Postponed Withholding: Balanced Decision-Making at the Margins of Viability.

Advances in neonatology have led to improved survival for periviable infants. Immaturity still carries a high risk of short- and long-term harms, and uncertainty turns provision of life support into an ethical dilemma. Shared decision-making with parents has gained ground. However, the need to start immediate life support and the ensuing difficulty of withdrawing treatment stands in tension with the possibility of a fair decision-making process. Both the parental "instinct of saving" and "withdrawal resistance" involved can preclude shared decision-making. To help health care personnel and empower parents, we propose a novel approach labeled "postponed withholding." In the absence of a prenatal advance directive, life support is started at birth, followed by planned redirection to palliative care after one week, unless parents, after a thorough counseling process, actively ask for continued life support. Despite the emotional challenges, this approach can facilitate ethically balanced decision-making processes in the gray zone.

European Electronic Personal Health Records initiatives and vulnerable migrants: A need for greater ethical, legal and social safeguards.

The effective collection and management of personal data of rapidly migrating populations is important for ensuring adequate healthcare and monitoring of a displaced peoples' health status. With developments in ICT data sharing capabilities, electronic personal health records (ePHRs) are increasingly replacing less transportable paper records. ePHRs offer further advantages of improving accuracy and completeness of information and seem tailored for rapidly displaced and mobile populations. Various emerging initiatives in Europe are seeking to develop migrant-centric ePHR responses. This paper highlights their importance and benefits, but also identifies a number of significant ethical, legal and social issues (ELSI) and challenges to their design and implementation, regarding (1) the kind of information that should be stored, (2) who should have access to information, and (3) potential misuse of information. These challenges need to be urgently addressed to make possible the beneficial use of ePHRs for vulnerable migrants in Europe.

Protect us from ourselves: Balancing the parental instinct of saving.

BACKGROUND: Neonatologists, legal experts and ethicists extensively discuss the ethical challenges of decision-making when a child is born at the limit of viability. The voices of parents are less heard in this discussion. In Norway, parents are actively shielded from the burden of decision-making responsibility. In an era of increasing patient autonomy, is this position still defendable? RESEARCH QUESTION: In this article, we discuss the role of parents in neonatal decision-making, based on the following research question: Should parents decide whether to provide lifesaving treatment when their child is born at the limit of viability? RESEARCH DESIGN: We conducted eight interviews with 12 parents, 4 individuals and 4 couples, all having experienced prenatal counselling at the limit of viability. The interviews took place at different university locations in Norway in the years 2014-2018. ETHICAL CONSIDERATIONS: All study participants gave their written informed consent. The Regional Committee for Medical Research Ethics approved the study. FINDINGS: We identified six main themes in parents' responses to the research question. Parents (1) experienced an emotional turmoil confronted with birth at the border of viability, (2) emphasized the importance of being involved in decision-making, (3) described and reflected on the need to balance the parental instinct of saving, (4) were concerned about the dilemmas involved in protecting the family, (5) were worried about the burden of overwhelming responsibility and (6) called for guideline relief. CONCLUSION: The perceived parental instinct of saving the life of their child makes it hard for parents to step away from a call for 'everything to be done'. Involvement of an interprofessional periviability team drawing on the experiences and viewpoints of nurses and neonatologists in decision-making is needed to protect both infants and parents against undue parental push for treatment and enable parents to make good decisions regarding their child.

«If you give them your little finger, they'll tear off your entire arm¼: losing trust in biobank research.

Why do some people withdraw from biobank studies? To our knowledge, very few studies have been done on the reflections of biobank ex-participants. In this article, we report from such a study. 16 years ago, we did focus group interviews with biobank participants and ex-participants. We found that the two groups interestingly shared worries concerning the risks involved in possible novel uses of their biobank material, even though they drew opposite conclusions from their worries. Revisiting these interviews today reveals a remarkable relevance to present concerns, since the possible developments that worried ex-participants and participants 16 years ago now are becoming realities. Drawing on conceptual distinctions by sociologist and philosopher Niklas Luhmann, we argue that while ex-participants express a loss of trust in the biobank institution to manage the use of their biobank material in a legitimate way, remaining participants expressed confidence in the management of the biobank institution to secure their interests. This analysis brings out important aspects of emerging trends in biobank research participation.

Withholding and Withdrawing Life-Sustaining Treatment: Ethically Equivalent?

Withholding and withdrawing treatment are widely regarded as ethically equivalent in medical guidelines and ethics literature. Health care personnel, however, widely perceive moral differences between withholding and withdrawing. The proponents of equivalence argue that any perceived difference can be explained in terms of cognitive biases and flawed reasoning. Thus, policymakers should clear away any resistance to accept the equivalence stance by moral education. To embark on such a campaign of changing attitudes, we need to be convinced that the ethical analysis is correct. Is it? In this article, I take a closer look at the moral relation between withholding and withdrawing. My conclusion is that withholding and withdrawing are not in general ethically equivalent. Thus, medical guidelines should be rewritten, and rather than being "educated" away from their sound judgments, medical professionals and patients should have nuanced medico-ethical discussions regarding withholding and withdrawing treatment.

Ethics of dead participants: policy recommendations for biobank research.

Respecting people's consent choices for use of their material and data is a cornerstone of biobank ethics. Participation in biobanks is characteristically based on broad consent that presupposes an ongoing possibility of informing and interacting with participants over time. The death of a participant means the end of any interaction, but usually not the end of participation. Research on causes of death makes biobank material from deceased participants extremely valuable. But as new research questions and methods develop over time, the question arises whether stored biobank material from deceased persons still can be used on the basis of their broad consent. In this paper, we discuss policies for postmortem use of biobank material, including consent options, proxy consent and criteria for limitation of types of use and duration of storage. We conclude that the interests of participants in biobank research are best served by asking at enrolment if and how the biobank material may be used after death. We state that the use of biobank material from deceased participants should be delimited both by their consent and by the prevailing broad consent choices of living participants.Biobanks also need to inform participants at enrolment about the duration of storage of biobank material or at minimum have procedures for deciding how long material will be stored for and for which purpose. For older collections, in the absence of such information or consent options, relevant authorities should decide.

We're not in it for the money-lay people's moral intuitions on commercial use of 'their' biobank.

Great hope has been placed on biobank research as a strategy to improve diagnostics, therapeutics and prevention. It seems to be a common opinion that these goals cannot be reached without the participation of commercial actors. However, commercial use of biobanks is considered morally problematic and the commercialisation of human biological materials is regulated internationally by policy documents, conventions and laws. For instance, the Council of Europe recommends that: "Biological materials should not, as such, give rise to financial gain". Similarly, Norwegian legislation reads: "Commercial exploitation of research participants, human biological material and personal health data in general is prohibited". Both articles represent kinds of common moral intuitions. A problem, however, is that legislative documents are too vague and provide room for ample speculation. Through the use of focus group interviews with Norwegian biobank donors, we have tried to identify lay intuitions and morals regarding the commercial use of biobanks. Our findings indicate that the act of donation and the subsequent uses of the samples belong to two different spheres. While concerns around dignity and commodification were present in the first, injustice and unfairness were our informants' major moral concerns in the latter. Although some opposition towards commercial actors was voiced, these intuitions show that it is possible to render commercial use of biobanks ethically acceptable based on frameworks and regulations which hinder commodification of the human body and promote communal benefit sharing.

Privacy and property in the biobank context.

A research biobank is a collection of personal health and lifestyle information, including genetic samples of yet unknown but possibly large information potential about the participant. For the participants, the risk of taking part is not bodily harm but infringements of their privacy and the harmful consequences such infringements might have. But what do we mean by privacy? Which harms are we talking about? To address such questions we need to get a grip on what privacy is all about and aim for a fruitful perspective on the issues of property and privacy rights in the context of biobanking. This paper argues that the limits and handling of private matters is determined in specific social relations. The crucial point is thus to determine which information and activities are or are not the legitimate concern of others. Privacy and property rights should be seen as balanced by duties, that is as inherently relational interests extending into the public sphere, rather than to see these rights as the control of an object--for instance the participant's biobank material.

Personal autonomy and informed consent.

Two ways of understanding the notion of autonomy are outlined and discussed in this article, in order to clarify how and if informed consent requirements in biotechnological research are to be justified by the promotion of personal autonomy: A proceduralist conception linking autonomy with authenticity, and a substantivist conception linking autonomy with control. The importance of distinguishing autonomy from liberty is emphasised, which opens for a possible conflict between respecting the freedom and the autonomy of research participants. It is argued that this has implications for how consent requirements based on different criteria of specificity and understanding should be viewed and justified.

Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research.

Biobanks have evolved, and their governance procedures have undergone important transformations. Our paper examines this issue by focusing on the perspective of the professionals working in management or scientific roles in research-based biobanks, who have an important impact on shaping these transformations. In particular, it highlights that recent advances in molecular medicine and genomic research have raised a range of ethical, legal and societal implications (ELSI) related to biobank-based research, impacting directly on regulations and local practices of informed consent (IC), private-public partnerships (PPPs), and engagement of participants. In our study, we investigate the ways that these concerns influence biobanking practices and assess the level of satisfaction of the cross-national biobanking research communities with the ELSI related procedures that are currently in place. We conducted an online survey among biobankers and researchers to investigate secondary use of data, informing and/or re-contacting participants, sharing of data with third parties from industry, participant engagement, and collaboration with industrial partners. Findings highlight the need for a more inclusive and transparent biobanking practice where biobanks are seen in a more active role in providing information and communicating with participants; the need to improve the current IC procedures and the role of biobanks in sharing of samples and data with industry partners and different countries, and the need for practical, tangible and hands-on ethical and legal guidance.

Correction: Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research.

[This corrects the article DOI: 10.1371/journal.pone.0221496.].

Justified by What? Three Ways to Provide an Ethical Basis for Neonatal Policies.

In this article, I identify 3 ways of justifying neonatal policies of when to provide life-saving treatment to infants who were born extremely premature: by appealing to universal principles or rights, to considerations of the best interests of the children, or to considerations of the best interests of the families. I go on to show how each of these justifications can be used to characterize the discourse on neonatal policies in 1 of the Scandinavian countries.

In the Best Interest of the. . .Parents: Norwegian Health Personnel on the Proper Role of Parents in Neonatal Decision-making.

OBJECTIVES: The role of parents in life-and-death decision-making for infants born at the border of viability is challenging. Some argue that parents should have the final say in decisions about life-sustaining treatment. Others disagree. In this article, we report views from health care personnel (HCP) on the appropriate parental role. METHODS: Focus group interviews with 5 different groups of HCP (neonatal nurses, midwifes, obstetricians, mother-fetal specialists, and neonatologists) dealing with life-and-death decisions throughout pregnancy and birth were performed at the Norwegian University of Science and Technology and at St Olav's Hospital in Trondheim, Norway in 2014-2017. Interviews were taped and transcribed. Inductive analysis was performed for each group discussion for emergent ethical themes. A summary of the transcribed discussion was sent to the relevant focus group participants for comments. RESULTS: Our participants felt strongly that doctors, not parents, should have the final say. They did not think parents should have to live with the burden of the decision. The possible disagreement between parents, lack of necessary knowledge, experience, time, and emotional stability all point toward the neonatologist as the optimal decision-maker, within a model of "Patient Preference-Satisfaction Paternalism." CONCLUSIONS: The general attitude of our groups was that parents should have a say and be included in a thorough information and decision-making process. The doctor, or a team of HCP, however, should make the final decision, being in the best position both epistemologically and normatively to promote the best interest of both parents and the child.

Biobank research and the right to privacy.

What is privacy? What does privacy mean in relation to biobanking, in what way do the participants have an interest in privacy, (why) is there a right to privacy, and how should the privacy issue be regulated when it comes to biobank research? A relational view of privacy is argued for in this article, which takes as its basis a general discussion of several concepts of privacy and attempts at grounding privacy rights. In promoting and protecting the rights that participants in biobank research might have to privacy, it is argued that their interests should be related to the specific context of the provision and reception of health care that participation in biobank research is connected with. Rather than just granting participants an exclusive right to or ownership of their health information, which must be waived in order to make biobank research possible, the privacy aspect of health information should be viewed in light of the moral rights and duties that accompany any involvement in a research based system of health services.