus on clarifying some of the general advantages of using such guidelines in an ethical analysis of the use of AI. Some disadvantages (...) will also be presented and critically discussed. Second, I will show that we need to distinguish between three kinds of conflict that can exist for ethical guidelines used in the moral assessment of AI. This section will be followed by a critical discussion of different answers to the question of how to handle what we shall call internal and external values conflicts. Finally, I will wrap up with a critical discussion of three different strategies to resolve what is called a ‘genuine value conflict’. These strategies are: the ‘accepting the existence of irresolvable conflict’ view, the ranking view, and value monism. This article defends the ‘accepting the existence of irresolvable conflict’ view. It also argues that even though the ranking view and value monism, from a merely theoretical point of view, are better equipped to solve genuine value conflicts among values in ethical guidelines for artificial intelligence, this is not the case in real-life decision-making. Keywords: AI; ethical guidelines; algorithm-based sentencing; value conflicts. (shrink)

Over the last decade, standards for when and how to undertake a wide range of medical interventions have poured forth from medical specialty groups, commercial and nonprofit organizations, and state and federal panels. Known by a variety of names—from practice parameters to clinical guidelines—and intended for a range of purposes—from diminishing the incidence of maloccurences in hospitals to cutting the costs of health care—these guidelines share one important feature: the intention of decreasing the range of variation in (...) medical practice. Such standardization immediately appeals to anyone interested in improving the quality of health care and, in particular, reducing inappropriate medical interventions, in light of the difficulties for a conscientious physician today in adhering to the best standard of practice when faced with ever increasing medical knowledge and the growing number and complexity of diagnostic, preventive, and therapeutic interventions. (shrink)

ABSTRACT:U.S. Organizational Sentencing Guidelines provide firms with incentives to develop formal ethics programs to promote ethical organizational cultures and thereby decrease corporate offenses. Yet critics argue such programs are cosmetic. Here we studied bank employees before and after the introduction of formal ethics training—an important component of formal ethics programs—to examine the effects of training on ethical organizational culture. Two years after a single training session, we find sustained, positive effects on indicators of an ethical organizational culture (observed (...) unethical behavior, intentions to behave ethically, perceptions of organizational efficacy in managing ethics, and the firm’s normative structure). While espoused organizational values also rose in importance post-training, the boost dissipated after the second year which suggests perceptions of values are not driving sustained behavioral improvements. This finding conflicts with past theory which asserts that enduring behavioral improvements arise from the inculcation of organizational values. Implications for future research are discussed. (shrink)

This article focuses on Court of Appeal sentencing practice in cases of marital and relationship rape. In particular, it examines the sentencing principle set out in the case of Berry in which it was stated that cases of marital and relationship rape sometimes involve less 'violation' and 'defilement' than cases of stranger rape and consequently are given reduced sentences. This article argues against such an approach on the basis that it is poorly reasoned and lacks support from the (...) research literature on rape trauma. In addition, a statistical analysis of Court of Appeal sentencing appeals indicates that the Berry principle is seriously undermining the Billam sentencing guidelines for rape. An analysis of appellate decisions in the USA indicates a very different attitude to the seriousness of marital and relationship rape based upon a willingness of the appellate judges to utilize research evidence in their decisions. (shrink)

The question of legalizing physician-assisted suicide has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians (...) have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.As support for PAS grows, it becomes increasingly likely that the practice will be legalized in at least some states in the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients; a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted. (shrink)

The rhetoric surrounding the creation of a 'knowledge-based economy/society' emphasizes the interrelationship between ICTs in knowledge and economic development and their continued trajectory throughout the next century. What, however, is really meant by the KBE/S agenda, and how are the important social issues surrounding KBE/S, including access, content, and citizenship being dealt with? Using Canada as an example, this discussion will focus on how Canadian federal policymakers are conceptualizing the issues surrounding KBE/S through recent and ongoing policy explorations.

Following the Texas standoff in 1993 between Federal agents and the Branch Davidians, the Society of Professional Journalists appointed a Task Force, chaired by Bob Steele and Jay Black to examine media conduct during that period and to draw lessons for such situations in the future. The following is the final section of a 27-page report that the Task Force submitted to the Society. It addressed a dozen issues arising from the event and contains reflections and guidelines from (...) the Task Force. (shrink)

Definition of the problemFrom an ethical point of view we analyse the ruling of the German Federal Joint Committee (Gemeinsamer Bundesausschuss, G‑BA) of September 2019 to revise the guidelines about the coverage of noninvasive prenatal tests (NIPT) by mandatory health insurance, in order to include them under specified conditions. The decision contains four essential elements: a definition of the aim of NIPT testing (to avoid invasive testing), a criterion of access (test must be “necessary” for the pregnant woman (...) to tackle her individual situation), statements about the process of decision-making (after counselling by a physician and case by case) and a normative contextualization (termination of pregnancy under § 218 a German penal law) which is to be found in its explanations. There are tensions in the proposed model that oscillate about two axes: (1) The suffering that results from a possible birth of a child with trisomy or from not knowing about the genetic condition of the fetus can ultimately only be evaluated subjectively, from the perspective of the pregnant woman. (2) The meaning of an individual decision in the case-by-case model remains unclear because when judging about individual cases general points of view also need to be considered. However, we argue that the model of the G‑BA could be a sociopolitically and ultimately also ethically defensible pragmatic solution, exactly because of its paradoxes and its inherent flexibility. (shrink)

The consistent sentencing of white collar criminals does not exist in today's judicial system. Guidelines for sentencing individuals and corporations have already been developed by the U.S. Sentencing Commission but have not yet been implemented in the courts. Pros and cons of the guidelines are given, as is the extent and form of sentencing deemed appropriate for the individual or corporation. The activities of the sentencing commission are depicted by a timeline.

This article explores the arguments for and against victims’ mitigating opinions on sentence. It describes a recent South African appeal case, compares it with a similar New Zealand appeal court judgment, and then investigates the legal position in England and Wales. It appears that, as a general rule, victims’ recommendations as to penalty must be avoided. However, unlike in South Africa and New Zealand, the jurisprudence in England and Wales has developed exceptions in this regard when certain categories of victims (...) request a more lenient sentence. Several cases from England and Wales reveal that, through considering the harms and needs of victims and ameliorating the sentences accordingly, a restorative justice approach is blended with a just deserts requirement for the protection of lower limits in sentencing. This ensures that the principles of proportionality, certainty and consistency are still adhered to. It is concluded that, had the South African court properly considered these comparative legal developments, it would, at the very least, have created a better precedent by providing guidelines to inform the complex, but important, process of considering victims mitigating opinions in the sentencing process. (shrink)

Conducting or overseeing research in correctional settings requires knowledge of specific federal rules and regulations designed to protect the rights of individuals in incarceration. To investigate the extent to which relevant groups possess this knowledge, using a 10-item questionnaire, we surveyed 885 IRB prisoner representatives, IRB members and chairs with and without experience reviewing HIV/AIDS correctional protocols, and researchers with and without correctional HIV/AIDS research experience. Across all groups, respondents answered 4.5 of the items correctly. Individuals who have overseen (...) or conducted correctional research had the highest scores; however, even these groups responded correctly only to slightly more than half of the items. These findings emphasize the need for ongoing training in federal guidelines governing correctional research, particularly for those individuals who are embarking on this type of research. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:At the Vortex of Controversy:Developing Guidelines for Human Embryo ResearchRonald M. Green (bio)Because of the unavoidable time delay between the submission and publication of this article, its readers will have a significant advantage over its writer: You will know whether the recommendations of the Report of the Human Embryo Research Panel, on which I have served as a member since its inception in January of this year, are (...) progressing smoothly as the basis for evaluating future, federally-funded embryo research—or whether any of the recommendations has become stalled in controversy and political dispute. Staid journals like Science already are predicting that the Panel's Report is likely to create a stormy autumn for the National Institutes of Health.The Panel formally presented its Report to NIH Director Harold Varmus on September 27. The Panel's recommendations will be reviewed by the Advisory Committee to the Director (ACD) until the ACD's next meeting in early December. At that time, the ACD will make formal recommendations to Dr. Varmus, who then will initiate the process of drafting federal regulations that could go into effect by Spring 1995.Historical BackgroundControversy is not new to the area of human embryo research. In the United States, federal regulations enacted in the mid-1970s required any research on the human embryo to be approved by a federally mandated Ethics Advisory Board (EAB). The EAB drafted a significant report that provided ethical guidelines for research on the early, ex utero, human embryo. However, before the report could be acted upon, a new administration, which was opposed to abortion and anything remotely viewed as threatening to prenatal life, came to office, and when the EAB's charter expired in 1980, it was not renewed. In this manner, the Reagan and Bush administrations forestalled any federal support for embryo research in the United States. The next 13 years saw a significant expansion of infertility services in this country, but in the absence of federal funding and [End Page 345] review, there was very little systematic research on either infertility procedures or the human embryo.In January 1993, the U.S. political environment changed again when the Clinton administration fulfilled a campaign promise to remove a nearly five-year-old ban on fetal tissue transplantation research. Although fetal tissue research, which uses the remains of an aborted fetus, significantly differs from embryo research, which involves the developing conceptus ex utero before its transfer to and implantation in a womb, the changed political environment stimulated public discussion of embryo research as well. As a result, in June 1993, Congress nullified the federal regulations requiring EAB review for embryo research. Although this presumably left NIH free to fund embryo research without restrictions, NIH officials felt that guidelines were needed to ensure that such research was conducted in an ethically and socially responsible manner. Accordingly, in January 1994, NIH formed the Human Embryo Research Panel to propose such guidelines.The Panel Begins its WorkChaired by Steven Muller, President emeritus of the Johns Hopkins University, the Panel's 19 members included 7 basic and clinical scientists, 4 ethicists, 2 lawyers, and 6 individuals representing various backgrounds relevant to the making of public policy. Patricia King of the Georgetown University Law Center and Brigid Hogan, a cell biologist at Vanderbilt University, were appointed policy and science co-chairs respectively. Meeting for the first time in early February, the Panel was told by its chair and co-chairs that NIH's need for guidance in the face of pending proposals meant that it had approximately six months—including five one- to two-day meetings each month in Washington—in which to complete its work.In his charge, Dr. Varmus asked the Panel to place the possible areas of research into three categories: (1) acceptable for federal funding; (2) warranting additional review; and (3) unacceptable for federal support. In addition, he asked the Panel to draft guidelines for the review and conduct of the research deemed acceptable.Looking back after months of work, I vividly recall a sense of the enormity of the task facing us. We were being asked, in a short period of time, not only to master... (shrink)

In its January 20th, 2010 decision in Citizens United vs. Federal Election Commission, the United States Supreme Court ruled that certain restrictions on independent expenditures by corporations for political advocacy violate the First Amendment of the Constitution, which provides that “Congress shall make no law […] abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.” Justice Kennedy, writing for the 5-4 (...) majority, held that “[b]y suppressing the speech of manifold corporations, both for-profit and non-profit, the Government prevents their voices and view-points from reaching the public and advising voters on which person or entities are hostile to their interests” (Citizens United vs. Federal Election Commission 558 U.S. 38-9 (2010); emphasis added). Much of the language of the opinion, and some of its reasoning, as this passage illustrates, presupposes that corporations are agents capable of speech, and that it is (at least in part) in the light of this that limitations on political advocacy by corporations are prohibited by the Constitution. -/- While there are other strands in the argument, they are interwoven with the conception of the corporation as agent and speaker, with its voice and its viewpoints. The dissenters on the court objected on precisely this point (among others). Justice Stevens wrote sarcastically in his dissent, joined by Justices Ginsburg, Breyer, and Sotomayor, that “[u]nder the majority’s view, I suppose it may be a First Amendment problem that corporations are not permitted to vote, given that voting is, among other things, a form of speech” (558 U.S. 33 (2010)). Justice Sotomayor suggested in oral argument that the Court’s century-old practice of treating corporations as persons rests on a conceptual mistake. -/- My concern in this essay is not with the question whether the restrictions violate the Constitution. There are many issues that bear on this which will be outside the scope of my discussion. My concern is with the proper conceptual framework for understanding the agency of corporations and corporate speech, and the role that conceptions of these play in the background of the majority’s reasoning. The issue is legal, but it also has philosophical, conceptual and semantic aspects. It will be the latter aspects, and their potential to shed light on legal reasoning, that are my main focus. An adequate framework requires saying what properly speaking the corporation is, how agency is expressed through the corporation, whose agency it is, centrally whether the corporation is an agent or person in its own right, and in what sense it can be said to be capable of speech. I draw on recent work in collective action theory, particularly with respect to the semantics of collective action sentences (Ludwig 2007) and the analysis of the proxy agency in collective action (Ludwig 2014), to show (i) that corporations are neither genuine agents nor (therefore) capable of engaging in genuine speech, (ii) that consequently the First Amendment does not apply to corporations per se, and (iii) that a better understanding of the mechanisms of corporate agency casts doubt on more indirect arguments for extending the First Amendment to “corporate speech” as well. (shrink)

Canada’s Tri-Council Policy Statement: Ethical conduct for research involving humans, first published in 1998, has recently been updated.1 The US Department of Health and Human Services has just issued an Advance Notice of Proposed Rulemaking that would substantially change the 20-year-old Common Rule governing most federally funded research involving human participants.2 A comparison of the two countries’ systems for protecting human research participants is therefore timely. This analysis situates the Canadian system in an international context, with particular attention to its (...) similarities and differences to the US system and their shared challenges going forward with their changes. (shrink)

Diabetes mellitus (DM) is a colossal burden in global health, its prevalence increases steadily throughout the world. This systematic review explores the pathophysiology and epidemiology of diabetes, which describes the interactions that implicate that is the result of the play between genetic, environmental, and lifestyle factors in the development and progression of the disease. The review also describes a plethora of pharmacological treatments available to manage diabetes, with the oral agent, insulin regimens, and new approaches to therapy. Integrating the wisdom (...) of the best clinical guidelines, those are from American diabetes association (ADA), European association for the study of diabetes (EASD), and International Diabetes Federation (IDF). Since these reviews are consistent with normative standards for evidence-based recommendations of optimal care of diabetes. The review goes further to cover technological advances in the management of diabetes. They include Continuous Glucose Monitoring, advanced insulin delivery systems, and Artificial Pancreas Systems. Such technologies hold more promising routes to better glucose control and patient quality of life. All this comes along with challenges that their deployment and maintenance that run through economic, adherence issues, and unequal access to healthcare. The future research and innovation in the battle against DM will include the application of personalized medicine and the development of advanced digital health solutions. This article will become a treasure for health professionals, researchers, and policymakers who have dedicated themselves to battling the adversities of diabetes mellitus. (shrink)

Many assumed that the Obama administration would usher in a sea change from the previous administration by expanding NIH support for human embryonic stem cell (hESC) research and reducing the patchwork of state and federal regulations that currently governs it. This article examines the extent to which NIH’s new Guidelines are likely to accomplish these goals.

Radio Frequency Identification (RFID) is quickly growing in its applications. A variety of uses for the technology are beginning to be developed, including chips which can be used in identification cards, in individual items, and for human applications, allowing a chip to be embedded under the skin. Such chips could provide numerous benefits ranging from day-to-day convenience to the increased ability of the federal government to adequately ensure the safety of its citizens. However, there are also valid concerns about (...) the potential of this technology to infringe on privacy, creating fears of a surveillance society. These are concerns that must be addressed quickly, with sensitivity to individual interests and societal welfare, allowing humanity to reap the benefits of convenience and safety without paying an unacceptable price in the loss of privacy. (shrink)