Franklin Miller

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.

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..

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...

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...

Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when they believed it had a higher price

Franklin Miller's thoughtful reply to our paper asks pointed questions about the role of the physician qua physician in physician-assisted death. Would making assisted dying available to treatment-resistant depressed people necessarily affect the professional integrity of healthcare professionals, as Dr Miller asserts? Dr Miller agrees with us on a number of crucial points: It is possible that some patients with treatment-resistant major depression are competent to make the decision to ask for assisted dying; it is possible that some such patients could make a rational choice if they requested such assistance. He also is generally supportive of physician-assisted death, at least for ‘terminally ill’ patients. He defines a terminally ill patient as someone who has a ‘predictable short life span and will die soon regardless of medical intervention’. We disagree with his conceptualisation of ‘terminal illness’ as requiring that death occurs within 6–12 months, given the existence of illnesses like Amyotrophic lateral sclerosis (ALS) or certain prostate cancers that are commonly considered to be terminal illnesses and that are taking their predictable course sometimes over years. If, all other things being equal, an illness is going to kill a patient at some point down the track, it surely should qualify for the label ‘terminal illness’. However, we will accept his definition for the sake of the argument. Dr Miller supports the availability of assisted dying for patients likely to die from that illness within 6 months from the day their request for assisted dying has been made. He broadly holds the kind of view we aimed to sway with our analysis. Apparently, we failed. Dr Miller thinks that physician-assisted death must be consistent with professional integrity, requiring that it is consistent with ‘the proper goals of medicine and the specific duties incumbent on clinicians in acting to realize …

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 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.

In the research ethics literature, there is strong disagreement about the ethical acceptability of placebo-controlled trials, particularly when a tested therapy aims to alleviate a condition for which standard treatment exists. Recently, this disagreement has given rise to debate over the moral appropriateness of the principle of clinical equipoise for medical research. Underlying these debates are two fundamentally different visions of the moral obligations that investigators owe their subjects.Some commentators and ethics documents claim that physicians, whether acting as care givers or researchers, have the same duty of beneficence towards their patients and subjects: namely, that they must provide optimal medical care. In discussing placebo surgery in research on refractory Parkinson's disease, Peter Clark succinctly states this view: “The researcher has an ethical responsibility to act in the best interest of subjects.”