The mission of the Indian Health Service affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards developed seven research Model Volunteer Consent Forms.

This paper explores the value of a Poststructuralist psychoanalytic model of persons, or Subjects, as an expanded frame for the question Whose consent is it anyway? The elaboration of the need for this expanded frame, its tenets and its value form the substance of the paper. This frame incorporates the emotional, linguistic, and socio-cultural dimensions that help restore patients and physicians to their full status as persons from their restricted status, in the current dominant theory and model, as unidimensional, rationalistic, (...) medico-legally constructed players; emphasizes their interconnectedness; and, focuses broadly on responsibility as bearing consequences, and not only accountability. This frame does not deny the role and importance of cognition or rationality, it supplements them. It does not supplant rationality, but rather includes it in a view of the person that also includes those other human capacities which are not based on an ideal of pure reason. (shrink)

In this paper we discuss differing discourses of research ethics committees and the clinical research field. Reflections on our experience of conducting research in a nursing home are used to highlight the tensions and inconsistencies that arise from these discourses and the need to behave ethically in the field. While accepting the need for adherence to guiding principles of duty based ethics, we have found that practical moral decisions in the field required that, as individual researchers, we needed to exercise (...) discretionary judgement, informed by the ethic of care and the concern for the well‐being of research participants. (shrink)

Randomization is the “gold standard” design for clinical research trials and is accepted as the best way to reduce bias. Although some controversy remains over this matter, we believe equipoise is the fundamental ethical requirement for conducting a randomized clinical trial. Despite much attention to the ethics of randomization, the moral psychology of this study design has not been explored. This article analyzes the ethical tensions that arise from conducting these studies and examines the moral psychology of this design from (...) the perspectives of physician-investigators and patient-subjects. We conclude with a discussion of the practical implications of this analysis. (shrink)

This article examines issues relating to ethics decision-making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH-GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH-GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with (...) the principles outlined in the ICH-GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH-GCP Guideline in its present form. (shrink)

This article examines issues relating to ethics decision‐making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of theICH‐GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existingICH‐GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles (...) outlined in theICH‐GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of theICH‐GCP Guideline in its present form. (shrink)

The attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the American Medical Association dropped (...) the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians. (shrink)

As research into Alzheimer's disease and other dementing disorders becomes more complex, risky, invasive, and commonplace, the need intensifies for discussion of the ethics of involving persons with dementia in research, specifically research of greater than minimal risk and of no expected direct benefit to the subject. Reviewing such studies pushes our traditional analysis tools to their limits. Simply balancing and prioritizing the basic ethical principles of respect for persons, beneficence, and justice that serves us well in reviewing the vast (...) majority of studies is inadequate when reviewing research of such ethical complexities as studies with marked risks and no expectation of direct benefit to subjects unable to consent or withdraw. Moving up to the level of theory, placing these principles within the commonly applied frameworks of consequentialism, deontology, or virtue ethics bring us no closer to reducing the tensions such research creates between upholding individual autonomy and advancing society's need to learn how to treat and cure these devastating diseases. What is needed is the introduction of more contemporary moral analyses. Specifically, we need to become more inclusive of the diversity of values perspectives of our general citizenry. In more theoretical terms, we ought to elevate to a more central role a communitarian perspective and a feminist ethics emphasis on relationships and context as we rush to keep in step, ethically, with this rapidly expanding area of medical inquiry. (shrink)