The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability rather than to prevent, cure, or mitigate disease . This essay examines this question (...) in order to ensure that subjects in biomedical enhancement research receive adequate protection. (shrink)

There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article by Rebecca Dresser on preimplantation (...) genetic modification — one of the most controversial enhancement technologies — in which she states, “Under existing research ethics principles, it would be unethical for investigators to perform modifications exposing embryos expected to develop into healthy children to significant risk in exchange for a possible physical or mental enhancement.” But Dresser does not explain why such an experiment would be unethical under existing principles, and her conclusion is not self-evident. (shrink)

The United States, along with other nations and international organizations, has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. These policies govern research that might provide direct health benefits to participants and research in which there is no prospect for participant health benefits. There has been little discussion, however, about how well these rules would apply to research designed to improve participants’ capabilities or characteristics beyond the goal of good health. When (...) mentioned at all in the literature, this so-called enhancement research, as opposed to research aimed at diagnosing, preventing, curing, or treating illnesses or medical conditions, is usually dismissed without explanation. (shrink)

The physician-patient relationship has changed over the last several decades, requiring a systematic reevaluation of the competing demands of patients, physicians, and families. In the era of genetic testing, using a model of patient care known as the family covenant may prove effective in accounting for these demands. The family covenant articulates the roles of the physician, patient, and the family prior to genetic testing, as the participants consensually define them. The initial agreement defines the boundaries of autonomy and benefit (...) for all participating family members. The physician may then serve as a facilitator in the relationship, working with all parties in resolving potential conflicts regarding genetic information. The family covenant promotes a fuller discussion of the competing ethical claims that may come to bear after genetic test results are received. (shrink)

The physician-patient relationship has changed over the last several decades, requiring a systematic reevaluation of the competing demands of patients, physicians, and families. In the era of genetic testing, using a model of patient care known as the family covenant may prove effective in accounting for these demands. The family covenant articulates the roles of the physician, patient, and the family prior to genetic testing, as the participants consensually define them. The initial agreement defines the boundaries of autonomy and benefit (...) for all participating family members. The physician may then serve as a facilitator in the relationship, working with all parties in resolving potential conflicts regarding genetic information. The family covenant promotes a fuller discussion of the competing ethical claims that may come to bear after genetic test results are received. (shrink)

There has been a rising interest in the study of Mary Wollstonecraft (1759-1797) in philosophy, political theory, literary studies and the history of political thought in recent decades. The Wollstonecraftian Mind seeks to provide a comprehensive survey of her work, not only placing it in its historical context but also exploring its contemporary significance. Comprising 38 chapters by a team of international contributors this handbook covers: the background to Wollstonecraft’s work Wollstonecraft’s major works the relationship between Wollstonecraft and other major (...) philosophers Wollstonecraftian philosophy Wollstonecraft’s legacy Essential reading for students and researchers in philosophy, Wollstonecraft’s work is central to the study of political philosophy, literature, French studies, political thought, and feminism. (shrink)

MENDENHALL TJ, BERGE JM, HARPER P, GREENCROW B, LITTLEWALKER N, WHITEEAGLE S and BROWNOWL S. Nursing Inquiry 2010; 17: 359–372 The Family Education Diabetes Series (FEDS): community‐based participatory research with a midwestern American Indian communityIndigenous people around the globe tend to struggle with poorer health and well‐being than their non‐indigenous counterparts. One area that this is especially evident is in the epidemic of diabetes in North America’s American Indians (AIs) – who evidence higher prevalence rates and concomitant disease‐related complications than (...) any other racial/ethnic group. As researchers and AI communities work together to transcend conventional top‐down, service‐delivery approaches to care, community‐based participatory research is beginning to show promise as a way to partner contemporary biomedical knowledge with the lived‐experience, wisdom, and customs of Indigenous people. This study describes the Family Education Diabetes Series (FEDS) as an example of such effort, and highlights pilot findings assessing its value and impact across key diabetes‐relevant variables. Following 36 intervention participants across baseline, 3‐month, and 6‐month time periods, data show significant improvements in weight, blood pressure, and metabolic control (A1c). Strengths and limitations of this investigation are presented, along with suggestions about how to further advance and empirically test the work across other Indigenous communities. (shrink)

Background: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent.Objective: The aim of this study was to explore critically ill patients’ experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent.Design: 11 stroke patients (...) who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews.Results: None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors’ responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous.Conclusions: The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients’ experiences with the process of informed consent. (shrink)

Background: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent.Objective: The aim of this study was to explore critically ill patients’ experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent.Design: 11 stroke patients (...) who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews.Results: None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors’ responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous.Conclusions: The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients’ experiences with the process of informed consent. (shrink)

Background: Thrombolytic drugs to treat an acute ischaemic stroke reduce the risk of death or major disability. The treatment is, however, also associated with an increased risk of potentially fatal intracranial bleeding. This confronts the patient with the dilemma of whether or not to take a risk of a serious side effect in order to increase the likelihood of a favourable outcome. Objective: To explore acute stroke patients’ perception of risk and willingness to accept risks associated with thrombolytic drug treatment. (...) Design: Eleven patients who had been informed about thrombolytic drug treatment and had been through the process of deciding whether or not to participate in a thrombolytic drug trial went through repeated qualitative, semistructured interviews. Results: Many patients showed a limited perception of the risks connected with thrombolytic drug treatment. Some perceived the risk as not relevant to them and were reluctant to accept that treatment could cause harm. Others seemed to be aware that treatment would mean exposure to risk. The patients’ willingness to take a risk also varied substantially. Several statements revealed ambiguity and confusion about being involved in a decision about treatment. The patients’ reasoning about risk was put into the context of their health-related experiences and life histories. Several patients wanted the doctor to be responsible for the decisions. Conclusion: Acute stroke patients’ difficulties in perceiving and processing information about risk may reduce their ability to be involved in clinical decisions where risks are involved. (shrink)

The Ethical Responsibilities of Journalism Vis-à-Vis the Economics of News Earlier this year, Dr. Ryan Thomas reached out to me about a potential topic for the Trends section of the journal. He had...

In this interview with Jan Hendrik van den Berg, the Dutch phenomenologist and psychiatrist addresses the origins of his work, his most significant influences, and the purpose of metabletic phenomenology in the modern age. In the course of the interview. Dr. Van den Berg provides a basic overview of his work, and highlights the central finding of his metabletic analyses: a loss of wonder before nature, which results from the more fundamental loss of genuine spirituality in the modern (...) world. (shrink)