There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with (...) prevailing norms governing human subjects research. Some maintain that only randomized controlled trials with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs. (shrink)

If scientists can successfully clone sheep, will humans be next? Today's headlines read like a science fiction novel! Due Consideration takes a poignant look at the rapidly changing field of biomedicine and the consequences it will have on our lives. Arthur Caplan, one of this nation's leading bioethicists, explores these issues and analyzes moral questions including: * Will we retain our essential humanity if we modify our biological blueprint? * Would it be irresponsible to procreate without a thorough genetic (...) examination? * Who will decide if physical traits like short stature and baldness are considered diseases? * Can biomedicine make our lives better? You'll also learn about the most current and controversial topics such as: * Cloning, abortion and assisted suicide. * Genetically engineering a human to be immune from infectious diseases. * The ability to "design" our children from head to toe. * Diagnosing and treating illnesses during fetal development. * Programs to prevent the transmission of HIV. No other book on the market today combines this analytic clarity with the latest from medical journals and media headlines. Now, you can decide for yourself what the future ought to hold in store. (shrink)

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

Mechanisms in a theory are defined here as bits of theory about entities at a different level (e.g., individuals) than the main entities being theorized about (e.g., groups), which serve to make the higher-level theory more supple, more accurate, or more general. The criterion for whether it is worthwhile to theorize at lower levels is whether it makes the theory at the higher levels better, not whether lower-level theorizing is philosophically necessary. The higher-level theory can be made better by mechanisms (...) known to be inadequate in the discipline dealing with the lower level. Conditions for the usefulness of lower-level theorizing are proposed, with many examples from various social and physical sciences. (shrink)

The field of medical rehabilitation is relatively new.... Until recently, the ethical problems of this new field were neglected. There seemed to be more pressing concerns as rehabilitation medicine struggled to establish itself, sometimes in the face of considerable skepticism or hostility. There also seemed no pressing moral questions of the kind and intensity to be encountered, say, in high-technology acute care medicine or genetic engineering.... Those in biomedical ethics could and did easily overlook the quiet, less obtrusive issues of (...) rehabilitation.... The Hastings Center set out in 1985 to rectify that situation.... To explore the issues, the Center assembled a group of practitioners in the field, Hastings Center staff members, and individuals experienced in other areas of medical ethics.... The report that follows was written by Arthur Caplan and Daniel Callahan, assisted by Dr. Janet Haas of the Moss Rehabilitation Hospital in Philadelphia... (shrink)

The transplant community has quietly initiated efforts to expand the current pool of cadaver organ donors to include those who are dead by cardiac criteria but cannot be pronounced dead using brain-based criteria. There are many reasons for concern about "policy creep" regarding who is defined as a potential organ donor. These reasons include loss of trust in the transplant community because of confusion over the protocols to be used, blurring the line between life and death, stress on family members, (...) and burdens imposed on health care providers when a long-standing policy regarding who can serve as a cadaver organ donor is unilaterally changed. While these concerns are not sufficient reason for abandoning efforts to broaden existing eligibility standards for cadaver donation, they are sufficient reasons for the transplant community to desist in changing existing standards without widespread professional and public discussion. (shrink)

Traditionally, species have been treated as classes or kinds in philosophical discussions of systematics and evolutionary biology. Recently a number of biologists and philosophers have proposed a drastic revision of this traditional ontological categorization. They have argued that species ought be viewed as individuals rather than as classes or natural kinds. In this paper an attempt is made to show that (a) the reasons advanced in support of this new view of species are not persuasive, (b) a reasonable explication can (...) be given of the treatment of species as classes that is consistent with current theory and practice in evolutionary biology and systematics, and (c) that once certain confusions concerning the species concept have been clarified, there are good theoretical grounds for maintaining that species are best viewed as classes or kinds. (shrink)

For decades The People’s Republic of China has been expanding its capacity to perform organ transplants, primarily kidneys and livers but also hearts, lungs and multiorgan transplants. The annual number of organ transplants performed is estimated to be over 30 000. The number is expected to grow with a projected market for immunosuppressants expected to be over ¥30 billion/$4.3 billion by 2024.1 China is second only to the USA and is expected to become the country with the largest number of (...) organ transplants by 2021 or 2022. Many transplants are performed on Chinese citizens but an active market in transplants for ‘tourists’ is ongoing.2 The source of the supply of organs to fuel this rapid growth has long been suspect.3 China had no system for obtaining organs for many years from cadaver sources making it impossible to credit claims that gifts from the newly dead were the sole or even majority source of transplantable organs. Critics, including myself, have long alleged that the only possible source of organs for both Chinese citizens and transplant tourists are executed prisoners. Many accounts, commissions and investigations have confirmed an immoral reliance on this vulnerable …. (shrink)

Doctoral students in clinical, counseling, and school psychology programs often collaborate with faculty on research projects in their training as scientist-practitioners. Yet, the determination of publications' credit and order of authorship on resulting manuscripts continues to be a major concern and challenging process for professional psychologists and student collaborators. This article describes the use of case-based learning and semi-structured interview approaches to instruct first-year clinical psychology doctoral students in publication ethics during a research seminar. The instructor models ethical decision-making with (...) 1) a discussion of four cases from his own professional experiences and 2) a description of the Authorship Eligibility Assessment form, which he developed for use with junior researchers. The authors advocate for more educational strategies to supplement the APA standards in teaching the ethics of the publication process. Implications in terms of graduate student development and research collaborations in the field of professional psychology were discussed. (shrink)

Experts discuss the economic, legal, and social issues surrounding the use of genetic testing in determining eligibility for life insurance. Insurance companies routinely use an individual's medical history and family medical history in determining eligibility for life insurance; this is part of the process of medical underwriting. Insurers have also long used genetic information, often derived from family history, in underwriting. But rapid advances in gene identification and genetic testing are changing the way we look at genetic information. Should the (...) results of genetic testing (which might identify a predisposition toward disease not related to medical history) be available to life insurance medical underwriters? Few if any life insurers currently require genetic testing, but there are no laws or regulations prohibiting its use. Genetics and Life Insurance examines the complex economic, legal, and social issues surrounding the use of genetic information in life insurance underwriting. The contributors are legal scholars, representatives of the life insurance industry (including an actuary and an insurance physician), a geneticist, a genetic counselor, a philosopher, and a consumer advocate. They explore all aspects of an issue that has only recently drawn the attention of policymakers and the public. The book opens with a report on the results of a public opinion poll on genetics and life insurance. Succeeding chapters present the insurer perspective, a discussion of the economics of risk selection in life insurance, background information on the process of underwriting, a scientific analysis of genetic risks and mortality rates, a philosophical discussion of fairness and genetic underwriting, the viewpoints of consumers and genetics counselors, a comparison of different international policy approaches to the issue, and a legal analysis of antitrust implications when insurers collaborate in setting standards for medical underwriting. In the final chapter the editor addresses various policy options, examining the pros and cons of each one and assessing their political feasibility. (shrink)

The essays in this collection, on stratification, organization and the discipline of sociology, all bear upon a general theoretical question: what models of rationality are necessary or suitable to explain individual and collective action in institutional contexts? Professor Stinchcombe was one of the first sociologists to write on this question; and this collection includes a new essay which takes account of recent work done in the tradition Stinchcombe did much to institute. The first group of essays - on class, stratification (...) and mobility - addresses core problems of the discipline and offers imaginative conceptualizations with interesting empirical consequences. The second section - essays on the sociology of organizations - displays, like the first, Stinchcombe's wide knowledge of sociological traditions from structuralism to Marxism. The final section, 'comments on the discipline', deepens the readers understanding of sociological theorizing by presenting different modes of analysis of universities and research institutions and providing challenging, and often funny, insights into the subject. (shrink)

If social relations often require the choice of a cooperative solution to a prisoners' dilemma, we must ask how people generally solve the games. Three possible devices are that those who choose non-cooperative strategies get a bad reputation and so learn to be cooperative, that people are taught by parents that non-cooperators have unhappy lives, or that an official can be paid a salary to make the cooperative choice. By analyzing erotic love and marriage, and why people try to do (...) their jobs, it is suggested that these devices result in people often solving prisoners' dilemma games without being conscious of them. How then do these structures that 'have the function' of solving prisoners' dilemmas get created and maintain themselves? It is suggested that Deweyan consciousness, existing only when structural strains or unsolved games create personal problems, is adequate to explain many such functional structures. (shrink)

Fibroblast growth factors (FGFs) comprise a large family of developmental and physiological signaling molecules. All FGFs have a high affinity for the glycosaminoglycan heparin and for cell surface heparan sulfate proteoglycans. A large body of biochemical and cellular evidence points to a direct role for heparin/heparan sulfate in the formation of an active FGF/FGF receptor signaling complex. However, until recently there has been no direct demonstration that heparan is required for the biological activity of FGF in a developmental system in (...) vivo. A recent paper by Lin et al.(1) has broken through this barrier to demonstrate that heparan sulfate is essential for FGF function during Drosophila development. The establishment of a role for heparan sulfate in FGFR activation in vivo suggests that tissue-specific differences in the structure of heparan may modulate the activity of FGF. BioEssays 22:108–112, 2000. ©2000 John Wiley & Sons, Inc. (shrink)