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Biomedical subjects

K Lebacqz

Publications and source records attributed to K Lebacqz.

5 recordsLinked to original sources

Humility in health care.

Humility, properly understood as a sense of one's limits, is one of the goods internal to the practice of health care. Humility in Christian tradition has both a relational aspect and an epistemological aspect. Each of these is evident in the practice of medicine. In its relational aspect, humility includes reverence or awe for the grace and strength of patients and their care-givers, a sense that the care-provider is not self-sufficient but needs the care-receiver, and recognition of the worth of those who are oppressed and outcast. In its epistemological aspect, humility is exhibited in respect for the meaning system of the patient and recognition of the limits of medical paradigms and their need for correction from the patient's perspective. The power wielded by the profession of medicine in contemporary society does not preclude the exercise of humility within the profession.

Christianity

Some ethical considerations in clinical trials.

The ethical norms established in various codes and regulations are inadequate to resolve some of the ethical problems presented by clinical trials. They are stated too vaguely to provide unequivocal answers to many specific questions. In order to remedy this situation, many commentators have proposed the development of more specific and complex regulations. We propose that a more fruitful approach would be to examine the ethical principles underlying the norms and to apply these principles to the specific problems. We apply this approach to two questions: (1) Is it ethical to select subjects for a randomized clinical trial (RCT) exclusively from Veterans Administration (VA) hospitals? (2) In the conduct of a RCT is it necessary to disclose the fact that therapy will be determined by chance? We conclude that problems of justice arise not only because of the vulnerability of patients in VA hospitals but also because of the loss of the physician-patient relationship in an RCT. However, the use of patients in a VA hospital is not always unjust; in most cases such use can be made more just through various modifications in design. We also conclude that the fact of randomization should be disclosed in any situation in which it might materially affect the prospective subject's decision, and that the values and preferences of the subjects should be taken into account in determining what information might be material. This work is only a preliminary step toward analyzing ethical issues in clinical trials. While some would challenge our conclusions, we hope that our methods will facilitate clarity about the locus of disagreement in current controversies and about the value questions that must be answered in order to set an ethical context for the conduct of clinical trials.

Clinical Trials as Topic

The National Commission and research in pharmacology: an overview.

Participation in research of children, prisoners, or those institutionalized as mentally infirm is problematic because it appears to violate one or the other of two fundamental ethical principles: the principle of respect for persons, which requires that subjects give voluntary and informed consent, and the principle of justice, which requires that vulnerable persons not bear burdens in order that others may benefit. The National Commission recommends that conditions of constraint be minimized so that prospective subjects can make truly voluntary choices, that special protections such as third-party permission and national review be brought to bear for non-comprehending subjects, and that vulnerable persons be used only when less vulnerable persons are not suitable subjects or when the research is designed to develop or evaluate therapeutic interventions intended to benefit the individual subject. These recommendations might have the practical effect of restricting certain types of research (e.g., Phase I drug testing), but they are less restrictive than other proposals, and they reflect a conviction that research using special subject populations can be conducted in accord with fundamental ethical principles.

Adult