Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

Background Over the last few decades biobanks have been recognised as institutions that may revolutionise biomedical research and the development of personalised medicine. Poland, however, still lacks clear regulations regarding the running of biobanks and the conducting of biomedical research. While the awareness of the general public regarding biobanks is low, healthcare professions and medical students also lack basic knowledge regarding biobanks, and such ignorance may affect their support for biobanks. Methods This study is aimed at assessing the knowledge and (...) attitudes of future healthcare professionals towards the donation of human biological material for research purposes and is based on a sample of 865 Polish medical students at Poznań University of Medical Sciences. Results This research has shown that the awareness of medical students’ regarding biobanks is low. It has also shown that while the majority of future healthcare professionals enrolled in this study supported the idea of biobank research and declared themselves willing to donate, still many students felt ambivalent about the biobanking of human biological material for research purposes and expressed concerns over biobanking research. While the primarily motivation to participate in biobank research was the desire to help advance science and to develop innovative therapies, the most common reason for a refusal was the fear that the government, insurance companies or employers, might have access to the samples. Concerns over unethical use of samples and data safety were also prevalent. More than half of students opted for a study-specific model of consent and only a few opted for broad consent. Conclusions This research suggests that a lack of knowledge about biobanks, their role and activities may affect medical students’ support for biobanks and their active participation in the collection and management of biospecimens for research purposes. Since in the future medical, nursing and pharmacy students will be involved in the collection, storage, testing and analysis of biospecimens from their patients, medical students in all professional fields should be trained regarding the concept, purposes and operational procedures of biobanks, as well as the ethical, legal and social implications of biobank research. (shrink)

The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole (...) exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. (shrink)

The rise of precision medicine has led to an unprecedented focus on human biological material in biomedical research. In addition, rapid advances in stem cell technology, regenerative medicine and synthetic biology are leading to more complex human tissue structures and new applications with tremendous potential for medicine. While promising, these developments also raise several ethical and practical challenges which have been the subject of extensive academic debate. These debates have led to increasing calls for longitudinal governance arrangements between tissue providers (...) and biobanks that go beyond the initial moment of obtaining consent, such as closer involvement of tissue providers in what happens to their tissue, and more active participatory approaches to the governance of biobanks. However, in spite of these calls, such measures are being adopted slowly in practice, and there remains a strong tendency to focus on the consent procedure as the tool for addressing the ethical challenges of contemporary biobanking. In this paper, we argue that one of the barriers to this transition is the dominant language pervading the field of human tissue research, in which the provision of tissue is phrased as a ‘donation’ or ‘gift’, and tissue providers are referred to as ‘donors’. Because of the performative qualities of language, the effect of using ‘donation’ and ‘donor’ shapes a professional culture in which biobank participants are perceived as passive providers of tissue free from further considerations or entitlements. This hampers the kind of participatory approaches to governance that are deemed necessary to adequately address the ethical challenges currently faced in human tissue research. Rather than reinforcing this idea through language, we need to pave the way for the kind of participatory approaches to governance that are being extensively argued for by starting with the appropriate terminology. (shrink)

In this paper, we explore the recent creation of “iBlastoids,” which are 3-D structures that resemble early human embryos prior to implantation which formed via self-organization of reprogrammed ad...

Donors to biobanks are typically asked to give blanket consent, allowing their donation to be used in any research authorized by the biobank. This type of consent ignores the evidence that some donors have moral, religious, or cultural concerns about the future uses of their donations – concerns we call “non-welfare interests”. The nature of non-welfare interests and their effect on willingness to donate to a biobank is not well understood. In order to better undersand the influence of non-welfare interests, (...) we surveyed a national sample of the US population using a probability-based internet panel. Logistic regression models assessed the demographic and attitudinal characteristics associated with participants’ willingness to give consent for unspecified future uses of their donation when presented with 7 research scenarios that raised possible non-welfare interest concerns. Most people had non-welfare interests that significantly affect their willingness to donate to a biobank using blanket consent. Some non-welfare interests are associated with subgroups but others are not. A positive attitude toward biomedical research in general was associated with increased willingness to donate, while concerns about privacy and being African American were associated with decreased willingness. Non-welfare interests matter and can diminish willingness to donate to a biobank. Our data suggest that trust in research promotes willingness to donate. Ignoring non-welfare interests could erode this trust. Donors’ non-welfare interests could be accommodated through greater transparency and easier access to information about the uses of donations. (shrink)

BackgroundBiobanks and biomedical research data repositories collect their samples and associated data from volunteer participants. Their aims are to facilitate biomedical research and improve health, and they are framed in terms of contributing to the public good. Biobank resources may be accessible to researchers with commercial motivations, for example, researchers in pharmaceutical companies who may utilise the data to develop new clinical therapeutics and pharmaceutical drugs. Studies exploring citizen perceptions of public/private interactions associated with large health data repositories/biobanks indicate that (...) there are sensitivities around public/private and/or non-profit/profit relationships and international sample and data sharing. Less work has explored how biobanks communicate their public/private partnerships to the public or to their potential research participants. MethodsWe explored how a biobank’s aims, benefits and risks, and private/public relationships have been framed in public facing recruitment documents.ResultsBiobank documents often communicate their commercial access arrangements but not the detail about what these interactions would entail, and how risks and benefits would be distributed to the public.ConclusionWe argue that this leads to a polarised discourse between public and private entities and/or activities, and fails to attend to the blurred lines between them. This results in a lack of attention to more important issues such as how risks and benefits in general are distributed to the public. We call for a nuanced approach that can contribute to the much-needed dialogue in this space. (shrink)

Obtaining human genetic samples is vital for many biobank research purposes, yet, the ethics of obtainment seems to many fraught with difficulties. One key issue is consent: it is by many considered ethically vital that consent must be fully informed (at least ideally speaking) in order to be legitimate. In this paper, we argue for a more liberal approach to consent: a donor need not know all the specifics of future uses of the sample. We argue that blanket consent is (...) ethically defensible, and that this is buttressed by considerations of (justified) trust-relations. Given robust institutional oversight, blanket consent is a permissible form of consent in the bio-banking context. (shrink)

As donor trust legitimises research, trust is vital for research in the fields of biomedicine, genetics, translational medicine and personalised medicine. For parts of the donor community, the consent signature is a sign of trust in research. Many consent processes in biomedical research ask donors to provide their data for an unspecified future use, which introduces uncertainty of the unknown. This uncertainty can jeopardise donor trust or demand blind trust. But which donor wants to trust blindly? To reduce this uncertainty, (...) we explore first, which future-proof actors donors could trust when signing a consent form. Second, we discuss the question Can we know if donor trust expires? and what prevents donor trust from expiring. Finally, we present possible measures that can help to nurture trust in the far future. In this article, we draw on our previous research on trust in biomedical research, on trust in the broader healthcare system and Niklas Luhmann’s and Anthony Giddens’ trust theories. Our findings suggest that, in the far future, researchers will need to consider donor autonomy, as well as societal norms and values of the time period in which the data were donated. They will need to find mechanisms where possible to publicly announce the use of old data sets. However, foremost researchers will need to treat the data respectfully. It remains vital that professionals and the society continue to elaborate on the norms and values that shape the common understanding of what is morally right and wrong when researching data. (shrink)