In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.

Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, (...) and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature. (shrink)

Categorial grammar is well-known for its elegant analysis of coordination enabled by the flexible notion of constituency it entertains. However, to date, no systematic study exists that examines whether this analysis has any obvious empirical advantage over alternative analyses of nonconstituent coordination available in phrase structure-based theories of syntax. This paper attempts precisely such a comparison. We compare the direct constituent coordination analysis of non-canonical coordinations in categorial grammar with an ellipsis-based analysis of the same phenomena in the recent HPSG (...) literature. We provide a set of empirical evidence, consisting of cases in which non-canonical coordinations interact with scopal operators of various sorts, which systematically falsifies the predictions of the latter, ‘linearization-based’ ellipsis approach to coordination. We propose an alternative analysis in a variant of categorial grammar called Hybrid Type-Logical Categorial Grammar. The proposed framework builds on both the Lambek-inspired variants of categorial grammar and a more recent line of work modelling word order via a lambda calculus for the prosodic component. The flexible syntax–semantics interface of this framework straightforwardly captures the interactions between non-canonical coordinations and scopal expressions, demonstrating the broader empirical payoff of the direct constituent coordination analysis of non-canonical coordinations pioneered by Steedman :523–568, 1985; Linguist Philos 13:207–263, 1990) and Dowty hitherto not explicitly recognized in the literature. (shrink)

All international codes of research ethics and virtually all national legislation and regulation in the field of research involving human subjects project an attitude of protectionism. Written with the aim of avoiding a repetition of atrocities like those committed by the Nazi physician-researchers, calamities like the thalidomide experience, or ethical violations like those of the Tuskegee syphilis study, their dominant concerns are the protection of individuals from injury and from exploitation. In recent years, however, society's perception of clinical research has (...) shifted dramatically. Now, largely as a consequence of the efforts of the AIDS activists, clinical research is widely perceived as benign and beneficial. Although this shift in attitude has resulted in some important improvements in research policies and practices, this new perception is just as wrong-headed as was the earlier excessive protectionism. It is necessary to maintain a balanced perspective; our policies should encourage the conduct of ethical research while maintaining the vigilance necessary to safeguard the rights and welfare of the subjects. (shrink)

This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. ?Social context? refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking about social contexts is (...) introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences. (shrink)

If you casually greet Americans with the question “How are you?” they’re liable to respond about how busy their life is, perhaps scrunching up their faces and bodies to show how anxious and stressed they feel. The odd thing about this is that both parties understand the response may be a type of bragging, as in “Look how important I am.” This would seem exceedingly curious to visitors from many other cultures--like bragging that you’re having a nervous breakdown. It is (...) readily accepted, however, in a culture which assumes that time is money and that every moment not doing something is a wasted one. To be busy, is to be a worthwhile person. Compare this to a student from Eastern Africa whom I once interviewed about the meaning of wasted time. “How can a person waste time?” he asked. “If you’re not doing one thing, you’re doing something else” . J.T. Fraser, the founder of the International Society for the Study of Time, wrote, “Tell me what to think of time, and I shall know what to think of you.” The temporal norms of a culture—how people conceive, measure and use time--provide an exceedingly informative window on what the people of that culture value; and no temporal values divide cultures more than those related to busyness. How much and often should people work? What is the appropriate balance between work and play? Is speed a good thing? Should it be work before play or the other way around? Is there such a thing as doing nothing? Can time be wasted? I propose that the subjective experience of feeling busy has two main components: speed and activity. (shrink)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing countries, especially (...) expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)