An empirical exploration of the effects on legislative structure, distribution of influence, power, and decision outcomes, of recent changes in the Congress and state legislatures. The book focuses on changes in rules, parties, and committees and the impact or lack of impact of these changes on subsequent activity. Originally published in 1978 by D.C. Heath and Company. Co-published with the Policy Studies Organization.

LB.2 This proposition implies that you hold it to be at least possible that some four hundred men should, by some process or other, become invested with the right to make laws of their own – that is, laws wholly of their own device , and therefore necessarily distinct from the law of nature, of the principles of natural justice; and that these laws of their own making shall be really and truly obligatory upon the people of the United States; (...) and that, therefore, the people may rightfully be compelled to obey them. (shrink)

Congress's national-security legislation will often require clear and specific congressional authorization before the executive can undertake certain actions. The War Powers Resolution, for example, prohibits any law from authorizing military hostilities unless it "specifically authorizes" them. And the Foreign Intelligence Surveillance Act of 1978 required laws to amend FISA or repeal its "exclusive means" provision before they could authorize warrantless electronic surveillance. But efforts to legislate clear-statement regimes in national-security law have failed to induce compliance. The Clinton Administration inferred (...) congressional "authorization" for the 1999 Kosovo War from an appropriations statute that failed to specifically authorize the conflict. And the Bush Administration inferred congressional "authorization" for the NSA surveillance program from ambiguous language in the post-September 11th Authorization to Use Military Force. In both situations, executive-branch lawyers employed expansive theories of implied repeal and constitutional avoidance to evade the codified clear-statement requirements, and Congress and the courts acquiesced to the President's actions. Recent proposals to strengthen the clear-statement requirements in Congress's national-security framework legislation are unlikely to be effective without institutional mechanisms, such as points of order, that can deter future legislators from enacting vague or ambiguous legislation from which the executive might claim implicit congressional "authorization," and that can induce Congress to confront Presidents that act without specific congressional authorization. Simply enacting more narrow or explicit clear-statement requirements, or adding funding restrictions to Congress's framework legislation, fails to counter the aggressive interpretive doctrines that executives of both political parties have used to concoct congressional "authorization" from vague or ambiguous statutory language. (shrink)

Legislative hearings on the Helms Human Life Statute (S.158) and the Hatch Human Life Amendment (S.J.Res.110) revealed the depth of the philosophical differences between pro- and anti-abortionists on fundamental values, and on the relationship between law and morality and between science and politics. These differences could have profound implications for national policy. They could also have an impact on the basic separation of powers between the legislative and judicial branches of the national government and the boundaries between federal and state (...) political activity. (shrink)

In Rousseau’s political theory, the Legislator’s task is to draft the best possible Constitution for a given people. His goal is to maintain the public liberties and to ensure the preservation and prosperity of the State. However, the main problem is “to put law above men” – that is: above the citizens in general and the members of the executive in particular. This paper examines how the Legislator takes up the problem by educating the citizens. The process of education implies (...) the development of reasonable thinking as well as the education of desire. Reasonable thinking is achieved through the formation of the general will. Education of human desire must be understood with respect to the distinction between amour-propre and amour-de-soi. The extension of amour-de-soi to a communityof fellow citizens plays a central role in the formation of the general will and contributes to the development of solidarity among the different social classes. Education of amour-propre plays a role in the development of a national identity. It plays also a role in the political governance of individual desires by means of an administration based on a hierarchy of functions, supervised by public opinion. However, the political governance of desire is challenged by the invisible power of money, which Rousseau tried to neutralize by limiting and slowing down the monetary circulation. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Contradiction and Legislation Regarding the Right to LifeKevin L. Flannery, S.J.Unborn Human Life and Fundamental Rights: Leading Constitutional Cases under Scrutiny. Edited by Pilar Zambrano and William Saunders, with concluding reflections by John Finnis. Berlin: Peter Lang, 2019.The most fundamental principle of law is the principle of non-contradiction. This is Thomas Aquinas's position in the seminal article on the natural law, Summa theologiae I-II, question 94, article 2, (...) where, citing Aristotle, he formulates the principle as, "One should not simultaneously affirm and negate." Lafter in the same article, Thomas offers a practical formulation of the same principle, "Good is to be done and pursued and evil avoided"; but in law, since it is contained in propositions (airmations and negations) as distinct from ideas regarding the pursuit of goods, the prior formulation is the more immediately relevant of the two.The book under review is important in that, by going through the legal history regarding abortion and related issues in a number of different countries—the United States, Canada, Italy, Spain, Poland, Ireland (Eire), Costa Rica, Argentina, Chile, Mexico, and Peru—it causes to emerge any number of times the realization that legislation and judicial decisions in favor of abortion "rights" invariably infect a legal system with contradictions and inconsistencies of various sorts. The present essay is, therefore, not your typical book review. Its objective is simply to list some of the legal contradictions and inconsistencies identified by the book's various authors as they describe the legal status of the unborn in their respective nations. [End Page 1323]William Saunders's very clear and comprehensive first chapter is entitled, "Judicial Interference in the Protection of Human Life in the United States: Actions and Consequences." In it, he describes, among other things, the Human Cloning Prohibition Act passed by the U.S. House of Representatives in 2003, which prohibited "any person or entity, public or private" from performing human cloning (23). He speaks also of a bill proposed in the U.S. Senate once the Human Cloning Prohibition Act had passed in the House of Representatives. This Senate bill (which was entitle, "The Human Cloning Ban and Stem Cell Research Protection Act") would have prohibited "any person or other legal entity" from conducting human cloning, even while allowing nuclear transplantation, which it defines as "transferring the nucleus of a human somatic cell into an oocyte from which the nucleus... ha[s] been... removed or rendered inert." The problem here, as Saunders explains, is that this latter definition "is the very definition of cloning" (25). In other words, in the same year, two pieces of legislation were considered in the Congress of the United States, both purporting to ban human cloning, one of which would have permitted what the other described (correctly) as human cloning and so prohibited.In the second chapter, "Whither United States Abortion Law?" by Gerard V. Bradley, discussed, among other things, is the inconsistency between the United States Supreme Court's pro-abortion decision Roe v. Wade and various laws, both state and federal, prohibiting feticide. Bradley says of the 2004 federal Unborn Victims of Violence Act that, "in pertinent part it says that 'whoever' 'causes the death of or bodily injury to,' a 'child who is in utero' is guilty of an offense apart from any accompanying offense against the woman carrying the child." The penalty for such an act is the same as would be imposed if the act were inflicted upon the unborn child's mother: if, for instance, the mother was killed. "A child in utero," reports Bradley, "is defined as a member of the species homo sapiens, at any stage of development, who is carried in the womb'" (37).The problem here is that prosecutable under this law are acts identical with those performed legally by abortionists. Bradley mentions two cases in which a woman's male partner—in one case the woman's husband—effected by stealth the abortion of her child. In one case, the male purchased abortion pills and affixed to their container a pharmacy label indicating that it contained a common antibiotic; in the other, the husband obtained the same type of... (shrink)

One of the most important and contentious policy issues surrounding genetics is whether genetic information should be treated separately from other medical information. The view that genetics raises distinct issues is what Thomas Murray labeled “genetic exceptionalism,” borrowing from the earlier term “HIV exceptional-ism.” The issue of whether the use of genetic information should be addressed separately from other health information is not merely an academic concern, however. Since the Human Genome Project began in 1990, nearly every state has enacted (...) legislation prohibiting genetic discrimination in health insurance; two-thirds of the states have enacted laws prohibiting genetic discrimination in employment, and other state laws have been enacted dealing with genetic discrimination in life insurance, genetic privacy, and genetic testing. Bills in Congress also would prohibit genetic discrimination in health insurance and employment. (shrink)

Genetic discrimination is becoming an increasingly important problem in the United States. Information acquired from genetic tests has been used by insurance companies to reject applications for insurance policies and to refuse payment for the treatment of illnesses. Numerous states and the United States Congress have passed or are considering passage of laws that would forbid such use of genetic information by health insurance companies. Here we argue that much of this legislation is severely flawed because of the difficulty (...) in distinguishing genetic from nongenetic tests. In addition, barring the use by insurance companies of a genetic test but not a nongenetic test (conceivably for the same multifactorial disease) raises issues of fairness in health insurance. These arguments suggest that ultimately the problems arising from genetic discrimination cannot be solved by narrowly focused legislation but only by a modification of the entire health care system. (shrink)

It was a happy surprise when, overcoming partisan divisions and interest‐group lobbying, Congress enacted the No Surprises Act, which bans unfair out‐of‐network “balance billing.” Although this is only a modest legislative victory, key efforts by the health policy community made a real difference in a time of legislative gridlock.

In 2022, the Research Center for Islamic Legislation & Ethics (CILE) and the World Innovation Summit for Health (WISH) submitted a proposal to host the 17th edition of the World Congress of Bioethics. After announcing that the CILE‐WISH proposal was the winning bid, concerns were raised by bioethicists based in Europe and the USA. To address these concerns, the International Association of Bioethics (IAB) developed a dedicated FAQ section, in coordination with the host institutions, for the first time in (...) IAB history. One‐to‐one communication ensued and individual responses were shared with these colleagues. As a continuation of this conversation, we (CILE Acting Director, WISH Research Fellow and Head of Content, and WISH CEO) address the concerns raised in the Letter‐to‐the‐Editor of Bioethics by Graaf et al. As we support the call to revisit some contentious issues within the global community of bioethicists, we maintain that this should be based on meticulously discussed, informed, consistent and equitable criteria. We also argue that mutual learning from diverse cultures and moral traditions is the optimal way for our scholarly community to be truly global and to eschew the flaws ensuing from ethnocentric discourses. (shrink)

On May 3, 1999, at the Cato sponsored conference, "Forfeiture Reform: Now, or Never?", Representative Henry Hyde announced that he was, once again, introducing Forfeiture Reform legislation to Congress. For six years, he has been trying to get legislation passed that would..

This paper focuses on the debate about the utilization of new reproductive technologies in Brazil, and the paths taken in the Brazilian National Congress in an attempt to draw up legislation to regulate the clinical practice of human assisted reproduction. British documents, such as the Warnock Report and Human Fertilization and Embriology Authority (HFEA) are used for thorough reference. The analysis of the Law Projects in the National Congress, the Resolution by the Federal Medicine Council, Resolution 196/96 and documents (...) by the Ministério Público (Public Prosecution Office), suppled the bases for the discussion. The principal question involved is the observation of different technical and moral prientations that influence the conduct of the issue in the legislative process. It is possible to observe that the main focus of the projects relates to the rights and interests of the children, to those possibly benefited by the technique and to embryo reduction. Very little attention has been directed to the issues of sexual and reproductive rights and to the health of the women submitted to the new reproductive techologies. (shrink)

In the late 1990s, Mexican feminists mobilized transnationally to demand state accountability for the feminicidios of women in Ciudad Juarez. Feminicidio refers to the misogynous killing of women and the state’s complicity in this violence by tolerating it with impunity. Drawing on debates of the Mexican Federal Congress and interviews with feminist state and non-state actors, I examine feminist legislators’ response to transnational activism, which was to pass the “General Law on Women’s Access to a Life Free of Violence” and (...) to create the penal-type code of feminicidio, which includes provisions to punish negligent state actors. These laws make the state a target of its own punitive power. To pass these acts, feminist legislators faced resistance from male legislators and the Federal Executive. I build on feminist institutionalism to theorize this resistance as gendered. Gendered state resistance was pervasive because feminist legislators practiced accountability by identifying the complicity of state institutions, including Congress, in perpetuating feminicidio. As part of the process, they built alliances with other female legislators and framed their arguments with notions of modern statehood. Although this framing strategy resulted in innovative legal change, I interrogate the assumption that modernity is the solution to feminicidio, because it can lead gendered state resistance to manifest as a simulation of accountability. (shrink)

Citizenship regimes are institutionalized systems of formal and informal norms that define access to membership, as well as associated rights and duties. This paper studies illegalized migration as one of the major tests to assess whether citizenship regimes are fair institutions, based on a historical analysis of legislation meant to reduce illegalized migration in the United States between 1995 and 2022. We build our empirical research starting from a simple observation: despite the great number of bills introduced to reduce (...) illegalized migration to the US, most of such initiatives fail to become law. In fact, 93.5% of all immigration initiatives did not even pass the chamber of Congress in which they were originally presented. Such a high rate of failure shows that these proposals are motivated by electoral aspirations, rather than coming from a genuine wish to help migrants or grant them citizenship. Furthermore, there is also an economic interest that justifies the maintenance of low-cost disposable immigrant labor, with no right to citizenship. Our analysis is an example of how state regulation processes seem to work to formalize, rather than alleviate or eradicate, the precarious legal statuses of illegalized migrants. We conclude that a globalized phenomenon such as citizenship requires going beyond merely institutional and formal conceptions. We need to rethink the institutional notion of citizenship, as a merely status held under the authority of a state and consider it from a cosmopolitan perspective and a multilateral basis. But as long as citizenship remains under the responsibility of states, illegalized migrants will continue to experience precarious citizenship. (shrink)

There is widespread agreement that the significant threat of terrorist activity and the importance we attach to safety and security demands that terrorists and terrorist activity be stifled as quickly and effectively as possible. However, much dominant thought about the very nature or approach taken to anti-terrorism legislation has gone without critical reflection. Drawing on a recent article by contemporary political philosopher Ronald Dworkin, in this paper I shall examine whether the metaphor of a balance, with safety or security (...) pitted against individual rights or civil liberties, is an appropriate way to understand or approach anti-terrorism legislation. To simplify matters, I shall depart from close consideration of Canada's new anti-terrorism legislation (in particular the new power of preventive arrest which it creates), with the observation that it is reflective of many other countries' legislative response to terrorism. (shrink)

In this article, I will analyse the conduct of the Brazilian legislative process regarding new reproductive technologies, mainly the moral assumptions of three categories that are essential to the debate: the status of the child generated by these techniques; the number of embryos transferred in each cycle ; and the issue of women’s eligibility for such techniques. The analysis will be a sociological study of the Brazilian legislative debate, using feminist perspectives in ethics as the theoretical reference. The focus will (...) be the bills in progress in the Brazilian National Congress, the public and official declarations of legislators involved in the issue and the regulation of the medical class, which has influenced the legislative process. Aside from the analysis of the legislative process, I include a section on the justification of these bills, since that is where the legislator exposes what he/she believes is the moral support for the bill. (shrink)

This paper deals with the genesis, development, and impact of Military Keynesianism in the U.S. Its impact on the civilian sector is examined in terms of: geographical distribution of military spending, sectoral militarization, labor market and occupational distortion, the militarization of R & D, R & D's impact on American competitiveness in the international market, the parasitic role of the military contract system and the unethical and exploitative role of military contractors. This paper exarnines the issues related to disarmament and (...) economic conversion with special reference to bills pending before the Congress. The author suggests are definition of "national security" in tune with the INF Treaty and the end of cold-war ideology. (shrink)

This paper uses a materialist feminist discourse analysis to examine how women’s movement organizations, liberal Democrats, and conservative Republican legislators shaped the Violence Against Women Act and the consequences for intersectional and carceral feminism. Drawing on qualitative analysis of Congressional hearings, published feminist and conservative discussion of VAWA, and accounts of feminist mobilization around VAWA, I first show how a multi-issue coalition led by feminists shaped VAWA. Second, I show how discourses of crime intermixed with feminism into a polysemic gendered (...) crime frame that facilitated cross-ideological support. Third, I show how, in contrast, intersectional issues that activists understood as central to violence against women were discursively and structurally separated from gendered crime in Congress. Although a multi-issue movement coalition advocated for expansions in VAWA dealing with immigrants, unmarried partners, same-sex partners, transgender people, and Native Americans, these issues were understood in Congress through more controversial single-issue discourses and often considered in administratively separate Congressional committees. Fourth, I show how VAWA’s outcomes played out in terms of carceral and intersectional feminist goals. (shrink)

This Paper argues that to protect at-risk communities — and all Americans — from the deadly effects of environmental racism, Congress must pass the Environmental Justice for All Act. The Act is intended to “restore, reaffirm, and reconcile environmental justice and civil rights.” It does so by restoring an individual’s right to sue in federal court for discrimination based on race, ethnicity, or national origin regardless of intent under the Civil Rights Act of 1964, strengthening the National Environmental Policy Act, (...) and providing economic incentives focused on environmental justice. (shrink)

This paper is emphatically focused in the analysis on the indigenous problem such as it had been ruled by law in the different Venezuelan Constitutions since the foundation of the Republic in 1811. Our purpose does not go as far as to treat the ancestral indigenous problem in Venezuela because this would exceeds the limits of our study; although, we will do some references in relation to this question.

In the 1996 overhaul of federal welfare legislation, Congress included provisions to promote employment, marriage, and responsible fatherhood to prevent poverty among low-income families. Little previous research has focused on how marriage promotion policies construct paternal identity. Drawing on data from an 18-month study of a federally funded relationship skills program for low-income, unmarried parents, I analyze how responsible fatherhood policies attempt to shape ideas of successful fatherhood and masculinity in the service of the government’s pro-marriage, antipoverty agenda. The (...) program promoted a class-specific version of what I call marital masculinity, one that seeks to redefine marriageability for low-income men by claiming that marriage comes before financial success and encourages fathers to earn more. It did this by targeting fathers’ masculine identities in two ways: first, by emasculating fathers who only provide financially for their children, and second, by promoting a highly gendered conception of paternal caregiving. By analyzing how this strategy can be understood as both empowering and controlling for low-income men, this research adds to the sociological literature on how welfare policies shape paternal identity and gendered family practices. (shrink)

Consider the following examples of political activity: Immediately upon the recent passage of health care reform legislation by the United States House of Representatives, announcements were made by attorneys general in several states that they would be challenging the constitutionality of the law in court. South Carolina Attorney General Henry McMaster thus contended that the "health care legislation Congress passed tonight is an assault against the Constitution. A legal challenge by the states appears to be the only hope (...) of protecting the American people from this unprecedented attack on our system of government." While the specifics of the proposed lawsuits varied, they were united in their goal of overturning the new law via court decision. In so doing, they were advancing a particular line of argument against that bill to the public—an argument that appealed to the alleged conflict between the legislation and the United States Constitution. (shrink)

ABSTRACT Legislation recently adopted by the United States Congress provides producers of pandemic vaccines with near‐total immunity from civil lawsuits without making individuals injured by those vaccines eligible for compensation through the Vaccine Injury Compensation Program. The unusual decision not to provide an alternative mechanism for compensation is indicative of a broader problem of inconsistency in the American approach to vaccine‐injury compensation policy. Compensation policies have tended to reflect political pressures and economic considerations more than any cognizable set of (...) principles. This article identifies a set of ethical principles bearing on the circumstances in which vaccine injuries should be compensated, both inside and outside public health emergencies. A series of possible bases for compensation rules, some grounded in utilitarianism and some nonconsequentialist, are discussed and evaluated. Principles of fairness and reasonableness are found to constitute the strongest bases. An ethically defensible compensation policy grounded in these principles would make a compensation fund available to all individuals with severe injuries and to individuals with less‐severe injuries whenever the vaccination was required by law or professional duty. (shrink)

This text provides a comprehensive and timely examination of the most pertinent factors affecting institutional ethics committees, for ethicists, trustees, administrators, physicians, clergy, nurses, social workers, attorneys and others with an interest in ethics committees.

Congress passed the Genetic Information Nondiscrimination Act of 2008 in order to remove a perceived barrier to clinical genetic testing. By banning health insurance companies and employers from discriminating against an individual based on his or her genetic information, legislators hoped that patients would be encouraged to seek genetic testing that could improve health outcomes and provide opportunities for preventive measures. Their explicit legislative goal was to fully protect the public from discrimination and allay their concerns about the potential for (...) discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies.However, GINA left a number of issues unresolved, most notably failing to define the concept of disease manifestation. GINA was structured such that it only provides protection against misuse of genetic information up until the point when an individual's disease has manifested. It protects an individual with a genetic predisposition for a disease, but not an individual actively suffering from that disease. (shrink)

Ongoing legislative proposals to overhaul United States immigration policy look very much like a new wave of nativism is sweeping the Congress. The movement, mounted in early 1995, is in full swing to limit immigrant populations from arriving, settling, producing, and benefiting as our parents' generations have done. Legislators and the courts are now considering the most complete antiimmigration social legislation since the decades following the First World War.

Can Congress require AIDS service organizations to pledge fidelity to the government's view opposing prostitution as a condition of receiving funding? This term, the Supreme Court will decide whether the First Amendment permits such censorship in USAID v. Alliance for Open Society International (AOSI). The 2008 legislation reauthorizing the President's Emergency Plan for AIDS Relief (PEPFAR) requires host countries to support “activities promoting abstinence, delay of sexual début, monogamy, and fidelity.” PEPFAR's “conscience clause” allows organizations with a moral or (...) religious objection to opt out of providing services to patients with a sexual orientation of which they disapprove. In addition, the law requires grantees to adopt “a policy explicitly opposing prostitution” and to refrain from any speech or activities the government deems “inconsistent” with that policy. The antiprostitution pledge extends not only to what a recipient says or does with PEPFAR funds, but even to what it says or does with its own private funds. The government, however, has not enforced the pledge against U.S.‐based nongovernmental organizations partly because of a preliminary injunction granted by the lower courts. That injunction is now at risk if the Supreme Court upholds the loyalty oath. (shrink)

In the early 1970s, Congress considered enacting comprehensive privacy legislation, but it was unable to do so. In 1974, it passed the Privacy Act, applicable only to information in the possession of the federal government. In the intervening years, other information privacy laws enacted by Congress, such as the Health Insurance Portability and Accountability Act, have been weak and sector specific. With the explosion of information technology and the growing concerns about an absence of effective federal privacy laws, the (...) legal focus has shifted to the states. Signaling a new direction in state data privacy and consumer protection law, the California Consumer Privacy Act establishes important rights and protections for California residents with regard to the collection, use, disclosure, and sale of their personal information. The CCPA is certain to spur similar legislation and to affect national and international businesses that collect data from California's residents. Understanding the new law is important for all data‐driven industries, including health care. (shrink)

This study examines the endogenous relation between corporate social responsibility and tax avoidance by focusing on a common strategy of corporate tax avoidance, i.e., establishing entities in offshore tax havens. Using hand-collected data on a sample of U.S. firms, we find that firms’ CSR ratings increase substantially in the two years after they first open tax haven affiliates. We provide evidence by using the controlled foreign corporations look-through rule enacted by Congress in 2006 that facilitates offshore profit shifting. We find (...) that firms that are affected by the CFC legislation increase their CSR practices in response. Overall, our results are consistent with the risk management theory, which argues that firms hedge against the potential negative consequences of aggressive tax avoidance practices through an increase in positive CSR activities. (shrink)

Torture used to be incompatible with American values. Our Bill of Rights forbids cruel and unusual punishment, and that has come to include all forms of corporal punishment except prison and death by methods purported to be painless. Americans and our government have historically condemned states that torture; we have granted asylum or refuge to those who fear it. The Senate ratified the Convention Against Torture, Congress enacted antitorture legislation, and judicial opinions spoke of "the dastardly and totally inhuman (...) act of torture.” Then came September 11. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:IRBs Under the MicroscopeJonathan D. Moreno (bio)The spring and summer of 1998 were seasons in the sun for institutional review board (IRB) aficionados. Rarely have the arcana of the local human subjects review panels been treated to so much attention in both the executive and the legislative branches of government, not only at the federal but also at the state level. And it looks as if the attention will (...) continue for some time. The spate of interest is due to a series of coincidences: a powerful House of Representatives subcommittee held hearings after its chairman learned about the IRB system during a previous session on research in underdeveloped communities; the Department of Health and Human Services’s Inspector General (DHHS-IG) released a report on IRBs; the National Institutes of Health (NIH) Office of Extramural Research completed a report on clinical trial monitoring; the National Bioethics Advisory Commission (NBAC) readied a report on research involving persons with mental disorders; the states of Maryland and New York completed studies of research with subjects who lack decision-making capacity; and advocacy groups protested a psychiatric research project involving inner city children.Underlying these proximate causes for the IRB blitz is a growing realization that the already considerable clinical trial enterprise will expand significantly over the next few years. Congress is talking about giving the politically popular NIH half again the budget it currently receives, which in turn will stimulate more commercially supported research. The director of the National Cancer Institute is considering a five-fold increase in the number of subjects enrolled in oncology studies over the next several years. Phase I cancer studies are among the most ethically sensitive, so IRBs will have more work cut out for them if this goal is reached. Adding to the rush of interest in IRBs are the government’s recent apology to the survivors of the syphilis study in Tuskegee, continuing congressional dissatisfaction with the way the Pentagon handled its vaccine distribution during the Gulf War, and the controversy about AZT trials in developing countries.On the HillCongressman Christopher Shays, the moderate Connecticut Republican who has developed an interest in human research issues, convened hearings on human [End Page 329] subjects research and the IRB system on 11 June 1998. Shays chairs the House Government Reform/Human Resources Subcommittee. The committee’s ranking minority member is Edolphus Towns of Brooklyn, NY, who shares Shays’s interest in this area.The immediate rationale for the hearings was the release that day of the DHHS-IG report, Institutional Review Boards: A Time for Reform. The subtitle was changed from A System in Jeopardy apparently after some people in DHHS expressed reservations about its seemingly alarmist tone, but the IG staffers who testified before Shays’s subcommittee insisted that they stood behind the message that the IRB system is in trouble if considerable reforms are not undertaken. Among the factors in the research environment cited as support for the bleak forecast: managed care, commercialization, multi-site trials, high IRB workloads, minimal IRB oversight of approved studies, conflicts of interest, insufficient training of IRB members and investigators, and lack of IRB self-studies (DHHS-IG 1998).As is normally the case for congressional oversight hearings, the first panel of witnesses consisted of executive branch officials, including Eric Meslin, Executive Director of the National Bioethics Advisory Commission, and Gary Ellis, Director of the Office for Protection from Research Risks (OPRR). Shays pressed Ellis on the extent to which OPRR conducts on-site investigations of complaints about abuse of human subjects. Admitting that on-site investigations are rare, Ellis suggested that the agency is inadequately staffed to follow up on complaints as quickly as it might wish. The members of Congress who were present at the hearings generally expressed concern about the DHHS-IG’s findings.The second panel that day, which Shays was unable to attend, set a different tone. Four of the panelists—Paul Appelbaum of the University of Massachusetts at Worcester, Robert Levine of Yale University, Angela Bowen of the Western IRB (a private clinical trials review firm), and I—were invited as authorities on the current condition of the IRB system. Bert Spilker... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.1 (2003) 53-64 [Access article in PDF] Incentives for Providing Organs Patricia Milmoe McCarrick and Martina Darragh After a contentious debate at its 2002 annual meeting, the American Medical Association's House of Delegates voted to endorse the opinion of its Council on Ethical and Judicial Affairs that the impact of financial incentives on organ donation should be studied (Josefson 2002). The shortage of organs (...) for transplantation has been an ongoing problem for more than 20 years. In June1981, Representative Philip Crane (R-IL) introduced legislation in the U.S. House of Representatives proposing a $25,000 income tax deduction and a $25,000 estate tax exclusion for donating an organ (Tax Incentives 1981). Still the National Organ Transplant Act enacted in October 1984 prohibited the offering of any "valuable consideration" in return for organs (United States 1984).The developments of a legal market for tissues in the United States and a black market for organs around the world have raised the question of whether donation without compensation is the only ethically viable option. Some critics of the current system claim reliance on donation actually promotes a black market in organs (Kaserman and Barnett 2002, p. 38; Palmer 1999, p. 36). In addition, a new set of compensation issues has arisen as living kidney donor transplantations begin to rival those performed with cadaveric organs (United States 2001).As a result, current suggestions for incentives go far beyond the traditional death benefit payment to include such ideas as medals of honor for donors, reimbursement for funeral expenses, exchange programs for organ donation, and special medical insurance for living organ donors. Numerous bills introduced into the 107th Congress have proposed such incentives (Delmonico et al. 2002.) In October 2002, the U.S. Department of Health and Human Services awarded $5.2 million in grants to study both clinical and behavioral interventions for increasing organ donations that do not involve incentives. The inspiration for some of the funded proposals comes from the successes of Spain's social services and the United Kingdom's clinical administration of organ procurement programs (Robeznieks 2002). [End Page 53]With a nod to evidence-based medicine, the underlying concern expressed in much of the current literature is that no idea for increasing the supply of organs should be discounted before it is studied. This bibliography provides a short introduction to the range of opinions expressed on the issue of incentives for providing organs.al-Mousawi, M.; Samhan, M.; al-Mezairee I.; Razzak, M.A.; and Khawari, F. Cadaver Organ Procurement in Kuwait. Transplantation Proceedings 31 (8): 3375-76, 1999.The authors describe a protocol that significantly increased cadaveric organ donation and credit it with fostering the expansion of an organ sharing program among the Arab Gulf states. Developed by Kuwaiti neurologists and anesthetists after a continuing education course on transplantation, the protocol places a special emphasis on the role of local transplant coordinators who facilitate the investigation of brain death cases by neurologists.Arnold, Robert; Bartlett, Steven; Bernat, James; et al. [Ethics Committee of the American Society of Transplant Surgeons] Financial Incentives for Cadaver Organ Donation: an Ethical Reappraisal. Transplantation 73 (8): 1361-67, 27 April 2002.To prepare for proposed studies of financial incentives for organ donation, the American Society of Transplant Surgeons convened a panel to develop a methodology for evaluating the ethics of such research. Comprised of organ procurement organization executives, physicians, surgeons, and ethicists, the panel generated a list of nine criteria for use in judging any incentives proposal. While opposed to direct payment or tax incentives for organ donation, a majority of the members support funeral expense reimbursement or charitable contributions as incentives that would not violate or undermine the ideal of altruism.Cameron, J. Stewart, and Hoffenberg, Raymond. The Ethics of Organ Transplantation Reconsidered: Paid Organ Donation and the Use of Executed Prisoners as Donors. Kidney International 55 (2): 724-32, February 1999.After reviewing arguments for and against payment for organ procurement, the authors apply these arguments to the specific case of obtaining organs from executed... (shrink)

This volume takes a look at the status quo of whistleblowing in several jurisdictions from around the world. Covering a topic that draws the attention of a broad public and is gaining importance amongst legislators, practitioners and scholars all over the globe, the book examines the various aspects of whistleblowing. It looks at what kind of legal protection of whistleblowers is in force, who is protected, what kind of behaviour is protected, and what kind of behaviour whistleblowers are protected against. (...) This is achieved by a combination of a general comparative report with country-specific reports that give information on whistleblowing in various jurisdictions. These countries include, amongst others, Canada, Germany, France, Italy, the Netherlands and the USA. A synopsis comprises information on whistleblowing in 23 countries in one tabula. The chapters of this book were originally prepared for the XIXth International Congress of Comparative Law (20th and 21 July 2014) of International Academy of Comparative Law in Vienna.shrink)

It has been pending in Congress for twelve years, despite the support of the last two presidential Administrations and the National Institutes of Health. It has been the subject of extensive affirmative lobbying by academic medical centers, pharmaceutical and biotech companies, genetic disease advocacy groups, and civil rights organizations. It has overcome vehement objections by employers and insurers. Its final passage, however, has been thwarted by a few Congressional leaders, who have prevented enactment despite overwhelming bipartisan support in both houses (...) of Congress.Based on this legislative history, one could not help but assume that the Genetic Information Nondiscrimination Act is a revolutionary piece of legislation that, if finally enacted, would provide extensive, effective, and comprehensive protection against genetic discrimination in health insurance and employment Unfortunately, such an assessment would be incorrect. Indeed, GINA may be a case of too much ado about too little. (shrink)

Contrary to much of what has been said about the decision of the United States Supreme Court last term in Exxon Shipping Co. v. Baker, it hardly put an end to the discretion of American judges to make awards of punitive damages in cases within admiralty jurisdiction. Rather, it confirmed judicial authority to make such awards in the absence of legislative direction, rejected the view that the Clean Air Act signals any intent of Congress to foreclose them in cases in (...) which that statute is implicated, and sets for them a cap, but only for an uncommon category of cases. (shrink)

The IAB’s selection of the Qatar-based Research Center for Islamic Legislation & Ethics (CILE) for hosting the 2024 World Congress of Bioethics does not leave the international bioethics community...

Pharmaceutical firms seek to fulfill their responsibilities to stakeholders by developing drugs that treat diseases. We evaluate the social and financial costs of developing new drugs relative to the realized benefits and find the industry falls short of its potential. This is primarily due to legislation-mandated reliance on animal test results in early stages of the drug development process, leading to a mere 10 percent success rate for new drugs entering human clinical trials. We cite hundreds of biomedical studies (...) from journals including Nature, Science, and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs. Legislation still requires animal testing prior to human testing even though the pharmaceutical sector has better options that were unavailable when animal modeling was first mandated. We propose that the U.S. Food and Drug Administration and Congress should work together to abolish regulations and policies that require animal use. Doing so will benefit pharmaceutical industry stakeholders, including patients whose health depends on drugs and the many people who rely on the financial well-being of pharmaceutical firms. (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)

In lieu of an abstract, here is a brief excerpt of the content:The Patient Self-Determination ActElizabeth Leibold McCloskey (bio)What are the ethics of extending the length of life? We know that we cannot artificially end life (Thou Shalt not Kill), but how about artificially extending life? Is that always good, sometimes good?... In ethics, is keeping people alive the highest good? Should our priority be to keep people breathing?... What does basic religious ethics say about this?(John C. Danforth, letter to (...) the author, 19 August 1989)The Patient Self-Determination Act, signed into law as part of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) last November, marks the first time that Congress has passed legislation concerning the ethics of life-sustaining medical treatment. The bill was spearheaded by Senator John C. Danforth (RMO), who has a special interest in this area. An Episcopal priest, Danforth was formerly an assistant chaplain at New York's Memorial Sloan-Kettering Cancer Center and now sits as a senior member of the Senate Finance Committee, which oversees Medicare and Medicaid. Although Senator Danforth's legislative initiative was not a result of the Cruzan case, it was in his state of Missouri that the U.S. Supreme Court case involving removal of Nancy Cruzan's feeding tube arose (Cruzan v. Director of Missouri Department of Health, U.S. Supreme Court, 58 LW 4916, 26 June 1990). From his unique vantage point, he felt it was time to craft a legislative response to some of the difficult issues surrounding prolongation of life.The short answer to Senator Danforth's questions about when to artificially extend life is simple enough: people must be free to determine that for themselves. Common law and common sense dictate such a conclusion; living will and health care proxy statutes, enacted in almost every state, codify that right. The Catholic moral tradition teaches that one is not morally obligated to use extraordinary means to prolong life, a tradition shared both by the mainline Protestant and the reform and conservative Jewish community. Yet most people are unaware of their fundamental legal right to make such decisions, and as court cases from Quinlan (In re Quinlin, 137 N.J. Super. 227, 1975) to Cruzan demonstrate, few know [End Page 163] how to make arrangements for this right to be exercised if they become incapacitated.Meanwhile, health care practices are often driven by a denial of death. When Senator Danforth and Senator Daniel Patrick Moynihan (D-NY) introduced the bill on October 17, 1989, Senator Danforth said:More and more it is arguable that we play God by subjecting people to unwanted and sometimes unnecessary treatment, treatment that unnaturally prolongs the dying process. Our health care system has become obsessed with extending life, at times neglecting the caring component of medicine and trampling on the rights of patients.(Congressional Record 1989, 135:5.13566)The American Hospital Association estimates that 70 percent of deaths now occur after a determination to withhold or withdraw medical treatment. Many of those decisions are made without the benefit of an incapacitated patient's views, yet a Harvard study revealed that 95 percent of the population would like to prepare in advance for such decisions. Only 4 percent of hospitals have a systematic method of asking patients if they have an advance directive. Family members confront painful choices in the face of uncertainty about their loved one's wishes and it can be even more painful when a family knows the patient's desires but providers and the courts act otherwise because clear evidence is lacking.The Patient Self-Determination Act is rooted in the belief that people should be given information that enables them to specify the extent of medical treatment they wish to receive should they become incapacitated. The public should be educated about applicable state laws that protect the individual's right to make such choices through the use of an advance directive.The Act moves toward that goal by promoting knowledge of state laws. It requires every hospital, nursing home, home health agency, hospice, and health maintenance organization that participates in Medicaid or Medicare to routinely give all adult patients information about advance directives. Patients will also be given information on the... (shrink)

Due to society's need to control health care costs and to the failure of legislated health care reform, managed care is expanding at a rapid rate and will soon be the predominate form of health care delivery. Plans by Congress to bring Medicare and Medicaid under managed care will further consolidate this trend. Barring some legislative fiat, managed care is here to stay.The term managed care describes a diverse set of organizational forms. Wide variations in approach, financing, physician involvement, and (...) philosophy exist among the different types of managed care organizations. While many articles on the ethics of managed care acknowledge this variety, most analyses focus on the for-profit entities, paying less attention to the ethical distinctions among the different forms of managed care. This paper discusses the key distinctions among MCO types, in particular the difference between for-profit and non-profit plans; the relationship of the physician to the MCO; the incentives used to control costs; the incentives that improve patient care; and the organizational features that nurture the principled practice of medicine. (shrink)

Our challenge begins with America's aversion to science. The problem is, of course, that nonscientists could understand scientific thinking, and would understand it, if they were encouraged and expected to do so. Though Members of Congress and their staff may avoid science, the institution itself cannot. Until the day comes when science is fully integrated into education for all, and even Members of Congress and congressional staff Members can deal with technical subjects, we will need special help for our (...) class='Hi'>legislation. Likewise, ensuring that good science informs and infuses good public policy requires scientists engage in the process of self-governance. Science should not only be a tool of public policy, it should be its foundation. With a scientifically literate society and public policy grounded in sound science, America can maintain its leadership in the emerging global knowledge economy. Without these, America will lose the very things that have fueled its greatness. (shrink)

This book traces the early history of the Civil Rights Movement in the United States, showing how brutal police treatment of civil rights demonstrators in Birmingham, Alabama, forced President Kennedy to send a strong civil rights bill to Congress in June of 1963. The various legislative strategies used to get the Civil Rights Act of 1964 through Congress are detailed.

In 1985, after nearly a decade of inconclusive professional response to public concern about misconduct in research, Congress passed legislation requiring action. Subsequent to this legislation, federal agencies and research universities adopted policies for responding to allegations of misconduct in research. Conferences, sessions at professional meetings, and special publications were organized. New educational initiatives were begun, many in response to a 1989 National Institutes of Health/ Alcohol, Drug Abuse, and Mental Health Administration requirement to include ethics instruction in (...) training grants. Notwithstanding a few key unresolved issues, such as the lack of a uniform federal definition of misconduct in research, the years since 1985 have witnessed a marked change in the professional response to misconduct in research. This paper evaluates the change since 1985 from the perspective of three key goals: 1) confronting misconduct, 2) promoting integrity and 3) ensuring integrity. While significant progress has been made in achieving the first two goals, the third remains largely unaddressed. The latter is due to the fact that researchers have not been interested in studying the integrity of their own profession. It is therefore suggested that studies are needed of routine or normal research practices and their impact on integrity for use in making decisions about research conduct policy. (shrink)

Times of heightened risk to the physical safety of their citizens inevitably cause democracies to recalibrate their institutions and processes and to reinterpret existing legal norms, with greater emphasis on security, and less on individual liberty, than in "normal" times. This article explores the ways in which the American courts have responded to the tension between civil liberties and national security in times of crises. This history illustrates that courts have rejected both of the two polar positions that characterize public (...) discourse on these issues. Civil libertarians argue that political bodies are too easily gripped by passions, hysteria, and self-interest in these times and that courts therefore ought to play a central role in protecting liberty. Executive unilateralists argue that the qualities that uniquely characterize the executive branch, such as decisiveness, access to information, and efficiency, must become so dominant in these moments that few checks, if any, should constrain executive prerogatives. Oddly, civil libertarians and executive unilateralists find implicit consensus in the view that, in times of war, courts have tended not to play a significant role in overseeing executive power. We argue to the contrary: historically, a significant constitutional tradition of judicial scrutiny in the United States during times of war does exist. But this scrutiny does not take the form of courts making first-order substantive judgments about the content of liberty or other claimed constitutional rights. Nor does it take the form of judicial assessment of how significant or credible the national security claims of the executive branch might be. Instead, judicial oversight has been focused on preserving the institutional structures and processes through which decisionmaking on these issues takes place. The judicial role has centered on the second-order question of whether the right institutional processes have been used to make the decisions at issue, rather than on what the content of the underlying rights ought to be. This approach has historically rejected or resisted most claims of executive unilateralism. When courts have upheld the government's actions, they have done so only after a judgment that Congress, as well as the executive, has endorsed the action. This approach has also rejected the civil libertarian framework. When courts find bilateral institutional endorsement, they have typically accepted the joint political judgment of how liberty and security tradeoffs ought to be made. By focusing on congressional endorsement of emergency measures, the courts have created a broad-based political accountability for the actions taken in the name of national security. We suggest that even if congressional endorsement is more apparent than real in some of these contexts, the judicial maintenance of this structure of rhetorical justifications sustains desirable understandings of political structure. Because the President and Congress draw from different political constituencies in a presidential rather than a parliamentary system, we also raise questions about whether the American judicial approach to these questions should be limited to political systems with separated executive and legislative powers. (shrink)

In February 1975, a group of leading scientists, physicians, and policymakers convened at Asilomar, California, to consider the safety of proceeding with recombinant DNA research. The excitement generated by the promise of this new technology was counterbalanced by concerns regarding dangers that might arise from it, including the potential for accidental release of genetically modified organisms into the environment. Guidelines developed at the conference to direct future research endeavors had several consequences. They permitted research to resume, bringing to an end (...) the voluntary moratorium that the National Academy of Sciences had instituted several months earlier. They also served to illustrate that the scientific community was capable of self-governance, thereby securing public trust and persuading Congress not to institute legislative restrictions. Finally, they underscored the importance of weighing unforeseen risks inherent in some research against potential benefits that may arise from these same endeavors. (shrink)