Not worth the paper it's written on? Informed consent and biobank research in a Norwegian context (original) (raw)
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Biobank research, informed consent and society. Towards a new alliance?
Journal of Epidemiology and Community Health, 2015
With the rise of -omics disciplines and biobank research, personal data and biosamples crossing national borders pose new ethical questions. In this article, informed consent, as originally conceived, is shown as not being sufficient to address aims of research and interests of patients any more. Therefore the author has, after having scrutinised issues in biobanking, sketched a model of dynamic consent and a manner of scrutinising ethical issues through empirical data.
Beyond "Good Governance":Trust, Consent, Exploitation and Vulnerability in Cross-Cultural Biobanking
2017
Article 1 is co-authored by Jesper Lassen and Peter Sandøe. I am responsible for the collection, transcription and analysis of interview data, and for developing and drafting the manuscript. Jesper Lassen and Peter Sandøe have both contributed with supervision in qualitative methods (semistructured interviews), in analysis and interpretation of data, and with substantial critical discussion and revision of the manuscript. Article 2 is co-authored by Klemens Kappel. I am responsible for the development and drafting of the manuscript. Klemens Kappel has contributed with development of ideas and arguments, as well as substantial critical discussion and revision of the manuscript. Article overview The present dissertation is comprised of three research articles. Article 1 details the findings of our empirical study executed in Pakistan, and Articles 2 and 3 each provide a thorough philosophical investigation of two issues that emerged as relevant in this study. Article 1, "I didn't have anything to decide, I wanted to help my kids"-An interview based study of consent procedures in sampling human biological material for genetic research in rural Pakistan", details the qualitative study that has served as empirical basis for the dissertation's other two articles. This study was comprised of 10 semi-structured interviews with families who have donated blood samples to NIBGE for research on a genetic disorder in their family, and 5 semi-structured interviews with NIBGE researchers. Interviews with donors focused on their motivations to donate samples, their experience of consent and donation, and what factors were central in the decision to give consent. Interviews with researchers focused on the institute's requirements for consent, and the researchers' strategies for and experiences with obtaining consent in the field. The study found that researchers often modify standard procedures for informed consent in the field to the local context, in order to gain the trust, good will and cooperation of the families. In turn, the donors reported that central to their participation in the research was their hope for getting something out of their participation (in the form of a cure, or knowledge about the disorder), and above all their trust in the researchers as both human beings and medical professionals as being capable and willing to look after their interests in this regards. Noting that several of the donors may have suffered from therapeutic misconception with respect to the potential benefits they may gain from their participation, the article concludes that while trust is important in consent to research, it should be supplemented by efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research per se (as opposed to diagnostics). This article is co-authored with Peter Sandøe and Jesper Lassen, and has been accepted with revisions for publication in AJOB Empirical Bioethics. Article 2, "Is consent based on trust morally inferior to consent based on information?" engages in the philosophical and medico-ethical discussion regarding the theoretical justifications for the practice of informed consent to medical research. In much of medical ethics it is standardly assumed and claimed that decisions based on information (e.g., about a medical intervention, or about the drug used in a clinical trial) are more robust and prudent than decisions based merely on trust (in e.g. the doctor, researcher and/or the medical institution). This attaches a superior moral value to decisions based on information, and in turn places moral weight on the information itself, as a means to reach decisions that are, ostensibly, morally superior. In contrast to this standard claim, we argue that decisions based on trust are not morally inferior to decisions based on information. This argument is carried forward through a systematic analysis of the moral values underlying and essential to informed consent-i.e., autonomy, voluntariness, nonmanipulation and non-exploitation-with respect to whether these values are less protected by consent based on trust than they are by consent based on information. The analysis finds that this is not the case, and on this basis we conclude that trust-based consent is not inferior to information-based consent. The article concludes by considering and rejecting possible objections to this stance, and considers the implications this new perspective on informed consent may have for current practice, e.g. in the case of practices for ethical committees, and the practice of broad consent to genomic and biobank research.
Scientists’ perspectives on consent in the context of biobanking research
European Journal of Human Genetics, 2014
Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking.
With the progress in bioinformatics, genomics, and epidemiology, biobanks, as repositories of populations’ biological samples as well as of personal and medical information, are becoming an essential research tool. Despite the potential benefits biobanks may bring and the options presented by some of the current biobanks’ consent policies, there remain ethical concerns regarding the autonomy and dignity of research participants if consent is not fully informed as dictated in the terms of traditional informed consent. This article aims at providing an overview of the approaches taken by the main international norms with respect to informed and broad consent and how well these norms are integrated by biobanks or biobank consortia. We conclude that broad consent could be an important tool to achieve the benefits of large-scale biobanks projects. If it is to be accepted, its regulation and implementation need to be mindful of the participant’s dignity and autonomy and sensitive to the need for international coherence and harmonization.
Journal of Public Health Research, 2013
Background. The Center for Transfusion Medicine, Cell Therapy and Cryobiology, Milan, Northern Italy, is the headquarter of the POLI-MI biobank. It co-ordinates the biobank activities of the Fondazione Ca' Granda Ospedale Maggiore Policlinico of Milan. Such activities require specific safeguarding of donors' rights and protection of sensitive and genetic data. The Fondazione Ca' Granda Ospedale Maggiore Policlinico has set up a project on informed consent with the aim of developing awareness and understanding of this issue. Within this project, it has been decided to evaluate how consent for biobanking material is expressed.
Journal of law and medicine, 2009
Collections of human tissue removed from patients in the course of medical diagnosis or therapy are believed to be an increasingly important resource for medical research (biobank research). As a result of a number of tissue-related "scandals" and increasing concern about ownership and privacy, the requirements to obtain consent from tissue donors are becoming increasingly stringent. The authors' data show that members of the general public perceive academic biobank researchers and their institutions to be highly trustworthy and do not see the need for recurrent, project-specific consent. They argue, on the basis of their empirical findings, that we should question the trend, at least in some settings, toward ever more stringent consent requirements for the use of tissue in research. They argue that this approach, while perhaps counterintuitive in the current regulatory environment, can be both ethically and legally sound so long as channels of communication are mainta...
Background Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. Methods Review question: Which empirical data are available on research participants’ perceptions and views regarding information and elicitation of consent for biobank research? Search of articles published till March 1st 2014 in Pubmed. Review of abstracts and potentially relevant full text articles by two authors independently. As categories for content analysis we defined (i) understanding or recall of information, (ii) preferences regarding information or consent, and (iii) research participants’ concerns. Results The search in Pubmed yielded 337 abstracts of which 10 articles were included in this study. Approaches to information and consent varied considerably across the selected studies. The majority of research participants opted for some version of limited consent when being informed about such possibility. Among the factors influencing the type of preferred consent were information about sponsoring of biobank research by pharmaceutical industry and participants’ trade-off between privacy and perceived utility. Studies investigating research participants’ understanding and recall regarding the consent procedure indicated considerable lack of both aspects. Research participants’ perceptions of benefits and harms differ across those studies. Conclusion The knowledge, perceptions and views of research participants who have undergone a consent procedure within the context of biobank research raise several questions on the issue of how to inform and elicit consent in an ethically acceptable way. In our empirical-ethical analysis we develop suggestions on how the practice of eliciting consent in the biobank context should be improved.
Special report Biobank research and ethics: the problem of informed consent in Polish biobanks
Archives of Medical Science, 2011
Introduction: The dynamic development of biobanks causes some ethical, social, and legal problems. The most discussed problems are obtaining informed consent, especially for future research, from minors and from deceased people. The aim of this article is to present the current standards held by Polish biobanks concerning obtaining a participant's informed consent in some aspects. Material and methods: Survey was carried out by anonymous questionnaire among 59 institutions which deal with the collecting and storage of human cells and tissues in the year 2008. Twenty four filled-in copies of the questionnaires were sent back (return = 41%). Results: Almost every institution (92%) obtains written consent, but a third of the surveyed institutions (29%) do not obtain consent for the future use of the samples. The majority of the respondents (83%) support the idea of using biological materials for research purposes of a donor who died if he did not leave any written objection to such practices and 46% of respondents stated that biobanks should obtain the consent from the already mature donor who gave their samples as a child. Conclusions: The practice and rules for obtaining informed consent for the scientific research require improvement. The possibility to use the human materials in the future, conditions for getting access to the data, the possibility of their withdrawal from the database and using the materials and data after the death of the donor should be clearly determined when the informed consent to collect the material is obtained.