The American journal of the medical sciences
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For as long as the federal regulations governing human subjects research have existed, the practice of informed consent has been attacked as culturally biased, legalistic, ritualistic and unevenly enforced. Its focus on meeting the regulatory requirements is seen as undermining a truly ethical process that produces informed and voluntary participation in medical research. ⋯ Study participants are asked to consent to future studies with unspecified aims, broad data sharing policies and ongoing uncertainties regarding confidentiality protections and the potential benefit of incidental genomic research findings. Because more research is conducted under these new conditions, the very nature of the researcher-subject relationship is shifting and will require new governance mechanisms to promote the original goals of informed consent.
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Informed consent is one of the great puzzles of modern medical research and practice. As Professor Henderson has argued in her article, there is ample reason to be concerned that many, and maybe all, of the goals announced for informed consent law and ethics have not been reached. In this article, I will review the goals that theorists and judges have assigned to the doctrine and discuss some of the evidence concerning the difficulties of meeting those goals. Finally, I will suggest some of the reasons that might account for our continued commitment to informed consent despite its difficulties.
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Equipoise is widely endorsed as a necessary requirement for ethical design and conduct of randomized controlled trials. Nevertheless, I argue in this article that the equipoise principle suffers from fundamental defects. In particular, equipoise provides flawed ethical guidance for placebo-controlled trials and for decisions to terminate trials early based on interim data relating to benefit. ⋯ Because of this mistaken therapeutic orientation, equipoise fails to adequately account for the central purpose of randomized trials in providing evidence sufficient to guide health policy decisions relating to licensing new treatments and insurance coverage. I conclude that it is time to dispense with equipoise. The principles of research ethics are sufficient to provide adequate guidance to protect subjects and to promote socially valuable research without any appeal to equipoise.
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In recent years, various authors have proposed that the concept of equipoise be abandoned because it conflates the practice of clinical care with clinical research. At the same time, the equipoise opponents acknowledge the necessity of clinical research if there are unresolved uncertainties about the effects of proposed healthcare interventions. As equipoise represents just 1 measure of uncertainty, proposals to abandon equipoise while maintaining a requirement for addressing uncertainties are contradictory and ultimately not valid. ⋯ This approach is based on the view that considerations of ethics and rationality cannot be separated. I analyze the response to uncertainties as it relates to the dual-processing theory, which postulates that rational approach to (clinical research) decision making depends both on analytical, deliberative processes embodied in scientific method (system II), and good human intuition (system I). Ultimately, our choices can only become wiser if we understand a close and intertwined relationship between irreducible uncertainty, inevitable errors and unavoidable injustice.
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Opposition to the use of animals in biomedical research rests on diverse scientific and ethical arguments. Here I offer a response to key objections and argue that the responsible use of animals in biomedical research with the goal of advancing medical knowledge, science and human health, is scientifically and morally justified. ⋯ Thus, I hope this personal perspective persuades other scientists, public health officials, scientific organizations and our academic leadership to join the debate and invites opponents of animal research to create an atmosphere where civil discourse can take place, free of threats and intimidation. The public deserves an open and honest debate on this important topic.