Some scholarly fields are very healthy (e.g., physics). Some are fairly unhealthy (e.g., evolutionary psychology, sad to say). Some are outright crazy (e.g., philosophy of religion).
How good or bad is bioethics? How rigorous and truth-tracking is it? How much social benefit or harm does it cause?
Looking at lots of random examples is an under-used tool for making progress on this kind of question. It's fast, it avoids the perils of cherry-picking, and it doesn't require you to trust someone else's high-level summary of the field.
I picked the two highest-impact-factor "medical ethics" journals that have the word "bioethics" in the title: The American Journal of Bioethics and Bioethics. Together, these two journals release about 500 reports, book reviews, etc. per year.
I then picked a random article from 2014 through 2020 from each journal, plus extra random articles from the more cited journal (The American Journal of Bioethics): five from 2016, 2018, and 2020, and two from 2017 and 2019.
For each article, I quoted the abstract (if there is one), the first two paragraphs, and the final paragraph. These are provided below, sorted by year.
Obviously this breadth-first approach won't provide a full sense of the quality of argumentation in these papers; but it will hopefully provide a picture of what kinds of views tend to get argued for in the field, what those arguments tend to look like, what tends to get taken for granted, what tends to get ignored, and so on.
I expect more accurate conclusions and faster consensus-building about bioethics if conversation is grounded in a common pool of examples (which can then be drilled down on to spot-check a particular paper's arguments, etc.).
Added: aphyer summarized the articles in the comment section; I've put aphyer's summaries in an editable Google Doc to make it easier to improve on the summaries (and to encourage article-by-article critiques, in the comments below or in the Doc).
Ingmar Persson and Julian Savulescu. The American Journal of Bioethics 14(4). Open Peer Commentaries.
We respond to Sparrow’s (2014) criticisms of our support for a project of moral bioenhancement. We distinguish between a confident and cautious proposal, arguing that his objections only apply to a confident proposal, while we endorse a cautious proposal. We argue that the project of moral bioenhancement (1) need not be more compulsory than traditional moral education, which should supplement it; (2) is not dependent on “shonky” sociobiology or biologism that downplays the importance of traditional education and the role of cognitive processes; (3) is not committed to increasing inequality, but if judiciously applied would rather reduce it; and (4) would be desirable even if, as he believes, it leads to a democracy in which a moral elite has more political power. Sparrow fails to appreciate the extent of existing inequalities in moral as well as socioeconomic respects. He displays a fetish about egalitarianism and labors under a prescientific understanding of the relationship between the brain and moral behavior. We also argue that he confuses liberal neutrality with moral relativism, and fails to realize the extent to which all functioning societies have to be based on common core of norms and values.
When Robert Sparrow criticizes our work on moral bioenhancement (see Persson and Savulescu 2012), he doesn’t bother to make precise the claims by us to which he objects. It’s important to distinguish two types of proposals about moral bioenhancement, a confident one and a cautious one. (This is a simplification; there is in fact a whole spectrum of possible views with varying degrees of confidence/cautiousness.) These types of proposals differ with respect to the following three issues.
We believe that judicious moral bioenhancement will reduce the inequality between people with respect to moral motivation, rather than exacerbating it. But let’s play along with Sparrow and hypothesize that it will create a morally enhanced elite and that this will result in an inegalitarian democracy “restricting participation in government to the morally enhanced” (25). He suggests that nonetheless our current commitment to egalitarianism “might provide reasons to resist bringing it about such that an inegalitarian politics should be justified” (42). This is strong stuff. Sparrow seems to saying that even if a morally elitist democracy would pursue the morally right politics—that would bring anthropogenic climate change to a halt, put an effective check on the use of weapons of mass destruction, and so on—we should still prevent it coming into existence, clinging to our current more “egalitarian” democracies that leave us teetering on the brink of disaster. This seems to us to be making a fetish out of current egalitarianism, which—considering the huge socioeconomic inequalities it tolerates both within democratic states and globally—is surely far from perfect.
Francesca Minerva. Bioethics 28(4). Symposium: 'Anonymised Publishing in Bioethics'.
‘The point of philosophy is to start with something so simple as not to seem worth stating, and to end with something so paradoxical that no one will believe it’ Bertrand Russell, The Philosophy of Logical Atomism
In ‘New Threats to Academic Freedom’ I suggested that new media may represent a threat to academic freedom. In particular, I argued that academic freedom may be limited ab ovo if people fear that they will have to go through media storms when publishing papers that might be perceived as controversial.
I would prefer a world where people were free to ask questions and to attempt to give answers to those questions without being dragged into media frenzies, missing out on job opportunities (as happened to both me and Alberto Giubilini) and being threatened with physical harm. But as we do not live in such an ideal world, the best we can do in order to change the current society into a less violent and intolerant one is to keep asking questions, and to keep seeking answers.
Shlomo Cohen. The American Journal of Bioethics 15(10). Open Peer Commentaries.
Ploug and Helm's (2015) insightful article criticizes recent views—mainly those advanced by Saghai (2013) and me (Cohen 2013)—that allow "nudging" patients while obtaining their informed consent (IC). Although many of their arguments deserve discussion, this short commentary focuses on one philosophical point that I see as pivotal in determining perspectives in the debate. The authors indeed open their criticism of my approach by reference to this point: "First and foremost, while tacitly assuming that the value of informed consent is derived from the protection of personal autonomy, Cohen's view fails to provide a coherent and plausible account of personal autonomy." Although seemingly trivial and overwhelmingly common, the diagnosis that one's conception of valid IC is determined by one's theoretical conception of personal autonomy is in my view wrong: The specific amount of autonomy often makes little difference. If we derived the ethics of IC from the concept of autonomy, we would probably conclude with the authors that nudging is incompatible with respecting autonomy, since, conceptually, manipulation and respecting autonomy point in opposing directions. However, the idea that the ethics of IC can be determined by theories of autonomy is wrong. I must leave the more theoretical discussion for another occasion, and restrict myself to showing how this is exemplified in the authors' own account.
The requirements for IC entailed by the authors' theoretical account of autonomy are very unspecific: We must provide "adequate" information; the patient needs to "understand" it; the patient cannot be "unduly influenced" while deliberating; these conditions are supposed to enable "reasonable" choice. The problem is that all these parameters are terribly underdetermined ("not unduly influenced" may be question-begging): Except for hard paternalism or outright deception, they can allow the entire spectrum of views under debate. I too can embrace these formulations—nothing in them rules out nudging. Why don't the authors provide more precise directives? They are not guilty of sloppy work; the deep point is rather that beyond general pronouncements, conceptions of autonomy cannot provide practical ethical guidelines generally or specifically for IC. One central reason for this is that true autonomy is an exceedingly superhuman possibility and therefore cannot reliably prescribe what providing the conditions for humanly possible autonomy requires morally (e.g., whether to avoid nudging entirely)—that must rather be determined by some different method.
In this short commentary I have argued that the guidelines for a valid practice of IC are not predominantly determined by theoretical conceptions of autonomy, that they are rather determined by relevant social conventions, and that those conventions allow room for some types of nudging. Once this philosophical point is clear, the question ceases to be whether nudging is permissible, but which nudging is.
4. Why not Commercial Assistance for Suicide? On the Question of Argumentative Coherence of Endorsing Assisted Suicide
Roland Kripke. Bioethics 29(7). Article.
Abstract: Most people who endorse physician‐assisted suicide are against commercially assisted suicide – a suicide assisted by professional non‐medical providers against payment. The article questions if this position – endorsement of physician‐assisted suicide on the one hand and rejection of commercially assisted suicide on the other hand – is a coherent ethical position. To this end the article first discusses some obvious advantages of commercially assisted suicide and then scrutinizes six types of argument about whether they can justify the rejection of commercially assisted suicide while simultaneously endorsing physician‐assisted suicide. The conclusion is that they cannot provide this justification and that the mentioned position is not coherent. People who endorse physician‐assisted suicide have to endorse commercially assisted suicide as well, or they have to revise their endorsement of physician‐assisted suicide.
For many years, there has been a fierce controversy regarding the question of the ethical evaluation of assisted suicide. Surprisingly, there is broad agreement on one point, namely the rejection of commercial assistance for suicide. ‘Commercial assistance for suicide’ means that professional non-medical providers assist people in the implementation of their suicidal intents in return for payment. Not only opponents of physician-assisted suicide (PAS) but also most of its proponents think that commercially assisted suicide (CAS) is immoral and should not be permitted – if they discuss this form of assisted dying at all. For whilst the legitimacy or illegitimacy of PAS is the subject of intense discussion, the question of CAS leads a miserable existence within the international ethical discussion.
However, the issue is in no way far-fetched. Firstly, in some countries at least, there is ethical and political discussion on this topic. In Germany, for example, not only have some cases of CAS come to public attention in recent years, but also several legislative initiatives to prohibit CAS were launched. Secondly, the issue of CAS seems to be reasonable because of the well-known general tendency towards commercialization of various areas of life. Thirdly, the issue is important due to theoretical reasons, namely as a touchstone for the coherence of the ethical position of the proponents of PAS.
If one does not want a society in which suicide and its support is normal and taken for granted like other services, and if one wants to adhere at the same time to the claim of coherence for their own ethical position, the only possibility is to reject PAS. Those who do not endorse CAS cannot endorse PAS, either.
John D. Lantos, Julie Caciki, and Jeremy R. Garrett. The American Journal of Bioethics 16(1). Guest Editorial.
For more than 50 years, most industrialized countries have mandated population screening of newborns for medical conditions that meet a few straightforward criteria (Wilson and Jungner 1968). The condition must be an important health problem. The screening test should be accurate. There must be an effective treatment that is readily available to the people who have been screened. The cost of the program, including screening, diagnosis, and treatment, must be reasonable. When all these conditions are met, then the medical, legal, and ethical consensus has been that it is justifiable to mandate newborn screening. Screening tests that meet these criteria have been endorsed by the Institute of Medicine, the American Society of Human Genetics and the American College of Medical Genetics, an NIH Task Force on Genetic Testing, the American Academy of Pediatrics, and the President's Council on Bioethics (Committee on Assessing Genetic Risks 1994; Botkin et al. 2015; Holtzman 1997; American Academy of Pedriatrics Newborn Screening Task Force 2000; President's Council on Bioethics 2008). For all of these organizations, the ethical justification for screening is that it provides direct benefit to the newborn and that avoiding or delaying screening could cause harm to that newborn.
In their target article in this issue, Hom and colleagues (2016) raise the question of whether parental religious beliefs should allow exemptions to mandated screening for critical congenital heart disease (CCHD). It is important to be clear that in making this argument, they are not addressing three of the important and thorny controversies that are the usual focus of debates about newborn screening. The three controversial issues are (1) screening to detect conditions for which there is no effective treatment; (2) the use of stored samples from newborn screening for research unrelated to the screening program; and (3) tests for conditions that do not manifest until adulthood and for which there are no beneficial interventions in childhood. All three of those situations are appropriately controversial for traditional newborn screenings. None of them, however, is relevant to the central issue addressed in the target article or to the type of screening that is done for CCHD.
We acknowledge that some CCHDs are not easily correctable and thus that parents can ethically refuse treatment for the most severe CCHDs. But at present, the screening tests do not distinguish the easily correctable ones from those that are not so easy to treat. It is appropriate, then, to mandate newborn screening, without exceptions for religious beliefs, for CCHDs.
6. The Curious Case of the De-ICD: Negotiating the Dynamics of Autonomy and Paternalism in Complex Clinical Relationships
Daryl Pullman and Kathleen Hodgkinson. The American Journal of Bioethics 16(8). Article.
Abstract: This article discusses the response of our ethics consultation service to an exceptional request by a patient to have his implantable cardioverter defibrillator (ICD) removed. Despite assurances that the device had saved his life on at least two occasions, and cautions that without it he would almost certainly suffer a potentially lethal cardiac event within 2 years, the patient would not be swayed. Although the patient was judged to be competent, our protracted consultation process lasted more than 8 months as we consulted, argued with, and otherwise cajoled him to change his mind, all to no avail. Justifying our at times aggressive paternalistic intervention helped us to reflect on the nature of autonomy and the dynamics of the legal, moral, and personal relationships in the clinical decision-making process.
Several years ago our ethics consultation service faced a particularly vexing and exceptional case that forced us to reconsider our ethical and professional responsibilities in the face of what appeared to be a legally permissible but ill-advised medical decision. We had to reexamine the relationship between the legal and the moral, and the role of our ethics consultation service in this process. In addition to revisiting the much-discussed question of the relationship between autonomy and justified paternalistic intervention, we had to reflect upon the nature of the relationships between various health care professionals, the patient, and his family. Additionally, we had to assess the roles and responsibilities of members of our ethics consultation group who resisted this patient’s legally permissible but ethically problematic request, and of the cardiologist who eventually facilitated it. Finally, we had to manage the tension between private interests and public goods when the decision in question involved the allocation of scarce resources in a publicly funded health care system.
There is a vast and expanding literature on the concept of autonomy and the nature of justified paternalistic intervention. Perspectives vary from those that acknowledge the primacy and centrality of autonomy in biomedical decision making (Gillon 2003; Wolpe 1998) to those that present a somewhat more nuanced perspective (O’Neill 2002; Kukla 2005; Levy 2014). Our intent is not to review this literature in any systematic or robust fashion, but rather to draw upon various perspectives in assessing, critiquing, and in some respects justifying the manner in which we managed this complex and difficult case. Our emphasis is less on analytic precision and more on practical understanding as we continue to rely on these and related concepts in navigating the ambiguities of moral space.
Finally, we comment briefly on the implications of acceding to a patient’s demands when the economic consequences of those choices are borne by a publicly funded health care system. When James’s initial clinical assessment determined he needed an ICD, there was no question about cost; as a resident of a society that has deemed access to basic medical care a positive right, James was entitled to the provision of his basic health care needs. When he subsequently requested that the ICD be removed against all medical advice to the contrary, there was still no mention of the potential financial costs in discussions with James, although the issue did come up in conversation among the health care and clinical ethics teams. In this case the surgeon who offered to remove the ICD said he would not bill the provincial health plan for the usual fee associated with the procedure. But the cost of the removal was insignificant compared to the additional costs of maintaining James after his cardiac event, the subsequent replacement of the ICD, and the eventual heart transplant. What responsibilities should individual patients bear for the consequences of their decisions? Are the considerations in the current case different from those that arise in the context of other “lifestyle choices” where individuals make poor decisions that affect their health, resulting in a greater burden for the health care system? These latter issues are beyond the purview of the current discussion but should not go unmentioned. Talk about money will put a strain on any relationship, and for this reason we often tiptoe around such issues in our personal lives. Nevertheless, when all personal relational resources have been exhausted, as they were eventually in our dealings with James, perhaps the financial consequences of his decision should have been raised. Indeed, at that point the relationship was more contractual than personal in nature, and in the interests of transparency and full disclosure the real financial costs of the transaction he was insisting upon could have been revealed and discussed. But again, such financial considerations and discussions should occur only at the end of the relational encounter, not at the outset. In any case, in our publicly insured health care system talk of costs would serve only as one last (and perhaps desperate) attempt at moral suasion, as there are no coercive financial mechanisms available by which to recoup the costs of an unwarranted and frivolous demand for services. However, such mechanisms might exist in health care systems that rely more heavily on private insurance and where the “ethics of strangers” are often more readily apparent. Thus, while an ethic of intimacy may encourage care and compassion, an ethic of strangers may more readily accommodate individual responsibility. Finding the means by which to assess and nurture the full continuum of relational values and responsibilities is thus an ongoing challenge.
Joseph J. Fins, et al. The American Journal of Bioethics 16(3). Target Article.
Abstract: Although clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems, progress in developing standards for quality is challenging. In this article, we describe the results of a pilot project utilizing portfolios as an evaluation tool. We found that this approach is feasible and resulted in a reasonably wide distribution of scores among the 23 submitted portfolios that we evaluated. We discuss limitations and implications of these results, and suggest that this is a significant step on the pathway to an eventual certification process for clinical ethics consultants.
In 2013, the American Society for Bioethics and Humanities Quality Attestation Presidential Task Force (ASBH QAPTF) published a proposed two-step model for evaluating and attesting to the quality of clinical ethics (CE) consultants (Kodish and Fins et al. 2013). The first part of this two-step process envisioned the submission of a portfolio that summarizes the education, experience, philosophy, and substance of ethics case consultation to establish a consultant’s eligibility to undergo a subsequent examination.
The Quality Attestation Presidential Task Force (QAPTF) was formed to develop a means to assess the performance of CE consultants. The task force functions under the aegis of ASBH, the primary society of bioethicists and scholars in the medical humanities and the organizational home for many individuals who perform clinical ethics consultation (CEC) in the United States. Members of the task force were appointed for their breadth and depth of experience in clinical ethics consultation and the diversity of their professional and educational backgrounds.
Much work remains to be done. The first experience with an ethics consultation portfolio has yielded ways to improve it and leaves undecided what the next steps should be. Future developments will require (1) more resources in time and expertise, (2) attention to governance with regard to the appropriate institutional home for CE consultant attestation/certification, and (3) financial self-sufficiency. Nonetheless, the field has moved further along the path toward a process to demonstrate professional competency of CE consultants and to develop robust quality standards consistent with the expectation for other members of the health care professions. Remaining challenges notwithstanding, this is a positive development for both clinical ethics consultation and for the patients and caregivers it serves.
Andrea Segal and Dominic Sisti. The American Journal of Bioethics 16(4). Open Peer Commentaries.
We wish to point out an additional consequence of the Catch-22 described by Andreae and colleagues (Andreae et al. 2016). The decades-long research gridlock of controlled drugs has unintentionally resulted in wide-scale off-label use of one such drug, ketamine, in free-standing private psychiatric clinics. The growth of these clinics and burgeoning consumer demand for ketamine raise important ethical and policy issues related to patient safety, consent, and the future of research on controlled drugs.
Ketamine was approved in 1970 as a dissociative anesthetic, and by the 1980s researchers began to use ketamine for the treatment of psychiatric disorders. Ketamine’s properties as an NMDA (N-methyl-D-aspartate) receptor antagonist have spurred enthusiasm about a new line of psychiatric treatment for very depressed patients (Sisti, Segal, and Thase 2014). Outpatient clinics have sprung up worldwide purporting to treat serious depression with ketamine. Unfortunately, a market has developed where unscrupulous clinics haphazardly provide ketamine to all comers. In Australia, one clinic was selling ketamine-filled syringes for at-home use, raising serious concerns about patient safety and drug diversion (Worthington 2015).
Off-label commercial use of generic ketamine will accelerate as long as the clinical research on generic ketamine is not incentivized in some way. As this dynamic continues to unfold, we are concerned that desperate, potentially incapacitated patients will be harmed, and that a clinical mishap could set back legitimate research for this highly stigmatized drug. With proper clinical oversight of ketamine administration, and clear systematic assessments of its risks and benefits, some of the ethical concerns about off-label ketamine use can be assuaged. However, unchecked enthusiasm and market forces may take us down “a slippery ketamine slope” (Schatzberg 2014). In addition to pushing for research dollars for ketamine and other controlled substances, we also recommend stricter regulation and oversight of off-label use.
Birgitta Sujdak Mackiewicz. The American Journal of Bioethics 16(7). Case Commentaries.
Four-year-old James was transferred from an outlying hospital in a critically ill state and has not responded to conventional therapies. For the last day and a half he has been treated with inhalational sevoflurane. James’s condition is not worsening, but he remains critically ill, suffering from a life-threatening condition. If inhalational sevoflurane remains the optimal treatment for James, then there is no clinical justification for transitioning him to VV ECMO given its risks and lack of clinical benefit—in this case there is no indication that any clinical benefit in doing so exists.
The case as presented constitutes both a clinical and an organizational ethics issue. The physicians who accepted James for transfer a few days ago are now faced with the decision of whether they can transition James off an effective therapy. The decision is necessitated by organizational decisions about the level of anesthesia staffing on weekends. In short, if the facts of the case hold, the answer is “no.” It is not under ordinary circumstances, citing the case summary, “ethically permissible to transition a patient to a therapy that is working to another therapy, which has increased morbidity and mortality, due to insufficient staffing.” To do so represents a failure of the facility to provide the necessary and reasonably expected resources tacitly promised by the acceptance of James from the outlying hospital. To switch James to a riskier treatment due to institutional inability to provide the appropriate care also constitutes an injustice to James. His initial transfer was based on the understanding that the accepting facility was able to provide the necessary care. James might instead have been refused admission and transferred to a facility able to meet his needs.
The physician must consider whether the current treatment of inhalational sevoflurane is optimal for James even if staffing is maintained. Physicians have an ethical obligation to reassess patient status throughout the course of treatment and to recognize when a patient who is not declining, but is still critically ill, has an insufficient response to the current treatment warranting a new approach. This determination is outside of the scope of the ethicist’s practice; however, it is not unreasonable for an ethicist to inquire as to the clinical factors at play and how the physician arrived at his or her decision. The ethicist may also recommend that physicians consider whether it is appropriate to seek further opinions from other institutions who may have had similar cases. This is not a questioning of the physician’s medical judgment or competency by the ethicist, but rather an interdisciplinary exploration of the case at hand, examining the facts of the case, the literature, and the range of clinically and morally acceptable options from which physicians will make a recommendation.
Douglas MacKay and Alexandra Robinson. The American Journal of Bioethics 16(11). Target Article.
Abstract: Governments must determine the legal procedures by which their residents are registered, or can register, as organ donors. Provided that governments recognize that people have a right to determine what happens to their organs after they die, there are four feasible options to choose from: opt-in, opt-out, mandated active choice, and voluntary active choice. We investigate the ethics of these policies' use of nudges to affect organ donor registration rates. We argue that the use of nudges in this context is morally problematic. It is disrespectful of people's autonomy to take advantage of their cognitive biases since doing so involves bypassing, not engaging, their rational capacities. We conclude that while mandated active choice policies are not problem free—they are coercive, after all—voluntary active choice, opt-in, and opt-out policies are potentially less respectful of people's autonomy since their use of nudges could significantly affect people's decision making.
Governments must determine the legal procedures by which their residents are registered, or can register, as organ donors. Provided they recognize that people have a right to determine what happens to their organs after they die, an assumption underlying our analysis below, there are four feasible options to choose from. Opt-in requires people to actively register as organ donors, for example, by signing an organ donor registration card, or checking a box when renewing their driver’s license. Many jurisdictions, including Canada, some U.S. states, the United Kingdom, and Germany, currently register organ donors in this way. Opt-out presumes that people are willing to be organ donors and so automatically registers them as such, but provides them with the opportunity to opt out. This policy is employed by many European countries, including Spain, Austria, Belgium, Greece, and France. Voluntary active choice (VAC) presents people with the choice of registering as an organ donor or not, but does not require them to make a decision. This policy is employed by the U.S. states of California and Vermont. Finally, mandated active choice (MAC) presents people with the choice of registering as an organ donor or not, and requires them to make a decision, for example, by making the renewal of their driver’s license conditional on them stating their donation preference. This policy is employed by the U.S. states of Illinois and New York, as well as New Zealand.
Debates regarding the ethics of organ donor registration policies have largely concerned the permissibility of opt-out policies. Proponents of these policies argue that they are likely to yield the highest donor registration rate, but critics object that they are morally deficient since they do not secure the consent of potential donors (Veatch 2000, 167–174; den Hartogh 2011; MacKay 2015). In this article, we set the issue of consent aside, exploring instead a different way in which these policies can be more or less respectful of people’s autonomy. Organ donor registration policies differ not only in terms of whether they secure people’s consent or not, but also in terms of the types of influence they employ to affect people’s decision making. As Richard H. Thaler and Cass R. Sunstein make clear in Nudge, one possible reason that organ donor registration rates are so high in jurisdictions employing opt-out is that people exhibit status quo bias, a tendency to stick with the current state of affairs or choose default options (2008, 34– 35). By taking advantage of people’s status quo bias in this way, opt-out policies employ what Thaler and Sunstein refer to as a “nudge,” that is, a way of designing choice situations that “alters people’s behavior in a predictable way without forbidding any options or significantly changing their economic incentives” (2008, 6).
Consider second that people’s registration status need not be fully determinative of the disposition of their organs after death for our analysis to have important implications for the ethics of donor registration policies. Instead, all that needs to be the case is that people’s registration status significantly affects the disposition of their organs after death. That is, even if families continue to have a de facto or de jure veto over the disposition of their relative’s organs, our analysis is important if people’s registration status significantly affects the decisions that families make. Provided that people’s registration status has this effect, then it matters ethically how that registration status is secured, particularly if future studies show that under VAC, opt-in, or opt-out policies, people’s registration status is significantly influenced by their status quo bias. This point is important, since there is a good deal of evidence in the U.S. context showing that a person’s registration as a donor is highly associated with familial decisions to donate (Siminoff and Lawrence 2002; Rodrigue, Cornell, and Howard 2006; Christmas et al. 2008; Traino and Siminoff 2013). The choice of donor registration policies therefore matters morally, and we hope that our article makes an important contribution to the ethical analyses of these policy options, identifying a way in which opt-in, optout, and VAC policies are morally deficient, and MAC policies potentially morally superior.
Virginia Sanchini, et al. Bioethics 30(4). Original Article.
Abstract: Traditional Informed Consent is becoming increasingly inadequate, especially in the context of research biobanks. How much information is needed by patients for their consent to be truly informed? How does the quality of the information they receive match up to the quality of the information they ought to receive? How can information be conveyed fairly about future, non‐predictable lines of research? To circumvent these difficulties, some scholars have proposed that current consent guidelines should be reassessed, with trust being used as a guiding principle instead of information. Here, we analyse one of these proposals, based on a Participation Pact, which is already being offered to patients at the Istituto Europeo di Oncologia, a comprehensive cancer hospital in Milan, Italy.
Recent studies suggest that it is increasingly difficult to provide patients with accurate information during informed consent procedures. While this problem affects many areas of medicine, it is particularly urgent in the context of research biobanks. In this latter setting, in addition to other traditional issues – such as patients’ options at stake and their likelihood to develop a ‘therapeutic misconception’ – the kind of information to be delivered renders canonical informed-consent forms potentially ill-suited. Several criticalities have been identified concerning the use of traditional informed consent (henceforth IC) in the domain of research biobanks.
The most widely known objection to the use of traditional IC in biobanks relates to the requirement of providing participants with full information about the research projects in which the specimens will be utilized. However, since at the time of collection it is impossible to foresee the future role of tissue samples in research, the provision of full information prior to signing of the consent is unfeasible. Therefore, the very concept of an IC for research biobanks as a means to provide the prospective participant with ‘full information’ seems inconsistent.
From an applied bioethical viewpoint, one question is paramount. Does the PP work? From the initial data we described, it appears to be so. More than 97% of participants signed the Pact in a non-anonymous form, an almost two-fold increase with respect to the traditional IC, arguing for the relevance of trust in mediating the relationship between participants and researchers.
12. Responsible Translation of Psychiatric Genetics and Other Neuroscience Developments: In Need of Empirical Bioethics Research
Gabriel Lázaro-Muñoz. The American Journal of Bioethics 17(4). Open Peer Commentaries.
In recent years, billions of dollars have been allocated to large-scale neuroscience projects with the goal of advancing our understanding of neural function, developing neurotechnologies, and, ultimately, improving neuropsychiatric care and prevention. These projects include the U.S. Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the European Union’s Human Brain Project (HBP), the U.S. National Institute of Mental Health’s Research Domain Criteria (RDoC) Initiative, and the Psychiatric Genomics Consortium (PGC), among others. Although these initiatives will undoubtedly yield clinical benefits, if we aim to responsibly research and translate the knowledge and technologies they produce, it is essential to empirically examine the potential harms—including opportunity costs—and the ethical or “neuroethics” challenges generated.
These initiatives are already yielding benefits. For example, over the past 8 years, the PGC has identified more than 100 genomic loci that are reliably associated with schizophrenia (Schizophrenia Working Group of the PGC 2014). The PGC achieved this by pooling resources and large samples from studies around the world and using an unbiased array-based genetic testing approach. This recent progress is in stark contrast to the years of struggle psychiatric genetics researchers faced trying to replicate findings obtained through candidate gene approach studies with small samples and little collaboration across research laboratories (Farrell et al. 2015; Need and Goldstein 2014). The success of initiatives like the PGC is evidence of how large-scale neuroscience projects can accelerate our understanding of psychiatric illnesses, which are known to be multifactorial and highly complex from a biological standpoint. Findings such as the identification of genomic loci associated with schizophrenia can lead to better risk prediction, resource allocation, prevention, drug targets, diagnosis, and treatment selection.
At the end of the day, as bioethicists, our goal should not be to simply raise questions, but to set well-informed ethical agendas and search for answers to effectively address ethical challenges. These four actions can help us achieve that.
Jonathan Beever and Nicolae Morar. The American Journal of Bioethics 17(9). Open Peer Commentaries.
An increasing number of contemporary voices in both bioethics and environmental ethics have grown dissatisfied with the schisms, abysses, and raging torrents that continue to flow between those two domains of ethical inquiry. Thus, Lee’s (2017) call for a public health ethics that serves as a bridge between them is a welcome addition to an expanding literature that highlights in terms of “health” the interconnection between individuals, their communities, and their environments.
It is clear to us that public health ethics, in the footsteps of others seeking the same ecological understanding, has begun to articulate values based on “our connectedness with each other, animals, and the environment” (9). This conception comes not only from environmental philosophy (Jamieson 2001), from philosophy of ecology (Shrader-Frechette and McCoy 1993), and from eco-phenomenology (Brown and Toadvine 2003), but also from within bioethics and environmental ethics themselves (Beever and Morar 2016a; Morar and Skorburg 2016; Jennings 2016; Whitehouse 2003). Indeed, Lee’s argument is a revisitation of Van Rensselaer Potter’s own predominantly anthropocentric concerns about “environmental health” as both intend to capture the ways that environmental and nonhuman animal factors influence human health. All agree that there is a growing recognition of the intimate relations among previously siloed epistemic units and ethical domains.
In conclusion, in the absence of a careful distinction between interconnectedness and interdependence, public health ethics reaches too far and too fast so that it can account for the immense complexity of relations for which the challenges demand answers. It is, as of yet, not only epistemically impoverished concerning the nature of relationships, but also normatively impoverished of resources to sufficiently parse out the significance of certain moral contraventions. Yet even if we were to overcome such conceptual issues, focusing on bridges still tends to ignore the water for the sake of holding firm stable shores of inquiry. Perhaps the only way to pay attention to that flowing in between (which is why the bridge exists in the first place, of course) is to move beyond Potter and recognize there are no stable shores (Beever and Morar 2016b). Instead, we might be compelled to call into question the historical silos of applied ethical inquiry. Public health ethics hasn’t evidenced that it is robust enough to do that hard work— yet.
14. Expanded Access for Nusinersen in Patients With Spinal Muscular Atropy: Negotiating Limited Data, Limited Alternative Treatments, and Limited Hospital Resources
Benjamin S. Wilfond, Christian Morales, and Holly A. Taylor. The American Journal of Bioethics 17(10). Case Report.
The issue of resource allocation is not new to bioethics. From the early days of dialysis to current complex solid organ transplant systems, medical advances continue to generate rich questions about the distribution of resources that are limited. Who will qualify? How will we decide? Who will need to wait? Who will die waiting?
Spinal muscular atrophy 1 (SMA1) is a rare autosomal recessive disease (approximately 250 cases per year in the United States). The disease causes rapid, progressive decline in muscular strength with preserved intellectual function. Historically, 50% of infants die by age 1 year and the majority of the remaining patients by age 2 years, following the provision of comfort care. Until recently, life extension was limited to symptom management with long-term ventilator and nutrition support.
The Pediatric Neuromuscular Service requests an ethics consultation to assist in determining how to fairly allocate nusinersen to its patients, should they choose to participate in the EAP. Within driving distance of the center there are approximately 100 SMA1 patients, many of whom are already ventilator dependent. These patients are not all being followed by the service, but are not prohibited from applying for EAP therapy. There will likely be 5–10 new cases per year in the center’s catchment area. It is possible that the center will be the only hospital in the state to provide this treatment. Given their current staffing, procedural space, and bed space availability, the center is only able to reasonably guarantee therapy for 2–4 patients per month. The center worries about how to ethically prioritize patients, knowing it will be difficult to accommodate all those who might benefit from treatment. How should the group determine who will be treated and when?
David M. Shaw. Bioethics 31(6). Original Article.
Abstract: In this article I argue that vagueness concerning consent to post‐mortem organ donation causes considerable harm in several ways. First, the information provided to most people registering as organ donors is very vague in terms of what is actually involved in donation. Second, the vagueness regarding consent to donation increases the distress of families of patients who are potential organ donors, both during and following the discussion about donation. Third, vagueness also increases the chances that the patient's intention to donate will not be fulfilled due to the family's distress. Fourth, the consequent reduction in the number of donated organs leads to avoidable deaths and increased suffering among potential recipients, and distresses them and their families.
There are three strategies which could be used to reduce the harmful effects of this vagueness. First, recategorizing the reasons (commonly referred to as ‘overrules’ under the current system) given by families who refuse donation from registered donors would bring greater clarity to donation discussions. Second, people who wish to donate their organs should be encouraged to discuss their wishes in detail with their families, and to consider recording their wishes in other ways. Finally, the consent system for organ donation could be made more detailed, ensuring both that more information is provided to potential donors and that they have more flexibility in how their intentions are indicated; this last strategy, however, could have the disadvantage of discouraging some potential donors from registering.
Transplantation of organs from living and deceased organ donors saves and improves tens of thousands of lives globally every year. Despite a substantial increase in the number of living kidney donors in recent years, donation from deceased patients remains the leading source of organs for transplantation in most countries. In this article, organ donation is discussed in the context of the ethical and legal frameworks that apply in the United Kingdom, but most countries operate broadly similar deceased donation systems that are affected by similar issues of vagueness.
In England and Northern Ireland, people who wish to donate their organs after they die must consent to any such donation. They can do so by informing relatives of their wishes or by signing up to the organ donor register. In Scotland, the same applies, but the term used is 'authorization' rather than consent. Wales recently switched to a 'deemed consent' system where it will be presumed that a patient wished to donate in the absence of any evidence to the contrary (a so-called opt-out), but here too, those who wish to donate can register their intentions on the UK-wide database.
I have suggested three potential strategies for combating the problem of vagueness. Reclassifying 'overrules' and recognizing the importance of new evidence of refusal and reassessment of best interests will bring clarity to conversations with families. If donors broach the subject of donation with their families vagueness will be reduced, particularly if a personalized organ donation directive is created. Most importantly, preventing vagueness at the point of registration is better than attempting to cure it at the point of donation when the family is upset. Creating a new consent system and providing more detailed information might discourage some people from donating, but it would increase the chances that the wishes of someone who does want to donate will be respected, substantially increase health professionals' and families' confidence in the consent of donors, and consequently reduce the distress currently caused to both families and staff.
16. A Model for Communication About Longshot Treatments in the Context of Early Access to Unapproved, Investigational Drugs
Eline M. Bunnik and Nikkie Aarts. The American Journal of Bioethics 18(1). Open Peer Commentaries
When seriously ill patients run out of standard treatment options, they may consider nonstandard treatment options such as expanded access, also known as “compassionate use.” Through expanded access programs, patients are given access to investigational drugs that are still under development and not yet approved for marketing. As the safety and efficacy of unapproved drugs have not been fully established, it is uncertain whether these drugs will offer medical benefit. Especially when the compound is in an early stage of the drug development process, its odds of success may be low or “longshot.” Expanded access raises ethical concerns, notably that seriously ill patients may overestimate the benefits of an investigational drug and underestimate its safety issues, fail to make informed decisions, and become susceptible to false hope and exploitation (Darrow et al. 2015). The communication model proposed by Weiss and Fiester (2018) and its central distinction between low-odds and no-odds treatment can be used to assist seriously ill patients and their treating physicians not only with decision making with regard to initiating expanded access to investigational therapies but also with monitoring and managing their effects. Thus, it may help to overcome some of the ethical problems associated with expanded access.
Systems for expanded access differ across countries, but have a set of conditions in common: Patients must be suffering from serious or life-threatening diseases must have exhausted standard treatment options, and must not be eligible for participation in clinical trials (Jarow et al. 2017). The managing physician must believe that the potential benefits of the drug will outweigh the risks. A regulatory authority such as the Food and Drug Administration (FDA) will need to approve the request (FDA 2017). In some countries, including the United States, requests must also be evaluated by an institutional review board. Importantly, the pharmaceutical company must be willing to supply the drug, often at no cost. Finally, patients must provide informed consent.
As the—often criticized—Right-to-Try movement in the United States is raising awareness of expanded access and seeking to increase its accessibility (Holbein et al. 2015), demand among patients for unapproved drugs around the world is expected to rise. Adequate informed consent processes that explicitly rebut unwarranted therapeutic optimism will be crucial for morally responsible practices of expanded access in the future.
Demetrio Sierra-Mercado and Gabriel Lázaro-Muñoz. The American Journal of Bioethics 18(4). Open Peer Commentaries.
Participants in the study reported by Kraft and colleagues (2018) raised an issue that supports how having more diversity among researchers could help promote trust toward precision medicine research and, ultimately, more precise medicine for all. First, participants’ perceptions of trustworthiness in biomedical research were related to their personal or group experiences with racism. Ideally, experience with racism would not play a role in individuals’ willingness to participate in research, and participants would trust researchers who do not look or sound like them as much as they trust those that do. Unfortuantely, however, that does not seem to be the case. As discussed by Kraft and colleagues (2018), participants would feel more comfortable with researchers with whom they can identify, or as a participant described: “I think that people relate to people that look like them. They trust people that look like them more” (10). Researchers who share similar ethnic, racial, or cultural backgrounds, as potential participants, may share similar life experiences, like racism and discrimination. This common history or experiences could help those researchers better understand participants’ concerns and build rapport when interacting with them. Rapport between researchers and potential participants would help build trust toward precision medicine research and likely increase participation rates among minority populations.
Not only would increasing diversity among researchers promote participation rates among minority populations, but empirical evidence demonstrates that research is of higher quality when performed by diverse groups (Campbell et al. 2013). However, achieving the goal of more diversity among researchers may be more complex than it seems at first glance. The proportion of researchers from racial and ethnic minority groups such as African Americans, Hispanics/Latinos, and Native Americans in U.S. academic institutions is significantly less than expected based on their share of the U.S. population (National Science Foundation 2012). In order to increase diversity among researchers we must address multiple obstacles at different stages of academic and scientific career development. In the following, we discuss some of these obstacles and potential solutions to help increase the representation of underrepresented minorities (URMs) in the sciences.
A history of research misconduct against minority groups, coupled with research institutions in which potential participants from minority groups do not see themselves or their interests sufficiently represented, can help explain why it is difficult to recruit individuals from minority populations as participants in precision medicine research. How we address the lack of diversity among researchers will be key to promoting trust and participation in precision medicine research among individuals from minority populations and achieving precision medicine for all. Efforts to ensure that URM researchers who are currently in academia are involved in precision medicine research would go a long way. However, the significant disparity between the proportion of URMs in the U.S. population and scientists at research institutions conducting precision medicine research needs to be addressed. Finally, increasing diversity among researchers will enhance precision medicine research not only by increasing the participation rate of minority populations but also because the complex thought processes necessary to conduct quality science are facilitated by having researchers from diverse backgrounds (Antonio et al. 2004).
Steve Clarke. The American Journal of Bioethics 18(5). Open Peer Commentaries.
Clinical bioethicists (ethicists) work for hospitals, nursing homes, rehabilitation centers, and other health care institutions (Fox, McGee and Caplan 1998). They perform various work roles, including policy development, ethics education, and consulting with patients, surrogate decision makers, families, health care professionals, and administrators about ethical issues (Chidwick et al. 2010). Bibler and colleagues (2018) offer practical suggestions to ethicists who are asked to consult patients, or their surrogate decision makers, when a particular medical intervention or course of care is requested on the grounds that this may enable a miraculous cure to take place. They focus their discussion on Christian patients and surrogates who invoke the possibility of miracles.
Bibler and colleagues (2018) argue that when ethicists counsel patients or surrogates who invoke the possibility of miracles, “the overall interests of the patient should (ceteris paribus) take priority” (44) in shaping the counsel provided. I do not agree that ethicists should prioritize the overall interests of particular patients when counseling those patients or their surrogate decision makers. Ethicists should be sensitive to the needs of particular patients and should demonstrate respect for the beliefs and values of patients and their surrogates, including belief in the possibility of miraculous cures and the religious values that accompany such beliefs. However, ethicists are not advocates for particular patients. They have a professional duty to help patients and surrogates make, and accept, good all-things-considered ethical decisions. Sometimes such decisions will be ones that go against the overall interests of particular patients. This is especially likely when a proposed course of action, which is the interests of a particular patient, will have harmful consequences for other patients.
It may be, however, that the patient’s family members do not only intend to use the additional time that is being requested to pray, but also plan to undertake specific activities that, they hope, will make it more likely that divine intervention will occur. They may be planning to cast spells, offer sacrifices, recite incantations, and so on. If this is what they intend, then they are not proposing to wait and hope for a miracle. A miracle is usually understood as the consequence of a decision made by God to intervene in the natural world and is not usually understood as being subject to human prediction or control. Someone who acted in a way that, they supposed, would make it more likely for supernatural intervention in the natural world to occur than it would be otherwise, would be attempting to perform magic, rather than praying for a miracle (Clarke 1999). Even though resorting to magic is not uncommon, especially among those who are desperate to see their ill relatives cured, most religious traditions regard attempts to perform magic as incompatible with genuine religious faith (Clarke 2014). If all of this is explained to surrogates who propose to extend life support, in defiance of received medical opinion, then, after discussion with family members, those surrogates may be persuaded to reconsider their proposed course of action.
Nadia N. Sawicki. The American Journal of Bioethics 18(7). Open Peer Commentaries.
Prof. Nelson (2018) makes a compelling argument that conscientious objection to abortion (COTA) laws should not immunize health care providers from criminal prosecution when they deny abortions to women with life-threatening pregnancies. Conscience, he argues, should not be a defense to homicide. As a practical matter, however, only a small percentage of COTA laws protect providers from criminal prosecution—less than 15% of states have such protections. Far more concerning is that the majority of states—almost 75%—explicitly immunize providers from civil liability, even when their conduct falls below the standard of care and harms patients. That is, most COTA laws create a “conscience defense” to malpractice. And while state prosecutors may be politically disinclined to take action in such cases, patients have far greater incentive to use whatever legal tools are available to seek redress for their injuries. Thus, those advocating for limits on health care conscience laws would be better served by challenging the many state laws that protect providers from civil liability, rather than the few that protect providers from criminal prosecution.
As Prof. Nelson notes, many COTA laws offer “sweeping immunity” from adverse consequences that might result when a provider refuses to participate in abortion for reasons of conscience (Nelson 2018). I am currently conducting a nationwide study of health care conscience laws to evaluate the types of procedural protections they offer, and my research confirms Prof. Nelson’s assessment. While the protections offered vary significantly from state to state, they may include immunity from criminal prosecution, civil liability, administrative sanctions, adverse action by employers or other private entities, loss of government funding, and denial of educational opportunities, among other potential adverse consequences. However, my preliminary research indicates that immunity from civil liability is by far the most common form of procedural protection established by health care conscience laws.
There are good reasons for American law to grant some protections to health care providers whose deeply held conscientious beliefs limit the types of services that they are able to deliver. In many cases, it may be possible to respect a provider’s conscientious convictions without hindering patients’ rights to access high-quality medical care. But in cases of true conflict—such as when a patient seeking emergency treatment is refused care because her treating physician or hospital oppose even lifesaving abortions—the law must strike a balance. While it may not wish to compel a provider to perform a medical service that he considers unconscionable, it can demand that he face the consequences of his choice if his refusal causes patient injury that would otherwise be compensable under civil or criminal law (Sawicki 2018).
Joseph Millum. The American Journal of Bioethics 18(8). Open Peer Commentaries.
Johan Bester makes a compelling case against the use of the harm principle to guide medical decisions on behalf of children (Bester 2018). He notes that parents have positive obligations to their children over and above refraining from harming them. Moreover, the correct decision-making standard for children must take into account the competing duties of parents and clinicians: “The obligation to do what is best for the child should be weighed against competing ethical obligations and practical constraints” (16). Bester claims that a modified best interest standard—“do the best for a child, all things considered”—can achieve the requisite balancing. He proposes to operationalize the standard through two questions: (1) “Can a reasonable argument be offered that the decision is best for the child, all things considered?”; (2) “Does the decision expose the child to obvious risk of harm?” If the answers are yes and no respectively, then the decision meets the standard.
In this commentary, I argue that Bester’s framework for parental decision making is flawed. I propose an alternative—the “reasonable subject standard”—that can better achieve the goals that Bester endorses.
Bester is right that decisions for children are more complex than the harm principle would imply. He is also right that the standard parents use for proxy decision making must take into account other moral considerations in addition to the child’s interests. I reject only his framework for operationalizing his standard and recommend the reasonable subject standard as a workable alternative that I elaborate and defend elsewhere (Millum 2018, Chapter 6).
21. Keep It Simple
John J. Paris and Brian M. Cummings. The American Journal of Bioethics 18(8). Open Peer Commentary.
The multilayered “tool” proposed by the author of the target article (2018) for resolving disputes between parents and physicians over medical treatment decisions for seriously ill newborns involves not only a close parsing of the “best interest” standard, the “harm principle,” and the “zone of parental discretion,” but a journey through a “think list,” multiple “cues,” and color-coded “assists” for assigning weight “to the concerns queried.” Such a Rube Goldberg formula makes one pine for the simple explanation of “best interests” found in the President’s Commission report, Deciding to Forego Life-Sustaining Treatment (President’s Commission for the Study of Ethical Problems in Medicine & Biomedical & Behavoral Research, 1983).
The President’s Commission recommended that the decision maker take into account such factors as relief of suffering, the preservation or restoration of functioning, and the quality as well as the extent of life sustained. And because most people have an interest in the wellbeing of their families or close associates, the commission included consideration, from the patient’s perspective, of “the impact of a decision on the patient’s loved ones.” The commission acknowledged there would be cases in which there is no agreement on what the incapacitated patient would select. In such instances it proposed the surrogate have discretion to choose among a range of acceptable choices.
In such a world, one might ask, how do the “toolbox,” “stepladder,” or “multicolored assists” proposed by the author of the target article help understand, let alone resolve, family–physician conflicts on medical treatment? The President’s Commission approach provides a starting point, one that has helped numerous courts and multiple ethics committees resolve such disputes. The three-step AAP Guidelines are even more succinct and readily applicable. Keeping the standards simple is a good starting point.
22. Not a matter of parental choice but of social justice obligation: Children are owed measles vaccination
Johan C. Bester. Bioethics 32(9). Original Article.
Abstract: This article presents arguments that reframe the discussion on vaccination ethics. The correct starting point for discussions on vaccination ethics is not what society owes parents, but rather what society owes children. Drawing on the justice theory of Powers and Faden, two conclusions are defended by presenting and defending a set of arguments. First, a just society is obligated to protect its children against serious vaccine‐preventable diseases such as measles through adequate levels of vaccination. Second, this obligation of the just society rests on identifiable individuals and institutions: parents, healthcare professionals, government, and vaccine producers have important obligations in this regard. This removes vaccination out of the realm of individual or parental discretion, and situates it in the realm of societal obligation. Children are owed vaccination, society is obligated to provide it. If parents cannot or will not provide it, society ought to respond.
I will argue that a just society is obligated to protect its children against serious vaccine‐preventable illnesses such as measles. This societal obligation rests on various identifiable individuals and institutions. These arguments reframe the ongoing discussion on vaccination ethics: they move the primary focus of vaccine ethics and policy away from a dialogue on what is owed parents to focus instead on what is owed to children. This provides grounds for considering vaccination as a matter of a societal moral obligation owed to children rather than a matter of individual or parental choice. These considerations form the moral basis for sound vaccination policy and action.
Despite the fact that vaccines are one of the most successful public health and medical interventions of the contemporary world, ethical and policy issues raised by vaccination continue to be a topic of academic and philosophical reflection. This is understandable, given the persistence of vaccine‐preventable disease outbreaks, vaccine hesitancy, vaccine refusals, and various barriers to vaccination in some communities.
These conclusions reframe the dialogue on measles vaccination, moving it away from a framework of what is owed to parents, and instead placing it in the framework of what is owed to children. Vaccination is a moral obligation owed to children, and not a matter of individual choice or preference. This takes vaccination out of the realm of individual discretion and into the realm of social moral obligation. These considerations have implications for social practices and policy surrounding vaccination.
Julian Savulescu. The American Journal of Bioethics 19(7). Editorials.
“Life’s but a walking shadow, a poor player, that struts and frets his hour upon the stage, and then is heard no more; it is a tale told by an idiot, full of sound and fury, signifying nothing” (Macbeth, Act 5, Scene 5).
One of the well-worn objections in the enhancement literature is based on inequality. Enhancement will only be available to some, so it will create unjust inequality. This was captured in the popular film Gattaca. In the most common form, it is based on concerns about capitalist markets: the rich will buy superior enhancements, exacerbating existing injustice. In the case of genetic enhancement, that injustice will be written into our genes. I have responded elsewhere, arguing that regulation can enable enhancement to promote justice and correct natural inequality (Savulescu 2006).
Aging will make us all obsolete. In the end, we will all be dead and forgotten. Time’s passage is a great equalizer. The truly significant enhancement would be immortality. But short of this, we should each just hope for the best chance of the best life.
24. The Exploitation of Professional “Guinea Pigs” in the Gig Economy: The Difficult Road From Consent to Justice
Roberto Abadie. The American Journal of Bioethics 19(9). Open Peer Commentaries.
Willing to endure pain, discomfort, and, mainly, boredom, professional guinea pigs perceive themselves as independent contractors, placing their bodies at the service of an industry that both exploits and dehumanizes them. With flexible schedules and mobile lifestyles, they constitute the ultimate foot soldiers of global capitalism (Abadie 2010). When I began researching this topic in the early 2000s, Uber, Lift, Airbnb, We Work, and many other forms of the gig economy had yet to arrive. In retrospect, it is clear that guinea pigs were at the forefront of this new form of exploitation; after all, “guineapigging” had been already been their gig for years, raising tough ethical questions. In Beyond Consent, Kahn et al. (1998), almost two decades ago, called for a focus on justice while appraising the participation of human subjects in research. Yet the normative analysis of the human subjects participating in clinical trials has been dominated by issues of consent, coercion, and undue inducement, as Millum and Garnett (2019) and Malmqvist (2019) have pointed out in this volume.
Both articles make efforts to leave this framework behind, with one making an explicit call to consider social justice aspects and the other introducing the notions of acceptable alternatives, shared goals, and ample benefits. Yet what these authors fail to consider sufficiently is how the feasibility of their proposals is shaped by political and economic forces.
While it is easy to focus on the human subject protections in isolation, one particular phase at a time, or without addressing the sociopolitical context in which they are carried out, a more comprehensive approach might be needed if we are to address social justice issues in clinical trial research (Petryna 2009; Fisher 2008). A social justice approach cannot avoid the racialized, gendered, and class-based forms of inequality that compel mostly poor, desperate people to take risks while others more fortunate can just wait until the drug comes to market. Furthermore, tackling the politics of drug development from a social justice perspective requires asking who is benefiting, who is not, and how benefits could be distributed more equitably. These questions are difficult, but they are harder to avoid in the context of deepening social inequalities, where it is harder to pretend that the clinical trials research enterprise is a shared unmitigated social good. In turn, social inequality raises another challenge for social-justice-based redistributive policies. To succeed, they have to confront powerful economic actors that, thanks to decades of concentrated economic growth, have more access than ever to the economic and political resources to shut down any opposition.
Edwin N. Forman and Rosalind Ekman Ladd. The American Journal of Bioethics 19(12). Open Peer Commentaries.
Elisabeth Kübler-Ross provided an impetus for physicians and patients to begin thinking in new ways—or to begin thinking at all—about death and dying. Kübler-Ross' work led to expectations about changes and improvements in end-of-life care and consequent increased patient and family satisfaction. Have these expectations been met? Perhaps. But is it still only a myth that a) the development of palliative care has greatly improved the care of dying children and increased parent satisfaction and b) that medical education now prepares pediatricians to communicate effectively and deal with their emotions about death and dying? (Forman and Ladd 2010). Recent literature as well as personal experience indicate that the reality is different from the myths. We will review the literature and suggest some steps that could improve care.
There is evidence that often children with life threatening illness suffer unrelieved pain in their final months. Wolfe et al found that children with advanced cancer continue to experience high symptom distress. In the last 12 weeks of life, pain was reported as highly prevalent (Wolfe et al. 2015). Feudtner et al suggest that research is needed to dramatically advance the evidence base for pediatric palliative care, practices, and programs. They identified two challenges in particular: to improve symptom management and quality of life and to improve communication, elicitation of goals of care, and decision-making (Feudtner et al. 2019).
Myths are long-lived and die hard. But we need to do better to honor the legacy of Kübler-Ross.
26. Research versus practice: The dilemmas of research ethics in the era of learning health‐care systems
Jan Piasecki and Vilius Dranseika. Bioethics 33(5). Original Article.
Abstract. In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health‐care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health‐care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy‐making levels.
There is an ongoing controversy over the distinction between medical research and practice. On the one hand, the proponents of the therapeutic orientation argue that there is no morally significant difference between research and practice. Therefore, researchers have the same moral obligations in a learning health‐care system (LHS) as physicians. On the other hand, there are supporters of the research orientation who not only stress the differences between research and practice, but also distinguish between research and clinical moral duties. The proponents of the therapeutic orientation have high hopes for the implementation of an LHS that promises to dismantle not only conceptual differences between research and practice but also the regulatory system that differentiates between these two types of activities. Nevertheless, one can still ask whether the therapeutic orientation is really in harmony with the LHS. Here we want to reconstruct conceptual and ethical framework of the controversy between therapeutic and research orientations, then show how these two orientations relate to the concept of an LHS. We think that although there seems to be some concurrence of opinions between proponents of the therapeutic orientation and advocates of the LHS, this commonality is only superficial in character.
The distinction between research and practice is a focal concept for both clinical and research ethics. Both the ethical and regulatory requirements of an ethics review and informed consent hinge on this very division.] The debate begins with the definitions given by the Belmont Report. According to this influential document, research is an activity that produces generalizable knowledge and practice aims at enhancing the well‐being of an individual patient with a reasonable expectation of success. However, by drawing a clear line demarcating research and practice, the National Commission shaped the whole conceptual framework of research ethics. This sharp distinction implies that the concept of therapeutic research should be discarded as it is confusing and conflates research and treatment. But this is a controversial resolution, as some argue that in clinical research one tests the therapeutic character of new interventions. Thus, the problem of division between research and practice leads to the question of what researcher‐physicians actually do when conducting clinical research and what they should do. This problem of the demarcation between research and practice was recently addressed in the discussion over the LHS and quality improvement studies. Some authors argue that the development of medicine is transforming the very nature of medical practice and in consequences the ethical and conceptual lines between research and practice no longer exist. Therefore, one may think that the therapeutic orientation somehow harmonizes with the ethical and conceptual framework (ECF) for an LHS. In order to show that this is not the case we construct and compare two competing idealized models of the relationship between research and practice in medicine: a model that segregates (the segregation model) and a model that integrates (the integration model) scientific research and practice. Elements of both models can be found in current debate over the distinction between research and practice. We analyze the theoretical and ethical assumptions built into these models and show how the ECF for an LHS could change the discussion about the relation between research and practice. We distinguish five key issues that differentiate the segregation model from the integration model and we demonstrate that the ECF for an LHS cannot be treated as a middle position between the two, but instead it creates a separate approach to the issue of research and practice distinction. This new approach can be called the public health attitude towards research and practice.
It can be concluded that the ECF for an LHS model of relationship has not provided us with conceptual instruments that would resolve the ethical debate between proponents of the segregation and integration models. The ECF should be considered a third proposal for characterizing the ethical problems of research. Namely, it is a proposal that navigates between research and clinical ethics and heads towards public health ethics. The ECF also does nothing to resolve the problem of a researcher's clinical obligation. Rather, it creates a new source of moral obligation: a health‐care system. Next, the ECF for LHS seems not to resolve the controversy over the concept of clinical equipoise. Rather, the ECF may be interpreted as a skeptical approach to existing therapies, which aims at eliminating ineffective and inefficient treatments from a health‐care system. Finally, we have argued that the ECF for an LHS attributes less significance to the standard of informed consent and that instead, it stresses the principle of beneficence over the principle of respect for autonomy. This makes the ECF for an LHS similar to the integration model, although it is at odds with the integration model's skepticism towards research. Moreover, the ECF for LHS leaves some ethical questions unanswered, such as whether there exists an obligation to participate in biomedical research. Therefore the implementation of an LHS opens a new area for ethical analysis rather than resolving the old problems of research ethics.
George J. Annas and Catherine L. Annas. The American Journal of Bioethics 20(1). Open Peer Commentaries.
The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group 2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas 2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. 2013) attack the study’s methodology itself in this issue, arguing that even on its own terms SUPPORT was fatally flawed (Macklin and Natanson 2020). Specifically, they argue that one arm of the study (the low oxygen arm) was not followed anywhere and could not be reasonably considered “standard care,” but was rather “unusual” and therefore experimental care (Cortes-Puch et al. 2016; Macklin and Natanson 2020). They also make useful suggestions about how to prevent future mischaracterizations of “usual care.”
Another central problem with SUPPORT is denial of death, illustrated by the inability of researchers, IRBs, and supporters of SUPPORT, to acknowledge the fact that the study itself could put the newborn subjects at increased risk of death. This is understandable. It is, and should be, difficult to justify risky research on newborns. Even strong supporters of SUPPORT conclude that if it had been “known before the study began [that] standard clinical care would not have encompassed the lower oxygen range … it would have been unethical to conduct the study” (Hudson et al. 2013).
It seems reasonable to conclude that SUPPORT will be classified as an ironic, rather than an iconic, study: a study whose goal was to promote evidencebased medicine in the NICU, but whose execution failed to consider contemporary evidence that one of its two arms “differed markedly from usual care” (Cortes-Puch et al. 2016). This “groupthink” result could have been avoided had the human rights and human dignity of the research subjects been taken seriously enough to identify and disclose the risk of death inherent in SUPPORT.
David Ozar, et al. The American Journal of Bioethics 20(2). Open Peer Commentaries.
Berger (2020) argues effectively that “representativeness is more aptly understood as a variable that is multidimensional and continuous based on relational moral authority,” and also makes some useful suggestions about how taking this observation seriously might require changes in current patterns of practice regarding surrogates. But the essay raises additional important questions about how the Best Interest Standard (BIS) should be used among unrepresented patients and other patients as well because many surrogates besides those who “have no actionable knowledge of a patient’s preferences” find themselves in positions in which they need to determine, with the physician, what is in the patient’s best interests.
First of all, consider that much of the author’s argument is based on Pope’s recommendation that, for unrepresented patients, BIS decisions should not be made by any one person solo, but by “a robust and transparent multi-stakeholder process involving other institution-based health care professionals and extrainstitutional parties” (citing Pope 2013). Despite this recommendation being foundational to Berger’s argument, however, Berger does not provide an argument—neither Pope’s nor the author’s own—for the ethical correctness of this method for reaching a BIS judgment about an unrepresented patient, or about any other patient who is incapable of relevant decision making. This omission is internally problematic for the author’s argument since the author’s criticism of permitting “self-identified surrogates” who “have no actionable knowledge of a patient’s preferences” depends on the assumption that the multi-stakeholder process is superior.
It might also be argued that the core values of the medical profession as it has been developed in our society have been sufficiently consistent from physician to physician that they can be depended on to counter the charge of arbitrariness. While that might once have been true, the history of medically related values in our society over the last four decades, and the extent to which they are or aren’t reflected in a particular physician’s own practice-guiding values does not encourage confidence on this matter.
29. The Healthcare Ethics Consultant-Certified Program: Fair, Feasible, and Defensible, But Neither Definitive Nor Finished
Armand H. Matheny Antommaria, et al. The American Journal of Bioethics 20(3). Guest Editorials.
In June 2018, the Healthcare Ethics Consultant (HCEC) Certification Commission (the Commission) began accepting applications, and since then three candidate cohorts have received the Healthcare Ethics Consultant-Certified (HEC-C) designation. While these individuals have reported favorable experiences, concerns about the HEC-C program—both the certification process and what the designation represents—exist.
As members of the Commission, we welcome dialogue about these concerns and wish to enhance understanding of the Commission’s reasoning behind key aspects of the HEC-C program. This program is part of an evolving system of professional structures, for which much work remains. In developing the HEC-C program, we were guided by well-established standards. The HEC-C program is not set in stone, but instead will evolve over time. We hope that transparency will encourage productive dialogue, improving the practice of, and access to, healthcare ethics consultation.
The Commission continuously seeks to improve the HEC-C program. To this end, all comments, suggestions, and criticisms are welcome. The Commission proactively seeks feedback from individuals who pursue the HEC-C designation. Based on this ongoing dialogue and new knowledge, the Commission may change the program, for example, the initial qualifications or the requirements for recertification. The examination itself will certainly change, with new questions written and evaluated. We encourage individuals to participate in developing questions or join the Commission. We hope that these and other improvements in the HEC-C program will be supplemented by the development of other professional structures, and that jointly these developments not only will enhance the value of certification but also will improve the quality of healthcare ethics consultation.
Julie Aultman and Cynthia Pathmathasan. The American Journal of Bioethics 20(3). Open Peer Commentaries.
As clinical ethics continues to evolve as a part of the nation’s healthcare system, there remains a disconnect between its practice and application across various healthcare organizations. This disconnect has led the American Society for Bioethics and Humanities (ASBH) to call for the standardization of clinical ethicists via the creation of the Healthcare Ethics Consultant-Certified (HEC-C) Program. Although this certification process aims to create a well-developed and equal representation of ethical knowledge, there are associated limitations with the HEC-C exam and eligibility criteria that can be addressed with opportunities for standardized training and additional assessment criteria.
From our perspectives as a clinical ethics educator and a dual enrolled 4th year medical and clinical ethics graduate student, we recently examined the benefits and burdens of the HEC-C examination, considering it as a promising opportunity for clinical ethics trainees and experts in the field. Many of these benefits and burdens were eloquently described by Horner et al. (2020) and confirmed our initial assessment of this promising certification program, in addition to a few additional concerns centering on issues of diversity and inclusion. In order for a HEC-C examination and program to be valued among professionals and trainees throughout the United States, it is important to recognize the heterogeneity of clinical ethics consultation services, hospital ethics committees, and community-based ethics consultation programs, and the diversity of providers, patients, and their families who require critical ethical deliberation and person-centered guidance. From alternative systems of ethics training and education to the current HEC-C exam, which is limited in scope and diversity in the 110-question, multiple choice options it provides, there is a need to create a training and certification program that strengthens and assesses foundational ethical concepts and guiding principles, while training clinical ethicists how to deliberate and reflect on complex, diverse ethical situations.
By expanding the HEC-C program to include mock ethics consultation cases (i.e., video simulations) and standardized patient assessments, clinical ethicists could better demonstrate their abilities to empathize and consider patient and others’ values and interests, utilize their own professional experience and ethical knowledge, and be better prepared to address diverse, challenging ethical issues following certification. We have personally found this approach from an educator and a student perspective to be very beneficial for training and assessment, and a mechanism to address issues of diversity and inclusion that often are ignored or misinterpreted in standard multiple-choice questions. We are in support of standardization for clinical ethics consultations, but also argue that supporting resources and more guidance is needed for educators and institutions (beyond the ASBH handbook and accompanying publications) to better prepare future clinical ethicists unless such training can be appropriately provided without significant financial burdens through the HEC-C program.
Charles Foster. The American Journal of Bioethics 20(3). Open Peer Commentaries.
Bester (2020) is right to observe that “beneficence” is not self-defining: it does not determine its own substance. And there is indeed at least apparent tension between (a) the objective functioning/health of the patient and (b) the patient’s view of her own good. If beneficence is to be defined (or at least enacted) as a conversation between (a) and (b), Bester’s suggestion as to how that conversation should be conducted is as good as any and better than most.
But Bester’s analysis is tainted by the besetting sin of modern clinical ethics: he sees the patient-clinician relationship as essentially contractual. For him, there are only two people in the consulting room: the patient and the clinician. They are the two contracting parties. And usually (for Bester) there is no difficulty in identifying the patient, and hence her interests. In fact, identifying the patient is tremendously difficult. All human beings change hats, and hence preferences and interests, all the time (Foster 2019). Sometimes the patient will be primarily a mother, steered mainly by her perception of her children’s interests—which might include an interest in not burdening them with the stress and financial cost of her care. Sometimes she will be a wife, for whom the priority is to keep an ailing husband company. Sometimes she will be a tired old woman, desperate for the rest and palliation that presumably comes with death. Sometimes she will be a mentally sprightly woman, looking forward to next spring’s flowers. Sometimes she will be a religious Catholic, determined to stay alive because that’s what she thinks the Church (which is a big part of her) requires. If she is normal she will oscillate queasily between all of these states. This is one reason why informed consent, as commonly conceived, is nonsense. It is also a reason why Bester’s account does not address the human condition as it really is.
So: there is a better way of conceiving and enacting beneficence than that articulated by Bester. It entails seeing the patient as a quintessentially relational entity—defined by the network of relationships in which she exists. Seen this way, beneficence always refers to the objective good of the patient and (since it is the same thing) of the people who comprise the relevant network. This sounds tyrannous, and it may indeed lead sometimes (in the interests of the welfare both of the patient and the network members) to autonomy not having the last word. Yet this is how ethicists and lawyers traditionally and uncontroversially talk about resource allocation questions.
Dhristie Bhagat and Ariane Lewis. The American Journal of Bioethics 20(6). Open Peer Commentaries
Berkowitz and Garrett (2020) provide an excellent overview of the ethical and legal discussion about the need for consent prior to apnea testing (Berkowitz and Garrett 2020). However, we disagree with their conclusions that (1) apnea testing is a medical procedure necessitating consent and (2) the right to refuse treatment is applicable to apnea testing. The brain death exam is unique from other medical testing. Requiring consent for apnea testing would obligate a false equivalence between the test and medical procedures, leading to confusion as well as inappropriate and unjust allocation of resources.
The authors defend the need for consent by citing the right to refuse medical treatment (Berkowitz and Garrett 2020). While this is an important concept, it does not pertain to this context, as apnea testing is not medical treatment; rather, apnea testing is an integral component of the evaluation to distinguish life from death, and clarify whether or not a person exists, or has ceased to exist. The intent of apnea testing is not to ameliorate brain injury, nor is there even potential for a therapeutic secondary effect of apnea testing. Furthermore, no matter how broadly one defines “medical treatment,” the term cannot apply if there is no person left to treat.
There are numerous ethical and legal considerations associated with the question of whether consent should be required prior to apnea testing. We thank Berkowitz and Garrett for their contribution to the literature on this topic (Berkowitz and Garrett 2020). We believe that universal legal clarification about both the need for consent and management of dissent is warranted to ensure practice does not vary from patient to patient, hospital to hospital and state to state. It is necessary to keep in mind the fact that apnea testing is neither akin to any other medical procedure nor to treatment. Rather, it is a unique process that clarifies whether or not a person still exists, and that this process has been proven to be low risk when guidelines are followed and prerequisites are met. As such, we disagree with the need for informed consent before apnea testing, and note that this would have profound consequences.
Philip Charles Hébert. Bioethics 34(9). Book Review.
A new book by Rosamond Rhodes is an ambitious undertaking, arguing for a new approach to medical ethics. She specifically takes issue with “principlism,” “[t]he well-entrenched approach that regards medical ethics as an extension of common morality.” Rhodes asserts: “the ethics of medicine is distinct and different from the ethics of everyday life” and “the vast bioethics literature of the past 50-odd years that largely adopts that view, is simply mistaken.”
The author claims that: (a) “[d]octors need a different touchstone for their professional behavior, a theory of medical ethics that provides them with clear and reliable moral guidance,” and (b) “[t]he most popular approaches to medical ethics were not particularly useful in resolving dilemmas in clinical practice.” Her duty-based analysis, she promises, is intended to provide a better, more reliable, and insightful guide for medical professionals.
Ethical principles and the requirements of common morality, as well as Rhodes’ duty-based perspective, can aid us in arriving at consensual responses to ethical issues in medicine. To paraphrase Raymond Carver, there are many paths to the waterfall.