BACKGROUND: There is growing consensus that individual genetic research results that are scientifically robust, analytically valid, and clinically actionable should be offered to research participants. However, the general practice in European research projects is that results are usually not provided to research participants for many reasons. This article reports on the views of European experts and scholars who are members of the European COST Action CHIP ME IS1303 (Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives) regarding challenges to the feedback of individual genetic results to research participants in Europe and potential strategies to address these challenges.

MATERIALS AND METHODS: A consultation of the COST Action members was conducted through an email survey and a workshop. The results from the consultation were analyzed following a conventional content analysis approach.

RESULTS: Legal frameworks, professional guidelines, and financial, organizational, and human resources to support the feedback of results are largely missing in Europe. Necessary steps to facilitate the feedback process include clarifying legal requirements to the feedback of results, developing harmonized European best practices, promoting interdisciplinary and cross-institutional collaboration, designing educational programs and cost-efficient IT-based platforms, involving research ethics committees, and documenting the health benefits and risks of the feedback process.

CONCLUSIONS: Coordinated efforts at pan-European level are needed to enable equitable, scientifically sound, and socially robust feedback of results to research participants.

This essay performs a speculative ethics in designing with a researcher's own bodily fluids. This is through the creation of "performative texts", which are autoethnographic accounts of past experiences in which written words perform through visual and spatial compositions alongside verbal readings aloud. I present three performative texts about moments of discomfort in designing with milk from my own breastfeeding relationship. They are to reflect upon felt experiences of potential harm and to understand social and material relations of care. From these I offer three possibilities for how HCI might consider the ethics of first-person research in attending to more-than-human entanglements: unsafe spaces, situated escapes, and censored inclusion. These possibilities and the approach of performative texts contribute to research for more sustainable futures by exploring the decentering of humans through an intimate engagement with the self.

This essay performs a speculative ethics in designing with a researcher's own bodily fluids. This is through the creation of "performative texts", which are autoethnographic accounts of past experiences in which written words perform through visual and spatial compositions alongside verbal readings aloud. I present three performative texts about moments of discomfort in designing with milk from my own breastfeeding relationship. They are to reflect upon felt experiences of potential harm and to understand social and material relations of care. From these I offer three possibilities for how HCI might consider the ethics of first-person research in attending to more-than-human entanglements: unsafe spaces, situated escapes, and censored inclusion. These possibilities and the approach of performative texts contribute to research for more sustainable futures by exploring the decentering of humans through an intimate engagement with the self.

What role should trust have in biobank research? Is it a scarce resource to be cultivated, or does its moral significance lie elsewhere? How does it relate to the researcher’s individual responsibility?

In this thesis I draw four general conclusions. First, trust is still very much present in at least some biobanking settings, notably in Sweden, but possibly also internationally. Second, a morally relevant conception of trust entails that to be trustworthy, researchers must consider the normative expectations that people have of them, and renegotiate expectations that are mistaken. Third, this conception differs from “public trust” assessed through surveys. The main use of the latter is to legitimate policy, not to identify moral duties. Fourth, in spite of ethics review, guidelines and informed consent procedures, ethical issues will always arise during the course of a research project. Researchers can therefore never avoid their individual moral responsibility. Ensuring that one is adequately trusted is one step towards conducting morally acceptable research.

Study I indicates that few Swedes refuse storage of samples in healthcare-associated biobanks and their use in research. Study II suggests that people are somewhat more willing to donate samples than surveys indicate, especially when approached face-to-face by health care personnel. Relationships of trust might thus be important in people’s decision-making. Study III investigates trust as a moral concept. The trustee is often in a unique position to determine what the other’s trust amounts to. When it is mistaken, the trustee has an obligation to counteract it, compensate for it, or renegotiate the expectations that cannot be met. In Study IV, I critique the feasibility of guaranteeing the trustworthiness of the research apparatus through formal measures such as ethics review and guidelines. Not only are there limitations of such measures to consider. They also risk blinding researchers to ethical issues that are not covered by the rules, fostering moral complacency, and alienating researchers to ethics.

Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents, overseeing bodies, and formal procedures. The process of institutionalising distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure public trust. This paper examines some limitations of this approach. First, past atrocities cannot provide the necessary justification unless institutionalised distrust is a necessary or efficient means to prevent future ones; and there are several reasons to doubt that this is the case. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers—the kinds of qualities that institutionalised distrust calls into question. Third, ethics guidelines cannot, as it is sometimes assumed, educate or guide researchers to moral behaviour unless they already have considerable capacity for moral judgment. Fourth, institutionalised distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics as a pursuable activity. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences of allowing their moral competence to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and not obstructed from doing so.

Biobanks are an organized collection of biological material and associated data. They are a fundamental resource for life science research and contribute to the development of pharmaceutical drugs, diagnostic markers and to a deeper understanding of the genetics that regulate the development of all life on earth. Biobanks are well established in High Income Countries (HIC) and are rapidly emerging in Low and Middle Income Countries (LMIC). Surveys among biobanks operating in a LMIC setting indicate that limited resources and short term funding tied to specific projects threaten the sustainability of the biobanks. Fit-for-purpose biobanks targeting major societal challenges such as HIV and Malaria provide an excellent basis for integrating biobanks with the available research communities in LMIC regions. But to become sustainable for the future it is important that biobanks become an integrated part of local research communities. To achieve this, the cost of operating biobanks must be lowered, templates must be developed to support local ethics committees and researchers must be given the opportunity to build experience in successfully operating biobank based research projects. The B3Africa consortium is based on these conclusions and set up to support biobank based research by creating a cost efficient Laboratory Information Management System (LIMS) for developing biobanks and also contribute to the training and capacity building in the local research community. The technical platform called the eB3Kit is open source and consists of a LIMS and a bioinformatics module based on the eBiokit that allow researchers to take control over the analysis of their own data. Along with the technical platform the consortium will also contribute training and support for the associated infrastructures necessary to regulate the ethical and legal implications of biobank based research.

Within the myriad articles about participants' opinions of genomics research, the views of a distinct group - people with a rare disease (RD) - are unknown. It is important to understand if their opinions differ from the general public by dint of having a rare disease and vulnerabilities inherent in this. Here we document RD patients' attitudes to participation in genomics research, particularly around large-scale, international data and biosample sharing. This work is unique in exploring the views of people with a range of rare disorders from many different countries. The authors work within an international, multidisciplinary consortium, RD-Connect, which has developed an integrated platform connecting databases, registries, biobanks and clinical bioinformatics for RD research. Focus groups were conducted with 52 RD patients from 16 countries. Using a scenario-based approach, participants were encouraged to raise topics relevant to their own experiences, rather than these being determined by the researcher. Issues include wide data sharing, and consent for new uses of historic samples and for children. Focus group members are positively disposed towards research and towards allowing data and biosamples to be shared internationally. Expressions of trust and attitudes to risk are often affected by the nature of the RD which they have experience of, as well as regulatory and cultural practices in their home country. Participants are concerned about data security and misuse. There is an acute recognition of the vulnerability inherent in having a RD and the possibility that open knowledge of this could lead to discrimination.

Public health ethics is commonly analyzed within a consequentialist or rights-based perspective, but recent approaches explore public health from a virtue ethical perspective. Rozier focuses on the virtues of individual members of the public and I discuss public health professionals. MacKay emphasizes the role of the collective level, the practice and social structure of public health. The structure can be important in two ways. First, it potentially affects the cultivation of the virtues of individuals. Second, the structure itself could have virtues. MacKay defends the latter notion and argues that structures become objective reality that is non-reducible to individuals. She implicitly describes public health as an actor, as having hopes and aspirations. MacKay’s account is an interesting contribution to the field. I agree with that the social structure is important but argue that it is primarily important in relation to the cultivation of individual virtues. Public health is not an agent and if it is described as such, it needs a supporting argument concerning moral group agency. I argue that there are no collectives without individuals. Future studies should focus on the links between the individual and social levels and discuss which virtues are the most important.

BACKGROUND: Psychiatric staff members have the power to decide the options that frame encounters with patients. Intentional as well as unintentional framing can have a crucial impact on patients' opportunities to be heard and participate in the process. We identified three dominant ethical perspectives in the normative medical ethics literature concerning how doctors and other staff members should frame interactions in relation to patients; paternalism, autonomy and reciprocity. The aim of this study was to describe and analyse statements describing real work situations and ethical reflections made by staff members in relation to three central perspectives in medical ethics; paternalism, autonomy and reciprocity.

METHODS: All staff members involved with patients in seven adult psychiatric and six child and adolescent psychiatric clinics were given the opportunity to freely describe ethical considerations in their work by keeping an ethical diary over the course of one week and 173 persons handed in their diaries. Qualitative theory-guided content analysis was used to provide a description of staff encounters with patients and in what way these encounters were consistent with, or contrary to, the three perspectives.

RESULTS: The majority of the statements could be attributed to the perspective of paternalism and several to autonomy. Only a few statements could be attributed to reciprocity, most of which concerned staff members acting contrary to the perspective. The result is presented as three perspectives containing eight values.Paternalism; 1) promoting and restoring the health of the patient, 2) providing good care and 3) assuming responsibility.Autonomy; 1) respecting the patient's right to self-determination and information, 2) respecting the patient's integrity and 3) protecting human rights.Reciprocity; 1) involving patients in the planning and implementation of their care and 2) building trust between staff and patients.

CONCLUSIONS: Paternalism clearly appeared to be the dominant perspective among the participants, but there was also awareness of patients' right to autonomy. Despite a normative trend towards reciprocity in psychiatry throughout the Western world, identifying it proved difficult in this study. This should be borne in mind by clinics when considering the need for ethical education, training and supervision.

BACKGROUND: Psychiatric staff members have the power to decide the options that frame encounters with patients. Intentional as well as unintentional framing can have a crucial impact on patients' opportunities to be heard and participate in the process. We identified three dominant ethical perspectives in the normative medical ethics literature concerning how doctors and other staff members should frame interactions in relation to patients; paternalism, autonomy and reciprocity. The aim of this study was to describe and analyse statements describing real work situations and ethical reflections made by staff members in relation to three central perspectives in medical ethics; paternalism, autonomy and reciprocity.

METHODS: All staff members involved with patients in seven adult psychiatric and six child and adolescent psychiatric clinics were given the opportunity to freely describe ethical considerations in their work by keeping an ethical diary over the course of one week and 173 persons handed in their diaries. Qualitative theory-guided content analysis was used to provide a description of staff encounters with patients and in what way these encounters were consistent with, or contrary to, the three perspectives.

RESULTS: The majority of the statements could be attributed to the perspective of paternalism and several to autonomy. Only a few statements could be attributed to reciprocity, most of which concerned staff members acting contrary to the perspective. The result is presented as three perspectives containing eight values.Paternalism; 1) promoting and restoring the health of the patient, 2) providing good care and 3) assuming responsibility.Autonomy; 1) respecting the patient's right to self-determination and information, 2) respecting the patient's integrity and 3) protecting human rights.Reciprocity; 1) involving patients in the planning and implementation of their care and 2) building trust between staff and patients.

CONCLUSIONS: Paternalism clearly appeared to be the dominant perspective among the participants, but there was also awareness of patients' right to autonomy. Despite a normative trend towards reciprocity in psychiatry throughout the Western world, identifying it proved difficult in this study. This should be borne in mind by clinics when considering the need for ethical education, training and supervision.

This paper outlines some of the challenges faced by regulation of genetic biobanking, using case studies coming from the Italian legal system. The governance of genetic resources in the context of genetic biobanks in Italy is discussed, as an example of the stratification of different inputs and rules: EU law, national law, orders made by authorities and soft law, which need to be integrated with ethical principles, technological strategies and solutions. After providing an overview of the Italian legal regulation of genetic data processing, it considers the fate of genetic material and IP rights in the event of a biobank's insolvency. To this end, it analyses two case studies: a controversial bankruptcy case which occurred in Sardinia, one of the first examples of private and public partnership biobanks. Another case study considered is the Chris project: an example of partnership between a research institute in Bolzano and the South Tyrolean Health System. Both cases seem to point in the same direction, suggesting expediency of promoting and improving public-private partnerships to manage biological tissues and biotrust to conciliate patent law and public interest.

This is not a contribution to the polarised embryo debate but an attempt to understand its obstinacy. Instead of aiming towards the “correct” ethical position on the permissibility of embryonic stem cell research, this chapter examines an assumption on which the debate is based. This is the assumption that moral concerns about embryo destruction arise from doctrines about embryos, from beliefs that make these concerns reasonable. This epistemic interpretation of moral concerns produces the target at which debaters aim: which one of the competing doctrines can be demonstrated to be the logically coherent and true one? Through a combination of fresh examples and alert attention to familiar facts – inspired by Wittgenstein’s emphasis on producing an understanding that consists in “seeing connections” – this chapter indicates a less intellectual origin of moral concerns: in human sensitivities towards existence that, to distinguish them from beliefs and doctrines, could be called “ways of relating to life”. After indicating how the rigid intellectual target of the debate is a mirage, the chapter concludes by briefly indicating a gentler approach to people’s moral concerns.

As embryonic stem cell research is commercialized, the stem cell debate may shift focus from concerns about embryo destruction to concerns about exploitation of the women who donate eggs and embryos for research. Uncomfortable with the polarization of the embryo debate, this paper proposes a more “contemplative” approach than intellectual debate to concerns about exploitation. After examining pitfalls of rigid intellectual positions on exploitation, the paper investigates the possibility of a broader understanding of donation for research where patients are seen as the intended beneficiaries of the donation. Together with other actors, research is perceived as mediating altruistic gift relationships that extend from donors to patients. The paper explores how this broader perspective on “donation for research” can open up new possibilities of understanding donation and addressing risks of exploitation. 

This contribution aims to unpack the ontological nexus of cyborg identity and culture. It highlights a set of core assumptions driving its operations that merit critical attention as cyborgic and AI discourses continue to unfold and penetrate societies deeper, ultimately questioning the normative and conceptual logic and social distribution of these core assumptions.

With the discovery and development of CRISPR, the technology that might allow us to modify the human germline is at our fingertips, and, consequently, serious practical and ethical consideration is warranted. In the following paper, I examine the ethics of using CRISPR in this way and argue that modifying the human germline for the purpose of preventing serious genetic disease is, in principle, ethically acceptable and ought to be allowed. I present several arguments to this effect including arguments that rely on the principles of beneficence and autonomy. I also examine the larger societal implications of human germline modification. I then respond to six of the most prominent objections that have been raised against CRISPR and germline gene modification before concluding with a brief discussion of the biggest challenge that we face as we move forward with CRISPR, that of limiting the use of this promising and incredibly versatile technology. 

Ethics is a field of emerging importance to NordForsk, and the Nordic Committee on Bioethics adds new perspectives to the ongoing activities within NordForsk. Based on the feedback received about Legislation on biotechnology in the Nordic countries – an overview 2014, the report clearly filled a gap for researchers and stakeholders working within the field. We are pleased to publish this updated version, and hope it serves its purpose of enhancing the understanding for each other’s regulatory framework within biotechnology in the Nordic countries.