Introduction Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. Methods I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. Results IRBs wrestled with (...) defining of ‘coercion’ and ‘undue inducement’, most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on ‘gut feelings’, and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should ‘get paid’ versus ‘volunteer’ (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research. Conclusions These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 175-188 [Access article in PDF] Scope Note 38 Bioethics Resources on the Web * Once described as an "enormous used book store with volumes stacked on shelves and tables and overflowing onto the floor" (Pool, Robert. 1994. Turning an Info-Glut into a Library. Science 266 (7 October): 20-22, p. 20), Internet resources now receive numerous levels of organization, from basic directory (...) listings to elaborate "links" (cross-references to other Internet documents) that flash and glow in the dark. In many ways, the Internet functions as a direct extension of the traditional library. Following linked references across various sites is an electronic version of browsing library stacks, and the serendipitous discoveries made while "surfing the Net" recall the wonders of physically going "book-to-book." Although many of the Internet's best aspects augment library strengths by eliminating physical distance from sources, Net resources pose unique problems for researchers. It is not always clear who is responsible for the content of Web documents, when the document was produced, or how often (if ever) it is updated. Internet resource tools, then, must enable researchers to identify appropriate resources and to evaluate what they find when they get there. Web Research as Taking "Snapshots" Given the Internet's visual nature and fluid content, the process of conducting research on the Web has been likened to taking an informal picture of information on a specific date at a particular time. This metaphor also conveys the "zoom-in" aspect of searching through Web pages by going from general to specific categories. In the first section of this Scope Note, National Reference Center for Bioethics Literature (NRCBL) staff present a snapshot of bioethics resources taken during the spring months of 2000. Entries are divided into the categories of directories, electronic journals, full-text documents, news/current awareness, and teaching resources. In the two subsequent sections, this series of categories is repeated for entries on a specific topic within bioethics-genetics-and again for general search and evaluation tools. Where a Web site may contain pages applicable [End Page 175] to more than one category, multiple entries are made for that site with appropriate information for each category.Much as telecommunication advances have strengthened the relationship of patients and providers as partners, the dynamic nature of the Internet acknowledges that the researcher functions as a librarian whenever accessing the Web. It is our hope that BIOETHICSLINE and the other NRCBL databases not only will enable researchers to search the Web more efficiently, but also will help them to evaluate what they find when they get there. Bioethicsline on the Web: An International Plan in Progress Once only available through libraries, the U.S. National Library of Medicine (NLM), the funding agency for the ongoing development of the BIOETHICS LINE® database from the Kennedy Institute, has provided free Web access to that database of 63,000 citations since September 1998 through Internet Grateful Med. Plans are now underway to eliminate such specialty databases and incorporate all citations into PubMed (for journal articles) or LOCATORplus (for book-like materials and chapters in books). Both of these databases are likewise available at no cost on the Web. In the transition to PubMed and LOCATORplus some features of BIOETHICSLINE that presently are available may be lost. Researchers are encouraged to contact the National Reference Center for Bioethics Literature with search requests or for search strategy assistance with either the current or the future system (medethx@georgetown.edu).The inclusion of bioethics citations in PubMed and LOCATORplus will have several advantages. First, unique keywords from the Bioethics Thesaurus will be considered for inclusion in Medical Subject Headings (MeSH), the indexing vocabulary for PubMed and LOCATORplus, thereby enhancing retrieval of relevant clinical literature by offering more precise terminology covering ethical issues. Second, it will be easier to identify foreign-language materials, which are not currently included in the scope of BIOETHICSLINE. Third, the updating schedule will become more frequent. On the other hand, there may be some loss of searching precision because certain specialized features... (shrink)

The UK’s National Institute for Health and Care Excellence is responsible for conducting health technology assessment on behalf of the National Health Service. In seeking to justify its recommendations to the NHS about which technologies to fund, NICE claims to adopt two complementary ethical frameworks, one procedural—accountability for reasonableness —and one substantive—an ‘ethics of opportunity costs’ that rests primarily on the notion of allocative efficiency. This study is the first to empirically examine normative changes to (...) NICE’s approach and to analyse whether these enhance or diminish the fairness of its decision-making, as judged against these frameworks. It finds that increasing formalisation of NICE’s approach and a weakening of the burden of proof laid on technologies undergoing HTA have together undermined its commitment to EOC. This implies a loss of allocative efficiency and a shift in the balance of how the interests of different NHS users are served, in favour of those who benefit directly from NICE’s recommendations. These changes also weaken NICE’s commitment to AfR by diminishing the publicity of its decision-making and by encouraging the adoption of rationales that cannot easily be shown to meet the relevance condition. This signals a need for either substantial reform of NICE’s approach, or more accurate communication of the ethical reasoning on which it is based. The study also highlights the need for further empirical work to explore the impact of these policy changes on NICE’s practice of HTA and to better understand how and why they have come about. (shrink)

Context: Although ethics consultation is commonplace in United States hospitals, descriptive data about this health service are lacking. Objective: To describe the prevalence, practitioners, and processes of ethics consultation in U.S. hospitals. Design: A 56-item phone or questionnaire survey of the “best informant” within each hospital. Participants: Random sample of 600 U.S. general hospitals, stratified by bed size. Results: The response rate was 87.4%. Ethics consultation services were found in 81% of all general hospitals in the U.S., and in (...) 100% of hospitals with more than 400 beds. The median number of consults performed by ECSs in the year prior to survey was 3. Most individuals performing ethics consultation were physicians, nurses, social workers, or chaplains. Only 41% had formal supervised training in ethics consultation. Consultation practices varied widely both within and between ECSs. For example, 65% of ECSs always made recommendations, whereas 6% never did. These findings highlight a need to clarify standards for ethics consultation practices. (shrink)

Nearly 90 % of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we discuss the laws that empower federal agencies that can oversee (...) investigations of biomedical research misconduct: the Office of Research Integrity and the Office of the Inspector General, both located within the Department of Health and Human Services. Research misconduct investigations pertaining to U.S. physical sciences funded through the National Science Foundation are overseen by the NSF’s OIG. While OIGs may provide some improvement over the ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits of the effectiveness by which allegations of research misconduct are handled in the United States. Specifically, sufficient data do not need to be retained by U.S. research institutions funded by HHS or NSF to allow effective audit of why allegations of research misconduct are dismissed before being seen by faculty inquiry or investigative committees. U.S. federal Generally Accepted Government Auditing Standards, if applied to the research misconduct oversight process, would allow a determination of whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. In particular, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct. (shrink)

The 2024 U.S. election will shape the future of global health policy, with crucial implications for continuing U.S. leadership in global health. The United States has long played a critical role in global health governance, through multilateral institutions under the United Nations (UN) and bilateral assistance to advance U.S. priorities. However, political shifts have challenged U.S. engagement in global health, with the politicization of global health policy threatening global governance under the World Health Organization (...) (WHO) and dividing global health support across political parties. This political polarization in global health proved catastrophic in the COVID-19 pandemic response and influential in the 2020 Presidential Elections. With the United States again seeking to advance global health policy, the 2024 Elections present a clear contrast in global health visions across U.S. political parties – with sweeping impacts on global governance, health funding, sexual and reproductive health, corporate regulations, tax equity, humanitarian challenges, and climate change. The future of U.S. leadership in global health hangs in the balance of this election, raising an imperative for candidates to highlight their global health positions and for voters to consider the global health implications. (shrink)

The National Institutes of Health is the largest biomedical research institution in the world. It has become one of the world's most highly respected research centers in part because of its efforts over the years to provide the research community with leadership in both the ethical and scientific parameters of research involving humans. As its 113th birthday approaches at the turn of the century, its great legacy is providing an environment to stimulate and nourish the diversity and (...) creativity of ideas, and thereby enable science to progress. This research must continue to be guided and tempered by consistent and critical federally-supported ethical analyses. (shrink)

Many studies have documented gender differences in attitudes toward and experiences with science. Compared to men, for example, women are less likely to study science and to pursue careers in science-related fields. Given these findings, should we expect gender differences in support for scientific involvement in U.S. environmental policy? This study empirically examines the relationship of gender to attitudes toward science and preferred roles of scientists in environmental policy among various environmental policy participants. Data collected in 2006 and 2007 from (...) national surveys of four different groups involved in environmental policy and management suggest that social context, including education and occupation, shapes the way that gender matters. Specifically, we find that gender is less important among scientists and managers than among interest groups and the general population regarding attitudes toward science and views about preferred roles of scientists in environmental decision making. (shrink)

In the premises, the author analyses how the different historiographical trends concerning the Atlantic world have reduced the centrality of the State, and recent researches which focused on the processes of State-building and on the financial revolutions between the Seventeenth and the Nineteenth centuries. Within this frame, the essay outlines an Atlantic history of the foundation of the U.S. through a reading of the Report on Public Credit (1782) of Robert Morris, Superintendent of Finances, and some writings of Alexander (...) Hamilton, Secretary of the Treasury. The author argues that the institution of public debt and the foundation of the national bank constituted an adequate response not only to the need of State which characterized European history, but also to the capitalistic practices which marked European economies. The author underlines the continuity between the processes of State-building and the transition to capitalism in Europe and America in the age of the democratic revolutions. (shrink)

Context: Although ethics consultation is commonplace in United States (U.S.) hospitals, descriptive data about this health service are lacking. Objective: To describe the prevalence, practitioners, and processes of ethics consultation in U.S. hospitals. Design: A 56-item phone or questionnaire survey of the "best informant" within each hospital. Participants: Random sample of 600 U.S. general hospitals, stratified by bed size. Results: The response rate was 87.4%. Ethics consultation services (ECSs) were found in 81% of all general hospitals in the U.S., (...) and in 100% of hospitals with more than 400 beds. The median number of consults performed by ECSs in the year prior to survey was 3. Most individuals performing ethics consultation were physicians (34%), nurses (31%), social workers (11%), or chaplains (10%). Only 41% had formal supervised training in ethics consultation. Consultation practices varied widely both within and between ECSs. For example, 65% of ECSs always made recommendations, whereas 6% never did. These findings highlight a need to clarify standards for ethics consultation practices. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Human Genome ProjectSharon J. Durfy (bio) and Amy E. Grotevant (bio)In recent years, scientists throughout the world have embarked upon a long-term biological investigation that promises to revolutionize the decisions people make about their lives and lifestyles, the way doctors practice medicine, how scientists study biology, and the way we think of ourselves as individuals and as a species. It is called the Human Genome Project, and its (...) ultimate goal is to map and determine the chemical sequence of the three billion nucleotide base pairs that comprise the human genome. The feat is expected to take about fifteen years (see General Surveys).These three billion base pairs include an estimated 50,000 to 100,000 genes. The rest of the genome—perhaps 95 percent of it—is nongenic sequences with unknown function, sometimes called "junk." Determining the order and organization of all this material has been likened to tearing six volumes of the Encyclopaedia Brittanica into pieces, then trying to put it all back together to read the information (Surveys: Hall 1990). The effort could be well worth it, many scientists say, because it is expected to yield major insights into many common and complex diseases, including cancer, cardiovascular disease, and Alzheimer's disease (Debate: Dulbecco 1986; Koshland 1989).The Human Genome Project is not without controversy, however (Debate: Davis 1990; Leder 1990; Rechsteiner 1990). Many scientists fear that funding for it will be diverted from other areas of research, rather than obtained from new funding sources. This has enlivened the debate about the relative value of "big" versus "small" science. Also, the value of undertaking a complete sequencing of the genome has been questioned, especially given the high proportion of non-genic sequences.Advocates of the effort converted many critics by making two alterations in the original plan. Plans were included to simultaneously determine the nucleotide sequence of the genomes of other organisms; this provides comparisons and points of reference for the human sequence (U.S.: NIH/DOE 1990). Second, in response to concerns about the high cost of developing technology to sequence the whole [End Page 347] genome, the focus moved from large-scale sequencing to mapping the genome, which would hasten the search for disease genes (U.S.: NIH/DOE 1990).The ideal map would be both genetic, locating DNA markers, or signposts, at closely spaced intervals along the chromosomes, and physical, indicating the exact distance between these markers (Map: McKusick 1991). Since 1973, Human Gene Mapping workshops (HGM) have been held at least every two years to locate, compare, and compile genetic markers. This information is published and is accessible through Genome Database at Johns Hopkins University (McKusick 1991). The most recent Human Genome Mapping workshop was held in August 1991, at which the Human Genome Organization (HUGO) began to assume increased responsibility for coordination of the international mapping effort (Surveys: Maddox 1991).Historical Background of the United States EffortThe first serious discussions about sequencing the entire human genome occurred at a workshop at the University of California at Santa Cruz in 1985 (U.S.: Sinsheimer 1989). A second workshop, organized by the U.S. Department of Energy (DOE) and held in March 1986, addressed the feasibility of an organized program (U.S.: DOE 1986). Shortly thereafter, DOE instituted its own genome project (U.S.: DOE 1987). Reports in early 1988 from both the National Research Council (NRC) of the National Academy of Sciences (NAS) and Congress' Office of Technology Assessment (OTA) (U.S.: NRC 1988; OTA 1988) served as catalysts, and in fiscal year 1988, the U.S. Congress officially launched the Human Genome Project by appropriating funds to both the Department of Energy and the National Institutes of Health (NIH).To avoid potential congressional "meddling" (U.S.: Roberts 1988), NIH and DOE drafted a memorandum of understanding for interagency coordination in October 1988 (U.S.: NIH/DOE 1990). The agencies then created both separate and joint committees, and working groups to administer the project. NIH established the Office of Human Genome Research in 1988 (directed by James D. Watson) to plan and coordinate NIH genome activities. That office has evolved into the National Center for Human Genome Research (NCHGR... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 15.2 (2005) 199-210 [Access article in PDF] Conflict-of-Interest Policy at the National Institutes of Health: The Pendulum Swings Wildly* Evan G. DeRenzo **This article addresses the National Institutes of Health (NIH) employee conflict-of-interest (COI) policy that went into effect February 2005. It is not, however, merely an account of another poorly crafted government policy that cries out for (...) revision. Instead, it is also a story about one of our nation's most important and prestigious institutions and its struggles to navigate the crosscurrents of scientific aspirations, power politics, public ambivalence toward capitalist economics in the biosciences, and the media's inclination to exaggerate problems and under report complicated facts. It is also a tale of greed, politics, purgatory, and redemption. The dramatic and abrupt change in the NIH COI policy demonstrates the difficulty of balancing the production of cutting-edge science with the demands for transparency resulting from work performed in the public interest on the public tab. It is an unhappy chapter in the life of a government agency that is also a national treasure. And, one hopes, it will be an example of how harmful and ill-conceived law can be revised and amended to advance national health and well-being. What is the New NIH COI Policy? The new NIH COI employee policy, more accurately referred to as the Interim Final Rule (Federal Register 2005), is a sweeping set of prohibitions on activities and holdings to reduce the possibility that NIH employees will have any actual [End Page 199] or apparent conflicts of interest. For the most part, the prohibitions are applied across-the-board—i.e., without distinction to employee category or function. The new policy includes prohibitions on outside activities, stock holdings, and awards. It prohibits all NIH employees from engaging in any compensated or uncompensated employment, including consulting, serving on advisory or other such boards, and compensated teaching, speaking, writing, or editing with certain kinds of entities. The first class of such entities is referred to as substantially affected organizations, defined as biotechnology, pharmaceutical, medical device companies, and others with similar interests. But these are not the only entities included in the prohibitions. Other organizations from which NIH employees now are cut off are hospitals, clinics, and other health care institutions; health, science, or health research-related professional associations and consumer and advocacy groups. Included also are educational institutions and not-for-profit independent research institutes that are, or were, recent NIH funding applicants, grantees, contractors, or cooperative research and development agreement (CRADA) partners. The only exemptions appear to be for health care institutions at which NIH employees provide clinical care and some forms of writing—e.g., an NIH physician who moonlights at her/his local hospital's emergency room or submits a manuscript to a peer-reviewed journal that receives only unrestricted funding from a prohibited entity. Prohibited and/or restricted holdings include stock in biotechnology, pharmaceutical, and medical device companies and others in research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. The prohibitions apply to senior NIH employees; restrictions in the amount of such holdings apply to all remaining employees. Both apply to the spouses and minor children of NIH employees. If an NIH employee wins an award, the monetary allowance in most cases is limited to $200. In sum, the scope of this policy is vast, too vast to be reasonable. Too many employees are restricted in too many ways. Where appropriate restrictions have been placed on senior NIH employees, even these constructive aspects of the policy are overshadowed by the unfairness and destructiveness of other aspects. This policy far exceeds anything that could be considered sound. Fortunately, the policy has a built-in assessment process to begin at the end of the policy's first year of implementation. One can only hope that a fair and open evaluation will be conducted, the results of which surely must result in major revisions to what is now bad regulation. Why the Policy... (shrink)

A 1999–2000 national study of U.S. hospitals raised concerns about ethics consultation (EC) practices and catalyzed improvement efforts. To assess how practices have changed since 2000, we administered a 105-item survey to “best informants” in a stratified random sample of 600 U.S. general hospitals. This primary article details the methods for the entire study, then focuses on the 16 items from the prior study. Compared with 2000, the estimated number of case consultations performed annually rose by 94% to 68,000. (...) The median number of consults per hospital was unchanged at 3, but more than doubled for hospitals with 400+ beds. The level of education of EC practitioners was unchanged, while the percentage of hospitals formally evaluating their ECS decreased from 28.0% to 19.1%. The gap between large, teaching hospitals and small, nonteaching hospitals widened since the prior study. We suggest targeting future improvement efforts to hospitals where needs are not being met by current approaches to EC. (shrink)

The requirements of the UK Equality Act 2010 and some high profile criticism for using a potentially ageist methodology have prompted the National Institute for Health and Clinical Excellence (NICE) to assess the processes and methodology it uses to make appraisal decisions. This paper argues that NICE has established rigorous systems to protect against ageist decisions, has no track record of ageism and is well placed to meet the requirements of new UK equality legislation.

BackgroundAs hospitals have grown more complex, the ethical concerns they confront have grown correspondingly complicated. Many hospitals have consequently developed health care ethics programs (HCEPs) that include far more than ethics consultation services alone. Yet systematic research on these programs is lacking.MethodsBased on a national, cross-sectional survey of a stratified sample of 600 US hospitals, we report on the prevalence, scope, activities, staffing, workload, financial compensation, and greatest challenges facing HCEPs.ResultsAmong 372 hospitals whose informants responded to an online (...) survey, 97% of hospitals have HCEPs. Their scope includes clinical ethics functions in virtually all hospitals, but includes other functions in far fewer hospitals: ethical leadership (35.7%), regulatory compliance (29.0%), business ethics (26.2%), and research ethics (12.6%). HCEPs are responsible for providing ongoing ethics education to various target audiences including all staff (77.0%), nurses (59.9%), staff physicians (49.0%), hospital leadership (44.2%), medical residents (20.3%) and the community/general public (18.4%). HCEPs staff are most commonly involved in policy work through review of existing policies but are less often involved in development of new policies. HCEPs have an ethics representative in executive leadership in 80.5% of hospitals, have representation on other hospital committees in 40.7%, are actively engaged in community outreach in 22.6%, and lead large-scale ethics quality improvement initiatives in 17.7%. In general, major teaching hospitals and urban hospitals have the most highly integrated ethics programs with the broadest scope and greatest number of activities. Larger hospitals, academically affiliated hospitals, and urban hospitals have significantly more individuals performing HCEP work and significantly more individuals receiving financial compensation specifically for that work. Overall, the most common greatest challenge facing HCEPs is resource shortages, whereas underutilization is the most common greatest challenge for hospitals with fewer than 100 beds. Respondents’ strategies for managing challenges include staff training and additional funds.ConclusionsWhile this study must be cautiously interpreted due to its limitations, the findings may be useful for understanding the characteristics of HCEPs in US hospitals and the factors associated with these characteristics. This information may contribute to exploring ways to strengthen HCEPs. (shrink)

Can a democratic Global Society become the alternative to Empire and bring order into present international anarchy? One hundred percent sovereignty in nation states gives “security” to each but creates “anarchy” in relations between states. To bring order into international relations some sovereignty has to be surrendered. Empire, which does bring an order of sorts, is imposed from outside, is undemocratic and aggrandising. Global Society can be conceptualised as its alternative. Sharply contrasting Global Society to Empire tends to pose the (...) former as a panacea, but it is important to know its potential faults. Global Society can be envisioned at the constitutive stage and as continuing to exert influence within the institutions it creates. At the difficult constitutive stage, it will be fragile and of unwieldy size and ought only be called into play at critical junctures. The institutions it creates will be a democratic federal regime of regional blocks of states. To resolve issues, Global Society presumes effective consocial dialogue and participation rather than violent contention. Classical and Hellenistic Greece provide examples where vision and honour battled with the ambitions and greed of Empire and remarkably sometimes won. All the Greek city-states were under some sort of regional federal alliance at different times and drew strength from shared religious sanctuaries and their attached Games. The various interchanges between democratic Federalism and Empire in ancient Greece offers a microcosm of today's interregnum between modern and postmodern international relations. For as democratic political theorists at the start of the twenty first century, we do not seem to be able to do without the legitimizing idea of the People, but we do not know what to do with it. —Margaret Canovan, “The People, the Masses, and the Mobilization of Power: The Paradox of Hannah Arendt's ‘Populism’” Lysistrata: Don't you share a cup at common altars, for common gods, like brothers, at the Olympic games, Thermophylai and Delphi? —Aristophanes, Lysistrata. (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)

This paper compares the moral reasoning of 363 auditors from Canada and the United States. We investigate whether national institutional context is associated with differences in auditors'' moral reasoning by examining three components of auditors'' moral decision process: (1) moral development, which describes cognitive moral capability, (2) prescriptive reasoning of how a realistic accounting dilemma ought to be resolved and, (3) deliberative reasoning of how a realistic accounting dilemma will be resolved. Not surprisingly, it appears that institutional factors are (...) more likely to be associated with auditors'' deliberative reasoning than their prescriptive reasoning in both countries. Additionally, our findings suggest that the national institutional context found in the United States, which has a tougher regulatory and more litigious environment, appears to better encourage auditors to deliberate according to what they perceive is "the ideal" judgment as compared to the Canadian context. We then discuss the implications of these findings for regulators and for ethics research. (shrink)

Book reviewed in this article: Medicine and Culture: Varieties of Treatment in the United States, England, West Germany, and France. By Lynn Payer. Health Care Systems: Moral Conflicts in European and American Public Policy. Edited by Hans‐Martin Sass and Robert U. Massey.

Scholars have mostly analyzed information from mental health practitioners, attorneys, and institutions to critique mental health practices in the War on Terror. These sources offer limited insights into the suffering of detainees. Detainee accounts provide novel information based on their experiences at Guantánamo. Mohamedou Ould Slahi’s Guantánamo Diary is the only text from a current detainee that provides a first-person account of his interrogations and interactions with health professionals. Despite being advertised as a diary, however, it has (...) undergone redaction from American government officials. This article examines Slahi’s account of his interrogations and representations of mental health at Guantánamo and considers its role within the narrative function of the nation. At stake is the right of detainees to narrate, scholars to critique medical practices in the War on Terror, and the nation’s attempts to control its narration. (shrink)

On September 26th, 2023, the National Institute on Minority Health and Health Disparities (NIMHD) officially designated disabled people as a health disparity population, marking the most significant event for disabled people's health as it relates to the NIH. In this paper, I discuss the larger socio-political context as well as the clinical import of this historic decision.

In lieu of an abstract, here is a brief excerpt of the content:Introduction VIOLENCE AND INSTITUTION IN CHRISTIANITY Robert J. Daly, SJ. Boston College We need both to define our terms and to indicate whether we are using them in a normative or descriptive sense. Thus the question: "Is Christianity"—or, if you will—"Are the institutions of Christianity violent or nonviolent?" can be answered with either a Yes, or a No, or with anything in between, depending on the meaning we (...) attach to theterms "violence," "institution," and "Christianity" (Daly 1997, 321-43). When we speak normatively, or take Christianity and its institutions accordingto its best ideals, Christianity isessentially nonviolent. But when we speak descriptively, i.e., take Christianity according to what the institutions ofChristianity have actually done, and according to how those who call themselves Christian have actually acted, we can make the argument that Christianity is violent, ffanalogous distinctions can be made from within the other four traditions, this might offer a good starting point for discussion. Adapting to my purpose standard dictionary definitions, I understand violence to include in a broad way the justified or unjustified human exertion of internal or external power or force in order to achieve an injurious or abusive end, i.e., an end that is against the will, the good, or the interests of those who suffer it. (This includes all war and avoids, at least at the outset, arguments about whether a war is or can be a "just war.") I understand institution in its ordinary meaning of: any significant or established practice, relationship, structure, system, or organization in a society or culture. I understand Christianity also in its ordinary sense: the Roberti. Daly, SJ.5 religion which, derived from Jesus Christ, and based on the Bible, is professed by Eastern, Roman Catholic, and Protestant bodies. Now, to help set the background for our discussion, I will try to list and briefly describe, relative to this theme, some of the major aspects or "moments" of Christianity (or Christian History), and do this in an approximately diachronic or chronological order. Much of this will be descriptive, but I will not go out of my way to dissociate the descriptions from the effects of all normative claims. I.Violence and Institution in the History of Christianity [1] The biblical foundation of Christianity in the Hebrew Scriptures. [2]The pervasiveness of violence in the Bible. [3]The Christian Scriptures present themselves as a gospel of peace. [4]Jesus and nonviolence. [5]Early Christians and nonviolence. [6]The early Christians and the military. [7]The "Constantinian turn." [8]Caesaro-papism. [9]The relegation ofChristian pacifism to religious and monastic life. [10]The just war theory. [11]The medieval Christian taken-for-grantedness of violence. [12]The Crusades. [13]Medieval Christian peace movements [14]Christians and heretics. The Inquisition. See [11] above. [1 5]Christianity and the witches. See [U] above. [16]The Reformation. [17]The Radical Reformation and the Peace Churches. [18]St. Bartholomew's Day Massacre (August 1572). [19]The religious wars. [20]Absolutism. [21]Modernity. [22]The Quakers—Religious Society of Friends. [23]The Enlightenment and Modernity. [24]Christianity and world mission; Christianity and colonialism. [25]Slavery. [26]Christianity and the "war" against native cultures. [27]Christianity and the First World War. [28]The Second World War. [29]The Holocaust. 6 Violence and Institution in Christianity [30]Christianity and the modern peace movement. [31]Christians and the "seamless ethic of life." [32]Christianity and International Communism. [33]Liberation theology. [34]The liberation of women. [35]Christianity and the resurgence of tribal and nationalist violence. [36]Christianity and human rights. [1] The biblical foundation of Christianity in the Hebrew Scriptures. Christians and Jews have the same family origins. Since believing Christians no less than believing Jews accept and revere the Hebrew Scriptures as the inspired word of God, Christians and Jews are indeed, to paraphrase Pope John XXIII, siblings. There is, beyond this, fromJudaism to Christianity, a significant parent-child relationship. In recent years (but not early enough to have prevented the Holocaust), the main line churches ofChristianity have rejected the supersessionism (the doctrine that the Old Testament has been abrogated by the New Testament) that used to characterize Christian attitudes towards the Jews and that... (shrink)

Resistance is a concept understudied in the context of health and healthcare. This is in part because visible forms of social protest are sometimes understood as incongruent with professional identity, leading healthcare workers to separate their visible actions from their working life. Resistance takes many forms, however, and focusing exclusively on the visible means more subtle forms of everyday resistance are likely to be missed. The overarching aim of this study was to explore how resistance was enacted within the (...) workplace amongst a sample of twelve healthcare workers, based in the United Kingdom; exploring the forms that such action took and how this intersected with health and healthcare. In depth-interviews were conducted and results were analysed utilizing Lilja’s framework ( 2022 ). Our findings suggest that resistance took a number of forms, from more direct confrontational acts, to those which sought to avoid power or which sought to create alternative or prefigurative practices or norms. These findings speak to the complexities, ambiguities, and contradictions of resistance, as carried out by healthcare workers in the workplace. While many acts had clear political motives, with issues like climate change in mind for example, participants also described how the act of providing care itself could be an act of resistance. While saying something about our participants, this also said something about the healthcare systems in which they worked. These findings also raise a range of normative issues. Perhaps needless to say, there appears to be substantial scope to expand and interrogate our findings and apply the idea of resistance to health and healthcare. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons (...) for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

Tens of millions of adults and children die each year from illnesses that are treatable or preventable with existing medicines. Each year over 500 million people are infected with malaria, and the disease kills two million people annually. Hundreds of thousands more die annually from a myriad of lesser known diseases including diphtheria, measles, tetanus, and syphilis. Approximately 30 percent of the world’s population, over 1.7 billion people, has inadequate access or no access at all to essential medicines.Not surprisingly, the (...) vast majority of these illnesses are contracted in poor countries. Four million lives could be saved annually through prompt diagnosis and treatment of illnesses in Africa and Southeast Asia alone, and access to pharmaceutical drugs could likely save millions more. Many of the health problems facing the developing world do not arise from lack of understanding of complex diseases. Rather, the problem arises from a striking lack of availability of life-saving medicines for the consumers that need these medicines the most. (shrink)

In 2013, the U.S. National Institutes of Health funded four large interdisciplinary research projects exploring the “implications, challenges and opportunities associated with the possible use of g...

In 1983, Dr. J. Robin Warren and Dr. Barry Marshall reported finding a new kind of bacteria in the stomachs of people with gastritis. Warren and Marshall were soon led to the hypothesis that peptic ulcers are generally caused, not by excess acidity or stress, but by a bacterial infection. Initially, this hypothesis was viewed as preposterous, and it is still somewhat controversial. In 1994, however, a U. S. National Institutes of Health Consensus Development Panel concluded that (...) infection appears to play an important contributory role in the pathogenesis of peptic ulcers, and recommended that antibiotics be used in their treatment. Peptic ulcers are common, affecting up to 10% of the population, and evidence has mounted that many ulcers can be cured by eradicating the bacteria responsible for them. (shrink)

Institutional review boards are almost universally considered to be overworked and understaffed. They also require substantial commitments of time and resources from their members. Although some surveys report average IRB memberships of 15 people or more, federal regulations require only five. We present data on IRB meetings at eight of the top 25 academic medical centers in the United States funded by the National Institutes of Health. These data indicate substantial contributions from primary reviewers and chairs during (...) protocol discussions but little from other members, which implies that it may be possible for smaller IRBs to accomplish the same tasks with no reduction in the quality of review. (shrink)

Claiming the legacy of revolutionary of 1789, the Republicans organise at the end of nineteenth century the French school in its modern form and developpe a philosophy that is “fondationnaire” placing educational institution as foundation of the nation. The idea of the emancipation of the people by rational instruction without neglecting the moral and civic education is well located in the heart of the French school project and aims abstract rational subjects, despite their unique characteristics and affiliations. The phrase “the (...) Republic will be educator or she will not! “claim this fundamentally political intent stay up until the Second World War. After this period, the school system begin to be invested by the economy; during the period of the welfare state, an original synthesis seems to occur between “republican meritocracy, [...] social equality mass... [the] concern individualistic “(Gauchet, 2002), the rising concerns of the economy and employment, making the question of the qualifications of a concern more central. This delicate balance then seems to break during the Twenty pitiful’s years, then the school is characterized by a multiplicating of its missions, the lost of landmarks and the difficulty to make sense. The actual siginification of the scholar system will be questioned regarding to economic and anthropological influence of neo-liberalism, the requirement for long life education and its consequences, and also the education-socialization-qualification relations. (shrink)

Background The American Society for Bioethics and Humanities (ASBH), a professional organization that certifies ethics consultants who pass the qualifying examination, published standards for the conduct of ethics consultations (EC). A national survey of adult hospital ethics consultants identified adherence to these standards, but no assessment of pediatric hospitals’ adherence has been done.Methods In this cross-sectional study, a national questionnaire was distributed electronically in 2022 to pediatric ethics consultants at children’s hospitals, collecting information about adherence to the ASBH (...) standards. Hospital characteristics were extracted from the Children’s Hospital Association Annual Benchmark Report. Quantitative analysis included descriptive statistics to assess adherence and analyses of variance to investigate associations between hospital characteristics and the time taken to respond to consultations.Results Of the 181 eligible pediatric hospitals, we received 104 completed surveys (57%) from 45 states. Pediatric EC have similar adherence rates to ASBH standards as adult hospitals. High-adherence (>75%) areas included having an expert available for EC and permitting any staff member to request EC. Low-adherence areas included having comprehensive policies covering all aspects of EC activities, having a response plan for egregious violations, and the elicitation of formal feedback after EC. There is an increased average response time for ethics consultation services in smaller pediatric hospitals and church-operated hospitals.Conclusions Pediatric hospitals overall have moderate adherence to the ASBH EC standards, with the highest rates occurring for standards that are shared by the American Academy of Pediatrics. Additional research into the barriers to standard adherence and the effectiveness of standards is warranted with emphasis on the impact of adherence on consultation quality. (shrink)

Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnology-based drugs and delivery systems had entered preclinical, clinical, or commercial development. (...) The European Medicines Agency reviewed 18 marketing authorization applications for nanomedicines in 2010. In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health data base, www.clinicaltrials.gov. Although the fastest growing areas of nanomedicine are applications in medical imaging and diagnosis using contrast-enhancing agents, most nanomedicine research and commercialization is in the area of cancer drug therapy, including nano gold shells. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Gene TherapyMary Carrington Coutts (bio)On September 14, 1990, researchers at the U.S. National Institutes of Health (NIH) performed the first approved gene therapy procedure on a four-year-old girl named Ashanti DeSilva. Born with a rare genetic disease, severe combined immune deficiency (SCID), Ashanti lacked a healthy immune system and was extremely vulnerable to infection. Children with SCID usually develop overwhelming infections and rarely survive to (...) adulthood; even a common childhood illness like chicken pox is life-threatening. Ashanti led a cloistered existence, avoiding contact with people outside her family, remaining in the sterile environment of her home, and battling frequent illnesses with massive amounts of antibiotics.In Ashanti's gene therapy procedure, her own white blood cells were genetically modified and then infused back into her bloodstream. Laboratory tests show that the therapy has strengthened Ashanti's immune system. She no longer has recurrent colds, has been allowed to attend school, and has been immunized against whooping cough. This gene therapy procedure is not a cure, however. The genetically-treated white blood cells only survive for a few months and must then be replaced, but Ashanti's future is much brighter because of the new therapy (VI, Thompson [The First] 1993).Although this simplified description of Ashanti's gene therapy procedure sounds like a happy ending, it is little more than an optimistic chapter in a long story. The road to the first approved gene therapy procedure was rocky and fraught with controversy. The biology of human gene therapy is very complex, and there are still many techniques that need to be developed and diseases that need to be understood more fully before gene therapy is well established. The public policy debate surrounding the possible use of genetically engineered material in human subjects is equally complex. Major participants in the debate come from the fields of biology, government, law, medicine, philosophy, politics, and religion, each bringing different views to the discussion.In studying the ethics of gene therapy, one should draw a distinction between [End Page 63] therapy on somatic (non-reproductive) cells and germ (reproductive) cells. Only the germ cells carry the genes that will be passed on to the next generation. Reactions to gene therapy have varied widely. Some commentators on gene therapy object to any form of genetic manipulation, no matter how well-intentioned (VI, Rifkin 1983). Another reaction is to allow the use of somatic-cell therapy, but not to approve the use of germ-line therapy, which could have unforeseeable effects on future generations. A different stance is that, with proper regulation and safeguards, germ-line gene therapy is a logical extension of the progress made to date and that it is an ethically acceptable procedure.TechniquesTo date, 43 research protocols have been approved for somatic-cell gene therapy in the United States. The techniques employed in each protocol vary, but in general a virus is used as a "vector" to insert the desired gene into the DNA of the patient's cells, in order to compensate for a defective gene. For Ashanti's gene therapy, this technique involved obtaining white blood cells and introducing properly functioning genes into as many of the cells as possible. The normal genes were delivered through the use of a specially-engineered virus.Although similar techniques are used in germ-line gene therapy, the procedure is more difficult. There are two basic ways to perform germ-line gene therapy: (1) to treat a preimplantation embryo that carries a serious genetic defect before its implantation in the mother, which necessitates the use of in vitro fertilization techniques; or (2) to treat the germ cells (sperm or egg cells) of afflicted adults so that the genetic defects would not be passed on to their offspring, which requires the technical expertise to delete the defective gene and insert a properly functioning replacement. Because of the complexity of the procedures involved and the attendant ethical controversy, germ-line therapy is not currently performed.Candidate Diseases for Gene TherapyAt present, gene therapy is likely to be most successful in treating diseases that are caused by single-gene defects and has been approved for treating diseases such... (shrink)

Despite exponential growth in the past decades, most aspects of the assisted reproductive technology industry remain largely unregulated; recently, pressure has been mounting for coordinated study and regulation of this developing industry. On March 28, 2008, lawyers, health care professionals, representatives from sperm banks, consumers of ART services, and other stakeholders in ART industry gathered at DePaul University College of Law for its Health Law Institute’s symposium titled “Tracking Change: The Feasibility of a Voluntary Gamete Donor Registry in (...) the United States.” The implementation of a registry would mark the first effort in the United States to centralize, maintain, and disseminate information about gamete donors by collecting and storing genetic and identifying information about egg and sperm donors. Establishing a registry requires balancing the interests of donor-conceived individuals, their parents, gamete donors, health care professionals, and society as a whole, as well as ensuring the privacy and safety of all involved. (shrink)

The publication of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders has stirred many emotions both inside and outside of the psychiatric community. But when the director of the U.S. National Institute of Mental Health, Thomas Insel's, critique of the DSM-5 became public, even some antipsychiatrists were surprised. Insel argued that although the DSM's diagnostic categories have become the standard to obtain research grants and to conduct trials, they are not based on objective measures, (...) lack validity, do not make accurate predictions about illness trajectory, and fail to map onto findings from neuroscience and genetics. In contrast with the... (shrink)

In 1983, Dr. J. Robin Warren and Dr. Barry Marshall reported finding a new kind of bacteria in the stomachs of people with gastritis. Warren and Marshall were soon led to the hypothesis that peptic ulcers are generally caused, not by excess acidity or stress, but by a bacterial infection. Initially, this hypothesis was viewed as preposterous, and it is still somewhat controversial. In 1994, however, a U. S. National Institutes of Health Consensus Development Panel concluded that (...) infection appears to play an important contributory role in the pathogenesis of peptic ulcers, and recommended that antibiotics be used in their treatment. Peptic ulcers are common, affecting up to 10% of the population, and evidence has mounted that many ulcers can be cured by eradicating the bacteria.. (shrink)

Decisions concerning use of gene therapy will probably not be made within the privacy of what was once a dyadic doctor–patient relationship. More likely, some overarching guidelines will emerge directing or limiting the practice. Debate and position-taking over the myriad scientific, social, ethical, legal, and political implications of research into and manipulation of the human genome has intensified since the U.S. government officially launched the Human Genome Project in 1988 by appropriating funds to the Department of Energy and the (...) class='Hi'>National Institutes of Health for genome research. The discourse this costly research endeavor has generated in the scientific and bioethics literature and even in the popular press outlines a host of issues likely to evoke attempts at line drawing and policymaking. Many of these issues lend themselves easily to the shorthand of dualistic opposition: somatic cell therapy versus germ line therapy or engineering ; correction of defects and disease only versus enhancement of conditions not considered defects or diseases; intervening on the basis of phenotype only versus intervening on the basis of genotype also. (shrink)

In his paper “The Catholic Church, the American Military, and Homosexual Reorientation Therapy,” David W. Lutz ultimately concludes that it is “appropriate, and highly ethical” for the American military to offer reorientation therapy to help homosexuals overcome “the vice of sodomy.” The major thrust of his paper, however, is to call for abandonment of the “Don’t Ask/Don’t Tell” policy currently in place in the military. Lutz’s paper covers much ground, and this review begins by examining whether such a wide view (...) is necessary for the ultimate conclusions. It goes on to ask whether Lutz has omitted to mention important considerations bearing on this issue, and whether Lutz’s call for the introduction of reorientation therapy is a serious call or a symbolic response to homosexual activities. Lutz fails to address essential issues such as the actual experiences of other nations having homosexuals in the military, and issues regarding what constitutes “reorientation therapy,” the latter leading to questions about how such a therapy would actually be implemented. (shrink)

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: (...) US IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’.CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Ethical, Legal, and Social Implications Research Program at the National Human Genome Research InstituteEric M. Meslin (bio), Elizabeth J. Thomson (bio), and Joy T. Boyer (bio)Organizers of the Human Genome Project (HGP) understood from the beginning that the scientific activities of mapping and sequencing the human genome would raise ethical, legal, and social issues that would require careful attention by scientists, health care professionals, government officials, (...) and the public. The establishment of the ELSI (ethical, legal, and social implications) programs at the National Human Genome Research Institute (NHGRI) and the Department of Energy (DOE) was thought to be vital to the success of the HGP in the United States. It also provided a novel approach to the simultaneous study of ethical, legal, and social issues and basic scientific issues. Eric Juengst, the first director of the ELSI program, described its origins in a previous issue of the Kennedy Institute of Ethics Journal (Juengst 1991). Now in its seventh year, the ELSI program has accomplished much. This article summarizes the evolution and goals of the ELSI program at NHGRI, outlines the program’s current research priorities with examples of activities within each priority area, and provides a look to the future, including the initiation of a strategic planning process.Evolution and Goals of the ELSI Research ProgramThe HGP’s “genomic” goals are unique: to map and sequence the entire human genome—some 3 billion base pairs that make up approximately 80–100,000 genes—and the genomes of related model organisms by the year 2005. This goal was particularly ambitious since, when it was proposed, the technologies for mapping and sequencing had yet to be developed. When the HGP was first established, its organizers also elaborated a set of ELSI goals, which they saw as vital to the success of the genome project. The original ELSI goals were: (1) to anticipate and address the implications of the HGP for individuals and society and (2) to examine the ELSI consequences of mapping and sequencing the human genome in order to stimulate public discussion. To meet these goals, the NHGRI created its ELSI research program in 1990. Along with mapping, sequencing, [End Page 291] and mammalian genetics, ELSI was one of four original branches in the NHGRI Division of Extramural Research that funded research in those areas. Although the individual “branches” no longer exist, the mechanisms for funding research remain much the same. While the overall goals of the program have not changed, the specific ways of achieving the goals have continued to evolve. The importance of the ELSI program lies not in the collection of a full set of data that will be valuable in and of itself, but in the value of using and interpreting this new set of information.Early on, the NHGRI described a set of somewhat more specific goals: (1) to develop a program to help understand the ethical, legal, and social implications of the human genome project and (2) to identify and define the major issues of concern and develop policy options to address them. These more specific goals have been largely met. As the most recent biennial NHGRI Progress Report notes, “a robust ELSI research and education program has been established, many of the most urgent ELSI issues have been identified, and many policy options to address these issues have been proposed” (NCHGR 1995, p. 21). Between 1990 and 1996, ELSI provided more than $32.5 million in funding through 128 research and education grants in more than 30 states and in Canada (Table 1). The ELSI research budget is unique in that when originally created, it was specifically tied to the amount of money provided for the overall NHGRI budget. The NHGRI originally devoted 3 percent of its extramural budget to fund ELSI projects, but in FY 1991, it increased the ELSI budget to 5 percent, a figure that remains today. Table 2 lists the expenditures for each fiscal year since 1990 and the cumulative expenditures to date. The ELSI research budget at NHGRI this year will be about $7 million. When other sources of funding—e.g., co-funding arrangements with other institutes and agencies and the funding of ELSI... (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)

In lieu of an abstract, here is a brief excerpt of the content:Principles and Theory in BioethicsPat Milmoe McCarrick (bio)The following citations were selected from BIOETHICSLINE, the online database prepared at the Kennedy Institute of Ethics for the National Library of Medicine's MEDLARS system. Searching the keywords autonomy, beneficence, casuistry, justice, and virtues, as well as the text word principlism produced more than 400 citations. Only the citations concerned with theory and principle in the practice of bioethics are included (...) here—e.g., works about justice in resource allocation have been deleted.Arkes, Hadley V. When Bungling Practice Is Joined to Absurd Theory: Doctors, Philosophers, and the Right to Die. In Set No Limits: A Rebuttal to Daniel Callahan's Proposal to Limit Health Care for the Elderly, ed. Robert L. Barry and Gerard V. Bradley, pp. 31-44. Urbana: University of Illinois Press, 1991.Arnason, Vilhjalmur. Towards Authentic Conversations: Authenticity in the Patient-Professional Relationship. Theoretical Medicine 15 (3): 227-42, September 1994.Arras, John D. Getting Down to Cases: The Revival of Casuistry in Bioethics. Journal of Medicine and Philosophy 16 (1): 29-51, February 1991.Arras, John D. Principles and Particularity: The Role of Cases in Bioethics. Indiana Law Journal 69 (4): 983-1014, Fall 1994.Beauchamp, Tom L. Principles and Other Emerging Paradigms in Bioethics. Indiana Law Journal 69 (4): 955-71, Fall 1994.Beauchamp, Tom L. The Principles Approach. Hastings Center Report 23 (6): S9, November-December 1993.Beauchamp, Tom L., and Childress, [End Page 279] James F. Principles of Biomedical Ethics. 4th ed. New York: Oxford University Press, 1994. 752 p.Beauchamp, Tom L., and Walters, LeRoy. Ethical Theory and Bioethics. In their Contemporary Issues in Bioethics. 4th ed., pp. 1-38. Belmont, CA: Wadsworth, 1994.Beldecos, Athena, and Arnold, Robert M. Gathering Information and Casuistic Analysis. [Commentary]. Journal of Clinical Ethics 4 (3): 241-45, Fall 1993.Bole, Thomas J. The Rhetoric of Rights and Justice in Health Care. In Rights to Health Care, ed. Thomas J. Bole and William B. Bondeson, pp. 1-19. Boston: Kluwer Academic, 1991.Broome, John. Fairness Versus Doing the Most Good. [Commentary]. Hastings Center Report 24 (4): 36-39, July-August 1994.Campbell, Courtney S. Gifts and Caring Duties in Medicine. In Duties to Others, ed. Courtney S. Campbell and B. Andrew Lustig, pp. 181-97. Boston: Kluwer Academic, 1994.Carson, Ronald A.; Callahan, Sidney; Ross, Judith Wilson; and May, William F. Spirit, Emotion, and Meaning: The Many Voices of Bioethics. Hastings Center Report 24 (3): 26-27, May-June 1994.Charlesworth, Max. Bioethics in a Liberal Society. New York: Cambridge University Press, 1993. 172 p.Cherbas, Peter. Paradigms and Our Shrinking Bioethics. Indiana Law Journal 69 (4): 1105-13, Fall 1994.Childress, James F. Ethical Theories, Principles, and Casuistry in Bioethics: An Interpretation and Defense of Principlism. In Religious Methods and Resources in Bioethics, ed. Paul F. Camenisch, pp. 181-201. Boston: Kluwer Academic, 1994.Childress, James F., and Fletcher, John C. Individualism and Community: The Contested Terrain of Respect for Autonomy. Hastings Center Report 24 (3): 34-35, May-June 1994.Clouser, K. Danner, and Gert, Bernard. A Critique of Principlism. Journal of Medicine and Philosophy 15 (2): 219-36, April 1990.Devettere, Raymond J. Clinical Ethics and Happiness. Journal of Medicine and Philosophy 18 (1): 71-89, February 1993.DeGrazia, David. Moving Forward in Bioethical Theory: Theories, Cases, and Specified Principlism. Journal of Medicine and Philosophy 17 (5): 511-39, October 1992.Donnelly, William J. From Principles to Principals: The New Direction in Medical Ethics. [Commentary]. Theoretical Medicine 15 (2): 141-48, June 1994.Downie, Robin. Health Care Ethics and Casuistry. [Editorial]. Journal of Medical Ethics 18 (2): 61-62, 66, June 1992. [End Page 280]DuBose, Edwin R.; Hamel, Ronald P.; and O'Connell, Laurence J., eds. A Matter of Principles? Ferment in U.S. Bioethics. Valley Forge, PA: Trinity Press International, 1994. 381 p.Fox, Renée C. The Entry of U.S. Bioethics into the 1990s: A Sociological Analysis, pp. 21-71.Gudorf, Christine E. A Feminist Critique of Biomedical Principlism, pp.164-81.Campbell, Courtney S. Principlism and Religion: The Law and the Prophets, pp. 182-208.Charon, Rita. Narrative Contributions to Medical Ethics: Recognition, Formulation, Interpretation, and Validation... (shrink)

Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current (...) standards reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Ethics Committees in HospitalsPat Milmoe McCarrick (bio)(Literature about hospital ethics committees has grown enormously since Scope Note 3 first appeared. This update provides new information about resources and documents now available while continuing to include important earlier sources.)Hospital ethics committees increasingly have taken hold in the United States since 1983, when the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research encouraged their (...) creation in its report, Deciding to Forego Life-Sustaining Treatment (III, 1983, p. 5).The President's Commission report (pp. 160-64) suggested the following roles for ethics committees: 1) review of treatment decisions made on behalf of incompetent, terminally ill patients; 2) review of medical decisions having ethical implications with the option, in cases of disagreement, to refer cases to a court with proper jurisdiction; 3) provision of social, psychological, spiritual, or other counseling for patients, family members, physicians, or other hospital staff; 4) establishing guidelines regarding treatment or other medical decisions; and 5) sponsoring or conducting educational programs to inform all concerned, including the public, about ethical problems in medicine.No exact count of these committees is available. According to estimates cited by Donald F. Phillips, managing editor of Hospital Ethics, about two-thirds to three-fourths of hospitals with more than 200 beds have ethics committees, as do about one-third of hospitals under 200 beds. He thinks that about half of the 6,000 hospitals in the United States now have working ethics committees.Several journal articles and a court decision in the late 1970s influenced their formation. A 1975 journal article by pediatrician Karen Teel (VII A) urged the use of hospital ethics committees to provide for dialogue in individual care situations as an appropriate sharing of responsibility. Another early article suggested that beyond parents and treating physicians, a "disinterested," mixed lay and medical committee could consider cases about defective newborns to improve the ethical decisionmaking process (VII A, Robertson and Fost, 1976). Three 1977 discussions in the Hastings Center Report highlighted this new concept (VII A, Levine; Shannon; Veatch).Produced at the National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University, Washington, DC 20057. It is supported by funds provided under grant number LM04492 from the National Library of Medicine, National Institutes of Health. Literature available through June 1992 is represented in this Scope Note. [End Page 285]The court decision was the March 31, 1976 ruling by the New Jersey Supreme Court in the Karen Quinlan case. The parents of a young woman in a persistent vegetative state had requested that she be taken off a respirator. The court designated a "prognosis" role for the hospital ethics committee and stipulated that the committee must concur that the patient will never return to a "cognitive, sapient state" before the life-support system can be withdrawn (In the Matter of Karen Quinlan, 70 N.J. 10, 355 A.2d 647, cert. denied sub nom. Garger v. New Jersey, 429 U.S. 922 (1976)). Shortly after the Quinlan decision, Massachusetts General Hospital's Clinical Care Committee created an ad hoc subcommittee (a psychiatrist, a legal counsel, an ICU nurse, an oncologist/internist, a surgeon, and a lay person who had recovered from serious cancer disease) which looked at 15 cases. Based on the subcommittee's success, establishment of a permanent committee to review treatment of the terminally ill was recommended by the critical care committee (VII A, Clinical Care Committee 1976).In its 1984 Baby Doe rules, the federal government recommended establishment of infant care review committees, which promoted the growth of hospital ethics committees (VII C, Povar 1991). In July 1987 Maryland became the first state to require by law that hospitals establish patient care advisory committees to offer advice about choices available in the care of life-threatening illnesses; this requirement was extended to nursing homes in 1990 [codified as amended at Md. Health-Gen. Code Ann. Sections 19-370 to -374 (1990)] (VII C, Hollinger 1991).Recently the role for these committees has been noted in the Accreditation Manual for Hospitals, 1992 Supplement (p. 10, Patient Rights, Section RI. 1.1.6.1) of the Joint Commission... (shrink)

This paper describes the Gender Equity Project at Hunter College of the City University of New York, funded by the U. S. NSF ADVANCE Institutional Transformation Award program. ADVANCE supports system-level strategies to promote gender equity in the social and natural sciences, but has supported very few teaching-intensive institutions. Hunter College is a teaching-intensive institution in which research productivity among faculty is highly valued and counts toward tenure and promotion. We created the GEP to address the particular challenges that faculty, (...) especially White women and faculty of color, face in maintaining research programs and advancing in their careers at teaching-intensive institutions. During the course of the ADVANCE award, its centerpiece was the Sponsorship Program, a multifaceted paid mentorship/sponsorship program that paired each participant with a successful scholar in her discipline. It offered extensive professional development opportunities, including interactive workshops and internal grants to support research. The GEP helped change key policies and practices by ensuring that all faculty were treated fairly in areas like provision of research start-up funds and access to guidance on how to prepare for tenure and promotion. Qualitative and quantitative evidence suggests that participation in the Sponsorship Program boosted research productivity and advanced the careers of many of the women who participated; the Program was highly rated by all participants. Some of the policy and practice changes that the GEP helped bring about were sustained at Hunter beyond the award period and some were adopted and disseminated by the central office of CUNY. However, we were not able to sustain the relatively expensive Sponsorship Program. We share the lessons we learned, including that creating a diverse, successful social and natural scientific workforce requires sustained support of female faculty employed at teaching-intensive colleges. We acknowledge the difficulties of sustaining gains, and offer ideas about how to make the case for gender equity when women seem to be doing “well enough.” We underscore the imperative of building support for women’s research in teaching-intensive institutions, where most women scientists are employed, and well over 90% of all college students—a disproportionate percentage of whom are female, minoritized, or both—are educated. (shrink)

The fight for public health primacy in U.S. emergency preparedness and response to COVID-19 centers on which level of government — federal or state — should “call the shots” to quell national emergencies?

In lieu of an abstract, here is a brief excerpt of the content:EPILOGUE Robert J. Daly, SJ. Boston College April 2002 Iwill arrange my comments under four headings: (1) what we had hoped to accomplish; (2) what we actually did accomplish; (3) what we may have learned from this; (4) what this might now enable us to do in thefuture. This epilogueisbeingwritten in April, 2002,twenty-twomonths after the conference. To draw what good we can from this delay, writing at this (...) distance allows me to summarize and draw conclusions with, perhaps, a bit more balance. On the other hand, my listening again to the audio record in the course ofpreparing this publication has enabled me to relive something of the original experience. (1)As I indicated in the introduction, we had unrealistically hoped that, by the time ofthe conference, the five presenters, and perhaps also the twoprincipals inthe "Girard-Lonergan Conversation," wouldhavealready exchanged with each other not just first drafts, but even second drafts of their papers, and that the conference itself would then be invited to join a conversation that was already well under way. As it turned out, I couldn't muster the organizational skills and resources needed to achieve this. But reflecting after the fact, I can see that so carefully detailed a preparation might have been counterproductive. Carrying out our original plan might have been at the cost ofimposing more ofa Western analytic pattern on our discussion ofother traditions, and of!thus smothering from the outset some of the insight that did occur. We had also hoped that the opening "Girard-Lonergan Conversation" would provide an analytic resource for the rest of the meeting. But that did not happen to any great extent. (2)The proximate preparation for this conference began with a draft version ofmy paper being sent to the other major presenters. I opened with 194Robert J. Daly, SJ. a series of brief sketches of salient points in the often unhappy but also occasionally felicitous history ofChristianity on this theme ofviolence and institution. Then, after emphasizing the importance of distinguishing between the normative and the descriptive, I tried to make some sense, both rational and theological, of all this data, especially by reflecting on the influences and consequences ofthe belief in hell, on the one hand, and the hope of universal salvation, on the other. The next major religious theme was Judaism. Reuven Kimelman provided a detailed—and, for some, overwhelming—glimpse of the way the talmudic traditions deal with the theme of war and its restrictions. This highly text-oriented and interpretation-of-texts driven presentation seemed to many, at first, to be irrelevant to mimetic theory and to the need to be confronting actual violence. But, in the course of Sandor Goodhart's response, and in the course ofthe at times spirited discussion that followed, we began to understand that how one interprets texts and traditions, and how these are played off against each other, is indeed fundamental to the way Jews typically try to deal with the practical challenges of violence. Qamar-ul Huda's presentation on IsIamfocused stronglyonthe way the spiritual teachings of Islam—i.e., islam as a religion rather than Islam as a political or national institution—foster peace. The initial reaction was somewhat similarto the reaction to Kimelman's paper: disappointment that Huda was not talking more directly about contemporary Muslim extremist violence. But here, too, the discussion enabled us to catch a glimpse both of the inner spiritual resources of Islam, and of the limitations ofthe range of concerns that Westerners typically bring to the table. Francis Clooney, in his presentation ofHinduism, strongly emphasized the great variety in Hinduism, stressing that one cannot speak ofHinduism as such. Much of this variety comes from the several millennia of Hindu history, and from the complex relationships to Buddhism and Jainism which, themselves, are important parts of Hindu history, and also from the fact that only recently have Hindus, after centuries of Moslem or Colonial domination, once again returned to positions of political and military power. Finally, Christopher Ives's presentation on Buddhism, in a way similar to my presentation on Christianity, but more extensively or more consequently, pointed out the various ways in which Buddhism has been politically and... (shrink)