Franklin Miller

In lieu of an abstract, here is a brief excerpt of the content:“Unduly Iterative Ethical Review?”Franklin G. MillerMadam:Renée C. Fox and Nicholas A. Christakis have written a provocative article, “Perish and Publish: Non-Heart-Beating Organ Donation and Unduly Iterative Ethical Review” (KIEJ, December 1995). The language of their argument and some of the implicit assumptions on which it rests deserve critical scrutiny. They describe the articles presenting and commenting on the University of Pittsburgh protocol as “disquieting” because the display “trial-and-error ethics.” To dismiss “trial-and-error ethics” implies that we antecedently possess all the moral knowledge we need to evaluate and regulate developments in medicine. Should we summarily reject experimentation in ethics, particularly with respect to complex issues involving scientific and technological changes? For if we need to reconsider and possibly revise what counts as moral knowledge, the proposing an experimental approach to the ethics of a novel practice, which is presented publicly and made open to revision, as in the Pittsburgh protocol, may be precisely the best way to proceed.Fox and Christakis resort to invidious insinuation in their criticism of ethicists who have written, and journals that have published, articles about non-heart-beating organ donation. Publication on this issue has given ethicists the opportunity of “adding numerous items to their vitae.” Their appraisal of the vitae-boosting behavior represents an interesting rhetorical specimen: “Although there is nothing inherently dishonorable about this it does create tension between two motives: conviction about the importance of perfecting ethical conduct, on the one hand, and the desire to advance one’s professional career, on the other” (p. 340). I am not sure what the authors mean by “perfecting ethical conduct.” Yet they suggest that a group of reputable scholars, who have taken diverse positions on the ethics of non-heart-beating organ donation, have come perilously close to venality.Finally, in order to avoid further legitimating what they consider to be an ethically objectionable practice, the authors advocate that journals exercise “restraint” in publishing articles about this topic. Perhaps in a future pronouncement they will enlighten us about how enforcing a publication policy that avoids the vice of “unduly iterative ethical review” might work without compromising freedom of discussion. Moral dogmatism and censorship have a long history of association.Franklin G. MillerCenter for Biomedical Ethics University of Virginia Charlottesville, VACopyright © 1996 The Johns Hopkins University Press...

Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. Traditionally, death was understood to occur when a person stops breathing, their heart stops beating and they are cold to the touch. Today, physicians determine death by relying on a diagnosis of ‘total brain failure’ or by waiting a short while after circulation stops. Evidence has emerged, however, that the conceptual bases for these approaches to determining death are fundamentally flawed and depart substantially from the established biological conception of death. We argue that the current approach to determining death consists of two different types of unacknowledged legal fictions. These legal fictions were developed for practices that are largely ethically legitimate but need to be reconciled with the law. The considerable debate over the determination of death in the medical and scientific literature has not informed the public that vital organs are being procured from still-living donors and it seems unlikely that this information can remain hidden for long. Given the instability of the status quo and the difficulty of making the substantial legal changes required by complete transparency, we argue for a second-best policy solution: acknowledging the legal fictions involved in determining death to move in the direction of greater transparency. This may someday result in more substantial legal change to directly confront the challenges raised by life-sustaining and life-preserving technologies without the need for fictions

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …

Although established in the law and current practice, the determination of death according to neurological criteria continues to be controversial. Some scholars have advocated return to the traditional circulatory and respiratory criteria for determining death because individuals diagnosed as ‘brain dead’ display an extensive range of integrated biological functioning with the aid of mechanical ventilation. Others have attempted to refute this stance by appealing to the analogy between decapitation and brain death. Since a decapitated animal is obviously dead, and ‘brain death’ represents physiological decapitation, brain dead individuals must be dead. In this article we refute this ‘decapitation gambit.’ We argue that decapitated animals are not necessarily dead, and that, moreover, the analogy between decapitation and the clinical syndrome of brain death is flawed

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of “research results,” specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action

Transplantation of vital organs has been premised ethically and legally on "the dead donor rule" (DDR)—the requirement that donors are determined to be dead before these organs are procured. Nevertheless, scholars have argued cogently that donors of vital organs, including those diagnosed as "brain dead" and those declared dead according to cardiopulmonary criteria, are not in fact dead at the time that vital organs are being procured. In this article, we challenge the normative rationale for the DDR by rejecting the underlying premise that it is necessarily wrong for physicians to cause the death of patients and the claim that abandoning this rule would exploit vulnerable patients. We contend that it is ethical to procure vital organs from living patients sustained on life support prior to treatment withdrawal, provided that there is valid consent for both withdrawing treatment and organ donation. However, the conservatism of medical ethics and practical concerns make it doubtful that the DDR will be abandoned in the near future. This leaves the current practice of organ transplantation based on the "moral fiction" that donors are dead when vital organs are procured

Debriefing is a standard ethical requirement for human research involving the use of deception. Little systematic attention, however, has been devoted to explaining the ethical significance of debriefing and the specific ethical functions that it serves. In this article, we develop an account of debriefing as a tool of moral accountability for the prima facie wrong of deception. Specifically, we contend that debriefing should include a responsibility to promote transparency by explaining the deception and its rationale, to provide an apology to subjects for infringing the principle of respect for persons, and to offer subjects an opportunity to withdraw their data. We also present recommendations concerning the discussion of deception in scientific articles reporting the results of research using deception.

: The "therapeutic misconception," described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials

Surgical clinical trials have seldom used a “sham” or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken, and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent.

A special report of The Hastings Center and the Association of American Medical Colleges addressed the ethical oversight of learning health systems, which seek to combine high‐quality patient care with routine data collection aimed at improving patient outcomes. The report contained two position papers, authored by a number of distinguished bioethicists, and several commentaries. The position papers urged two changes. First, they urged a rethinking of our approach to the regulation of human subjects research, so as to make it easier in the future for learning health systems to function well. Second, they argued that the rethinking required dispensing with a strict distinction between research and therapy, which has been a major tenet of bioethics since the Belmont Report, which explicated basic ethical principles governing human subjects research. We fully support the objectives of the authors, and we agree that the learning health system is an important advance that serves patients well. Unnecessary regulatory burden ought not impede this progress. We disagree, however, that the best way to bring about these needed changes in the regulatory environment is to reject the basic distinction between research and treatment. Unfortunately, we find the arguments in favor of that strategy to be, in places, reminiscent of what we take to be basic conceptual errors that hampered the ethical understanding of human subjects research prior to adoption of the Belmont Report. To see why one need not reject the research‐treatment distinction in order to promote learning health systems, we first investigate in some detail the arguments offered for eliminating the distinction. We next turn to an issue not addressed by those authors, namely, the relationship between the physician or investigator and the patient or subject, to illustrate why the distinction is important and what is lost if it is jettisoned.

The results of the first randomized controlled trial of a medical treatment were reported in 1947. The antibiotic streptomycin was demonstrated to be dramatically superior to bed rest alone in treating tuberculosis. Looking back on this trial in 1990, A. B. Hill, the distinguished medical statistician who played a prominent role in the use of randomization in this study, made a telling statement about the moral climate of clinical research at the time: "Of course, there were no ethical problems in those days: we did not ask the patient’s permission or anybody’s permission. We did not tell them they were in a trial—we just did it" (1990, 78). From our perspective today it is obvious that it is not true that there ..

Research drawn from data contained in medical records is a common and immensely important means of scientific investigation in epidemiology and health services research. It provides valuable knowledge regarding risk factors for disease, the safety of pharmaceuticals and medical procedures, and the quality of medical care. Electronic information technology has greatly enhanced the capability of conducting research using medical records, but it has also generated increasing concern about invasions of privacy. Both practical and scientific considerations militate against soliciting consent for population-based observational research. Retrospective review of existing medical records, especially with large samples, poses insuperable barriers to locating human subjects in order to obtain their informed consent. When efforts are made to obtain informed consent for prospective research drawn from disease and treatment registries, mounting evidence has accumulated that substantial selection biases are introduced into the data, as those who consent are not necessarily representative of the population of relevant patients.

We seek to change the conversation about brain death by highlighting the distinction between brain death as a biological concept versus brain death as a legal status. The fact that brain death does not cohere with any biologically plausible definition of death has been known for decades. Nevertheless, this fact has not threatened the acceptance of brain death as a legal status that permits individuals to be treated as if they are dead. The similarities between “legally dead” and “legally blind” demonstrate how we may legitimately choose bright-line legal definitions that do not cohere with biological reality. Not only does this distinction bring conceptual coherence to the conversation about brain death, but it has practical implications as well. Once brain death is recognized as a social construction not grounded in biological reality, we create the possibility of changing the social construction in ways that may better serve both organ donors and recipients alike.

The “learning health care system” is being heralded as offering great potential for improving the quality and cost-worthiness of medical care by closely integrating the care of patients with the accumulation of aggregate data that can guide evidence-based medicine. By using electronic medical records, routine patient care and administrative data will be available for systematic observational studies. With the aid of these electronic medical records, quality-improvement studies of institutional practices and pragmatic, comparative effectiveness randomized trials of individual treatments could become standard features of the medical care environment in the LHS. In this..

Human life and death should be defined biologically. It is important not to conflate the definition of death with the criteria for when it has occurred. What is distinctively "human" from a scientific or normative perspective has nothing to do with what makes humans alive or dead. We are biological organisms, despite the fact that what is meaningful about human life is not defined in biological terms. Consequently, as in the rest of the realm of living beings, human beings die when they no longer function biologically as organisms. In contrast, a determination of exactly when death has occurred, required to serve various social purposes, combines social and normative considerations with biological facts.

Henry Beecher was a distinguished professor of anesthesia and clinical investigator at Harvard Medical School. He became an iconic figure in bioethics, best known for his 1966 article describing 22 examples of unethical clinical research. This is one of the most frequently cited articles on ethics in the medical literature. Indeed, it may be seen as marking a watershed in the moral climate of medical research. In his history of bioethics, Albert Jonsen characterized Beecher as one of the “stars in the bioethical firmament”. Daniel Callahan, founder of the Hastings Center, explained Beecher’s impact in a 1991 interview:“I think the role of Henry Beecher was very important in the mid 60s when he blew the...

The following article examines critically Robert Veaten's argument that respect for patient autonomy invalidates the concept of medically indicated treatment. I contend that when judgments of medically indicated treatment are distinguished from what ought to be done in a given case, all things considered, they are compatible with patient autonomy. Yet there remains a significant danger, which needs to be guarded against, that physicians will use these judgments to dominate their interactions with patients. Medicine would be impoverished, however, if physicians were barred from using clinical judgment to recommend medically indicated treatment. Keywords: clinical judgment, doctor's orders, medically indicated, physician-patient relationship CiteULike Connotea Del.icio.us What's this?

: The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in a research trial. This overlap is maximal when the same physician occupies both roles with respect to a particular patient-subject. We address the ethical tensions inherent in that role conflict and argue that the tensions are real but manageable. The difference position provides a sound ethical framework within which to manage those tensions, while the similarity position is unsatisfactory because it seeks to deny the existence of the tensions

The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry.