Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

This book is a small handbook designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient. The chapters of this book are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings.

Individual research protections provided by bioethical principles can be extended to group protections, particularly for place-based communities and cultural groups who may share a common harm or burden. In this article, an argument is made for the need to consider the group conditions of individual research subjects in the ethics of individual report-backs of human biomonitoring results. Human biomonitoring, the measuring of concentration of chemicals or their metabolites in blood, urine, breast milk, hair, and other biological samples, can provide an (...) assessment of an individual's exposure to a chemical and can integrate exposures from multiple pathways and sources. Biomonitoring studies have been increasing in the past decade for such purposes as measuring the levels of chemicals that are ingested by members of the general population and at what concentrations, to determine if exposure levels are higher in some groups vs. others, to track temporal trends to establish reference ranges for chemical exposures, and to investigate an association with health. (shrink)

In this article, an argument is made for extending bioethical principles to place-based community and cultural group protections when there are conflicting perspectives on reporting individual results of biomonitoring studies. Bioethical principles of beneficence, nonmaleficence, respect for autonomy, and justice can incorporate participatory decision-making and understandings of the group conditions of individual research participants, particularly for research studies with vulnerable groups. Arguments for and against biomonitoring communication to individual participants are reviewed here. Assessments of risks and benefits of biomonitoring communication (...) can be improved by considering the contextual conditions of cultural groups and place-based communities. Providing participatory decision-making with all stakeholders about biomonitoring communication can provide more fair benefits than adopting a general, prescriptive clinical standard that favors only group report-backs when clinical utility is low and the scientific understandings of low dose exposures of chemical contaminants to humans are still uncertain. (shrink)

Community-researcher partnerships constitute one of the most important recent developments in biomedical ethics. The partnerships protect vulnerable communities within which research is conducted and help ensure that the communities benefit from the research. At the same time, they embody deep, core values about the social nature of persons and the value of community that significantly modify the radical individualism too often associated with the prevailing concepts of autonomy and respect for persons. This article examines the burgeoning literature on community-researcher partnerships (...) to identify the main ways of thinking ethically about the obligations of investigators and the roles and rights of communities in scientific research. The paper helps to uncover the deep commonalities and differences that mark the current debate in this emerging arena of research ethics, a debate over the social nature of persons that is beginning to influence the understanding of other bioethical issues. (shrink)

In 2004, the Havasupai Tribe filed a lawsuit against the Arizona Board of Regents and Arizona State University researchers upon discovering their DNA samples, initially collected for genetic studies on type 2 diabetes, had been used in several other genetic studies. The lawsuit reached a settlement in April 2010 that included monetary compensation and return of DNA samples to the Havasupai but left no legal precedent for researchers. Through semistructured interviews, institutional review board chairs and human genetics researchers at US (...) research institutions revealed their perspectives on the Havasupai lawsuit. For interviewees, the suit drew attention to indigenous concerns over genetic studies and increased their awareness of indigenous views. However, interviewees perceived no direct impact from the Havasupai case on their work; if they did, it was the perceived need to safeguard themselves by obtaining broad consent or shying away from research with indigenous communities altogether, raising important questions of justice for indigenous and minority participants. If researchers and IRBs do not change their practices in light of this case, these populations will likely continue to be excluded from a majority of research studies and left with less access to resources and potential benefit from genetic research participation. (shrink)

This article reviews the history of medical and research abuses experienced by American Indians since European colonization. This article examines the unethical research of American Indians/Alaska Natives in light of the Tuskegee Study of Untreated Syphilis in the Negro Male. Literature citations indicate that significant unethical research and medical care incidents occurred both before and after the Tuskegee Syphilis Study among American Indians/Alaska Natives. The majority of these unethical abuses were committed by the federal government and within the historical context (...) of a long-term contentious relationship between American Indians and the federal government. Although President Clinton issued a highly visible public apology to the African American survivors of the Tuskegee syphilis experiment in 1997, American Indians have yet to experience such visible federal acknowledgment. To ensure ethical research in which benefits outweigh risks and findings are not value-laden or misrepresented, tribes have instituted their own Institutional Review Boards coupled with community-participatory activities. (shrink)

During the last decade a “technical” approach has become increasingly influential in health care priority setting. The various country reports illustrate, however, that non-technical considerations cannot be avoided. As they often remain implicit in health care package decisions, this paper aims to make these normative judgements an explicit part of the procedure. More specifically, it aims to integrate different models of distributive justice as well as the principle of solidarity in four different phases of a decision-making procedure, and to identify (...) important moral choices which present themselves. First four important justice models are discussed, then a justification is given for their inclusion in a four-step decision making procedure. This is followed by a discussion of different justice and solidarity problems—with their inherent conceptual difficulties in each of these stages. The paper concludes with a summary of the major moral choices that are to be made in health care package decisions. (shrink)

As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly cohesive. Although some protections may (...) be applicable to less-cohesive communities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto beyond the aboriginal communities for which they were developed. (shrink)