Gert Helgesson

Should donors be allowed to give broad consent to future biobank research

Large international biobank studies can make substantial contributions to scientific research by validation of the biological importance of previous research and by identification of previously unknown causes of disease. However, regulations for patient consent that are too strict and discrepancies in national policies on informed consent might hinder progress. Therefore, establishment of common ground for ethical review of biobank research is essential. In this essay, broad consent is defined on a scale between strictly specified (eg, for a specific study) and blanket consent (ie, with no restrictions regarding the purpose of the research). Future research includes that which might not be planned or even conceptualised when consent is obtained. In conclusion, broad consent and consent for future research are valid ethically and should be recommended for biobank research provided that: personal information related to research is handled safely; donors of biological samples are granted the right to withdraw consent; and new research studies or changes to the legal or ethical authority of a biobank are approved by an ethics-review board.

Potential harms, anonymization, and the right to withdraw consent to biobank research

This paper discusses the potential harms involved in biobank research and how ethical review, informed consent, withdrawals, and anonymization of samples should be handled in the light of these harms. There is less risk involved in biobank research than in human subject research; it should therefore be treated differently. In our view, anonymization should not be an automatically permissible response to requests for withdrawal. Nor should a request for withdrawal necessarily stop research on identifiable samples. Apart from not being particularly appropriate for protecting the interests of individuals, anonymization of samples has a negative impact on research. We suggest that the current view on withdrawal from research, supported by the Declaration of Helsinki and subsequent ethical guidelines, be abandoned in the context of biobank research and be replaced by an approach inspired by the Nuremberg Code. This approach requires those wishing to withdraw their samples from research to present sufficient reason for doing so. Our interpretation of ‘sufficient reason’ includes all those involving genuine, deeply felt concerns that are not based on misconceptions. Still, this underlines the fact that we all share a responsibility for health research and that no one should take withdrawal from biobank research lightly.

Ethical framework for previously collected biobank samples

973 criterion in the GM301 trial3 of Genasense plus dacarbazine versus dacarbazine alone in advanced melanoma because it is the best known prognostic marker in this disease. Unfortunately, the substantial therapeutic accomplishments of Genasense in a randomized, global, 771-patient trial in advanced melanoma (and specifically among 508 patients with a normal baseline LDH level, which showed statistically significant benefits in survival (P = 0.018), progression-free survival (P = 0.0007) and response rate (P = 0.009)) were ignored by Potera in favor of open-label, preliminary, phase 2 human data, and an additional single data set that involved antisense therapeutics in sick penguins. The most accurate assessment of the current situation in oligonucleotide therapeutics in Potera’s article came from John Rossi, who stated that “There’s a place for RNAi and antisense.” I hope that Potera takes careful note of this opinion, especially with respect to human cancer, and most importantly, that she takes greater care in her reporting of facts and their assessment. Readers should note that although I am not a Genta stockholder and have no contractual relationships with the company, I was formerly a member of their scientific advisory board (but have not been since 2005).

European Association for Palliative Care (EAPC) framework for palliative sedation: an ethical discussion

BackgroundThe aim of this paper is to critically discuss some of the ethically controversial issues regarding continuous deep palliative sedation at the end of life that are addressed in the EAPC recommended framework for the use of sedation in palliative care.DiscussionWe argue that the EAPC framework would have benefited from taking a clearer stand on the ethically controversial issues regarding intolerable suffering and refractory symptoms and regarding the relation between continuous deep palliative sedation at the end of life and euthanasia. It is unclear what constitutes refractory symptoms and what the relationship is between refractory symptoms and intolerable suffering, which in turn makes it difficult to determine what are necessary and sufficient criteria for palliative sedation at the end of life, and why. As regards the difference between palliative sedation at the end of life and so-called slow euthanasia, the rationale behind stressing the difference is insufficiently demonstrated, e.g. due to an overlooked ambiguity in the concept of intention. It is therefore unclear when palliative sedation at the end of life amounts to abuse and why.ConclusionsThe EAPC framework would have benefited from taking a clearer stand on some ethically controversial issues regarding intolerable suffering and refractory symptoms and regarding the relation between continuous deep palliative sedation at the end of life and euthanasia. In this text, we identify and discuss these issues in the hope that an ensuing discussion will clarify the EAPCs standpoint.

Patients’ refusal to consent to storage and use of samples in Swedish biobanks: cross sectional study

Objectives To estimate how many people object to storage of biological samples collected in health care in Sweden and to their use in research and how many withdraw previous consent. Design Cross sectional study of register data. Setting Biobanks used in Swedish health care, 2005-6. Population Data on refusal to consent were obtained for 1.4 million biobank samples per year from 20 of 21 counties. Main outcome measures Rates of preliminary refusal to consent, confirmed refusal, and withdrawal of consent. Results Patients refused consent to either storage or use of their samples in about 1 in 690 cases; about 1 in 1600 confirmed their decision by completing a dissent form. Rather than having the samples destroyed, about 1 in 6200 patients wanted to restrict their use. Of those who had previously consented, about 1 in 19 000 withdrew their consent. Conclusions Refusal to consent to biobank research in Sweden is rare, and the interests of individuals and research interests need not be at odds. The Swedish healthcare organisation is currently obliged to obtain either consent or refusal to each potential use of each sample taken, and lack of consent to research is used as the default position. A system of presumed consent with straightforward opt out would correspond with people’s attitudes, as expressed in their actions, towards biobank research.

How to handle informed consent in longitudinal studies when participants have a limited understanding of the study

Empirical findings from a Swedish longitudinal screening study show that many of the research subjects had a limited understanding of the study. Nevertheless they were satisfied with the understanding they had and found it sufficient for informed continued participation. Were they wrong? In this paper, it is argued that the kind of understanding that is morally required depends partly on the kind of understanding on which the research subjects want to base their decisions, and partly on what kind of knowledge they lack. Researchers must ensure that the information process is not flawed and that participants receive the information they want. To achieve this, new information efforts may be needed. Researchers must also ensure that research subjects have knowledge about aspects of importance to them. Lack of understanding may, however, be the result of conscious choices by research subjects to disregard some of the information because it is not important to them. Such choices should normally be respected.

In defense of broad consent.

Proper procedures for informed consent are widely recognized as an ethical requirement for biomedical research involving human beings, in particular as a means to respect the autonomy and personal integrity of potential and actual research participants. There is, however, considerable disagreement on how to handle informed consent in research that deviates from the standard case of clinical research, which is also reflected in the lack of uniformity in how informed consent routines are applied within the global research community. Whereas several authors have argued that any attempt to depart from the requirement that research information be study-specific compromises the ethical justification for these procedures, others have claimed that regarding some kinds of research it is not only acceptable to obtain less specific consent from those participants who are willing to give such consent but also preferable, because it facilitates important research, especially by reducing risk for unfounded dropout and thereby diminished research quality. In this article I argue that broad consent to future research is a legitimate and preferable alternative to specific consent for biobank research. I also critically discuss counterarguments to this view.

Ethical Dilemmas and Ethical Competence in the Daily Work of Research Nurses

In spite of the growing interest in nursing ethics, few studies have focused on ethical dilemmas experienced by nurses working with clinical studies as ‘research nurses’. The aim of the present study was to describe and explore ethical dilemmas that Swedish research nurses experience in their day-to-day work. In a qualitative study a purposeful sample of six research nurses from five wards of differing disciplines in four Swedish hospitals was interviewed. The analysis displayed several examples of ethical dilemmas, primarily tensions between the nurses’ obligations to the study and to the patients involved. A guiding moral principle for the nurses was patient-centeredness, where the interest of research must not override the interest of the patient. In situations where tensions between research and patient interests occurred, and doctors and nurses disagreed upon the judgement, the nurses sometimes chose to follow the doctors’ advice, and thus acted against their own moral judgment. Such situations seemed to create feelings of moral distress among the nurses. They described their profession as being ‘invisible’ and as lacking opportunities for ethical competence building. The conclusion is that research nurses frequently experience severe and difficult ethical dilemmas in their daily work. They need to be acknowledged as a particular profession in the health care organisation and encouraged to develop their specific ethical competence.

Against the principle that the individual shall have priority over science

This paper highlights a feature common to many ethical guidelines—namely, the idea that the interests of the individual shall always prevail over the interests of science and society. The paper presents how some major ethical guidelines treat the balancing of research interests against those of research subjects and spells out the difficulties in interpreting the principle of the primacy of the individual in a way that can be action-guiding. It suggests various alternative interpretations of the primacy of the individual and argues that they do not hold. Finally, the implications of this analysis for ethical guidelines are discussed.

The false academy: predatory publishing in science and bioethics

This paper describes and discusses the phenomenon ‘predatory publishing’, in relation to both academic journals and books, and suggests a list of characteristics by which to identify predatory journals. It also raises the question whether traditional publishing houses have accompanied rogue publishers upon this path. It is noted that bioethics as a discipline does not stand unaffected by this trend. Towards the end of the paper it is discussed what can and should be done to eliminate or reduce the effects of this development. The paper concludes that predatory publishing is a growing phenomenon that has the potential to greatly affect both bioethics and science at large. Publishing papers and books for profit, without any genuine concern for content, but with the pretence of applying authentic academic procedures of critical scrutiny, brings about a worrying erosion of trust in scientific publishing.