Human research is accepted in our society because it is seen as generating valuable new knowledge that may alleviate suffering and bring benefit to ill persons now and in the future (Brody 1998; Fa...

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training (...) and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, (...) in recognition that there may be personal benefit from participation in some studies?The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. (shrink)

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training (...) and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

(2003). The Ethics and Governance of Medical Research: What does regulation have to do with morality? New Review of Bioethics: Vol. 1, No. 1, pp. 41-58.

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

This paper attempts to provide a broader view into the ethical issues surrounding the field of emergency medicine (EM) research. It starts from defining bioethically relevant features of EM and presents this field in the context of different models of health care provider–patient relationship. The paper also provides a short overview of the “post-Nuremberg” evolution of the main international research ethics guidelines relevant to EM research which demonstrates a tendency of liberalization of research on incapable persons. This tendency culminates with (...) the exceptions to informed consent for EM research which is supposed to be balanced by other research ethics principles, especially a careful rationing of risks and benefits. This finally brings us towards a critical analysis of the minimal risk standard which is one of the main fundamental safeguards in EM research. (shrink)

Little is known about how researchers view ethically salient aspects of human studies. As part of a National Institutes of Mental Health-funded study, the authors performed a confidential written survey to assess the attitudes, views, and experiences of researchers with institutional review board approved protocols at the University of New Mexico. A total of 363 researchers (57% response rate) participated. Investigators overall held favorable views of general ethical aspects of research and ethics-based safeguards, and they identified a positive role of (...) ethics training. Investigators with more experience encountering ethical problems (p < .001), more ethics training (p = .001), and a PhD or MD/PhD (p = .003) held more favorable general ethical perspectives. Women investigators (p < .03), nonphysician investigators (p < .001), those whose training had been helpful in resolving ethical dilemmas (p = .006), and those for whom spirituality is important (p = .008) more strongly endorsed ethical safeguards. Investigators perceive the scientific and ethical aspects of their work as valuable and linked, and they affirm the role of safeguards in human studies. Formal ethics preparation and training initiatives were also viewed positively by investigators. (shrink)

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, (...) in recognition that there may be personal benefit from participation in some studies?The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. (shrink)

This paper deals with ethical issues of particular relevance to longitudinal research involving children. First some general problems concerning information and lack of understanding are discussed. Thereafter focus is shifted to issues concerning information and consent procedures in studies that include young children growing up to become autonomous persons while the project still runs. Some of the questions raised are: When is it right to include children in longitudinal studies? Is an approval from the child needed? How should information to (...) children be handled? A general point stressed is that autonomy considerations underline the importance of adjusting the information given to meet demands. A “presumption of competence” may be needed in research involving children, in order to pay their views sufficient attention. (shrink)