It is widely recognized that mineral fertilizers must play an important part in improving agricultural productivity in western Kenyan farming systems. This paper suggests that for this goal to be realized, farmers’ knowledge must be strengthened to improve their understanding of fertilizers and their use. We analyzed smallholder knowledge of fertilizers and nutrient management, and draw practical lessons from empirical collective fertilizer-response experiments. Data were gathered from the collective fertilizer-response trials, through focus group discussions, by (...) participant observation, and via in-depth interviews representing 40 households. The collective trials showed that the application of nitrogen (N) or phosphorous (P) alone was insufficient to enhance yields in the study area. The response to P on the trial plots was mainly influenced by incidences of the parasitic Striga weed, by spatial variability or gradients in soil fertility of the experimental plots, and by interactions with N levels. These results inspired farmer to design and conduct experiments to compare crop performance with and without fertilizer, and between types of fertilizers, or responses on different soils. Participating farmers were able to differentiate types of fertilizer, and understood rates of application and the roles of respective fertilizers in nutrient supply. However, notions were broadly generated by unsteady yield responses when fertilizers were used across different fertility gradients, association with high cost (especially if recommended rates were to be applied), association of fertilizer use with hybrids and certain crops, historical factors, among other main aspects. We identified that strengthening fertilizer knowledge must be tailored within existing, albeit imperfect, systems of crop and animal husbandry. Farmers’ perceptions cannot be changed by promoting more fertilizer use alone, but may require a more basic approach that, for example, encourages farmer experimentation and practices to enhance soil properties such as carbon build-up in impoverished local soils. (shrink)

Research subjects do not always conform to research requirements. When their personal interests conflict with the demands of participation, some subjects surreptitiously break the rules. These subjects are subversive — they undermine the research endeavor. In rejecting the restrictions research imposes, subversive subjects diminish the value of research results. From one vantage point, subversive subjects engage in unethical behavior. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At (...) the same time, subversive subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for subject subversion. Intensified policing and guidance are two common strategies for reducing subject subversion, but collaborative reforms are more consistent with the partnership model of clinical research. (shrink)

We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose (...) unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established. **NB we did not reccommend a NAC, we think it might be appropriate**. (shrink)

Memory Detection Tests (MDTs) are a general class of psychophysiological tests that can be used to determine whether someone remembers a particular fact or datum. The P300 MDT is a type of MDT that relies on a presumed correlation between the presence of a detectable neural signal (the P300 “brainwave”) in a test subject, and the recognition of those facts in the subject’s mind. As such, the P300 MDT belongs to a class of brain-based forensic technologies which have proved popular (...) and controversial in recent years. With such tests increasingly being proffered for use in the courtroom — to either support or call into question testimony — it would behoove the legal system to have some systematic framework for ensuring that they are used responsibly. In this paper, I defend one such framework for ensuring that this is the case: the legitimacy enhancing test. According to this test, it is appropriate to make use of technologies such as the P300 MDT whenever doing so would (probably) enhance the legitimacy of the trial. I argue that this test addresses tensions between scientific and legal norms of evidence, and exhibits a number of additional virtues including unification, simplicity and flexibility. Although the test is defended by considering the example of the P300 MDT, its significance is much broader than that. If it has the virtues I claim for it, it should provide a general framework for the responsible use of technologies, and the responsible innovation of social epistemic systems. (shrink)

Responsible research and good science are concepts with various meanings depending on one’s perspective and assumptions. Fellow researchers, research participants, policy makers and the general public also have differing expectations of the benefits of research ranging from accurate and reliable data that extend the body of knowledge, to solutions to societal concerns. Unless these differing constituencies articulate their differing views they may fail to communicate and undermine the value of research to society.

In this commentary on the previous paper it is explained that screen-detected Duct Carcinoma In Situ is effectively a new disease of unknown natural history. It is therefore impossible that 'the doctor knows best' and it is therefore both in the patient and the public's best interests that such cases are submitted to the rigours of the randomised controlled trial. Inevitably this brings the ethical dilemma of how to explain to patients the uncertainty and how to involve them in a (...) rational decision to take part in the randomised controlled trial. It is argued that as well as there being a collective benefit for future generations of women, that we should resolve this problem now, the individual woman is likely to benefit from being treated according to a strict protocol. Nevertheless the time of diagnosis is paradoxically not the best time for a patient to become aware of these matters and it is about time that the lay public and the opinion formers recognized their responsibility to become acquainted with the benefits and the needs of the randomised controlled trial in anticipation of the day when they themselves will be patients. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (...) University (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

When it comes to how to hold people responsible for wrongdoing, much of the African philosophical tradition focuses on reconciliation as a final aim. This essay expounds an interpretation of reconciliation meant to have broad appeal, and then draws out its implications for responsibility in respect to three matters. First, when it comes to criminal justice, prizing reconciliation entails that offenders should be held responsible to “clean up their own mess,” i.e., to reform their characters and compensate victims in ways (...) they find burdensome, an approach to punishment that differs from deterrence and desert theories. Second, regarding civil justice, reconciliation means that holding responsible to compensate wrongful harm means improving victims’ quality of life in ways they accept, which contrasts with a common prescription to put victims in the condition they would have been in had the wrong not occurred. Third, reconciliation can involve putting on trial more than just the direct offender, for instance family members who had been able to influence his behavior and were allied with him. The chapter provides reason to take the reconciliatory approaches seriously that will be found prima facie attractive by those from a variety of backgrounds. (shrink)

In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resourceconstrained settings can raise context-related challenges that have implications for study participants’ health and wellbeing. During the Ebola vaccine study, three participants were injured in road traffic accidents, but there were unexpected difficulties when trying to apply (...) the AC policy. First, because of the nature of the adverse events, the insurer refused to cover the costs. Second, the AC policy did not address treatments by traditional medicine, even though traditional medicines are frequently used and highly trusted in the study community. This highlighted a contrast between the researchers’ well-intentioned AC approach and the participants’ legitimate preferences. The way in which researchers should address their responsibility to provide AC is not straightforward; it requires contextualization. Our experience highlights the importance of involving community representatives and the local ethics committee to ensure development of an AC policy that is culturally and ethically appropriate. Additionally, the insurance contract should clearly stipulate which adverse events are linked to the trial participation, and thus eligible for coverage, to avoid controversies when claims are made. (shrink)

“Responsible research” and “good science” are concepts with various meanings depending on one’s perspective and assumptions. Fellow researchers, research participants, policy makers and the general public also have differing expectations of the benefits of research ranging from accurate and reliable data that extend the body of knowledge, to solutions to societal concerns. Unless these differing constituencies articulate their differing views they may fail to communicate and undermine the value of research to society.

We very much appreciate the helpful and generous commentaries in response to “Do Clinicians have a Duty to Participate in Pragmatic Clinical Trials?” (Garland, Morain, and Sugarman 2023). In that a...

This article analyzes the origins of the “responsible corporate officer” doctrine: the trial of Joseph Dotterweich. That doctrine holds that an officer may be personally liable for the criminal act of a subordinate if the officer was, in some indefinite way, able to prevent the violation. Applying this doctrine, the prosecution of Dotterweich entailed strict liability for a strict liability offense. The underlying offenses—the interstate sale of one misbranded and adulterated drug and one misbranded drug—were said to be strict liability (...) offenses. And then, with respect to Dotterweich as the corporation’s general manager, the government argued that he was strictly liable because he stood in “responsible relation” to the company’s acts. The government never tried to prove that the company, Buffalo Pharmacal, was negligent, nor did it try to prove that Dotterweich was negligent in his supervision of the employees of Buffalo Pharmacal. The prosecutor and judge were candid about this theory throughout the trial, although the judge conceded that it seemed bizarre and unfair. The defense lawyer repeatedly sought to inject what became known throughout the trial as the “question of good faith,” but was circumvented at almost every turn. What would thus seem to be the crux of any criminal trial—the personal fault of the defendant—was carefully shorn from the jury’s consideration. The government’s theory was so at odds with intuitive notions of liability and blame that, as one probes into the case, and looks at the language used in the government’s appellate briefs, imputations of moral fault inevitably crept in. Yet the government was not entitled to make such accusations, as it had pruned moral considerations from the trial. The article argues that the responsible corporate officer doctrine can never enjoy a secure place in our legal system. First, the doctrine is at a minimum in tension with, and often in direct opposition to, basic principles of the criminal law; and second, the doctrine fails, when followed to its logical conclusions, to accord with basic notions of fair play. The article concludes that the responsible corporate officer doctrine is either unnecessary, in cases in which the evidence establishes personal fault, or unjust, in cases in which it creates liability in the absence of personal fault through the unspecified notion of “responsibility.” The Dotterweich case illustrates what is contemplated by the latter possibility, and why it is problematic in any judicial system that purports, in the words of the Model Penal Code, “to safeguard conduct that is without fault from condemnation as criminal.”. (shrink)

_Clinical Trials and the African Person_ offers an account of the African notion of the self/person within the clinical trials context. As opposed to autonomy-based principlism, this other-regarding/communalist perspective is touted as the preferred alternative model particularly in multicultural settings.

After the typical theological and bioethical questions about in vitro fertilization (IVF) are vetted, there remains a three-dimensional understanding of responsibility that is not typically considered in Christian bioethics. This paper will explore responsibility to the spouses’ loving union, their bodies, and society in order to ascertain the morality of IVF. In a marriage partnership, the spouses’ primary responsibility is to each other. Although in matrimony physical union is essential to marriage, children are not. The second dimension of responsibility focuses (...) on the body—“the temple of God”—and on our responsibility to care for it. This concerns the woman, her husband, and even the newborn. Finally, the third understanding of responsibility leads us to address social concerns, with an emphasis on social dynamics, especially the cost of IVF procedures and how they siphon medical resources away from more urgent human needs in health care and within society. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page W1-W3, June 2011.

HIV intervention trials being conducted in developing countries continue to raise questions of ethics in clinical research. Most recently these questions have arisen because of a prospective study reporting the rate of transmission in discordant couples that was conducted in Uganda. The study raises serious questions about the minimum ethical standards required for this kind of research and the responsibilities of the researchers. We re-examine that research particularly focusing on issues of informed consent and duty of care, and place (...) this trial in the context of the broader debate. (shrink)

ObjectiveCo-morbid insomnia and sleep apnea is a common and debilitating condition that is more difficult to treat compared to insomnia or sleep apnea-alone. Emerging evidence suggests that cognitive behavioral therapy for insomnia is effective in patients with COMISA, however, those with more severe sleep apnea and evidence of greater objective sleep disturbance may be less responsive to CBTi. Polysomnographic sleep study data has been used to predict treatment response to CBTi in patients with insomnia-alone, but not in patients with (...) COMISA. We used randomized controlled trial data to investigate polysomnographic predictors of insomnia improvement following CBTi, versus control in participants with COMISA.MethodsOne hundred and forty five participants with insomnia and sleep apnea [apnea-hypopnea index ≥ 15] were randomized to CBTi or no-treatment control. Mixed models were used to investigate the effect of pre-treatment AHI, sleep duration, and other traditional, and novel [quantitative electroencephalography ] polysomnographic predictors of between-group changes in Insomnia Severity Index scores from pre-treatment to post-treatment.ResultsCompared to control, CBTi was associated with greater ISI improvement among participants with; higher AHI, less wake after sleep onset, and less N3 sleep. No quantitative electroencephalographic, or other traditional polysomnographic variables predicted between-group ISI change.DiscussionAmong participants with COMISA, higher OSA severity predicted a greater treatment-response to CBTi, versus control. People with COMISA should be treated with CBTi, which is effective even in the presence of severe OSA and objective sleep disturbance. (shrink)

The term ‘locked-in’ syndrome (LIS) describes a medical condition in which persons concerned are severely paralyzed and at the same time fully conscious and awake. The resulting anarthria makes it impossible for these patients to naturally communicate, which results in diagnostic as well as serious practical and ethical problems. Therefore, developing alternative, muscle-independent communication means is of prime importance. Such communication means can be realized via brain–computer interfaces (BCIs) circumventing the muscular system by using brain signals associated with preserved cognitive, (...) sensory, and emotional brain functions. Primarily, BCIs based on electrophysiological measures have been developed and applied with remarkable success. Recently, also blood flow–based neuroimaging methods, such as functional magnetic resonance imaging (fMRI) and functional near-infrared spectroscopy (fNIRS), have been explored in this context. After reviewing recent literature on the development of especially hemodynamically based BCIs, we introduce a highly reliable and easy-to-apply communication procedure that enables untrained participants to motor-independently and relatively effortlessly answer multiple-choice questions based on intentionally generated single-trial fMRI signals that can be decoded online. Our technique takes advantage of the participants’ capability to voluntarily influence certain spatio-temporal aspects of the blood oxygenation level–dependent (BOLD) signal: source location (by using different mental tasks), signal onset and offset. We show that healthy participants are capable of hemodynamically encoding at least four distinct information units on a single-trial level without extensive pretraining and with little effort. Moreover, realtime data analysis based on simple multi-filter correlations allows for automated answer decoding with a high accuracy (94.9%) demonstrating the robustness of the presented method.. (shrink)

Clinical trials in developing countries are often beset by ethical problems that would be considered unresolvable in countries like Australia and the U.S. Nevertheless, such trials continue to go ahead throughout Asia, Africa and South America, and are often conducted in ways that could be considered to be unethical. In this article I discuss two issues, focussing on an HIV preventative trial of a vaginal gel, the Nonoxynol 9 phase three trial being held in Kenya. The first of (...) these is what makes such a trial unethical given that it has approval from the WHO and seemingly conforms with acceptable standards of consent. The second issue involves using material from such trials, if we accept that they were conducted unethically. (shrink)

: This response to Nikolaus Knoepffler's paper in the same issue of the Journal agrees that if the arguments supporting the first two of the eight human embryonic stem cell research policy options discussed are unsound, as Knoepffler argues, then it seems natural to move to the increasingly permissive options. If the arguments are sound, however, then the more permissive options should be rejected. It is argued that three of the rejected arguments, taken together, constitute very good reasons to (...) hold that a human embryo is endowed with dignity from fertilization onward. Thus, countries that want their public policies to match the moral imperative of respect for human beings should refrain from allowing destructive human embryo research and should devote considerable energy and public funds to research and clinical trials using non-embryonic ("adult") stem cells. (shrink)

ABSTRACTDespite being held in something approaching universal esteem for its capacity to promote prosocial behavior and inhibit antisocial behavior, empathy has recently become the recipient of strong criticism from some of today’s leading academics. Two of the more high-profile criticisms of empathy have come from philosopher Jesse Prinz and psychologist Paul Bloom, each of whom challenges the view that empathy has an overall beneficial influence on human behavior. In this essay, I discuss the basis of their criticisms as well as (...) why I am not compelled by their arguments to believe that empathy does more harm than good. In the process of responding to empathy’s critics, I discuss the important role that empathy plays in our moral lives. I argue that, rather than employing rational considerations to minimize the role that empathy plays in our moral and political judgments, such considerations are put to better use by expanding empathy when conducive to the common good and suppressing it when it opposes th... (shrink)

Fertility treatment enables involuntary childless people to have genetically related children, something that, for many, is a valuable life project. In this paper, I respond to two sets of objections that have been raised against expanding state-funded fertility treatment provision for existing treatments, such as in vitro fertilisation (IVF), and against funding new treatments, such as uterine transplantation (UTx). Following McTernan, I refer to the first set of objections as the ‘one good among many’ objection. It purports that it is (...) unjustifiable for the state to prioritise the funding of the life project of becoming a parent through fertility treatment provision over the funding of other life projects that people might have. Following Lotz, I refer to the second set of objections as the ‘norm-legitimation’ objection. It maintains that the provision of costly forms of fertility treatment, such as UTx, would legitimise problematic social norms concerning genetic relatedness, reproduction and parenting, and that states should not engage in such a legitimation. In response to these objections, I defend the view that (reproductive) preferences ought to be taken more seriously when discussing fertility treatment provision and parental projects, and that not doing so can be costly, especially for women. The approach defended in this paper seeks to avoid disregarding and policing preferences and to reconcile their fulfilment with political projects aimed at improving the material and social conditions of sub-fertile people: people who, for social or biological reasons (or an intersection of the two), are unable to reproduce unassisted. (shrink)

BackgroundA recent paper presents an argument and mechanism for the possible stopping of clinical trials early based on opportunity costs.DiscussionAlthough we agree that the costs and opportunity costs of clinical trials need to be reduced wherever possible, we raise concerns about the motivation and mechanism for stopping clinical trials early raised by Lavery et al.SummaryWe argue that there are already enough acceptable criteria and actors in the clinical trials arena to justify early stoppage of clinical (...) class='Hi'>trials, and argue that factors other than efficacy need to be carefully considered, especially in developing country contexts. (shrink)