-
37A Personalized Patient Preference Predictor for Substituted Judgments in Healthcare: Technically Feasible and Ethically DesirableAmerican Journal of Bioethics 1-14. forthcoming.When making substituted judgments for incapacitated patients, surrogates often struggle to guess what the patient would want if they had capacity. Surrogates may also agonize over having the (sole) responsibility of making such a determination. To address such concerns, a Patient Preference Predictor (PPP) has been proposed that would use an algorithm to infer the treatment preferences of individual patients from population-level data about the known preferences of people with similar demographi…Read more
-
23What is Enough?: Sufficiency, Justice, and Health (edited book)Oxford University Press. 2016.What is a just way of spending public resources for health and health care? Several significant answers to this question are under debate. Public spending could aim to promote greater equality in health, for example, or maximize the health of the population, or provide the worst off with the best possible health. Another approach is to aim for each person to have "enough" so that her health or access to health care does not fall under a critical level. This latter approach is called sufficientar…Read more
-
79Standards of practice in empirical bioethics research: towards a consensusBMC Medical Ethics 19 (1): 68. 2018.This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the conc…Read more
-
23Do patients want their families or their doctors to make treatment decisions in the event of incapacity, and why?AJOB Empirical Bioethics 7 (4): 251-259. 2016.Background: Current practice relies on patient-designated and next-of-kin surrogates, in consultation with clinicians, to make treatment decisions for patients who lose the ability to make their own decisions. Yet there is a paucity of data on whether this approach is consistent with patients' preferences regarding who they want to make treatment decisions for them in the event of decisional incapacity. Methods: Self-administered survey of patients at a tertiary care center. Results: Overall, 11…Read more
-
30A new method for making treatment decisions for incapacitated patients: what do patients think about the use of a patient preference predictor?Journal of Medical Ethics 42 (4): 235-241. 2016.
-
168A framework for risk-benefit evaluations in biomedical researchKennedy Institute of Ethics Journal 21 (2): 141-179. 2011.One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are r…Read more
-
63Ethics: Would you sell a kidney in a regulated kidney market? Results of an exploratory studyJournal of Medical Ethics 35 (9): 558-564. 2009.Background: It is often claimed that a regulated kidney market would significantly reduce the kidney shortage, thus saving or improving many lives. Data are lacking, however, on how many people would consider selling a kidney in such a market. Methods: A survey instrument, developed to assess behavioural dispositions to and attitudes about a hypothetical regulated kidney market, was given to Swiss third-year medical students. Results: Respondents’ median age was 23 years. Their socioeconomic sta…Read more
-
19Patients’ Priorities for Surrogate Decision-Making: Possible Influence of Misinformed BeliefsAJOB Empirical Bioethics 13 (3): 137-151. 2022.
-
29Ethics of controlled human infection studies: Past, present and futureBioethics 34 (8): 745-748. 2020.
-
117Research led by participants: a new social contract for a new kind of researchJournal of Medical Ethics 42 (4): 216-219. 2016.
-
27Judging the social value of controlled human infection studiesBioethics 34 (8): 749-763. 2020.In controlled human infection (CHI) studies, investigators deliberately infect healthy individuals with pathogens in order to study mechanisms of disease or obtain preliminary efficacy data on investigational vaccines and medicines. CHI studies offer a fast and cost‐effective way of generating new scientific insights, prioritizing investigational products for clinical testing, and reducing the risk that large numbers of people are exposed to ineffective or harmful substances in research or in pr…Read more
-
30In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who ma…Read more
-
23Judging the Social Value of Health-Related Research: Current Debate and Open QuestionsPerspectives in Biology and Medicine 63 (2): 293-312. 2020.Several influential ethical guidelines and frameworks endorse the view that research with human participants is ethically acceptable only when it has “social value,” meaning that it generates knowledge which can be used to benefit society. For example, the Nuremberg Code requires that medical experiments on human beings “yield fruitful results for the good of society, unprocurable by other methods or means of study”. The Council for International Organizations of Medical Sciences guidelines hold…Read more
-
10The Challenge of Selecting Participants Fairly in High-Demand Clinical TrialsAmerican Journal of Bioethics 20 (2): 35-38. 2020.Volume 20, Issue 2, February 2020, Page 35-38.
-
19Evaluating the risks of public health programs: Rational antibiotic use and antimicrobial resistanceBioethics 33 (7): 734-748. 2019.Existing ethical frameworks for public health provide insufficient guidance on how to evaluate the risks of public health programs that compromise the best clinical interests of present patients for the benefit of others. Given the relevant similarity of such programs to clinical research, we suggest that insights from the long‐standing debate about acceptable risk in clinical research can helpfully inform and guide the evaluation of risks posed by public health programs that compromise patients…Read more
-
21What is Enough?: Sufficiency, Justice, and HealthOxford University Press. 2017.What is a just way of spending public resources for health and health care? Several significant answers to this question are under debate. Public spending could aim to promote greater equality in health, for example, or maximize the health of the population, or provide the worst off with the best possible health. Another approach is to aim for each person to have "enough" so that her health or access to health care does not fall under a critical level. This latter approach is called sufficientar…Read more
-
12The Next Wave in Health Care Priority SettingHastings Center Report 48 (4). 2018.A new problem in health care priority‐setting is currently emerging for wealthy countries: what should be done when a new drug is considered cost effective but implementing it would still be unaffordable? The standard approach to setting priorities in health care rests on cost effectiveness. This approach is now being tested by new drugs that are highly effective but very costly. Because they are so effective, these drugs deliver “value for money” despite their high cost. However, when the targe…Read more
-
31Setting risk thresholds in biomedical research: lessons from the debate about minimal riskMonash Bioethics Review 32 (1-2): 63-85. 2014.One of the fundamental ethical concerns about biomedical research is that it frequently exposes participants to risks for the benefit of others. To protect participants’ rights and interests in this context, research regulations and guidelines set out a mix of substantive and procedural requirements for research involving humans. Risk thresholds play an important role in formulating both types of requirements. First, risk thresholds serve to set upper risk limits in certain types of research. Se…Read more
-
27Individual and public interests in clinical research during epidemics: a reply to Calain: In response to: Calain P. The Ebola clinical trials: a precedent for research ethics in disastersJournal of Medical Ethics Recent Issues 44 (1): 11-12. 2017.In his stimulating target article, 1 Philippe Calain discusses how the traditional ethical framework for clinical research was challenged during the 2013–2016 Ebola epidemic in West Africa. One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’ 1, between individual and public interests in clinical research during this epidemic. I agree with this claim, but would like to provide a modified argument in its support. As Calain points …Read more
-
25Individual and public interests in clinical research during epidemics: a reply to CalainJournal of Medical Ethics 44 (1): 11-12. 2018.In his stimulating target article,1 Philippe Calain discusses how the traditional ethical framework for clinical research was challenged during the 2013–2016 Ebola epidemic in West Africa. One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’1, between individual and public interests in clinical research during this epidemic. I agree with this claim, but would like to provide a modified argument in its support. As Calain points ou…Read more
-
27Substantiating the Social Value Requirement for Research: An IntroductionBioethics 31 (2): 72-76. 2017.
-
555Can informed consent to research be adapted to risk?Journal of Medical Ethics 41 (7): 521-528. 2015.The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research parti…Read more
-
37Use of a Patient Preference Predictor to Help Make Medical Decisions for Incapacitated PatientsJournal of Medicine and Philosophy 39 (2): 104-129. 2014.The standard approach to treatment decision making for incapacitated patients often fails to provide treatment consistent with the patient’s preferences and values and places significant stress on surrogate decision makers. These shortcomings provide compelling reason to search for methods to improve current practice. Shared decision making between surrogates and clinicians has important advantages, but it does not provide a way to determine patients’ treatment preferences. Hence, shared decisio…Read more
-
121Justice and Procedure: How does “accountability for reasonableness” result in fair limit-setting decisions?Journal of Medical Ethics 35 (1): 12-16. 2009.Norman Daniels’ theory of justice and health faces a serious practical problem: his theory can ground the special moral importance of health and allows distinguishing just from unjust health inequalities, but it provides little practical guidance for allocating resources when they are especially scarce. Daniels’ solution to this problem is a fair process that he specifies as "accountability for reasonableness". Daniels claims that accountability for reasonableness makes limit-setting decisions i…Read more
-
32The 2008 Declaration of Helsinki — First among Equals in Research Ethics?Journal of Law, Medicine and Ethics 38 (1): 143-148. 2010.The World Medical Association's Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been r…Read more
-
38Prisoners as research participants: current practice and attitudes in the UKJournal of Medical Ethics 42 (4): 246-252. 2016.The use of prisoners as research participants is controversial. Efforts to protect them in response to past exploitation and abuse have led to strict regulations and reluctance to involve them as participants. Hence, prisoners are routinely denied the opportunity to participate in research. In the absence of comprehensive information regarding prisoners’ current involvement in research, we examined UK prisoners’ involvement through review of research applications to the UK National Research Ethi…Read more
-
22Will a Patient Preference Predictor Improve Treatment Decision Making for Incapacitated Patients?Journal of Medicine and Philosophy 39 (2): 99-103. 2014.
-
33Joachim Boos, Reinhard Merkel, Heiner Raspe, Bettina Schöne-Seifert (Hrsg) (2009) Nutzen und Schaden aus klinischer Forschung am Menschen. Abwägung, Equipoise und normative Grundlagen: Deutscher Ärzteverlag, Köln, 188 Seiten, 39,95 €, ISBN 978-3-7691-0589-6Ethik in der Medizin 22 (2): 167-168. 2010.
-
54Treatment Decision Making for Incapacitated Patients: Is Development and Use of a Patient Preference Predictor Feasible?Journal of Medicine and Philosophy 39 (2): 130-152. 2014.It has recently been proposed to incorporate the use of a “Patient Preference Predictor” (PPP) into the process of making treatment decisions for incapacitated patients. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Including a PPP in the shared decision-making process between clinicians and surrogates has the pote…Read more
-
46Kommentar I zum Fall: „Heimlicher Transfer von HIV-Medikamenten nach Afrika“Ethik in der Medizin 24 (1): 59-61. 2012.