In late 2019, He Jiankui, the Chinese scientist who created the world's first gene‐edited babies, and two embryologists were sentenced to prison and fined. Thirteen months earlier, when the world first learned about the experiment, He and his colleagues drew swift and nearly uniform international condemnation for prematurely moving to human trials, for the risks they took with the children's health, and for He's secrecy. The organizing committee for the second genome editing summit said the experiment failed to conform with (...) international norms.” In the United States, the legal picture is complex. No doubt the specific experiment He performed would have run afoul of long‐standing research regulations due to its problems with informed consent and ethical review. But other laws also affect this kind of work, in particular, a budget rider that for the past four years has been included in federal appropriations legislation. (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)

This paper focuses on the 1986 Amendments to the False Claims Act of 1863, which offers whistle-blowers financial rewards for disclosing fraud committed against the U.S. government. This law provides an opportunity to examine underlying assumptions about the morality of whistle-blowing and to consider the merits of increased reliance on whistle-blowing to protect the public interest. The law seems open to a number of moral objections, most notably that it exerts a morally corrupting influence on whistle-blowers. We answer these objections (...) and argue that the law is not objectionable on these grounds. Since there are no compelling moral objections to the law, it is appropriate and acceptable to judge the law in terms of its economic costs and benefits. We assess the most salient of these and conclude that the benefits outweigh the costs. We suggest that a mechanism similar to the Act should be considered for protecting stockholders' interests in the private sector. We conclude by making several proposals for improving the existing legislation. (shrink)

The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration , Environmental Protection Agency , Department of Agriculture , Occupational Safety and Health Administration , and National Institutes of Health . All can learn from assessment of the successes and failures of past oversight efforts aimed (...) at emerging technologies. This article reports on work funded by the National Science Foundation aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight. (shrink)

In this article, we address the public issue of mandatory Genetically Modified Organism (GMO) retail food labeling in the U.S., first by reviewing the policy arguments both in support and against labeling food containing GMOs; second, by describing the existing U.S. federal regulatory system pertaining to GMO labeling, and why it does not presently require labeling of food containing GMOs; third, by reviewing and interpreting the results of studies of American consumer attitudes toward mandatory GMO retail food labeling; fourth, (...) by evaluating, through the utilization of issue life cycle analysis in the nonmarket environment, where the issue of GMO retail food labeling stands in the national public policy process; fifth, summarizing the state of scientific evidence addressing the safety of GMO foods and the existing regulatory and public policy environment for this issue; and sixth, offering legislative and litigation strategies for the mainstream food nonmarket strategy framework to formally assess the GMO industry to protect their interests and those of American consumers not concerned with GMO food ingredients, while offering a voluntary labeling strategy for firms responding to and recognizing the “rights” of American consumers who “choose” to purchase non‐GMO food products. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 97-114 [Access article in PDF] Stem Cell Research in the U.S. after the President's Speech of August 2001 Cynthia B. Cohen On 9 August 2001, in a nationally televised speech, President Bush addressed the contentious question of whether to provide federal funds for human embryonic stem cell research (White House 2001).1 This research involves taking the primordial cells found in embryos (...) and transforming them into certain specialized cells, such as those of the heart, nerves, and muscles, with the ultimate goal of transferring these cells into patients to repair damaged cells and tissues. In his remarks, the President authorized funding for research only on stem cells already harvested from remaining embryos at in vitro fertilization (IVF) centers as of 9 August 2001, the date of the speech. In a "Fact Sheet" about embryonic stem cell research, he added the ethical requirements that (1) the donors of embryos gave informed consent to the derivation of stem cells from their embryos, (2) the embryos were created solely for reproductive purposes, and (3) no financial inducements were given to the embryo donors. The President also prohibited federally funded research on embryonic stem cells derived from embryos after 9 August 2001, as well as the creation of embryos for research purposes and the cloning of human embryos for both reproductive and research purposes. He did not seek to ban the pursuit of embryonic stem cell research with private funds. "This allows us to explore the promise and potential of stem-cell research without crossing a fundamental moral line by providing taxpayer funding that would sanction or encourage further destruction of embryos," the President stated (White House 2001).The President's speech stirred intense controversy. Many applauded the new policy because it allowed some embryonic stem cell research to proceed, thereby raising hope that treatments might be developed for those suffering from such conditions as Parkinson's disease, Alzheimer's disease, and diabetes. Others supported it on grounds that it would discourage the future destruction of embryos in stem cell research. They maintained that although it was wrong to have derived stem cells from embryos, this wrong was no longer remediable and it therefore was justifiable to allow research using such embryos to proceed. Some, however, objected to the new policy because they held that it unduly limited the [End Page 97] number of embryonic stem cells available for federally funded research. Still others opposed it on grounds that it made the federal government complicit in what they took to be the wrongful destruction of human embryos that had taken place prior to 9 August 2001. The President established the President's Council on Bioethics by executive order in November 2001 and charged it, among other tasks, with monitoring stem cell research and recommending guidelines and regulations for biomedical innovations.Questions about the moral status of human embryos have so captured public attention since the President issued his remarks that other significant ethical and policy issues raised about stem cell research inside the Beltway have remained in the shadows. A number of individuals and organizations—legislators, scientists, patient groups, the President's Council on Bioethics, ethicists, religious task forces, and social commentators—have attempted to bring these other issues to legislative and public attention. They also have revisited the more publicly prominent question of what sorts of protections we owe to human embryos. In response, Congress has attempted to address several of these newly emerging issues at hearings and in legislation. I review these efforts, consider developing issues and arguments, and conclude by exploring possible future directions for federal and private sector stem cell policy. The Availability of Embryonic Stem Cell Lines to Federally Funded Researchers President Bush, in developing his stem cell research policy, accepted a distinction between the "derivation" and the "use" of embryos enunciated by the General Counsel of the Department of Health and Human Services toward the end of the Clinton administration. This distinction was adopted to avoid contravening the Dickey-Wicker Amendment (added... (shrink)

There were two ways for the solicitor general of the United States to litigate the constitutional challenge to the Patient Protection and Affordable Care Act of 2010 brought by twenty‐six states and the National Federation of Independent Business. One path, which the solicitor general pursued, was to cautiously navigate judicial precedents, claim the barest increment of new congressional authority, and give the Supreme Court as many hooks as possible on which to hang a favorable decision.The road not traveled was to (...) offer a full‐throated defense of federal authority to comprehensively regulate the U.S. health care system, a multitrillion dollar commercial and social enterprise that represents the largest component of federal expenditure after national defense. The ACA has three cornerstones. First, make health insurance coverage as widespread as possible. Second, improve the quality and efficiency of health care delivery. Third, make individuals and communities healthier. The second and third pillars are sometimes overlooked because so much attention is paid to expanding coverage, but the hallmark of the ACA is that it combines major changes to health insurance, health care delivery, and health in a single piece of federal legislation.The Obama administration's timidity echoes what is strikingly absent from the new law. Although the ACA represents the successful culmination of a decades‐long struggle to universalize coverage, its structure and text never convey the intent that all Americans have a common stake in the health care system. This lack of shared national identity is the missing fourth pillar of the ACA. (shrink)

In this chapter I seek to rehabilitate and elaborate the so-called “mischief rule” of English law. I begin by interrogating two views of legal and constitutional interpretation which make symmetrical mistakes about legal interpretation: Larry Alexander and Emily Sherwin’s view in Demystifying Legal Reasoning and Jack Balkin’s in Living Originalism. Against these views I argue that the appropriate interpretation of laws is guided by the “mischief” the legislators were trying to remedy when they created the law and by what the (...) legislators and the subjects of the law understand when laws are created or changed. (shrink)

The use of medical records in research can yield information that is difficult to obtain by other means. When such records are released to investigators in identifiable form, however, substantial privacy and confidentiality risks may be created. These risks become more common and more serious as medical records move to an electronic format. In 1996, the state of Minnesota enacted legislation with respect to consent requirements for the use of medical records in research. This legislation has been widely (...) criticized because—it is claimed—it creates an unnecessary impediment to research. In this article, we show that these arguments rest upon misinterpretation and/or misrepresentation of the 1996 legislation. A consent requirement had actually been present in Minnesota since 1976 (though codified in a patient rights statute rather than a privacy statute). The 1996 law does not require specific consent, as often claimed, but rather only a general authorization. The campaign against the Minnesota legislation appears to have been motivated by concern with respect to the then impending federal privacy rule. The HIPAA rule, as enacted, is in fact less stringent with respect to consent than the Minnesota consent law. On the other hand, the Minnesota consent law has not been effectively applied or enforced. As we change the way we manage sensitive medical information, new efforts are needed to provide protection against the confidentiality risks in research. Patient consent is an important tool in this regard. New instrumentalities are needed to solicit and document consent. (shrink)

As a consequence of the problems caused by genetic discrimination, federal and state law makers are being pressured to pass a legislative remedy. A primary question is whether the Americans with Disabilities Act of 1990 applies to individuals with a potentially disabling genetic disorder who are pre-symptomatic or asymptomatic and may never become ill and to healthy individuals who are carriers of genetic conditions. At present, this question has relevance principally for individuals with the genotype for single gene disorders, (...) like Huntington disease and hemochromatosis, and to asymptomatic carriers of single gene disorders such as cystic fibrosis. Although many such single gene conditions exist, the total incidence of these conditions in the U.S. population is less than 0.4 percent. However, the question concerning the applicability of the ADA will become increasingly important because genetic tests will almost certainly be developed in the near future for common multifactorial diseases like diabetes, heart disease, and certain forms of cancer. (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)

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)

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)

Policy‐makers, bioethicists, and patient advocates have been engaged in a fierce battle about the merits and potential harms of a federal right‐to‐try law. This debate about access to investigational medical products has raised profound questions about the limits of patient autonomy, appropriate government regulation, medical paternalism, and political rhetoric. For example, do patients have a right to access investigational therapies, as the right‐to‐try movement asserts? What is government’s proper role in regulating and facilitating access to drugs that are still (...) in development? In this review, we analyze the history of the right‐to‐try movement, review the arguments put forth by supporters and opponents of the legislation, and consider the movement’s consequences. Two possible scenarios may emerge. One is that the right‐to‐try pathway may fail to meaningfully increase patient access to investigational products. Alternatively, certain companies may attempt to rely on the federal right‐to‐try legislation to sell investigational products, taking advantage of the provision that allows for direct costs, as there is currently no clear mechanism for enforcement or monitoring of cost calculations. (shrink)

Are federal prosecutions of non-federal officials for corruption likely to improve non-federal government? This essay suggests that such prosecutions can undermine the distinctive style of democracy at the state and local level, an effect that can be harmful to democracy in America overall. This conclusion rests on a larger argument about the different nature of federal and non-federal democracy in the United States. To insure that each official maintains impartial loyalty to values defined by a (...) single, popularly accountable policymaker, the federal system of bureaucratic populism strictly separates the officials’ public and private interests, through various devices such as civil service protection for executive officials, Article III life tenure, and fixed salary for federal judges, specialized training for federal officers, and conflict-of-interest rules that bar federal officers from acting when their judgment could be compromised by private interests. By contrast, participatory populism rejects this separation of the public and private spheres, instead mixing professional and lay decision-making by using thousands of part-time, under-paid executive and legislative officers who are expected to have substantial private interests in the communities that they represent. The essay argues that each style of democracy has mutually exclusive advantages and disadvantages. However, enforcement of federal anticorruption law against non-federal democracies can undermine their system of mingled private and public interests, reducing the degree to which such governments can provide laypersons with opportunities for political activity. As an illustration of the overextension of federal criminal law, I examine the First Circuit’s interpretation of 18 U.S.C. §§ 1341 and 1346, the federal mail fraud statute in United States v. Sawyer. Sawyer comes dangerously close to declaring that any undisclosed state or local officer’s conflict of interest constitutes a violation of § 1346 when it involves the U.S. mails. I argue that this view of § 1346 is an error. Participatory populism requires that private and public tasks be closely mingled in ways that bureaucratic populism forbids. Undoubtedly, this mixture of public and private creates a risk that public office will be used for private gain. However, it also avoids some of the bureaucratic sclerosis and lack of lay participation that can be endemic to the more centralized federal tradition. In conclusion, I suggest that federal prosecutors ought to content themselves with using § 1346 to enforce already-existing state criminal conflict-of-interest rules, for the sake of preserving a place in our federal regime for participatory populism. (shrink)

Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents (...) and licenses. Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create. (shrink)

The law within each legal system is a function of the practices of some social group. In short, law is a kind of socially grounded norm. H.L.A Hart famously developed this view in his book, The Concept of Law, by arguing that law derives from a social rule, the so-called “rule of recognition.” But the proposition that social facts play a foundational role in producing law is a point of consensus for all modern jurisprudents in the Anglo-American tradition: not just (...) Hart and his followers in the positivist school, most prominently Joseph Raz and Jules Coleman, but also the anti-positivist Ronald Dworkin, who argues that law necessarily synthesizes moral considerations with social facts. But which group’s practices ground each legal system? In particular, which group’s practices undergird U.S. law? Positivists since Hart have universally pointed to either officials or judges as the “recognitional community” (my term): the group such that its rules, conventions, cooperative activities, or practices in some other sense are the social facts from which the law of a given legal system derives. So Hart and all other positivists would identify either U.S. officials or U.S. judges as the recognitional community for U.S. law. This Article grapples with the tension between the positivist’s official- or judge-centered account of the recognitional community and the “popular constitutionalism” now so widely defended by constitutional scholars such as Larry Kramer, Robert Post, Reva Siegel, Mark Tushnet, Jeremy Waldron, and many others. Surely the popular constitutionalist would want to claim that U.S. citizens, not judges or officials, are the recognitional community for U.S. law. I term this position “deep popular constitutionalism.” Indeed, it turns out that Dworkin’s account of law, in its ambition to generate associative moral obligations for the citizenry as a whole, implies deep popular constitutionalism. Here there is a disagreement, hitherto unnoticed, between Dworkin and the positivists. My solution to this disagreement – to the debate between deep popular constitutionalists and deep official or judicial supremacists -- is to dissolve it by providing a group-relative account of law. Social norms, such as norms of dress or eating, are clearly group-relative. A particular dressing or eating behavior may be socially appropriate relative to one group’s norms, yet socially inappropriate relative to another’s. This Article extends the group-relative view from social norms to law itself, with a particular focus on U.S. law and constitutionalism. Part I surveys the jurisprudential literature. It shows how Hart and successor positivists identify the rule of recognition as a social practice engaged in by officials or some subset of officials (judges), rather than citizens generally, and argues that Dworkin by contrast sees the citizenry as a whole as his recognitional community. Parts II and III defend a group-relative account of law. Part II argues, with reference to the U.S. experience, that multiple groups can simultaneously instantiate the kind of social fact that undergirds law, be it a convention, a social norm, a “shared cooperative activity” (SCA), or something else. At many points in U.S. constitutional history, multiple official or citizen groups, defined along departmental, partisan, regional, state-federal, religious, or other lines, have accepted competing rules of recognition for U.S. law. Part III argues that “law” functions, primarily, as either an explanatory or a normative construct, and that insisting on a single recognitional community for each legal system would be arbitrary, both for explanatory purposes and for normative purposes. Part IV considers the many implications of the group-relative account for U.S. constitutional theory – in particular, for popular constitutionalism. (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)

We implemented a user-centered approach to the design of an artificial intelligence (AI) system that provides users with access to information about the workings of the United States federal court system regardless of their technical background. Presently, most of the records associated with the federal judiciary are provided through a federal system that does not support exploration aimed at discovering systematic patterns about court activities. In addition, many users lack the data analytical skills necessary to conduct their (...) own analyses and convert data into information. We conducted interviews, observations, and surveys to uncover the needs of our users and discuss the development of an intuitive platform informed from these needs that makes it possible for legal scholars, lawyers, and journalists to discover answers to more advanced questions about the federal court system. We report on results from usability testing and discuss design implications for AI and law practitioners and researchers. (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)

Current controversy over whether the Office of Management and Budget system of racial and ethnic classification should be used in pharmacogenetics research as suggested by the U.S. Federal Drug Administration has been couched in terms of realist-social constructionist debates on race. The assumptions both parties to these debates share instead need to be relinquished—specifically, dichotomies between the social and scientific and what is descriptive and evaluative/normative. This paper defends a pragmatic approach to the question of the appropriateness of the (...) OMB group categories in pharmacogenetics research, an approach that is local and context-specific rather than global, incorporates practical and ethical as well as theoretical dimensions, and recognizes intersections of the social and the biological in the constitution of group categories. (shrink)

Hastings Center Report, Volume 52, Issue 5, Page 4-5, September–October 2022.

This article analyzes the use of crowdsourcing to promote corporate sustainability by assessing compliance with supply chain disclosure laws. It draws on a case study of WikiRate.org as a novel example of crowdsourcing compliance with respect to the UK Modern Slavery Act and U.S. conflict minerals legislation (section 1502 of the Dodd-Frank Financial Reform Act). WikiRate is an open research platform whose mission is to crowdsource better companies by motivating corporations to be transparent about their environmental, social, and governance (...) performance. In particular, WikiRate’s projects on modern slavery and conflict minerals harness the power of citizens to evaluate the quality of corporate disclosures produced in accordance with these laws. Following an analysis of its projects on modern slavery and conflict minerals, I evaluate the challenges of using crowdsourcing to assess legal compliance, including the potential manipulation of data and the difficulty of relying on non-expert citizens to assess complex information in corporate disclosures. I argue that one must identify the appropriate “crowd” that would be most capable of assessing compliance with a given law. While crowdsourcing platforms such as WikiRate invite a broad range of stakeholders to assess compliance, the reality is that only a limited set of individuals may be able to meaningfully participate given the complexity of supply chain disclosures. Thus, “expertsourcing” may be a more appropriate tool for assessing compliance with certain laws as it limits participation to citizens with specialized expertise. (shrink)

In the absence of comprehensive immigration reform at the federal level, many American states and localities are undertaking their own legal reforms. The new state and local laws have been challenged by immigrant-rights organizations and individuals on the grounds that the federal government has already pre-empted the field. The lawsuits bring a new narrative voice—that of judges—into the boiling U.S. immigration debate. Judges engage the controversy over local enforcement of immigration enforcement, as they have other contentious disputes, both (...) as pragmatic decision-makers and as spokespersons for justice. The tensions this dual role entails are explored here in the context of a single, controversial case. Close-up analysis of the judge’s narrative strategy reveals a range of specific techniques to create moral distance from a decision, combined, ironically, with the enlistment of moral themes to justify the ruling. The inter-twining of rule-of-law and justice rhetoric mirrors and also shapes a broader politics of justice in the United States. (shrink)

Objectives:Over the past two decades, all U.S. states have incorporated alcohol ignition interlock technology into sentencing laws for individuals convicted of driving while intoxicated. This article provides the first 50-state summary of these laws to include changes in the laws over time and their effective dates. This information is critical for policy makers to make informed decisions and for researchers to conduct quantitative evaluation of the laws.Methods:Standard legal research and legislative history techniques were used, including full-text searches in the Westlaw (...) legal database and identification of state session laws. Because ignition interlock device laws often change over time, we identified the date of each law's initial enactment as well as the effective date of each law in its current form.Results:Beginning with California and Washington in 1987, all 50 states have enacted IID laws as a sentencing option for DWI offenders. Initially, most of these laws were discretionary. Today, however, 48 states mandate IID installation for at least some types of DWI offenders to maintain lawful driving privileges. Of these, 27 mandate an IID for all offenders; seven mandate an IID for repeat offenders only; and 21 for some combination of specific groups of DWI offenders, including repeat offenders, offenders with a blood alcohol content above a legislatively-specified level, and aggravated offenders.Conclusion:States have wrestled with a number of IID policy issues, including for whom to mandate IIDs and whether to suspend a license for DWI prior to reinstating driving privileges with or without an IID. By understanding how state interlock laws differ, policy makers and researchers can ultimately better ascertain the impact of these laws. (shrink)

Though lobbying for federal money may seem like business as usual today–with billions of dollars spent annually by companies, labor unions, and other organizations in an effort to win a piece of what has become an enormous federal pie–this was not always the case in the United States. An all-but-forgotten event, the Harrisburg Convention of 1827, may have been one of the key historical turning points in this regard, an opening of a floodgate that would transform the role (...) of the U.S. federal government forever. It was in the modest Pennsylvania capital that a hundred of the North’s most influential manufacturers and public servants–backed by legislators like Henry Clay and Daniel Webster–assembled to draft a “memorial” to Congress, imploring that body to pass a protectionist bill to save their industries from what they viewed as eventual ruin. As Jonathan J. Pincus observed and Thornton and Ekelund echoed, “it is not small cohesive individual groups but larger diverse ones that are necessary in order to effectively lobby representatives and senators to obtain majority coalitions” in comprehensive legislation. The convention would bring together this “larger diverse” group—with just such a legislative goal. Meanwhile, mostly in the South, anti-protectionist opinion continued to surge. The Harrisburg Convention of 1827 would lead to the passage of that most hated piece of protectionist legislation—the “Tariff of Abominations” of 1828–and it would do so by framing the protectionist agenda into a nationalist “cause” borne of “patriotic duty.”. (shrink)

In this paper, I aim to explicate the distinction between ‘unconditional relevance’ and ‘conditional relevance’ as those terms and related concepts are applied in the context of admissibility determinations in modern trials. I take the U.S. Federal Rules of Evidence to be my model in analyzing these concepts, though on my view any reasonable approach to legal evidence will have to distinguish between these concepts and make appropriate provisions for their separate treatment. I begin by explaining how the (...) class='Hi'>Federal Rules define and apply the concepts of relevance and conditional relevance, and I present an influential argument due to Vaughn Ball that threatens to undermine the distinction between the two concepts. I then argue that Ball's argument fails and I diagnose that failure. However, building on some insights from a variety of evidence scholars, I argue that the approach to conditional relevance adopted by the Federal Rules is crucially flawed for reasons entirely independent of the ones raised by Ball's argument. I identify the main constraints that, on my view, any reasonable approach to conditional admissibility must obey, and I argue for a specific proposal that obeys those constraints. On my positive view, two pieces of evidence should be admitted under a Conditional Admissibility Principle only when each piece of evidence would survive ordinary admissibility scrutiny, conditional on the admission of the other one. I conclude by considering the question of whether it should also be necessary for the two pieces of evidence to survive admissibility scrutiny together, as an ‘evidential package’; I argue that, though the issue may arise infrequently in practice, there is good reason to impose this additional requirement. (shrink)

The U.S. Supreme Court’s Dobbs ruling triggered a global debate about access to abortion and the legislative models governing it. In the United States, there was a sudden reversal of federal guidance about pregnancy termination that is unprecedented in Western and high-income countries. The strong polarization on the issue of abortion and the difficulty of finding a point of compromise lead one to consider the experiences of countries that have had different paths. Italy stands as a candidate for being (...) a partially alternative model because it allows abortion up to 12 weeks, but without considering it a subjective right. The legislation in place since 1978 aims to balance the interests of the fetus and those of the woman. An issue often raised concerning Italian law is that of conscientious objection granted to doctors. Many gynecologists declare themselves objectors, and this makes access to abortion more difficult in some regions of Italy. After discussing this issue and envisaging different ways to deal with it, the article concludes by highlighting new dilemmas about a possible divorce between the law and medical ethics in different directions and offers some avenues to begin setting up a response. (shrink)

Institutions receiving federal funding for research from the U.S.Public Health Service need to have policies and procedures to both prevent research misconduct and to adjudicate it when it occurs. The person who is designated to handle research misconduct is typically referred to as the research integrity officer (RIO). In this interview study we report on 79 RIOs who describe how they would handle allegations of research misconduct. Their responses were compared to two expert RIOs. The responses to the (...) allegations in the scenarios demonstrated that RIOs are not uniformly well prepared to handle activities associated with reported allegations of research misconduct. We recommend greater preparation through directed training, use of check lists of possible behaviors necessary to consider when situations arise, being involved in a network of RIOs so one can discuss options, and the possible need to certify RIOs. (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.

The U.S. Supreme Court has likely already decided how much, if any, of President Obama's signature Affordable Care Act it is going to strike down as unconstitutional; its holding will be published this summer. No matter what the Court decides, though, it will send state and federal legislators scrambling—either to implement the law or to deal with the consequences of its alteration. There are various decisions the Court might make, but it is still most apt either to leave the (...) ACA standing, or to selectively invalidate some of its mandate‐related provisions. In either case, there will be exchanges to design and manage, subsidies to allocate, transparency standards to design and enforce. The Court's decision will thus mark the beginning, not the end, of health reform. (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)

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

In relation to a thesis put forward by Marx Wartofsky, we seek to show that a historiography of mathematics requires an analysis of the ontology of the part of mathematics under scrutiny. Following Ian Hacking, we point out that in the history of mathematics the amount of contingency is larger than is usually thought. As a case study, we analyze the historians’ approach to interpreting James Gregory’s expression ultimate terms in his paper attempting to prove the irrationality of \. Here (...) Gregory referred to the last or ultimate terms of a series. More broadly, we analyze the following questions: which modern framework is more appropriate for interpreting the procedures at work in texts from the early history of infinitesimal analysis? As well as the related question: what is a logical theory that is close to something early modern mathematicians could have used when studying infinite series and quadrature problems? We argue that what has been routinely viewed from the viewpoint of classical analysis as an example of an “unrigorous” practice, in fact finds close procedural proxies in modern infinitesimal theories. We analyze a mix of social and religious reasons that had led to the suppression of both the religious order of Gregory’s teacher degli Angeli, and Gregory’s books at Venice, in the late 1660s. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.4 (2003) 393-406 [Access article in PDF] U.S. Defunding of UNFPA:A Moral Analysis Ronald M. Green Ethical decisions made inside the Beltway sometimes have global consequences. Nowhere is this more true than with respect to the decision by Secretary of State Colin Powell on 21 July 2002 to halt $34 million in U.S. funding for the United Nations Population Fund (UNFPA). Behind this decision (...) lay the forces of America's abortion politics as well as tangled issues in law and bioethics.I became involved in this debate when, in early September 2003, I served as a member of a nine-person delegation of U.S. religious leaders and ethicists that traveled to China to meet with those associated with the UNFPA program there. The delegation was assembled by Frances Kissling, of Catholics for a Free Choice, which also provided support and funding for the necessary travel and administrative services. In China, our contacts included UNFPA administrators, Chinese government officials, and ordinary villagers touched by UNFPA efforts. In the middle of its week-long stay, the delegation left Beijing in three separate groups to travel to remote provincial regions (Hubei, Gansu, and Ningxia). Our goal was to respond to the Bush administration's defunding decision by deepening our understanding of the current Chinese population program and UNFPA's relationship to it. In the course of this enquiry, I encountered challenging questions that drew on my own training in ethics in novel ways. Historical Background UNFPA is the world's largest organization providing family planning and reproductive health services. It was established in 1969 as the United Nations Fund for Population Activities. In 1987, the Economic and Social Council decided to rename it the United Nations Population Fund, but to retain the original abbreviation-acronym. UNFPA works to improve access to and the quality of family planning services in more than 140 of the poorest countries in the world. It is also very active in providing services aimed at preventing the spread of HIV/AIDS. It does not provide abortion services, but works to prevent abortion through family planning and to help countries provide services for women suffering from the complications of unsafe abortion. [End Page 393]Although UNFPA is officially an agency of the United Nations, its budget, currently about $200 million per year, comes from voluntary payments by donors, including UN member states. U.S. funding has been irregular. In 1985, the U.S. House of Representatives passed a foreign operations appropriations measure that has come to be known as the "Kemp-Kasten Amendment." This measure, which has been repassed in substantially unchanged form every year since, forbids funding for "any organization or program which, as determined by the President of the United States, supports or participates in the management of a program of coercive abortion or involuntary sterilization."1 From 1986 on, the Reagan and Bush administrations halted all U.S. funding for UNFPA activities around the world on the grounds that the agency's activities in China caused it to be involved in supporting or participating in the management of a program of coercive abortion or involuntary sterilization, and, hence, put it in violation of Kemp-Kasten.Efforts by the People's Republic of China to slow the increase of its population date from the early 1970s when, in a striking departure from classical Marxist theory, which had insisted on the positive value of added labor power and denied the need for demographic controls, the government imposed a policy of delayed marriage and birth spacing. In 1979, these efforts intensified with the advent of the "one child policy." (In fact, this name is misleading since the number of children allowed a couple varies significantly from urban to rural areas, with rural residents and members of ethnic minorities permitted to have larger families.) To implement this program, the government established a National Family Planning Commission (now National Population and Family Planning Commission) which, among other things, set up a network of family planning service centers around the country, where birth control... (shrink)

The rising cost of the opioid antagonist and overdose reversal agent naloxone is an urgent public health problem. The recent and dramatic price increase of Evzio, a naloxone auto-injector produced by Kaléo, shows how pharmaceutical manufacturers entering the naloxone marketplace rely on market exclusivity guaranteed by the patent system to charge prices at what the market can bear, which can restrict access to life-saving medication. We argue that 28 U.S.C. § 1498, a section of the federal code that (...) allows the government to use patent-protected products for its own purposes in exchange for reasonable compensation, could be used to procure generic naloxone auto-injectors, or at least bring Kaléo to the negotiating table. Precedent exists for the use of § 1498 to procure pharmaceuticals, and it could give meaning to the federal government's recent declaration of a public health emergency around the opioid epidemic, discourage new market entrants from charging exorbitant prices, and yield important public health benefits. (shrink)

In California Dental Association v. FTC, 119 S. Ct. 1604, the U.S. Supreme Court reviewed a decision by the U.S. Court of Appeals for the Ninth Circuit that a nonprofit affiliation of dentists violated section 5 of the Federal Trade Commission Act, 15 U.S.C.A. § 45, which prohibits unfair competition. The Court examined two issues: the Federal Trade Commission's jurisdiction over the California Dental Association ; and the proper scope of antitrust analysis. The Court unanimously held that (...) CDA was subject to FTC's jurisdiction, but split 5-4 in its finding that the district court's use of abbreviated rule-of-reason analysis was inappropriate.CDA is a voluntary, nonprofit association of local dental societies. It boasts approximately 19,000 members, who constitute roughly threequarters of the dentists practicing in California. Although a nonprofit, CDA includes for-profit subsidiaries that financially benefit CDA members. CDA gives its members access to insurance and business financing, and lobbies and litigates on their behalf. Members also benefit from CDA marketing and public relations campaigns. (shrink)

The United Kingdom has many bodies that play their part in carrying out the work of national ethics committees, but its nearest equivalent of a U.S. presidential bioethics commission is the Nuffield Council on Bioethics, established in 1991. The Council is charged with examining ethical questions raised by developments in biological and medical research, publishing reports, and making representations to appropriate bodies in order to respond to or anticipate public concern. It is a nongovernment organization with no defined or guaranteed (...) channels of influence. It has no authority merely by virtue of the position it holds. Rather, it has established relational authority based on its reputation. Unlike the U.S. bioethics commission, it is not part of executive government, nor is it constituted to contribute to the legislative branch, as does the French Comité Consultatif National d'Ethique. Its nongovernmental status notwithstanding, the Nuffield Council's work affects the U.K. government and the British public, and the Council has achieved international recognition for its reports. I was the chairperson from 2012 to 2017 and draw on my experience in this piece to consider three key audiences: governments, publics, and the international community. (shrink)

In 1997, the American Academy of Pediatrics issued a policy statement strongly supporting the physiological benefits conferred by human milk. It recommended that infants be breastfed for 12 months and called for employers to support breastfeeding. The following year, federal legislation was formulated to facilitate breastfeeding among women in paid work. Although both these events represented significant developments in the U.S. context, they nevertheless posed potential gender equity concerns. This article explores the National Organization for Women's response to (...) these developments. In doing so, it also examines the way in which the issue of breastfeeding and women's labor market involvement was addressed in equal-treatment/special-treatment debates in the previous decade. The article concludes by arguing that “equality and difference” discussions need to be extended to provide a new theoretical and practical framework for achieving equity in the workplace that would also accommodate the needs of women who wish to breastfeed or to express/pump breast milk. (shrink)

This Second Edition of A New Environmental Ethics: The Next Millennium for Life on Earth offers clear, powerful, and often moving thoughts from Holmes Rolston III, one of the first and most respected philosophers to write on the environment and often called the "father of environmental ethics." Rolston surveys the full spectrum of approaches in the field of environmental ethics and offers critical assessments of contemporary academic accounts. He draws on a lifetime of research and experience to suggest an outlook, (...) and even hope, for the future. This forward-looking analysis, focused on the new millennium, will be a necessary complement to any balanced textbook or anthology in environmental ethics. The First Edition guaranteed "to put you in your place." Beyond that, the Second Edition, asks whether you want to live a "de-natured life on a de-natured planet." Key Updates in the Second Edition - Covers the worsening environmental situation due to actions of the Trump administration, including withdrawal from the Paris accord and from the U.N. Framework Convention on Climate Change - Includes information on legislation in key U.S. states aimed to ameliorate the damage done at the Federal level - Increases coverage of group knowledge, group agreement and disagreement, and group action in collective environmental ethics, as distinguished from individual knowledge and action - Examines the deleterious effects of online consumer behavior - Explains how a loss of solidarity among a nation's citizens and even a larger solidary among humanity leads to environmental degradation - Offers new analysis of the effects of epistemic bubbles, echo chambers, and fake news on the behavior of voters and consumers - Provides an extended critique of the Anthropocene Epoch, and the prospect of geo-engineering Earth to become a synthetic environment. (shrink)

Since America's founding, the U.S. Supreme Court had issued a vast number of decisions on a staggeringly wide variety of subjects. And hundreds of judges have occupied the bench. Yet as Cass R. Sunstein, the eminent legal scholar and bestselling co-author of Nudge, points out, almost every one of the Justices fits into a very small number of types regardless of ideology: the hero, the soldier, the minimalist, and the mute. Heroes are willing to invoke the Constitution to invalidate state (...) laws, federal legislation, and prior Court decisions. They loudly embrace first principles and are prone to flair, employing dramatic language to fundamentally reshape the law. Soldiers, on the other hand, are skeptical of judicial power, and typically defer to decisions made by the political branches. Minimalists favor small steps and only incremental change. They worry that bold reversals of long-established traditions may be counterproductive, producing a backlash that only leads to another reversal. Mutes would rather say nothing at all about the big constitutional issues, and instead tend to decide cases on narrow grounds or keep controversial cases out of the Court altogether by denying standing. As Sunstein shows, many of the most important constitutional debates are in fact contests between the four Personae. Whether the issue involves slavery, gender equality, same-sex marriage, executive power, surveillance, or freedom of speech, debates have turned on choices made among the four Personae--choices that derive as much from psychology as constitutional theory. Sunstein himself defends a form of minimalism, arguing that it is the best approach in a self-governing society of free people. More broadly, he casts a genuinely novel light on longstanding disputes over the proper way to interpret the constitution, demonstrating that behind virtually every decision and beneath all of the abstract theory lurk the four Personae. By emphasizing the centrality of character types, Sunstein forces us to rethink everything we know about how the Supreme Court works. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Another Bioethics Commission?Renie Schapiro (bio)Ever Since the Ill-Fated Biomedical Ethics Advisory Committee (BEAC) ended almost before it began a few years ago, bioethicists and the members of Congress who take an interest in them have wondered whether a governmental commission is still a feasible way to address bioethics issues.The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, and the President's Commission (...) for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in the early 1980s, have generally received high marks for their work. But since the expiration of the President's Commission in 1983, no federal body has been able to sustain the momentum.Tempers around the abortion issue couldn't be tamed enough even to elect a board chairman for the BEAC, or for the body to begin studying the issues. From its inception, abortion politics threatened to dog its work.Both the National Commission and the President's Commission studied issues touching on the abortion question. The President's Commission reported on genetic screening. The National Commission looked at fetal research. Both were able to produce respected reports that largely steered clear of the abortion acrimony.But that was then. The question facing policy makers inside the Beltway is how we can learn from the past experiences to make some new body work now. The question extends far beyond the abortion issue, of course.When certain people in Washington start asking questions, the answer usually comes by way of a study. Sometimes, as in this case, more than one study.In the March 1992 issue, this Journal reported on an Institute of Medicine study on ethics commissions. That study is still underway. It is scheduled to be completed in January 1994.More recently, the Office of Technology Assessment (OTA), an arm of Congress, also took on the issue. The OTA project is intended to be a quicker, more confined study. It began last fall and a final report is expected later this month.The primary force behind the OTA study is Senator Mark Hatfield. In a September 8, 1992 letter, co-signed by Senators Edward Kennedy and Dennis DeConcini, he asked OTA to prepare a background report to assist Congress in [End Page 77] "determining what is the best approach to explaining policy problems with biomedical and ethical dimensions."The letter noted: "As the 21st Century approaches, Congress will face policy dilemmas for which an informed decision can only be made through understanding not just the legal or economic dimensions of the questions, but the ethical considerations as well."Hatfield's interest in bioethics issues over the past few years has centered largely on biotechnology, and particularly patent rights. He had planned to introduce legislation to put a moratorium on patenting of genetically altered organisms, which according to Hatfield staffer Douglas Pahl caused a "firestorm" in the biotechnology community.As a result, Kennedy and DeConcini said they would hold hearings on the issue if Hatfield would withdraw the amendment. The three agreed to request a short-term OTA report on possible governmental structures for dealing with bioethics issues and a longer report looking at patenting issues.In their letter, the three senators asked OTA to prepare a history of bioethics in public policy. Referring specifically to the past commissions, they asked, "What lessons can we learn from each of these—or similar—entities? What worked, or did not work, and why?" The request also asked OTA to examine international institutions.In response to the request, OTA held a workshop entitled "Biomedical Ethics in U.S. Public Policy" on December 4, 1992. It brought together 15 people who had participated in commissions—from local to international—as well as observers of these bodies and health professionals who used their products.1According to project director Robyn Nishimi, the workshop was meant to be a free-wheeling discussion. Although there was no total consensus, the focus of the discussion tended to be on how to make a commission function effectively, rather than on whether there should be one. That workshop will be part of a report of about 40-60 pages OTA hopes to... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.2 (2002) 215-224 [Access article in PDF] Bioethics Inside the Beltway Expanding Human Research Oversight Ellen Holt [Table]Overwhelmed by all the changes and proposed changes in the system to ensure human subject protection? It is an important subject and one in which everyone is interested. Being for human subject protection is like being for Mom. However, we all know that Mom sometimes can be (...) a handful! So I shall quickly review how we got to where we are, what is being done, and who is doing it. The table at the end of this article provides an additional summary of the current state of human subject protections. How We Got Here The current system of human subject protection was built 30 years ago with Institutional Review Boards (IRBs) as the cornerstone. Some well-publicized system failures in the last decade prompted evaluations that identified increasing volume and research complexity as primary threats to the system's effectiveness. In response, the Department of Health and Human Services (DHHS) Office of Inspector General (OIG 1998), and the National Bioethics Advisory Commission (NBAC 2001) issued recommendations calling for education and reform. Since then, initiatives in pursuit of these objectives have been rolling out non-stop. What Is Being Done The Office of Human Research Protections (OHRP) is leading the effort for DHHS, holding noncompliant research organizations accountable, while expanding the government's capacity for oversight, monitoring, and educating the research community. OHRP already has leveraged resources by: (1) implementing a unified federal registration system for all IRBs that identifies where IRBs are, how they are constituted, what kinds of research they are reviewing, and what volume of work they handle; (2) implementing a streamlined assurance process allowing all federal agencies to recognize a single, common assurance and avoid redundancy. The assurance is a commitment from any entity that receives federal funds for research to follow federal rules for protection of research subjects; and (3) redeploying resources from the process of negotiating assurances to supporting [End Page 215] quality improvement, including increasing the number site visits and providing IRBs with tools for self assessment and guidance for improvement.The goal is to prevent problems before they occur, and positive reinforcement and supportive training are the preferred themes. OHRP does wield a big stick and can shut down clinical studies in response to lax oversight, but it also has developed a big carrot by creating a national awards program to recognize excellence in protection of human research subjects—e.g., best practices, innovations in protecting research volunteers, and lifetime achievement for outstanding protection activities.Dr. Greg Koski, Director of OHRP, also is working with other government agencies to consolidate and build a comprehensive program. OHRP has four goals for a new oversight framework: Simplicity, Uniformity, Efficiency and Effectiveness. Selecting representatives from throughout the federal government, Dr. Koski has created the "SUEE" task force to identify and eliminate inefficiencies between the various agencies' human testing regulatory approaches. In addition, the SUEE task force will suggest improvements to current OHRP practices that can be achieved relatively quickly and easily.OHRP is working in concert with the Food and Drug Administration (FDA), which in October 2001, established the Office of Good Clinical Practice (OGCP) to improve the conduct and oversight of clinical research and to promote the protection of participants in FDA-regulated clinical research. Congressional Developments Although Dr. Koski is leading an aggressive charge to consolidate oversight across the federal government, many feel that reform will require legislation to succeed.Action on Capitol Hill is encouraging Bush administration efforts to reform oversight of clinical research. The House International Relations Committee has approved a measure that protects individuals in clinical trials overseas. A six-part Washington Post series (17-22 December 2000), "The Body Hunters," prompted an amendment to the Export Administration Act that, if finalized, will require drug companies to show that a U.S. ethics committee has approved the clinical trial as part of the application for authorization to export the investigational product.Members of Congress also are considering legislation to expand federal oversight of... (shrink)

Shortly before and during the Second World War, Japanese doctors and medical researchers conducted large-scale human experiments in occupied China that were at least as gruesome as those conducted by Nazi doctors. Japan never officially acknowledged the occurrence of the experiments, never tried any of the perpetrators, and never provided compensation to the victims or issued an apology. Building on work by Jing-Bao Nie, this article argues that the U.S. government is heavily complicit in this grave injustice, and should respond (...) in an appropriate way in order to reduce this complicity, as well as to avoid complicity in future unethical medical experiments. It also calls on other U.S. institutions, in particular the Presidential Commission for the Study of Bioethical Issues, to urge the government to respond, or to at least inform the public and initiate a debate about this dark page of American and Japanese history. (shrink)

As this nation embarks on new efforts to reform the U.S. health system, we face a critical unfinished agenda from the mid- 1960s: persistent racial, ethnic, and socioeconomic disparities in health and health care. Medicaid, Medicare, and Community Health Centers — public programs with very different legislative histories and financing mechanisms — were the first federally funded, nationwide efforts to improve health care access for low-income and elderly Americans. Members of racial and ethnic minority groups also greatly benefited from these (...) efforts because recipients of federal funds, such as Medicare, were required to comply with the newly passed Civil Rights Act of 1964, which barred racial discrimination. Unquestionably, government played a major role in the gains in health care access that have occurred in the last half century. Yet today all Americans do not have the same opportunities for health, access to care, or quality of care when they receive it. (shrink)

The first principle of the Nuremberg Code requires the informed consent of the subject. Proxy consent was not addressed until the Declaration of Helsinki. U.S. policies regarding consent for the participation of children in research would not be finalized for almost two more decades in subpart D of the federal regulations that govern the participation of subjects in research. In October 2000, the Children's Health Act was passed. Title X required the Secretary of the Department of Health and Human (...) Services to conduct a review of the regulations under subpart D and “to consider any modifications necessary to ensure the adequate and appropriate protection of children participating in research, and report the findings of the Secretary to Congress.” In this article, I provide a brief overview of the current informed consent requirements in pediatric research, which include requirements for parental permission and the child's assent. I then examine the moral bases for these requirements; whether the current policies are consistent with these moral foundations; and if not, how the policies ought to be modified. a. (shrink)

In recent years, there has been much discussion over how to assure scientific integrity. It has become clear that a few scientists have fraudulently collected or reported data, conducted harmful or unethical experiments, or practiced “unscientific” procedure. What are regulative bodies to do? The approach has been to define research misconduct and then use that definition to assess scientific practice.[1] But just how to define research misconduct and hence, regulate the conduct of scientists in research? The debate that resulted in (...) response to this question, and that led ultimately to the new federal definition (42CFR50), has both theoretical and political underpinnings. The political underpinnings have been greatly discussed. But the theoretical underpinnings (and their connection to the political) have not. To give a definition of “good” versus “bad” science requires some understanding of the scientific process itself. So theoretical ideas about what constitutes good or bad science—ideas that influence and help shape our ideas and applications of research misconduct definitions—have political implications for the regulation of science. However, as the debates within both the scientific and philosophical communities have made clear, there are significant limits to any appropriate legislation of what counts as “good” science. A definition of research misconduct (or “bad” science) that spells out the nature of science too stringently may stifle scientific innovation. Consider the case of sociobiology when it was first introduced in the 1970’s. The idea is to account for social behavior of various species (including Homo sapiens) in terms of evolutionary biology. To take one example from sociobiology, the greater tendency of males toward rape is to be explained in terms of the evolutionary advantage for the male’s genes. Not surprisingly, sociobiology met with great controversy; some considered it an inappropriate application of biological principles to the social-interpretive-human domain. Still, few did or would suggest that it is the province of any regulatory body to silence the advocates of the new field. We will endorse and reinforce the standard arguments that the scientific process is too complicated to provide mechanical rules of conduct.. (shrink)