Berge Solberg

Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem?

In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor–biobank relationship meet high ethical standards. Up until now, a ‘broad consent’ model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top–down governance. Recently, an approach termed ‘dynamic consent’ has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach.

Not worth the paper it's written on? Informed consent and biobank research in a Norwegian context

In January 2003 the Norwegian Parliament passed the Biobanks Act, regulating biobank research in Norway. There have been strong differences of opinion both in the process of making the law as well as in its first years of implementation. The main controversy relates to what kind of informed consent should be required for biobank research. Central to the controversy over current interpretations of the Biobanks Act is the informed consent given by the donors to the biobank of the Nord-Trøndelag Health Study (HUNT), and whether the consent given ‘was worth the paper it was written on’. This article traces the history behind the informed consent procedure of the blood samples in the largest research biobank in Norway, the HUNT biobank. Second, findings from a focus group study with biobank participants are presented. Third, a philosophical analysis is made of the concept of informed consent in light of the findings from the focus-group study as well as the history behind the HUNT biobank. Findings from the focus-group study show that the consenters base their participation on trust in the researchers and the regulation of research in Norwegian society, rather than on specific information on the research in question. The history behind the HUNT biobank fosters trust. The story provides a strong case for not limiting the debate to legalistic and formalistic ethics but also including a research ethics that says that process and trust matter. Otherwise no informed consent in medical research is worth the paper it is written on.

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.

Getting beyond the welfare of the child in assisted reproduction

The welfare of the child is the prevailing principle and concern regarding access to assisted reproduction in Western countries today, and there is a wish to avoid harm to future children. New research fields have developed in order to provide scientific evidence on the welfare of children living with different “types” of parents. Assisted reproductive technologies (ART) seems to be heading in a responsible direction where the care and concern for future children is vital. However, the claim of this article is that the principle of the welfare of the child confuses the ethical framing of ART. Several philosophers in the past have argued that potential people must be regarded as outside the moral domain, and therefore cannot be harmed or benefitted. This message has not reached the policymakers, probably because the welfare of the child principle seems to fit so elegantly with common sense. In this article a different ethical framing of ART is proposed. The author argues that “futile care” and not “the welfare of the child” should be the guiding principle for eventually rejecting access to ART. The desired goal of ART treatment should be understood to be the production of functional families. Assisted reproduction is primarily about us, actual people in an actual society, and how potential children may affect us.

The Health Dugnad: Biobank Participation as the Solidary Pursuit of the Common Good

Rosamond Rhodes and John Harris have recently argued that we all have a general moral duty to participate in medical research. However, neither Rhodes’ nor Harris’ arguments in support of this obligation stand up to scrutiny, and severe and convincing criticism has been levelled against their case. Still, to refute their arguments is not to refute the conclusion. There seems to be some truth to the view that when people are asked to take part in medical research, their choice is not completely morally neutral. In this chapter, we argue that the proper question to ask is when, rather than if, a certain moral duty to volunteer for medical research can be appealed to. To answer this question, we need a denser description of relevant research projects and their context rather than just describing medical research in general. Drawing on our study of participants in the Norwegian HUNT biobank, we use the normative implications of the Norwegian concept “dugnad” as an analogy to discuss the requirement of providing neutral information to potential biobank participants in order to promote their free and informed decision as to whether or not to take part. We suggest that normative recruitment is not just a question of principles and ethics. It is also a question of research design and the creation of the common good in the community where the research takes place.

Attitudes to prenatal screening among Norwegian citizens: liberality, ambivalence and sensitivity

BackgroundNorway’s liberal abortion law allows for abortion on social indications, yet access to screening for fetal abnormalities is restricted. Norwegian regulation of, and public discourse about prenatal screening and diagnosis has been exceptional. In this study, we wanted to investigate whether the exceptional regulation is mirrored in public attitudes.MethodAn electronic questionnaire with 11 propositions about prenatal screening and diagnosis was completed by 1617 Norwegian adults (response rate 8.5%).ResultsA majority of respondents supports increased access to prenatal screening with ultrasound (60%) and/or full genome sequencing of fetal DNA (55%) available for all pregnant women. Significant minorities indicate, however, that a public offer of prenatal screening for all pregnant women would signal that people with Down syndrome are unwanted (46%) or could be criticized for contributing to a ‘sorting society’ (48%).ConclusionsResults indicate deeper ambivalences and a cultural sensitivity to the ethical challenges of prenatal screening and subsequent abortions. The specific diagnosis of Down syndrome and the fear of becoming a ‘sorting society’ which sorts human life due to diagnoses, appear to play prominent roles in citizen deliberations. The low response rate means that a non-response bias cannot be excluded, yet reasons why results are still likely to be of value are discussed.

Vitenskapelig (u)redelighet

Siden 1980-ara har det vaert en markert okning i antall avsloringer av fusk i forskning. Slike saker svekker ikke bare tilliten til forskning i samfunnet, de bidrar ogsa til at selve forskningen blir svekket. Forskningsetikk handler imidlertid om mye mer enn gransking av uredelighet. Hvordan kan vi fremme god vitenskapelig praksis? Hva innebaerer det at forskning er redelig? Hvilke grasoner finnes, og nar gar man over grensen til uredelighet? Hvordan bor vi handtere mistanker om uredelighet? Hvilke konsekvenser far fusk i forskning, og hvilke sanksjoner bor folge? I denne antologien presenteres ulike perspektiver pa vitenskapelig redelighet og uredelighet gjennom bidrag fra norske forskere pa feltet. Formalet er ikke a gi entydige eller endelige svar pa hva vitenskapelig uredelighet er, men a formidle et mangfold av posisjoner og perspektiver. Noen av disse er overlappende, andre motstridende – og dette speiler ogsa feltet internasjonalt. Antologien vil vaere en viktig ressurs for studenter og forskere, ikke minst i undervisning og opplaering, men ogsa for andre som er involvert i arbeidet med a forebygge uredelighet og fremme god vitenskapelig praksis. Abstract Since the 1980’s, there has been a marked increase in disclosures of fraud in research. Cases of scientific fraud and misconduct do not only damage society’s confidence in research, they also contribute to reduce the trustworthiness in research in itself. Research ethics, however, involve much more than investigations of misconduct. How can we encourage good scientific practice? What does honest research entail? Which gray areas exist, and when is the limit to misconduct crossed? How should allegations of misconduct be handled? What are the consequences of fraud, and what sanctions should follow? In this anthology, Norwegian researches contribute to the discussion of various perspectives on scientific integrity and misconduct. The purpose of this book is not to give unequivocal or definitive answers to what scientific misconduct is, but to convey a diversity of positions and perspectives. Some of these are overlapping, others contradictory - which also reflects the field internationally. This anthology is an important resource for students and researchers, particularly in education and training. In addition, it will also provide insights for others involved in the prevention of misconduct and the promotion of good scientific practice.