Vulnerability in Clinical Research with Patients in Pain: A Risk Analysis

Some have characterized patients living with intractable pain as a vulnerable population in both clinical and research settings. Labeling the population as vulnerable, however, does not provide clarity regarding the potential risks that they face when they participate in research. Instead, research vulnerability for patients in pain is a function of an interaction between their pain conditions and elements of the research enterprise. Therefore, the identification of potential risks requires consideration not only of characteristics of patients with chronic pain, but also consideration of features of researchers, the quality of institutional oversight, and the medical/social environment within which the research is conducted. This paper provides an analysis of those risks and provides some suggestions as to how the risks might be better managed.     

The Use of Nonhuman Animals in Biomedical Research: Necessity and Justification

Discourse about the use of animals in biomedical research usually focuses on two issues: its empirical and moral use. The empirical issue asks whether the use of nonhumans in experiments is required in order to get data. The moral issue asks whether the use of nonhumans can be defended as matter of ethical theory. Although the use of animals in research may involve a plausible necessity claim, no moral justification exists for using nonhumans in situations in which we would not use humans.     

Vulnerability in Research: Individuals with Limited Financial and/or Social Resources

Individuals with limited resources are often presumed to be vulnerable in research. Concerns include the possibility of impaired decision making, susceptibility to undue inducement, and risk of exploitation. Although each of these concerns should be considered by investigators and IRBs, none justifies categorical exclusion of individuals with limited resources.     

Vulnerability as a Regulatory Category in Human Subject Research

This article examines and critiques the use of the term "vulnerability" in U.S. and international regulations and guidelines on research ethics. After concluding that the term is currently used in multiple, often inconsistent, senses, it calls on regulators to differentiate between three distinct types of vulnerability: "consent-based vulnerability,""risk-based vulnerability," and "justice-based vulnerability."     

Racial and Ethnic Categories in Biomedical Research: There is no Baby in the Bathwater

The use of racial categories in biomedicine has had a long history in the United States. However, social hierarchy and discrimination, justified by purported scientific differences, has also plagued the history of racial categories. Because "race" has some correlation with biological and genetic characteristics, there has been a call not to "throw the baby out with the bathwater" by eliminating race as a research or clinical category. I argue that race is too undefined and fluid to be useful as a proxy for biology or genetics.     

Legal Constraints on the Use of Race in Biomedical Research: Toward a Social Justice Framework

This article addresses three questions concerning the legal regulation of the use of race as a category in biomedical research: how does the law currently encourage the use of race in biomedical research?; how might the existing legal framework constrain its use?; and what should be the law's approach to race-based biomedical research? It proposes a social justice approach that aims to promote racial equality by discouraging the use of "race" as a biological category while encouraging its use as a socio-political category to understand and investigate ways to eliminate disparities in health status, access to health care, and medical treatment.     

Lessons from History: Why Race and Ethnicity Have Played a Major Role in Biomedical Research

Before any citizen enters the role of scientist, medical practitioner, lawyer, epidemiologist, and so on, each and all grow up in a society in which the categories of human differentiation are folk categories that organize perceptions, relations, and behavior. That was true during slavery, during Reconstruction, the eugenics period, the two World Wars, and is no less true today. While every period understandably claims to transcend those categories, medicine, law, and science are profoundly and demonstrably influenced by the embedded folk notions of race and ethnicity.     

The 14/2007 Law on Biomedical Research: comments on ethical and scientific aspects]

The Spanish Law on biomedical investigation is analyzed from the scientific and ethical points of view. In the author's opinion, some terms used in the text in order to avoid ethical and legal conflicts are not right from the biological point of view.     

Biomedical patents and ethics: a Canadian solution

World Trade Organization member states are preparing for the upcoming renegotiation of the Agreement on Trade-Related Aspects of Intellectual Property Rights. One of the important elements of that renegotiation is the ethical considerations regarding the patenting of higher life forms and their component parts (e.g. DNA and cell-lines). The interface between the genetic revolution, patentability, and ethical considerations is the subject of this article. The author identifies, explores, and critiques four possible positions Canada may adopt in respect of patentability of biomedical material. First, Canada could do nothing. This approach would mean keeping biomedical materials outside the patent system and outside the stream of commerce. Canada would simply wait for an international consensus to develop before adopting a position of its own. Second, Canada could go it alone. It could implement a policy that balances the incentive effects of patents with the need to incorporate ethical and social values into the decision-making process regarding the use of biomedical materials. In respect of this option, the author proposes a model whereby non-profit bodies would hold the exclusive rights to research, use, and exploit biomedical materials. Third, Canada could follow the United States, Europe, and Japan by providing for almost unrestricted patenting of biomedical materials. This would be the most industry-friendly alternative. The fourth and final option is to use the medicare system to promote discussion of ethical considerations involved in the use of biomedical materials. The power of provincial health agencies may be used as a lever to ensure the discussion of ethical considerations concerning the use of biomedical materials. The author concludes that the fourth and final option is the best alternative for Canada while waiting for an international consensus to emerge.     

Analyzing the Use of Race and Ethnicity in Biomedical Research from a Local Community Perspective

Lost in the debate over the use of racial and ethnic categories in biomedical research is community-level analysis of how these categories function and influence health. Such analysis offers a powerful critique of national and transnational categories usually used in biomedical research such as "African-American" and "Native American." Ethnographic research on local African-American and Native American communities in Oklahoma shows the importance of community-level analysis. Local ("intra-community") health practices tend to be shared by members of an everyday interactional community without regard to racial or ethnic identity. Externally created ("extra-community") practices tend to be based on the existence of externally-imposed racial or ethnic identities, but African-American and Native American community members show similar patterns in their use of extra-community practices. Thus, membership in an interactional community seems more important than externally-imposed racial or ethnic identity in determining local health practices, while class may be as or more important in accounting for extra-community practices.     

Introduction: Parliamentary Representation in France

The constitution of the Fifth Republic, adopted in 1958, was deliberately designed to weaken parliament. This trend was reinforced by the constant empowerment of the president and the bipolarisation of political life. For this reason, but also due to some of its specificities, French political science did not pay much attention to parliament and its members. The aim of the seven papers gathered in this issue is to fix this deficiency. They cover the main aspects of parliamentary representation in France, deliver the fundamental information and tackle the central questions about it. The papers use a wide range of data, methods and theoretical approaches. They deal with MPs' conceptions and practices of their mandate, their opinions on the French regime, their activities in the constituency, values, contribution to law-making and the use of parliamentary questions, as well as their perception by the citizens.