Following extensive examination of published and unpublished materials, we provide a history of the use of dexamethasone in pregnant women at risk of carrying a female fetus affected by congenital adrenal hyperplasia (CAH). This intervention has been aimed at preventing development of ambiguous genitalia, the urogenital sinus, tomboyism, and lesbianism. We map out ethical problems in this history, including: misleading promotion to physicians and CAH-affected families; de facto experimentation without the necessary protections of approved research; troubling parallels to the history (...) of prenatal use of diethylstilbestrol (DES); and the use of medicine and public monies to attempt prevention of benign behavioral sex variations. Critical attention is directed at recent investigations by the U.S. Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP); we argue that the weak and unsupported conclusions of these investigations indicate major gaps in the systems meant to protect subjects of high-risk medical research. (shrink)

On January 18, 2011, President Obama signed Executive Order 13563, Improving Regulation and Regulatory Review, which instructs federal regulators to do the following: coordinate their agencies activities to simplify and harmonize rules that may be overlapping, inconsistent, or redundant; determine whether the present and future benefits of a proposed regulation justify its potential costs (including taking into account both quantitative and qualitative factors); increase participation of industry, experts, and the public (“stakeholders”) in the formal rule‐making process; encourage the use (...) of warnings, default rules, disclosure requirements, and provisions of information to the public as an alternative to traditional “command‐and‐control” rule‐making restricting consumer choice; and mandate a government‐wide review of all existing administrative rules to remove outdated regulations. Executive Order 13563 includes a qualitative “values” provision to be considered in the required cost–benefit analysis, which can potentially counteract the alleged regulatory reform rationale of President Obama. Furthermore, in Executive Order 13563, President Obama established a deadline of May 18, 2011, for all executive branch agencies to submit their plans to streamline their rulemaking operations and repeal those “overlapping, inconsistent, or redundant” rules. These two issues, along with complementary regulatory review proposals being discussed in the U.S. Congress, are evaluated in this essay. (shrink)

The article is devoted to reviewing and analyzing the results of the All-Russian scientific and practical conference “Public administration in new realities: modern challenges and opportunities”, held in Chelyabinsk on October 26—27, 2022, and is a digest of the main events of the conference.

The purpose of the study is to reveal the essence of digital technologies in the municipal government system, to identify the main problems of their transformation in the territory of the subjects, and to develop directions for the mechanism of adaptation of the relationship between different management structures in the conditions of digitalization of processes. The article considers the author's vision of the development of digital technologies in the territorial aspect. In particular, the problems of technical equipment of remote territories (...) are considered, in particular, the problems of training personnel and territorial access to Internet resources are touched upon. When evaluating the legislative and regulatory acts of the Russian Federation, it is clear that digital technologies require a separate approach to solving problems of both legal and economic nature, while we focus on their relationship. It is obvious that when developing the strategic direction of digital technologies, the adapted elements require some adjustments and additions, which is currently being carried out. Such changes and additions are promoted not only through legislative and regulatory activities, but also on the basis of scientific research, which in turn develop new directions that contribute to solving problems in the development of digital technologies, not only in the management system, but also in the areas of business, professional education, training and retraining of personnel, etc. As a result, the identified problems in the resource provision of digital technologies allowed us to develop measures that specify the strategic direction. (shrink)

The article is devoted to a comparative analysis of the characteristics of the post-career of high-ranking PA officials who left their positions under President Yeltsin and in the post-Yeltsin period - and the factors that determine them. The empirical basis of the study is a database that includes biographical questionnaires on AP figures who at least once left a key position in this body. The study showed that the role of federal executive authorities (including the government of the Russian (...) Federation and law enforcement agencies) as a channel of post-career has increased. Transitions to the federal parliament are rare in both eras, but the proportion of officials who ended up in the State Duma after their resignation (especially a year later) slightly decreased, while the proportion of those who moved to the Federation Council, on the contrary, slightly increased in the post-Yeltsin period as a whole. While transitions to regional administrations were rare in both periods, PA officials were noticeably more likely to become governors in the post-Yeltsin era, which was facilitated by a centralization of power. Finally, the share of transitions from government to business is similar in both periods, as are their other characteristics: the dominance of big business as a place of work and the distribution of firms that have adopted officials by form of ownership. The pantouflage was aided by high salaries in big business and the firms' interest in recruiting officials in the context of crony capitalism. (shrink)

A review of the consent forms signed by those who donated embryos for the NIH-approved embryonic stem cell lines reveals several problems, providing ethical as well as scientific reasons to overturn the Bush administration’s restrictions on federal funding for stem cell research.

Over the past few years, the Virtual Organization (VO) paradigm has been emerging as an ideal solution to support collaboration among globally distributed entities (individuals and/or organizations). However, due to rapid technological and societal changes, there has also been an astonishing growth in technologies and services for mobile users. This has opened up new collaborative scenarios where the same participant can access the VO from different locations and mobility becomes a key issue for users and services. The nomadicity and mobility (...) introduces additional challenges for managing collaboration in VO environments. This paper focuses on the Identity Management challenge in a Mobile Dynamic VO environment, which is a VO that takes into account nomadicity and seamless mobility aspects as elaborated within the EU funded project Akogrimo (Access to Knowledge through the Grid in a mobile world). The resulting work is the design of the Akogrimo Identity Management system supporting the authentication and authorization process across the different administrative domains of the Mobile Dynamic VO. This design follows the service oriented approach and integrates the different perspectives: that of the network, that of the user and that of the service provider. Such an integration requires facing challenges; both from the architectural and technological viewpoints because different ‘worlds’ (i.e. network and service level) leverage different (and sometimes conflicting) approaches when addressing Identity Management. (shrink)

The regulation of narcotic medications used in narcotic addiction treatment is unique in medical therapeutics. Physicians who want to use narcotics for this indication must obtain a separate annual registration from the Drug Enforcement Administration. Annual registration is contingent on compliance with both the DEA's security regulations as well as treatment regulations jointly promulgated by the Food and Drug Administration and the National Institute on Drug Abuse.During the last decade, a number of events have occurred that persuaded NIDA (...) that it is time to reevaluate the current method by which the Department of Health and Human Services regulates methadone treatment. As a result of research during the past twenty years, we have learned about the effective components of methadone treatment. In comparison to other available treatment modalities for opioid addiction, methadone treatment is uniquely effective when administered by well-trained medical staffs. (shrink)

Retractions have traditionally been reserved for correcting the scientific record and discouraging research misconduct. Nonetheless, the potential for actual societal harm resulting from accurately reported published scientific findings, so-called information hazards, has been the subject of several recent article retractions. As these instances increase, the extent of support for such decisions among the scientific community and lay public remains unclear. Undergraduates (Study 1) and federally funded researchers (Study 2) reported their support for retraction decisions described as due to misconduct, honest (...) errors, or potential information hazards. Participants supported retraction on the former two grounds more than the latter. Despite limited support, women remained more receptive to retractions based on information hazards. Activist tendencies additionally predicted undergraduate men’s receptivity. Receptivity toward retraction due to information hazards was unrelated to scientists’ engagement in activism, suggesting that formal scientific training affords researchers an ability to separate personal and professional values in scientific discourse. Findings could inform the development of educational materials that may aid less experienced scientists and the lay public in understanding retraction ethics. (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration and, second, the scheduling decisions made by the Drug Enforcement Administration. If (...) a “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin and began marketing it as an analgesic. (shrink)

Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with (...) the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems. (shrink)

I would like to begin by discussing the legal and administrative framework of the role of the federal government in public health. At the heart of it is, of course, the Constitution. At the Department of Health and Human Services we depend, as does much of the federal government, on our power to regulate interstate commerce. Since the Supreme Court in 1942 removed essentially any restraint from the meaning of interstate commerce in Wickard v. Filburn, the federal (...) government has been regulating with wide latitude, in spite of small and, arguably, equivocal reverses in recent years. However, even though the Supreme Court no longer provides any real constitutional check on the federal government's interstate commerce power, some other restraints persist. For example, many parts of the health system have traditionally been deemed inherently state functions, such as the licensing and disciplining of doctors, nurses, and pharmacists, as well as the practice of medicine itself. (shrink)

This work examines the development and performance of federal independent regulatory bodies in Canada in the period up to 1979, with particular attention to the operation of legislative schemes that include executive review and appeal powers. The author assesses the impact of the exercise of these powers on the administrative law process, and proposes new models for the generation, interpretation, implementation, review, and enforcement of regulatory policy. The study includes a series of representative case studies based on documentation and (...) extensive interviews with individuals drawn from government, agencies, and other parties, including counsel for public interest groups. This enables author, writing from her experience as a participant-observer embedded in the public interest legal sector, to draw on the experiences and perspectives of a broad range of participants in the regulatory process, including but not limited to those dealing with the regulated energy, transportation, communications, and foreign investment sectors. Legal principles identified as emergent in leading judicial decisions in administrative law are used to assess the powers and practices used in executive reviews and appeals. The author finds those powers and practices to be flawed and proposes changes. The proposed models are designed to accord with emerging legal principles and avoid flaws of the types identified in the review and appeal provisions. This work, written under contract with the Administrative Law Project of the Law Reform Commission of Canada, formed one part of a comprehensive study of administrative law at the federal level in Canada. (shrink)

Federal regulations are the minimum requirements for conducting clinical studies. Some innovation would improve the situation of many involved in these studies, including: study subjects, those who monitor studies, and clinical investigators as well as Institutional Review Boards. Respecting patient and whistle-blower input; appreciating research staff contributions; and implementing a systems and partnership approach would foster quality and advance clinical research.

Following the Roosevelt administration’s implementation of New Deal programs in the 1930s, the federal courts began to interpret the Constitution in a way that accommodated the rise of the “administrative state,” and bureaucratic policymaking continues to persist as a central feature of American government today. This essay submits, however, that the three pillars supporting the administrative state—the congressional delegation of Article I powers to the executive branch, the combination of powers within individual administrative entities, and the insulation of (...) administrators from political control—might be reconsidered by the courts in the near future. After showing that the constitutionality of the administrative state has come under recent judicial scrutiny, the essay turns to the administrative law principle of deference, and argues that a reassessment of the Chevron doctrine seems imminent. Finally, the essay examines federal courts’ heavy use of “hard look” review as a means of curtailing agency discretion during recent administrations, and concludes that this judicial practice stands in uneasy tension with republican principles. (shrink)

In April 1992 the Food and Drug Administration (FDA) announced it was restricting the availability of silicone gel-filled breast implants to women enrolled in clinical trials. All candidates for breast reconstruction, but only a "very limited" number of augmentation candidates, would have access to the implants. This policy has been criticized as paternalistic, sexist, and unjustified by scientific data. I examine these charges and conclude that controversy surrounding the scientific data weakens the FDA's paternalistic mandate and that its policy (...) of treating reconstruction and augmentation candidates differently results in increased social injustice and perpetuates cultural biases concerning female beauty and women's rights to control their bodies. I also argue that these cultural biases shape women's subjective experience of their physical selves and should not, contrary to some feminist arguments, be viewed as precluding their giving informed consent to breast surgery. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When OPRR Comes Calling:Enforcing Federal Research RegulationsCharles R. Mccarthy (bio)In an update following this article, Ruth Macklin responds to the revelation that the controversial Hall-Stillman embryo-splitting experiment at George Washington University was conducted—contrary to federal regulations—without prior institutional review board (IRB) review. This revelation altered Dr. Macklin's view of the ethical status of the research. Undoubtedly such revelations also raise general questions for administrators and researchers in (...) many institutions, including, for example: How do allegations of noncompliance with federal regulations arise? When should allegations of infractions of the regulations be reported? Who has an obligation to report? To whom should reports be made? What sort of inquiry should take place? Who should conduct the inquiry? If a determination is made that infractions have occurred, what sanctions are appropriate? And, what publicity is given to the allegations, before, during, and after an evaluation?Some of these questions can be answered in a straightforward manner, while the answers to others depend on the circumstances of the case. This article provides some general answers to these questions.1BackgroundThe Department of Health and Human Services (DHHS) is the largest supporter of biomedical and behavioral research in the world. Somewhere between 25 and 33 percent of its medical research budget is devoted to the support of research involving human subjects. In accordance with the Public Health Service Act, DHHS has issued Regulations for the Protection of Human Subjects (45 CFR 46). The DHHS Secretary has delegated responsibility for promulgating and administering the regulations to the Office for Protection from Research Risks (OPRR), which is located within the National Institutes of Health.When an institution receives an award from a DHHS agency to carry out research involving human subjects, it is required to negotiate, or to have on file, an "assurance of compliance" document that provides detailed information [End Page 51] specifying how the institution plans to comply with the regulations for the protection of human subjects. Most major research institutions in the country have on file a "multiple project assurance" (MPA) document, which extends DHHS regulations to all human subjects research conducted or sponsored by that institution, irrespective of the source of funding. The regulations and the assurance of compliance require any research project involving human subjects to be reviewed and approved by an institutional review board (IRB) prior to initiation of the research. In addition, the project must be re-reviewed by the IRB at appropriate intervals—in no case, less than once a year. Institutional compliance with these and other requirements of the regulations has improved during the last 30 years and appears to be at a high level. However, from time to time, allegations of noncompliance arise, as they did in the George Washington University embryo-splitting experiment, and set in motion the review process described below.How do Allegations of Noncompliance Arise?Allegations or indications of noncompliance with federal regulations for the protection of human subjects may come from a variety of sources. Most commonly, the institution's IRB discovers that research involving humans is going forward without the required prior IRB review and approval, or that approved research is being conducted in a way that is contrary to the stipulations of the IRB. The Hall-Stillman case came to the attention of George Washington University's IRB because the research protocol was submitted to the IRB after the research had been carried out. In this case, there could be no doubt that an infraction had occurred.Information about possible noncompliance also frequently derives from a funding agency's Initial Review Group (IRG) (commonly called a Study Section) when it has reason to suspect noncompliance in a project it is reviewing for possible funding. An actual case that occurred some years ago involved a research application that proposed to perform brain biopsies on normal volunteers. The IRG that reviewed the application lost little time in questioning whether an IRB had approved the protocol. In this case, it was not enough for the IRG to recommend disapproval of the proposal for funding; it also was obliged to report the possible infraction to OPRR.Whistleblowers, including research subjects, nurses, students, members of the... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Working on the Clinton Administration's Health Care Reform Task ForceNancy Neveloff Dubler (bio)This narrative is based on my understanding of the elements of the Health Security Act that may have ethical implications. I have reconstructed these elements from my experience on the Health Care Reform Task Force and they are part of the health care plan that the President presented to Congress. (At the time this article went (...) to press, the actual legislation, which should answer my remaining specific questions more clearly, had not yet been released.) I perceive the most important features of the plan to be:• The legislation will create a "right" to health care for all citizens—access to care will be universal;• The plan will involve some form of managed competition in which groups of providers (called Approved or Accredited Health Plans (AHPs)) will offer comparable benefit packages at slightly (or widely) different costs;• The AHPs will negotiate with the Health Alliance (HA) to determine the price that they will charge their consumer-patients;• There will be open enrollment with no barriers to coverage, such as exclusions for pre-existing conditions;• Community rating will be in effect in different localities and enrolled persons in any AHP will pay the same premium;• The coverage for any enrolled person will be portable;• The overall structure will be a cooperative federal/state enterprise in which the states will have quite extensive abilities to fashion variations of the basic plan to meet their particular needs;• Primary care will be encouraged and incentives for physicians to train in primary care specialties provided;• Non-physician providers will be central to the functioning of the health care plans;• Efforts will be made to develop a "person power" pool so that people with an abstract "right" to health care will have real access to providers, in their localities, who can fulfill the promise that the right creates; [End Page 421]• The goal of cost containment will be central to the organization and regulation of the system;• Administrative simplicity and quality protections will be central.Co-chairing the Bioethics Working Group (BWG) of the White House Task Force on Health Care Reform was a unique experience. Approximately 40 Task Force working groups were established by Hillary Rodham Clinton, the President, and the senior Task Force staff. Various members of the President's office and other knowledgeable members of the Executive Branch selected the participants. In our group, appointments were made largely on the recommendations of the co-chairs. The BWG, among the last of the groups formed, carried the official name "The Working Group on the Ethical Foundations of the New System" and was jointly led by me and Marion Gray Secundy, a Professor of Bioethics at Howard University. The fact that the leadership of the Task Force saw fit to establish such a group, thereby confirming that bioethics is a player in the arena of health care policy, was in itself significant and was made no less so by the lack of clarity regarding the group's aims and goals.The working groups of the Task Force were organized into clusters, determined by the relatedness of the somewhat distinct, but always overlapping, content of their investigations. Separate clusters and working groups, for example, looked at mental health, long term care, and the benefit package and coverage for low-income and non-working families. On this last issue there was also a working group that explored health policy initiatives for underserved populations. This multiple focus on related issues proved to be an excellent method for ensuring that the complexity of these topics was sufficiently explored. There was a published schedule for when these groups met together, and members of other groups who had similar or overlapping concerns were invited to attend and to participate.Every week or so, all of the working groups reported to the Task Force leadership, under the direction of Ira Magaziner, in a process called a "tollgate." Prior to the tollgate, the working groups were required to submit formal written analyses of the problems they had most recently been considering. Copies of these documents were placed in a special room so that those who were interested could review... (shrink)

Pour recouvrer ou conserver un emploi, les personnes ayant des limitations professionnelles en raison de problèmes de santé peuvent postuler à des programmes de réadaptation professionnelle. En Allemagne, 20% des candidats n’entreprennent pas de réadaptation professionnelle. En utilisant des données administratives sur tous les candidats sous la responsabilité de l’Agence fédérale allemande pour l’emploi, une régression logistique à effets fixes est appliquée pour identifier les groupes n’effectuant pas de réadaptation professionnelle. Les analyses révèlent que les personnes ayant un emploi suivent (...) moins souvent une réadaptation professionnelle. Cependant, la probabilité que les personnes s’inscrivent à des programmes de réadaptation augmente de manière significative à la suite d’une perte d’emploi. Ainsi, par rapport aux autres candidats, les personnes ayant un emploi sont donc davantage exposées au risque de ne pas suivre la réadaptation professionnelle ou de la suivre (trop) tardivement. En utilisant la théorie des problèmes sociaux, on peut soutenir que les limitations professionnelles sont plus difficiles à évaluer dans le cas de candidats ayant un emploi. De plus, les candidats qui ont un emploi craignent particulièrement de perdre leur statut s’ils postulent à des programmes de réadaptation professionnelle. Les raisons de la non-utilisation ou de l’utilisation tardive devraient également être examinées. (shrink)

This article examines the municipal ID card programs in New Haven and San Francisco. With a municipal ID card, undocumented immigrants can access basic city services and identify themselves with police and other city officials. The article draws on twenty-eight interviews with key stakeholders to show that city officials navigated the conflicting demands of ID card supporters and opponents to create a local membership policy focused on improving city administration, not expanding the rights of undocumented immigrants. In capitalizing on (...) their discretionary administrative powers to develop programs that safeguard the health, safety, and welfare of all city residents, officials in New Haven and San Francisco managed to promote the integration of undocumented immigrants into city affairs without upsetting the federal monopoly over immigration and citizenship powers. This new form of local bureaucratic membership has implications for the urban citizenship literature and illustrates that city officials have some freedom to develop programs that benefit undocumented immigrants. (shrink)

In this book, Professor McGarity reveals the complex and problematic relationship between the 'regulatory reform' movements initiated in the early l970s and the United States' federal bureaucracy. Examining both the theory and application of 'regulatory reform' under the Reagan administration, the author succeeds in offering both a relevant analysis and critique of 'regulatory reform' and its implementation through bureaucratic channels. Using several case studies from the early Reagan years, this book describes the clash of regulatory cultures resulting from (...) the President's attempt to incorporate 'regulatory analysis' into the bureaucratic decision-making process. Yet while McGarity recognizes the limitations of regulatory analysis, he concludes with suggestions for enhancing its effectiveness. This book could be used not only as a textbook for political science and government courses but also for graduate applications in public policy and public administration. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:538 Feminist Studies 41, no. 3. © 2015 by Feminist Studies, Inc. Doreen J. Mattingly The Limited Power of Female Appointments: Abortion and Domestic Violence Policy in the Carter Administration In 1977 in the United States, Second Wave feminists were poised to make a meaningful impact on federal policy. Jimmy Carter’s successful 1976 presidential campaign had included an open wooing of feminist support : he had created (...) a “51.3 Percent” committee to address women’s issues and he had told feminist audiences that he “wanted to be known as the President who achieved equal rights for women, just as President Johnson had won civil rights legislation for blacks.”1 Once elected, Carter appointed an unprecedented number of feminist women to high office, many of whom were committed to addressing the concerns of marginalized women and advancing policy on issues such as sexual violence and reproductive rights. These appointees were linked to a dense feminist organizational presence in Washington that was unprecedented in its size and diversity. Not surprisingly, many feminists had high expectations for the new administration. 1. Cynthia Harrison, “Creating a National Feminist Agenda: Coalition Building in the 1970s,” in Feminist Coalitions: Historical Perspectives on Second-Wave Feminism in the United States, ed. Stephanie Gilmore (Urbana: University of Illinois Press, 2008), 30. See also John Dumbrell, The Carter Presidency: A Re-evaluation (New York: Manchester University Press, 1993); and Sara Evans, Tidal Wave: How Women Changed America at Century’s End (New York: Free Press, 2003). Doreen J. Mattingly 539 Despite these promising conditions, feminists made little headway on policy during the Carter administration (1977–1981). Federal funding for abortion was eliminated; no permanent offices that would have advocated for women’s issues were created; and bills supporting domestic violence shelters, support for “displaced homemakers,” and quotas for female-owned businesses were defeated or extremely diluted. In addition, no additional states ratified the Equal Rights Amendment (ERA) and several states rescinded earlier ratification votes. Some of these failures can be attributed to the general loss of feminist momentum and the emergence of a conservative backlash in the late 1970s. Anti-ERA organizing fueled the rise of a conservative “family values” movement that would shape social policies for more than a generation, and neoliberal economic conservatives were challenging the welfare-state programs that feminists sought to expand. But in Washington, there was an addition challenge —the unreliable support of Carter himself. Despite his promises, Carter felt that by appointing women he had met his commitment to feminists and did little to support feminist policy goals that went beyond eliminating discrimination. This paper makes an important contribution to the history of feminist action by looking in detail at the efforts of Jimmy Carter’s feminist appointees to influence policy. In particular, it discusses the actions of the most visible feminist in the White House, Margaret “Midge” Costanza. Carter named Costanza director of the Office of Public Liaison, a department that was created to manage relations between the White House and citizens’ groups. Her position as the first woman to serve as Assistant to the President, in concert with her gregarious nature and strong support for women’s issues, made Costanza a very visible symbol of affirmative action for Carter. Yet Costanza, like many other high-level feminist appointees, met opposition within the White House when she tried to advance women’s issues. Her persistent advocacy contributed to her marginalization within the White House. Just twenty months into the administration she resigned in frustration.2 This paper begins with a discussion of the unique circumstances surrounding Carter’s feminist appointees, followed by a detailed exploration 2. For Costanza’s complete story, see Doreen J. Mattingly, A Feminist in the White House: Midge Costanza, the Carter Years, and America’s Culture Wars (New York: Oxford University Press, 2016). 540 Doreen J. Mattingly oftwomeetingsheldbyCostanzainJuly1977.Thefirstwasanimpromptu meeting of roughly forty prochoice Carter appointees, all deeply troubled by a statement made by Carter in support of the Hyde Amendment banning federal funds for abortion. The same month, Costanza hosted a groundbreaking White House meeting about battered women, in which high-level bureaucrats heard testimonials from domestic violence victims and shelter advocates. While both meetings broke new... (shrink)

The U.S. Court of Appeals for the Fifth Circuit ruled, in United States u. Texus Tech University, 171 F.3d 279, that the Eleventh Amendment bars a private citizen from bringing a qui tam action in federal court against a state, absent federal intervention.Intervenor Carol Foulds was a dermatology resident at the Texas Tech Health Services Center. While a resident, Foulds examined patients, made diagnoses, and prescribed treatments for patients. Foulds alleged that she and other residents performed these medical (...) services without the supervision of staff physicians. Foulds further alleged that, after residents performed these services without physician oversight, staff physicians signed charts and Medicare and Medicaid billing forms certifying that they personally performed or supervised the administration of these services. Foulds estimates approximately 500,000 false claims occurred in a span of ten years.In 1995, Foulds filed a qui tam action with the U.S. District Court for the Northern District of Texas. As regulated by the False Claims Act, 31 U.S.C. § 3729, the complaint remained under seal. (shrink)

The “public charge” rule is a long-standing immigration policy that seeks to determine the likelihood that a prospective immigrant will become dependent on the government for subsistence. When the Trump administration sought to expand the criteria that would count against an applicant for permanent residency to include public benefits historically excluded from the calculation, thousands of commenters wrote to oppose or support the proposed changes. This paper explores the moral and practical reasons commenters provided for their position on the (...) public charge rule and considers the value of the public comment process for immigration, health, and social policy. (shrink)

Background U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention. Purpose Our goal is to elaborate on the updated 2013 (...) U.S. Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States. Methods Review of the 2011 and updated FDA guidance document on exemption from informed consent. Results The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document. Limitations The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that—guidelines. Therefore, they may not be followed as outlined in the guidance document within one’s own institution. Our goal is that, by elaborating on the guidelines for planned research involving human subjects in the ICU, institutional regulatory bodies may gain a better understanding in drafting their own document when faced with a clinician or a researcher who wishes to conduct planned research in an ICU. Conclusions We believe that the interpretations provided will allow clinicians to safely undertake planned research in ICUs without endangering the main tenets of ethical research involving human participants. This research is needed for the advancement of care in the critically ill. (shrink)

On December 7, 1994, the U.S. District Court of the Northern District of Illinois ruled that ERISA preempts a participant in an ERISA plan from suing the plan's administrator under a state common law theory of respondeat superior ) : at 208). On September 12, 1995, the Seventh Circuit of the U.S. Court of Appeals reversed this decision and ordered that the case be tried in state court ). The court held that the case had been improperly removed to (...) class='Hi'>federal court. The court of appeals stated that the federal court did not have jurisdiction because the plaintiff's claim did not fall within ERISA's provisions.In this case, plaintiff David Rice brought a medical malpractice suit against two doctors who provided treatment to him in accordance with his ERISA insurance plan. (shrink)

This essay explains how to use the calculus of consent framework to think more rigorously about self-governance, and applies this framework to the issue of evaluating federal regulatory agencies. Robust political economy is the idea that institutions should be designed to work well even under weak assumptions about decision-makers’ knowledge and benevolence. I show how the calculus of consent can be used to analyze both incentives and knowledge problems. The calculus is simultaneously a theory of self-governance and a tool (...) for robust political economy analysis. Applying this framework to the case of public administration leads to the conclusion that private goods (such as medicine) tend to be over-regulated, public goods tend to be under-regulated (such as enabling too much pollution), and regulatory agencies tend to be over-centralized (and should in most cases either be replaced with certification markets or moved to state level). (shrink)

Federal credit policies toward agriculture reflect the human values of maintaining the farm production sector largely as an industry characterized by small-scale, family farms. The Farmers Home Administration has implemented various credit programs designed to carry out this policy objective. As a result of the prolonged financial crisis in the farm economy, the agricultural community is becoming more aware of the controversies surrounding the mission of FmHA and its debt restructuring program. This paper discusses the debt restructuring program (...) administered by the Farmers Home Administration (FmHA), as authorized by the Agricultural Credit Act of 1987, and amended by the recently enacted Farm Bill of 1990. It discusses the key provisions of the Agricultural Credit Act authorizing FmHA to establish a debt restructuring and debt forgiveness program aimed at achieving the public policy objective of keeping financially stressed farmers in business, whenever possible.In the course of reviewing the restructuring program, FmHA officials and congressional committees reviewed the FmHA's mission and its program implementation. This review indicated that several unintended negative consequences resulted from several abuses stemming from inadequate administrative mechanisms and controls and conflicting legislative objectives of debt forgiveness and federal tax policy. In enacting the 1990 Farm Bill, Congress sought to reorient FmHA's mission to a temporary source of credit and to eliminate various abuses associated with the implementation of FmHA's debt restructuring program. The 1990 Farm Bill reflects an effort by Congress to address some the controversies surrounding federal credit policies toward agriculture. Although Congress placed limits on debt restructuring, the overall public policy objective of maintaining a family-farm posture in the agricultural sector continues to be an important social value. (shrink)

The purpose of the book is to attempt to ascertain the views of President Barack Obama related to the field of education. This is done by first studying his own personal education and then following his spoken and written comments as a social worker, college professor, and as a state and federal legislator. In addition, there is an analysis of the positions he has taken during his political campaigns. Following this, there is a description of the actions he has (...) taken thus far in the field of education during his presidency. Using this background the author seeks to suggest his likely initiatives in education during the remainder of his presidency. (shrink)

In the forty‐year history of U.S. bioethics commissions, these government‐sanctioned forums have often demonstrated their power to address pressing problems and to enable policy change. For example, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established in 1974, left a legacy of reports that were translated into regulations and had an enormous practical impact. And the 1982 report Splicing Life, by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and (...) Behavioral Research, became the basis for the National Institutes of Health's Recombinant DNA Advisory Committee as well as for the Food and Drug Administration's developing “Points to Consider” when contemplating the introduction of recombinant DNA into human beings. Some efforts of bioethics commissions, however, are not tightly connected to policy change or to outcomes directly linked to a specific report. While direct policy impact is indeed a useful metric for government bioethics commissions, it is not their only legitimate utility. For instance, bioethics commissions can also be incubators for deliberation on a hot topic, giving policy‐makers time to think through options while the political heat has some time to dissipate. Or a bioethics commission may stake out a position that enables a politician to take action while not necessarily following its recommendations. (shrink)

The obligation to provide reasons may appear rather a simple and straightforward, but in actual practice—as the mutually antagonistic Weiss rulings of the CJEU and the German Bundesverfassungsgericht amply demonstrate—is fraught with constitutional complication. On the one side, there lies the concern with a deeply intrusive form of judicial review which substitutes judicially determined “good” reasons for those of the reviewee decisionmaker—legislatures, administrative agencies, or, as in Weiss, the European Central Bank. On the other side lies the concern with judicial (...) abdication in the face of technical expertise, uncertainty and complexity, turning the reason-giving requirement into a mere façade thereby placing democratic accountability in the modern administrative state beyond law’s remit. Either way, normatively and conceptually, we seem left with a half-way house only. Drawing on the recent US administrative law discourse—the neo-Fullerian concept of an “internal morality of law” and democratic experimentalism —this paper explores the concept of process review as tertium datur. Process review responds to concerns over the rule of law and administrative discretion through indirect, procedural safeguards, by imposing requirements of reasoned justification, rather than through wholesale invalidation or aggressive substantive review. (shrink)

Among American adults 20 years and older, 59 percent take at least one prescription drug on a regular basis. Unlike most branded drugs, which are generally drugs that have a trade name and are protected by a patent, off‐patent generic drugs make up approximately 90 percent of prescriptions annually filled in the United States; yet in 2017, generic drugs made up only 23 percent of total drug costs in the U.S. The U.S. Food and Drug Administration has taken the (...) lead in encouraging increased competition in the nation's prescription drug marketplace, most recently with its release of the agency's Drug Competition Action Plan, but also with its regulatory guidance and enforcement efforts to eliminate “gaming” of the regulatory process by both branded and generic pharmaceutical manufacturers. Such “gaming” activities include “pay‐for‐delay” agreements involving financial compensation between branded and generic pharmaceutical manufacturers to forestall the emergence into the market of generic pharmaceuticals to compete against a formerly patent‐protected branded drug. A combination of new enabling legislation, federal judicial guidance, and agency regulatory activities show promise in encouraging increased competition in the prescription drug marketplace, with the American consumer the ultimate beneficiary of lower health care costs and improved overall personal health. (shrink)

Inequality is the defining feature of our times. Many argue that it calls for a policy response, yet the most obvious policy responses require legislative action. And if inequality is the defining feature of our times, partisan acrimony and gridlock are the defining features of the legislature. That being so, it is worth considering what role administrative agencies, and administrative law, might play in ameliorating or exacerbating economic inequality. Here, I focus on American safety net programs, many of which are (...) joint operations between federal administrative agencies and state governments. In this context, a central mode of bureaucratic policy innovation comes in the form of administrative waivers, whereby a federal administrative agency waives some statutory requirement that is otherwise binding on state administrators. For example, the Centers for Medicare and Medicaid Services recently granted waivers to allow several states to impose various “personal responsibility” requirements on Medicaid beneficiaries. Faced with a choice between legislative inactivity and policy innovation through waivers, many scholars and policymakers of both parties have tended to favor waivers. The appeal of waivers as a path around legislative gridlock is compelling. However, I argue that this view has neglected the federal structure of American safety net programs, and does not account for the state politics of implementation. Moreover, scholars have not focused on the severe information problems that federal agencies face when issuing waivers; a permissive waiver regime exacerbates these problems. Focusing on Medicaid implementation, I highlight the risks of waivers for American safety net programs. Before concluding, I discuss possible reforms to administrative procedures, and offer a case study of litigation surrounding one recent waiver application. The case study illustrates many of the theoretical arguments, and further demonstrates the failure of judicial review; it indicates how review might be adjusted to promote more effective use of waivers and diminish their perils. (shrink)

The federal government has a generally unquestioned obligation to provide health care to veterans for diseases or disabilities acquired during military service. Much argued, however, is the government's obligation to offer care for nonservice‐connected disorders. The Reagan administration has sharpened the debate recently by attempting to impose a means test on veterans over sixty‐five who are seeking such care. But the controversy focuses on the wrong issue. Society has a moral obligation to provide adequate health care to all (...) citizens but has no special obligation to care for nonservice‐connected health problems of veterans. (shrink)

The federal and corporate initiative to technologize education has transformed schools, colleges, and universities into a new frontier for the computer industry. While educational institutions have maintained an equivocal relationship with markets and the state, they had striven to preserve a simulacrum of independence until the early 1980s. Then, neoconservative ideologies and their accompanying discourse on restructuring education discovered in the computer the ideal neutral tool to promote, in its virtual clothes, their gospel. The Clinton administration and big (...) corporations, taking advantage of the myth of the computer and the new vocabulary associated with computers, launched a massive program of wiring schools. The process, still unfolding at a rapid pace, poses grave problems for the teaching profession and the role of schools in society. The author argues that the unethical ways in which computers force their ways into many educational institutions, the values they embody, the contexts of their multiple usages, the hyperfragmentation and increasing commodification of knowledge that they cause through online education, the vocationalization of education, and the atomization of teachers are likely to shrink pedagogical and democratic possibilities both at local and global levels. (shrink)

The authors are national school resource experts and have teamed up to write a comprehensive book on ethics and politics. It covers everything you need to know about ethical leadership and dealing with politics in schools. The book starts with an ethical framework and moves on to politics with unions, administrators, and School Boards with suggested strategies for effective conflict resolution. There are realistic cases in every chapter of the book with the final chapter focused on comprehensive ethical and political (...) cases to test the reader in addressing such issues in the educational or related settings. Benefits and Features of Book:.A comprehensive book covering all aspects of ethics and school politics..Each chapter objectives are aligned with the ELCC, InTASC, ISLCC, and TLEC standards used for accreditation and alignment in program content..Many federal and various state data sources are included..Each chapter contains a comprehensive case study and exercises for practical application..Provides a blend of academic, theoretical, and practical perspectives in handling and dealing in ethical and political situations..Several handy resources are included in the appendices.". (shrink)

Accelerated approval of aducanumab for mild Alzheimer's by the U.S. Food and Drug Administration on June 7, 2021, has generated substantial medical, scientific, and ethical controversy. That approval was contrary to the nearly unanimous judgment of the FDA's Advisory Committee that little reliable evidence existed of significant benefit, even though the drug did reduce β‐amyloid. Three major ethical problems were created by this approval: (1) Medicare resources would be unjustly squandered, given the drug's $56,000 annual price and the 3.1 (...) million older potential American patients needing the drug; (2) physicians will feel ethically compelled to provide the drug to desperate, insistent patients, given FDA approval and in spite of side effects of brain bleeds and brain swelling; (3) and false hopes are generated for patients. A needed corrective by the federal government would reduce reimbursement to the bare cost of producing the drug (plus only a modest profit) until a phase IV trial has been successfully completed. (shrink)

Legal challenges to the FDA’s approval of mifepristone have destabilized patients’ ability to access controversial medicines like medication abortion. We argue that federal courts’ receptiveness to this litigation undermines the coherence and integrity of prescription drug regulation in the U.S.

Abstract“What we call meaning is bound to vanish”: Under this heading, an interview with Max Horkheimer was published in Der Spiegel (Jan 5, 1970). Revisiting this interview, the article focuses on Horkheimer’s thesis that human beings share the “longing that the injustice which characterizes the world must not be the final word”. It examines the extent to which Horkheimer’s notion of the “desire for the totally other” may be inspired by Kant’s claim that religion is grounded in the “need of (...) practical reason”. A further topic of discussion is Horkheimer’s critical assessment concerning current tendencies toward a “total administration of the world” that may ultimately “reduce thinking to the level of industrial processes”. Relating this critique to Kant’s reflections on the “unbelief of reason (Vernunftunglaube)”, which is based on “the maxim of reason’s independence of its own need”, the article raises the question of Horkheimer’s significance today: What relevance does Horkheimer’s method of casting doubt on any “politics that is not based on theology, metaphysics and, of course, morality” have for today’s discourse on such matters? In this context a brief glance is cast at Jürgen Habermas’s post-metaphysical reading of Horkheimer’s “negative theology”. Die Forschung zu diesem Beitrag wurde durch das Russian Academic Excellence Project at the Immanuel Kant Baltic Federal University (Aleksandra Nevskogo Street 14, 236016 Kaliningrad, Russische Föderation) unterstützt. (shrink)

In calling for the transformation of military medical education and training, the 2005 Base Realignment and Closure Commission recommended relocating basic and specialty enlisted medical training to a single site to take advantage of economies of scale and the opportunity for joint training. As a result, a joint medical education and training campus (METC) has been established at Fort Sam Houston, Texas. Two of METC's primary long-term goals are to become a high-performing learning organization and to seek accreditation as a (...) community college. Such goals require a clear model of organizational improvement with well-defined metrics for measuring its performance and using research and evaluation to assess and improve that performance. Lessons learned from a review of practices at institutions with similar missions -- such as community colleges, corporate universities, the UK's Defence Medical Education and Training Agency, and other federal agencies, such as the Veterans Health Administration -- establish a clear need for an office of institutional research to help METC attain its organizational goals. They also provide useful recommendations regarding the METC office's structure, scope, and governance. (shrink)

Aujourd’hui, le gouvernement fédéral entreprend de diriger les situation d’urgence, un tâche si intimidante qu’elle fait appel à la panoplie de réglementation et de pouvoirs économiques résidant dans les institutions et les bureaucraties fédérales. L’Administration Fédérale de Gestion des Situations d’Urgence occupe la pôle position dans cet effort massif. Mais une société qui autorise le gouvernement à répondre face aux catastrophes naturelles et autres calamités de ce type peut-elle espérer préserver sa liberté? Non. En fait, le gouvernement d’une société (...) libre peut gouverner efficacement sans détruire la liberté, si et seulement si ses citoyens en ont décidé ainsi.Today, the federal government undertakes to manage emergencies, a task so daunting that it must call forth all of the concentrated regulatory and economic power that resides in federal institutions and bureaucracies. The Federal Emergency Management Administration takes the point position in this massive effort. But can a society which authorizes government to respond to natural disasters and other such calamities hope to preserve its liberty? No. In fact, the government of a free society can govern effectively without destroying freedom, if and only if the citizens are willing to be so governed. (shrink)

Meeting 5G high bandwidth rates, ultra-low latencies, and high reliabilities requires of network infrastructures that automatically increase/decrease the resources based on their customers’ demand. An autonomous and dynamic management of a 5G network infrastructure represents a challenge, as any solution must account for the radio access network, data plane traffic, wavelength allocation, network slicing, and network functions’ orchestration. Furthermore, federation among administrative domains (ADs) must be considered in the network management. Given the increased dynamicity of 5G networks, artificial intelligence/machine learning (...) (AI/ML) solutions are strong candidates able to learn, and take quick provisioning decisions upon fast changes in network conditions. Therefore, this chapter presents an analysis of the state-of-the-art solutions for 5G networks’ management, where AI/ML solutions are discussed and compared with traditional methods. Additionally, the chapter provides a technology overview of both standards, and existing solutions regarding the 5G network management, and directions toward the integration of AI/ML in 5G networks. (shrink)

The U.S. federal government provides two tracks for eligible patients to obtain access outside clinical trials to investigational interventions currently under study for potential clinical benefits: the Food and Drug Administration’s expanded access pathway and the pathway created by the more recent Right to Try Act. In this issue of the Hastings Center Report, with a critical focus on patients, industry, and the research enterprise, Kelly Folkers and colleagues frame the inherent challenges that these pathways are meant to (...) solve and have also inadvertently created. But an additional key focus is how the relevant situations should be managed at the bedside and how the system risks both inefficient and inequitable access to options at the institutional level. Although either pathway could be helpful to patients, the challenges of having the pathways coexist are greater than the sum of their parts. Individual clinicians represent the front line of the regulatory and eligibility challenges of expanded access and right to try, making clinical education a critical component of a comprehensive approach to using them well. But it is medical institutions that must take the lead on supporting access to investigational options in the most equitable and effective manner possible. (shrink)

There is currently great controversy over the contribution antimicrobial use in animal agriculture has made to antimicrobial resistance in pathogenic bacteria with negative consequences for human health. In light of this, the approval process for antimicrobials used in US animal agriculture, known as New Animal Drug Application or NADA, is currently being revised by the federal government. We explore the public deliberations over the development of these new policies focusing our attention on the interaction between pharmaceutical companies and the (...) U.S. Food and Drug Administration. What appears to be an antagonistic public discourse is examined in terms of its ability to simultaneously legitimate the roles of the Food and Drug Administration as the official arbiter of policy on antimicrobial use in animal agriculture and as a protector of the public welfare, as well as the role of pharmaceutical companies as the producers of safe and effective products necessary for the protection of public well-being. (shrink)

The Clinton administration's revised rules regulating but not prohibiting the common practice in managed care of linking physician compensation with cost cutting and control of services demonstrates the complexity of ethical issues in managed care. As originally proposed, the federal guidelines on payment for Medicare and Medicaid services would have precluded any interrelationship between payment to physicians and delivery of services. Such a restriction would have gutted the primary mechanism in managed care plans to curb the unacceptably high (...) cost of healthcare delivery: making physicians directly responsible for cost control by placing them at direct financial risk. At first blush such a linkage seems to involve an obvious and irreconcilable conflict of interest. How can a physician be responsible for the well-being of a patient while at the same time aware that a proportion of his or her income is linked to the provision of cost-conscious care? (shrink)

The Trump Administration has exposed both the durability and vulnerability of the Patient Protection and Affordable Care Act's insurance reforms. One of the Administration's first strikes at “Obamacare” was to discontinue federal government payment of cost-sharing reductions, which insurers pay to low-income enrollees on the exchanges to reduce their out-of-pocket share of medical spending. The states struck back with a clever solution that could hold insurers and enrollees harmless. This article examines this strategy and why, while impressive, (...) it reaffirms larger problems with the ACA's market-based approach to health reform and the need for new pathways forward. (shrink)

One of Tocqueville’s best-known empirical claims in Democracy in America is that there is no national-level public administration in the United States. He asserts definitively and repeatedly that “administrative centralization does not exist” there. However, in scattered passages throughout the text, Tocqueville points to multiple federal agencies that contemporary historians and APD scholars characterize as instances of a growing national administrative system, such as the Post Office Department and the Bureau of Indian Affairs. I reevaluate Tocqueville’s treatment of (...) bureaucracy in America in light of this evidence. I contend that Tocqueville, perhaps in spite of himself, reveals even the most paradigmatic examples of active, democratic self-government in Democracy in America—townships and other voluntary associations—to be embedded in and causally supported by a network of interrelated, centralized public administrative institutions. Crucially, Tocqueville never resolves the tension between his acknowledgment of the causal power of these institutions and his claims that they do not exist. This new picture of the empirical and normative complexity of Tocqueville’s treatment of bureaucratic institutions offers a rich set of conceptual resources for contesting, among other claims, the political construction of nostalgia for a lost age of do-it-yourself White settler democracy in a time before bureaucracy in America. (shrink)

Although there is no federal legislation yet on e-cigarettes, the U.S. Food and Drug Administration proposed regulations in April 2014 that would prohibit sales of e-cigarettes to anyone under eighteen and require that they be approved by the FDA as a tobacco product and carry warning labels for consumers on their packaging. Only three U.S. states have extended the same restrictions placed on tobacco products to e-cigarettes; however, eighteen states have passed legislation enacting use restrictions on venues such (...) as schools, state property, or workplaces. Until there is applicable legislation at the federal, state, or municipal levels, health care organizations will have to develop institutional policies if they wish to consistently address the use of e-cigarettes by patients and visitors on their property. (shrink)

Earlier this year, the U.S. Department of Health and Human Services announced its intent to strengthen enforcement of legal protections for health care providers' conscience rights. It proposed regulations that would give the DHHS Office of Civil Rights greater authority to ensure that recipients of federal funding comply with federal conscience laws. This recent development creates an opportunity for scholars and policy‐makers to revisit the perennial debate about whether and how law should protect health care providers' rights of (...) conscience. Arguments about who should be protected, what actions should be protected, and whether there should be any limitations on the exercise of conscience rights have brought us no closer to a resolution. However, there is one remaining avenue for analysis that has, surprisingly, received very little attention—the question of how providers are protected, and from what consequences. Existing U.S. conscience laws immunize health care providers from a wide range of adverse consequences—including civil liability, criminal prosecution, administrative penalties, adverse action by employers, and discrimination by private actors, among others. However, academic and public policy debates rarely acknowledge the breadth of these protections. It is essential to disentangle this network of possible protections. (shrink)