Informed consent is a key condition for prenatal screening programmes to reach their aim of promoting reproductive autonomy. Reaching this aim is currently being challenged with the introduction of non‐invasive prenatal testing (NIPT) in first‐trimester prenatal screening programmes: amongst others its procedural ease—it only requires a blood draw and reaches high levels of reliability—might hinder women’s understanding that they should make a personal, informed decision about screening. We offer arguments for a renewed recognition and use of informed consent compared to (...) informed choice, and for a focus on value‐consistent choices and personalized informational preferences. We argue for a three‐step counselling model in which three decision moments are distinguished and differently addressed: (1) professionals explore women’s values concerning whether and why they wish to know whether their baby has a genetic disorder; (2) women receive layered medical‐technical information and are asked to make a decision about screening; (3) during post‐test counselling, women are supported in decision‐making about the continuation or termination of their pregnancy. This model might also be applicable in other fields of genetic (pre‐test) counselling, where techniques for expanding genome analysis and burdensome test‐outcomes challenge counselling of patients. (shrink)

Is it morally justifiable to force non-consenting pregnant women to submit to caesarean surgery to save their fetus in distress? Even though proponents and opponents largely agree on the interests at stake, such as the health and life of the fetus and the respect for bodily integrity and autonomy of pregnant women, they disagree on which moral weight to attach to these interests. This is why disagreements about the justifiability of forced caesareans tend to be pervasive and intractable. To sidestep (...) this deadlock, we will focus on conditions that give rise to the ‘caesarean dilemma’ in the first place, namely the conflict between inherent norms and values medical professionals are committed to by virtue of being a medical professional. Using the reflective equilibrium, we will test the opponents’ and proponents’ considered judgments about forced caesareans against the norms and values they—as medical professionals—are committed to and determine whether they are coherent. Subsequently we will identify the proponents’ incoherencies between the considered judgments and norms and values they are committed to and conclude that as long as these incoherencies are in place, forced caesareans are morally impermissible. (shrink)

Retractions solicited by authors following the discovery of an unintentional error—what we henceforth call a “self-retraction”—are a new phenomenon of growing importance, about which very little is known. Here we present results of a small qualitative study aimed at gaining preliminary insights about circumstances, motivations and beliefs that accompanied the experience of a self-retraction. We identified retraction notes that unambiguously reported an honest error and that had been published between the years 2010 and 2015. We limited our sample to retractions (...) with at least one co-author based in the Netherlands, Belgium, United Kingdom, Germany or a Scandinavian country, and we invited these authors to a semi-structured interview. Fourteen authors accepted our invitation. Contrary to our initial assumptions, most of our interviewees had not originally intended to retract their paper. They had contacted the journal to request a correction and the decision to retract had been made by journal editors. All interviewees reported that having to retract their own publication made them concerned for their scientific reputation and career, often causing considerable stress and anxiety. Interviewees also encountered difficulties in communicating with the journal and recalled other procedural issues that had unnecessarily slowed down the process of self-retraction. Intriguingly, however, all interviewees reported how, contrary to their own expectations, the self-retraction had brought no damage to their reputation and in some cases had actually improved it. We also examined the ethical motivations that interviewees ascribed, retrospectively, to their actions and found that such motivations included a combination of moral and prudential considerations. These preliminary results suggest that scientists would welcome innovations to facilitate the process of self-retraction. (shrink)

Research involving children or other incompetent subjects who are deemed unable to provide informed consent is complex, particularly in the case of research that does not directly benefit the research subjects themselves. The Helsinki Declaration, the World Medical Association's landmark document for research ethics, therefore states that incompetent research subjects must not be included in such research unless it entails only minimal risk and minimal burden. In this paper, we argue that now that research in these groups is expected to (...) expand, this undifferentiated minimal risk and burden requirement does not suffice any more. In the upcoming revision of the Declaration, the paragraph at stake should be refined in such a way that it is not unnecessarily restrictive or more permissive than can be ethically justified. Our first recommendation is to stimulate research ethics committees to identify more accurately those risks and burdens that the research subjects must undergo solely for research purposes by distinguishing between two types of study procedures instead of between two types of studies. Our second recommendation is to allow for exceptions to the minimal risk and burden requirement in cases of exceptionally valuable studies that involve subjects who can give their assent to participate in the study and that involve at most a minor increase over minimal risk and/or burden. (shrink)

The prelims comprise: Introduction Chance, Choice, and Circumstances Genes and Lifestyle Third Parties' Susceptibilities Conclusion Notes.

Part 12: The fall of the house of ethics‘Sometimes a cliché is the best way to make ones point’From: Whatever works.For some seconds Gordon is blinded by the lights the television crews direct at him. More than 20 cameras focus on him, and one journalist yells “there he is!” Even Gordon is not used to that much attention, but vanity is a speedy advisor. Within seconds he has clad himself in the aura of important person, and knowledgeable ethicist, even if (...) he has no idea what that many journalists expect from him at precisely this moment. Particularly when he has little time, preparing for the world conference on bioethics in Singapore. Then a wave of disappointment hits the gathered gossip-mongering press. The floodlights are turned off, microphones are lowered, the buzzing quiets down.“Guys, this is not Testosterone Tony.”This Tony, the athlete who participated in the Olympic Games in Beijing, at that moment leaves the hospital by a back door, far away from the paparazzi. The armoured car of his sponsor Nanosock disappears from sight softly humming and brings him to a private clinic where he will be pampered and detoxified. His career in sports is over, but his reputation can certainly sell sports socks with nanofibres against sweaty feet. The only price he has to pay is to admit he has sweaty feet, not true, but a small price to pay considering the alternatives. In front of the hospital the disappointed and somewhat offended Gordon tries to save his ego and asks the journalists:“Maybe I can be of help? Do you want an ethical analysis of Testosterone Tony and enhancing evolution? My name is Gordon Mc….” Nobody listens, nobody reacts.A day later. Nurses Jake and Gwen return from the medication round. Jake looks at the unlit room in the Nuttree …. (shrink)

Is it morally justifiable to force non-consenting pregnant women to submit to caesarean surgery to save their fetus in distress? Even though proponents and opponents largely agree on the interests at stake, such as the health and life of the fetus and the respect for bodily integrity and autonomy of pregnant women, they disagree on which moral weight to attach to these interests. This is why disagreements about the justifiability of forced caesareans tend to be pervasive and intractable. To sidestep (...) this deadlock, we will focus on conditions that give rise to the ‘caesarean dilemma’ in the first place, namely the conflict between inherent norms and values medical professionals are committed to by virtue of being a medical professional. Using the reflective equilibrium, we will test the opponents’ and proponents’ considered judgments about forced caesareans against the norms and values they—as medical professionals—are committed to and determine whether they are coherent. Subsequently we will identify the proponents’ incoherencies between the considered judgments and norms and values they are committed to and conclude that as long as these incoherencies are in place, forced caesareans are morally impermissible. (shrink)

For each research protocol that they review, institutional review boards must assess whether the risks of the protocol are acceptable in relation to the potential direct benefits to study participants and/or society. This requirement means that an IRB should first identify risks that are not compensated by direct benefits to the subjects and then judge whether these so-called net risks are acceptable in relation to the benefits to society. We argue that the conventional approach to risk-benefit assessment is not accurate (...) enough to identify all net risks involved in any given protocol. Two relatively new approaches—the component analysis approach and the net risks test—can be of much more use to review boards, especially when used together. (shrink)

Given the plethora of weight loss interventions, Devine and Barnhill rightly propose to also investigate unintended consequences. I agree. Some questions need to be raised: unintended consequences is a messy concept. How to distinguish between surprises and pseudo-unintended consequences? How to make sure that such research is not a box-ticking formality? And will results be implemented?

In the Netherlands fertility doctors increasingly formulate protocols, which oblige patients to quit their unhealthy lifestyle before they are admitted to IVF procedures. We argue that moral arguments could justify parenting protocols that concern all future parents. In the first part we argue that want‐to‐be parents have moral responsibilities towards their future children to prevent them from harm by diminishing or eliminating risk factors before as well as during the pregnancy. This is because of the future children's potential to become (...) of a certain type, more specifically: a person that will be the want‐to‐be parents' child. Want‐to‐be parents intend to become pregnant and therefore have an additional moral reason to diminish the risks. Also, people who become pregnant unintentionally have the responsibility to prevent their children from harm, unless they become pregnant due to contraception failure. All people not wanting to become pregnant should use contraception methods carefully.In the second part of this paper we translate the want‐to‐be parents' responsibilities into practice. We distinguish four determinants of risk factors: modifiability, chance, severity and effort. We examine some evidence‐based risk factors based on these variables and deduce levels of responsibility.In conclusion, formulating informal requirements for want‐to‐be parents is morally required and therefore also for want‐to‐be parents in need of medical assistance. The protocols developed by fertility doctors in the Netherlands could be seen as the precursor for a general, informal Parenting Protocol that could be developed on the basis of an extended and thoroughly debated risk‐responsibility analysis. (shrink)

Poor pregnancy outcomes and inequalities in these outcomes remain a major challenge, even in prosperous societies that have high-quality health care and public health policy in place. In this article, we propose that justice demands the improvement of what we call the ‘health agency’ of parents-to-be as part of a response to these poor outcomes. We take health agency to have three aspects: the capacity to form health-goals one has reason to value, the control one perceives to have over achieving (...) those health-goals and the freedom one has to achieve those health-goals. We will moreover argue that this demand of justice can be best based on a perfectionist rather than neutralist method of justification. Subsequently, we will argue that perfectionist policy may be paternalistic but not wrongfully paternalistic. This leads us to conclude that perfectionism should be adopted to inform and justify public health policy that is aimed at improving health agency in general and counteracting poor pregnancy outcomes and inequalities in perinatal health outcomes in particular. (shrink)

In the Netherlands fertility doctors increasingly formulate protocols, which oblige patients to quit their unhealthy lifestyle before they are admitted to IVF procedures. We argue that moral arguments could justify parenting protocols that concern all future parents. In the first part we argue that want-to-be parents have moral responsibilities towards their future children to prevent them from harm by diminishing or eliminating risk factors before as well as during the pregnancy. This is because of the future children's potential to become (...) of a certain type, more specifically: a person that will be the want-to-be parents' child. Want-to-be parents intend to become pregnant and therefore have an additional moral reason to diminish the risks. Also, people who become pregnant unintentionally have the responsibility to prevent their children from harm, unless they become pregnant due to contraception failure. All people not wanting to become pregnant should use contraception methods carefully.In the second part of this paper we translate the want-to-be parents' responsibilities into practice. We distinguish four determinants of risk factors: modifiability, chance, severity and effort. We examine some evidence-based risk factors based on these variables and deduce levels of responsibility.In conclusion, formulating informal requirements for want-to-be parents is morally required and therefore also for want-to-be parents in need of medical assistance. The protocols developed by fertility doctors in the Netherlands could be seen as the precursor for a general, informal Parenting Protocol that could be developed on the basis of an extended and thoroughly debated risk-responsibility analysis. (shrink)

Epigenetic markers could potentially be used for risk assessment in risk-stratified population-based cancer screening programmes. Whereas current screening programmes generally aim to detect existing cancer, epigenetic markers could be used to provide risk estimates for not-yet-existing cancers. Epigenetic risk-predictive tests may thus allow for new opportunities for risk assessment for developing cancer in the future. Since epigenetic changes are presumed to be modifiable, preventive measures, such as lifestyle modification, could be used to reduce the risk of cancer. Moreover, epigenetic markers (...) might be used to monitor the response to risk-reducing interventions. In this article, we address ethical concerns related to personal responsibility raised by epigenetic risk-predictive tests in cancer population screening. Will individuals increasingly be held responsible for their health, that is, will they be held accountable for bad health outcomes? Will they be blamed or subject to moral sanctions? We will illustrate these ethical concerns by means of a Europe-wide research programme that develops an epigenetic risk-predictive test for female cancers. Subsequently, we investigate when we can hold someone responsible for her actions. We argue that the standard conception of personal responsibility does not provide an appropriate framework to address these concerns. A different, prospective account of responsibility meets part of our concerns, that is, concerns about inequality of opportunities, but does not meet all our concerns about personal responsibility. We argue that even if someone is responsible on grounds of a negative and/or prospective account of responsibility, there may be moral and practical reasons to abstain from moral sanctions. (shrink)

There is an increasing interest in the possibility of using nudges to promote people's health. Following the advances in developmental biology and epigenetics, it is clear that one's health is not always the result of one's own choices. In the period surrounding pregnancy, maternal choice behaviour has a significant influence on perinatal morbidity and mortality as well as the development of chronic diseases later in life. One's health is thus a matter of one's own as well as one's maternal choices. (...) Therefore, self-regarding and other-regarding nudges should be considered as viable strategies to promote health. In this article, we introduce the concept of other-regarding nudges. We use the harm principle and the principle of beneficence to justify these other-regarding nudges. We conclude by stressing the importance of a fair assessment of expectations towards the nudgee, when determining whether a nudge is aimed at preventing harm or promoting a good. (shrink)

Asking pregnant women to pay for non-invasive prenatal testing out of pocket leads to unequal access across socioeconomic strata. To avoid these social justice issues, first-trimester prenatal screening should be publicly funded in countries such as the Netherlands, with universal coverage healthcare systems that offer all other antenatal care services and screening programmes free of charge. In this reply, we offer three additional reasons for public funding of NIPT. First, NIPT may not primarily have medical utility for women and children, (...) but rather offers relevant information and reproductive options, and thus serves important autonomy interests of women. Second, public funding of NIPT can be justified because it results in a reduction of collectively borne costs associated with care and support for children with chromosomal abnormalities. It is important to note that this is not an argument for individual women to take part in screening or to terminate an affected pregnancy. However, it is a legitimate argument in policy making regarding funding arrangements for screening programmes. Finally, public funding would help to amend current misunderstandings among pregnant women, and thus to support informed consent for first-trimester prenatal screening. (shrink)

Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without direct benefit (...) that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent. (shrink)

In the Netherlands fertility doctors increasingly formulate protocols, which oblige patients to quit their unhealthy lifestyle before they are admitted to IVF procedures. We argue that moral arguments could justify parenting protocols that concern all future parents. In the first part we argue that want‐to‐be parents have moral responsibilities towards their future children to prevent them from harm by diminishing or eliminating risk factors before as well as during the pregnancy. This is because of the future children's potential to become (...) of a certain type, more specifically: a person that will be the want‐to‐be parents' child. Want‐to‐be parents intend to become pregnant and therefore have an additional moral reason to diminish the risks. Also, people who become pregnant unintentionally have the responsibility to prevent their children from harm, unless they become pregnant due to contraception failure. All people not wanting to become pregnant should use contraception methods carefully.In the second part of this paper we translate the want‐to‐be parents' responsibilities into practice. We distinguish four determinants of risk factors: modifiability, chance, severity and effort. We examine some evidence‐based risk factors based on these variables and deduce levels of responsibility.In conclusion, formulating informal requirements for want‐to‐be parents is morally required and therefore also for want‐to‐be parents in need of medical assistance. The protocols developed by fertility doctors in the Netherlands could be seen as the precursor for a general, informal Parenting Protocol that could be developed on the basis of an extended and thoroughly debated risk‐responsibility analysis. (shrink)

PART 9: GRAVITY'S ETHICSThis isn't a hospital! It's an insane asylum! And it's your fault! Shaking her head lightly, Doctor Van Tintelen leaves the room and softly closes the door. Empathy streaming through her veins, she never gets used to the unpolished grief of a patient she has to tell of inevitable death, never. She thinks, “There should be pipes to drain the tears in every room, or at least rinsing basins for grief. What a job.” The crying is that (...) of the sisters Barrio. Miranda and Monica are twins who always refer to themselves as M&M. Though Monica cries the hardest, it is Miranda who was just told that her breast cancer has spread into her liver. No more treatment available.“Don't cry, Monica, I took the risk purposely. We both knew breast cancer runs in our family. You had the test, I didn't.”“And now you see the result, Miranda, you are going to die. We aren't even fifty yet. Damn.” The irony is that the clock in the room doesn't work, its pointers silent and stiff.“Do you really think you are better off? I've never completely understood why you had the preventive double mastectomy.”“I have never felt less of a woman. You know that.”“I know, but some men felt differently about it.”The remark hurts Monica almost physically, and Miranda apologises immediately. “Sorry, sweetheart, I shouldn't have said that. The sisters embrace for the hundredth time.”“Maybe I was too much of a coward,” Miranda says, resigned, “or too proud of my breasts.” For a second she lifts the big breasts sadly with her hands. Cynically: “After all, they were my trumps in eroland.”“A coward? You? How about me?” Monica seems to calm down somewhat. “I was too afraid of the continual fear …. (shrink)

Part 10: The very old man and the sea of tears‘There is no time to waste, then, is there?' ‘He needs to be treated.’‘But he is 79 years old.’Two doctors in conflict. As happens often. The subject of the conversation is Mr Tyson, admitted to the hospital because of an aneurysm in his abdomen. Sarah Walters said ‘treat’. ‘Nonsense, too old, too risky’ is the opinion of Dr Jones. The squabble continues.Sarah: ‘So what? Does old age exclude you from society? (...) Of course we have to treat him.’‘But the investment will only last for a few years, and think of the risks, he may die from the operation. He should go home and, well, live what there is to live.’She shakes her head, her hair giving her a red aura. ‘I think he ought to have the operation.’‘I think it would be best if he should accept that time is running out, that life is finite, the whole existential rigmarole, et cetera.’‘Quite presumptuous of you to think he has not accepted that. Why? Just because he is old and did not kill himself?’ Sarah is indignant. ‘If he had done just that, we would have lamented about how we do not take care of our elderly, that society doesn't care, and that certainly there is no right to die unless your situation is totally hopeless and you're in a lot of pain. It doesn't make sense; in public health one does everything to increase life expectancy. Countries are proudly comparing themselves on the life expectancy list: mine is longer than yours. We worry because people have these unhealthy lifestyles, they are obese, they smoke, they get no exercise and they live a couch potato life. And then, lo and behold, they do grow old, in fact, and we go: …. (shrink)

Studie over de morele toelaatbaarheid van medische experimenten met mensen.

The central idea of this “article” is that certain developments such as extreme simplification, the politicisation of medical ethics, the “normative industry” and “empirethics”, may seriously threaten the (future) practice of medical ethics.

La nouvelle révolution copernicienne marquant la publication de la troisième Critique, un an après le choc de la Révolution française, offre trois pistes pour lire la philosophie du Droit de Kant : 1) la relation de l'universel et du particulier est liée à la conception de la liberté comme « clef de voûte » de tout l'édifice ébranlé par l'hétérogénéité du réel; 2) l'intersubjectivité de la communication humaine ressort de l'esthétique du beau en se rappelant, dans ce contexte, la mise (...) en abîme du sublime; 3) le corps organisé en relation avec la réflexion de Kant sur la République. Dans l'histoire, se pose le problème de la « destination » de l'humanité, puisque l'énigme du mal radical remet en question un développement pensé, par les Lumières, en terme de progrès. A year after the French Revolution, the third Critique creates a new Copernican Revolution by opening three ways of understanding Kant's Ph. of Right: 1) the relationship of the universal and the particular is linked to a conception of freedom as the keystone for the edifice, shaken by the recognition of the heterogeneity of the real; 2) the intersubjectivity results from the aesthetic of the beautiful, called into question by the experience of the sublime; 3) the human body in relation to Kant's thought on the Republic. Within history we are confronted with the question of human destiny, for the enigma of evil renders questionable the Enlightenment idea of human development as progress. (shrink)

Relatively subtle forms of exploitation of human subjects may arise from the inefficiency or incompetence of a researcher, from the existence of a power imbalance between principal and subject, or from the uneven distribution of research risks among various segments of the population. A powerful and knowledgeable person (or institution) may perpetrate the exploitation of an unempowered and ignorant individual even without intending to. There is an ethical burden on the former to protect the interests of the vulnerable. Excessive or (...) insufficient compensation may be exploitative. However, genuine economic imperatives motivating needy volunteers have to be considered. These forms of exploitation should be appreciated in the context of social and cultural factors suggesting that the relationship between researcher and subject cannot properly be appraised as a contractual undertaking. While compliance with pertinent codes and regulations minimises the exploitative potential, they cannot be enforced in a way that does not recognise a society's peculiar characteristics. The experience with some Filipino cultural traits illustrates this point. (shrink)

Relatively subtle forms of exploitation of human subjects may arise from the inefficiency or incompetence of a researcher, from the existence of a power imbalance between principal and subject, or from the uneven distribution of research risks among various segments of the population. A powerful and knowledgeable person (or institution) may perpetrate the exploitation of an unempowered and ignorant individual even without intending to. There is an ethical burden on the former to protect the interests of the vulnerable. Excessive or (...) insufficient compensation may be exploitative. However, genuine economic imperatives motivating needy volunteers have to be considered. These forms of exploitation should be appreciated in the context of social and cultural factors suggesting that the relationship between researcher and subject cannot properly be appraised as a contractual undertaking. While compliance with pertinent codes and regulations minimises the exploitative potential, they cannot be enforced in a way that does not recognise a society's peculiar characteristics. The experience with some Filipino cultural traits illustrates this point. (shrink)

On the ethics of extending human life: healthy people have a right to carry on livingHumanity has long demonstrated a paradoxical ambivalence concerning the extension of a healthy human lifespan. Modest health extension has been universally sought, whereas extreme health extension has been regarded as a snare and delusion—a dream beyond all others at first blush, but actually something we are better off without. The prevailing pace of biotechnological progress is bringing ever closer the day when humanity will be able (...) to act on the latter view by rejecting a clear and present opportunity for much longer healthy lives. Indeed, some biogerontologists contend that that day has already arrived, to the extent that our hesitation in embarking on a vigorous “war on ageing” is already delaying the point at which a cure for ageing will be developed. Here I consider whether our present caution concerning the wisdom of truly curing ageing is likely to survive the increased scrutiny that it will receive in coming years as a result of these technical advances. I conclude that it will not, because of its irreconcilability with values that are more deeply held by the large majority of humanity than any values that argue against the quest for a cure. I further conclude that all the major current reasons given for not curing ageing are mere crutches to help us cope with the immutability of ageing that we have been brought up to accept. Our failure to set aside such irrationality is already shortening potential longevity—quite probably of those already alive today—to a staggering degree. Once we realise this, our determination to consign human ageing to history will be second …. (shrink)

This paper takes the view that compensated donation and altruism are not incompatible. In particular, it holds that the arguments against giving compensation stand on weak rational grounds: the charge that compensation fosters “commodification” has neither been specific enough to account for different types of monetary transactions nor sufficiently grounded in reality to be rationally convincing; although altruism is commendable, organ donors should not be compelled to act purely on the basis of altruistic motivations, especially if there are good reasons (...) to believe that significantly more lives can be saved and enhanced if incentives are put in place, and offering compensation for organs does not necessarily lead to exploitation—on the contrary, it may be regarded as a necessity in efforts to minimise the level of exploitation that already exists in current organ procurement systems. (shrink)