Scientists’ perspectives on consent in the context of biobanking research (original) (raw)
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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.
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.
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.
The Journal of law, medicine & ethics, 2005
iomedical research has always relied on access to human biological materials and clinical infor-B mation, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important by far is the power of information technology, which has transformed our lives in almost every domain. In the research setting, it is now easy to abstract information from electronic medical records. Computers make it possible to analyze enormous datasets and have contributed in essential ways to the dramatic increases in our understanding of genomics and other areas of biomedical science. Information technology, however, has a potential Achilles heel. If inadequate attention is paid to security, others can access electronically stored information and perhaps use it to harm individuals and larger groups. As a result, people are increasingly worried about their privacy and want more control over who has access to information about them, and under what conditions. These desires are often manifested in requests for more stringent requirements for informed consent.
Sample and data sharing barriers in biobanking: consent, committees, and compromises
Annals of Diagnostic Pathology, 2014
The ability to exchange samples and data is crucial for the rapidly growth of biobanking. However, sharing is based on the assumption that the donor has given consent to a given use of her or his sample. Biobanking stakeholders, therefore, must choose 1 of 3 options: obtain general consent enabling multiple future uses before taking a sample from the donor, try to obtain consent again before sharing a previously obtained sample, or look for a legally endorsed way to share a sample without the donor's consent. In this study, we present the results of 36 semistructured qualitative interviews with Swiss biobanking stakeholders regarding these options and the role of ethics committees in the process of authorizing sharing. Our results show that despite a lack of legal or guideline-based barriers to general consent, some stakeholders and ethics committees have reservations about this method of consent. In most cases, however, a general consent form is already in use. Many interviewees describe processes involving the ethics committees as time-consuming and cumbersome and their requirements as too demanding for donors/patients. Greater awareness of donors' opinions and preferences and the content of guidelines and recommendations could therefore be helpful for a better justified perspective of biobanking stakeholders and ethical committee members, equally. Finally, it may be necessary to differentiate between procedures governing future samples, where general consent is clearly desirable, and the use of old yet still relevant samples, where the option of using them without consent can be highly beneficial for research.
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.
Informed Consent in the Newly Established Biobank
International Journal of Environmental Research and Public Health, 2019
Informed consent is an important document for every existing biobank or repository to obtain, store and use human biospecimens and associated data and information for current and future research. Biobanks have undergone great progress worldwide during the last three decades and have become an integral part of personalized medicine and health care systems and due to new scientific and social questions to be solved. Ethical, legal and social issues (ELSI) guarantee safe sample and data management, and informed consent is one of the key ELSI documents. The form and the consent given in biobank informed consent forms differs between biobank-related institutions, national biobanks, between EU states, and to find the optimal informed consent requires one to fulfil national and international laws and regulations. The Biobank in Pilsen, Czech Republic was officially opened on April the 20th 2017 as a hospital-integrated biobank, and the informed consent was one of the essential documents th...
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...
Genetic Testing and Molecular Biomarkers, 2017
Informed consent and return of research results are among the most debated topics in the biobank literature. We discuss ethical, social, and policy issues associated with returning results in the context of biobanks using a broad consent approach, in the light of data from a qualitative survey of citizens' and physicians' views. Materials and Methods: Data were collected through interviews and focus groups to investigate stakeholders' perspectives about a large-scale hospital-based biobank designed to foster biomedical research, including prospective genomics research, and ''personalized'' medicine. Results: Both physicians and citizens considered psychosocial impacts as crucial in the assessment of benefits expected from a return of results to biobank participants. In particular, physicians highlighted the possible consequences on the patient-doctor relationship and discussed implications for the concept of ''personalized'' medicine. Citizens held ambivalent attitudes toward returning individual research results: they defended the ''right not to know,'' while they also considered a sort of ''responsibility to know'' because of potential implications of results for family members. Moreover, physicians and citizens raised questions about the broad consent model used for inhospital biobank recruitment and expressed their needs for more training in genomics and more information on the biobank initiative. Conclusions: Stakeholders such as citizens and physicians, who may be concerned as potential biobank participants or as healthcare professionals involved in the management of clinically relevant research results, provide useful insights into several aspects of broad consent and return of results, related in particular to the interface between research and the clinic.