In the debate surrounding the introduction of non-invasive prenatal testing in prenatal screening programmes, the concept of routinisation is often used to refer to concerns and potential negative consequences of the test. A literature analysis shows that routinisation has many different meanings, which can be distinguished in three major versions of the concept. Each of these versions comprises several inter-related fears and concerns regarding prenatal screening and particularly regarding NIPT in three areas: informed choice, freedom to choose and consequences for (...) people with a disability. Three of the strongest arguments raised under the flag of routinisation are assessed for their validity: the threat that NIPT poses to informed choice, the potential increase in uptake of first-trimester prenatal screening and its consequences for social pressure to participate in screening or terminate affected pregnancies, and the negative consequences for disabled people. These routinisation arguments lack empirical or normative ground. However, the results of this analysis do not imply that no attention should be paid to possible problems surrounding the introduction of NIPT. At least two problems remain and should be addressed: there should be an ongoing debate about the requirements of informed choice, particularly related to an expanded scope of prenatal screening. Also, reproductive autonomy can only be achieved when expecting parents’ options are variegated, real and valuable, so that they can continue to choose whether or not to screen or to terminate a pregnancy. (shrink)

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)

The introduction of non-invasive prenatal testing in healthcare systems around the world offers an opportunity to reconsider funding policies for prenatal screening. In some countries with universal access healthcare systems, pregnant women and their partners are asked to pay for NIPT. In this paper, we discuss two important rationales for charging women for NIPT: to prevent increased uptake of NIPT and to promote informed choice. First, given the aim of prenatal screening, high or low uptake rates are not intrinsically desirable (...) or undesirable. Using funding policies to negatively affect uptake, however, is at odds with the aim of screening. Furthermore, copayment disproportionally affects those of lower socioeconomic status, which conflicts with justice requirements and impedes equal access to prenatal screening. Second, we argue that although payment models may influence pregnant women’s choice behaviours and perceptions of the relevance of NIPT, the copayment requirement does not necessarily lead to better-informed choices. On the contrary, external influences on women’s personal choices for or against prenatal screening should ideally be avoided. To improve informed decision-making, healthcare systems should instead invest in adequate non-directive, value-focused pretest counselling. This paper concludes that requiring copayments for NIPT in universal access healthcare systems fails to promote reproductive autonomy and is unfair. (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)

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)

As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers’ practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication of (...) incidental findings in imaging research. We conducted an interview study with a purposive sample of researchers at research facilities across the Netherlands. Based on a qualitative analysis of these interviews and on existing guidelines found in the literature, we developed a prototype ethical framework, which was critically assessed and fine-tuned during a two-day international expert meeting with bioethicists and representatives from large population-based imaging studies from the United Kingdom, Germany, Sweden and Belgium. Practices and policies for the handling of incidental findings vary strongly across the Netherlands, ranging from no review of research scans and limited feedback to research participants, to routine review of scans and the arrangement of clinical follow-up. Respondents felt that researchers do not have a duty to actively look for incidental findings, but they do have a duty to act on findings, when detected. The principle of reciprocity featured prominently in our interviews and expert meeting. We present an ethical framework that may guide researchers and research ethics committees in the design and/or evaluation of appropriate pathways for the handling of incidental findings in imaging studies. The framework consists of seven steps: anticipation of findings, information provision and informed consent, scan acquisition, review of scans, consultation on detected abnormalities, communication of the finding, and further clinical management and follow-up of the research participant. Each of these steps represents a key decision to be made by researchers, which should be justified not only with reference to costs and/or logistical considerations, but also with reference to researchers’ moral obligations and the principle of reciprocity. (shrink)

This interview study investigates the short- and long-term implications of incidental findings detected through brain imaging on research participants’ lives and their surroundings. For this study, nine participants of the Rotterdam Scan Study with an incidental finding were approached and interviewed. When examining research participants’ narratives on the impact of the disclosure of incidental findings, the authors identified five sets of tensions with regard to motivations for and expectations of research participation, preferences regarding disclosure, short- and long-term impacts and impacts (...) on self and others. The paper shows: that the impact of incidental findings may be greater than participants at first let on; incidental findings can have significant effects on participants’ social environment; and participants may not feel prepared for disclosure even if incidental findings have been discussed during the informed consent process. The authors call for investigators to be aware of research participants’ experiences and these short- and long-term impacts when designing suitable courses of action for the detection and management of incidental findings in research settings. (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)

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)

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)

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)

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)

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)

The American Journal of Bioethics, Volume 11, Issue 6, Page 29-31, June 2011.

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

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)

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)

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?

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)