Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...) consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

Pandemics first and foremost hit those who are most vulnerable, and the COVID-19 pandemic is not different. Although the infection rate in the nation’s poorest neighborhoods is twice as it is in th...

As a cornerstone of public health, epidemiology has lately undergone substantial changes enabled by, among other factors, the use of biobank infrastructures. In biobank-related research, the return of results to participants constitutes an important and complex ethical question. In this study, we qualitatively investigated how individuals perceive the results returned following their participation in cohort studies with biobanks. In our semi-structured interviews with 31 participants of two such German studies, we observed that some participants overestimate the nature of the personal (...) information they will receive from the study. Although this misestimation does not seem to jeopardize the validity of the consent provided at recruitment, it may still represent a threat for participants’ trust in research and thus their long-term commitment, crucial for such studies. We argue that such misestimation may have ethical consequences on the principles guiding the reflection on the return of results in biobank research, i.e. autonomy, beneficence, non-maleficence and reciprocity. We suggest that shifting from the idea of directly benefiting participants through the return of research results could help focusing on benefiting society as a whole, thereby increasing research trustworthiness of population-based studies using biobanks. (shrink)

The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is (...) engaged. In engaged consent, a participant's ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders' views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes. (shrink)

Volume 19, Issue 5, May 2019, Page 43-45.

The article discusses the impact different concepts of solidarity can have on debates on models of consent for non-interventional research. It introduces three concepts of solidarity that have been referenced in bioethical debates: a purely descriptive concept, a concept that claims some derivative value for most but not all practices of solidarity, as well as a clearly normative concept where solidarity is tied to justice and taken to ground moral duties. It shows that regarding the rivalling models of study-specific consent, (...) tiered consent and broad consent, the first two concepts can be taken to favour tiered consent while only normative solidarity supports a model of broad consent—or an argument to allow non-interventional research without requiring consent at all. As normative solidarity is tied to considerations of justice, however, the argument appears less straightforward than one might expect: It presupposes that the research contributes to overcoming existing social injustices. (shrink)

Building a biobank network in developing countries is essential to foster genomic research and precision medicine for patients’ benefit. However, there are serious barriers to establishing biobanks in low-income and middle-income countries (LMICs), including Ukraine. Here, we outline key barriers and essential milestones for the successful expansion of biobanks, genomic research and personalised medicine in Ukraine, drawing from the experience of other LMICs. A lack of legal and ethical governance in conjunction with limited awareness about biobanking and community distrust are (...) the principal threats to establishing biobanks. The experiences of LMICs suggest that Ukraine urgently needs national guidelines covering ethical and legal aspects of biospecimen-related research. National guidelines must be consistent with international ethical recommendations for safeguarding participants’ rights, welfare and privacy. Additionally, efforts to educate and engage physicians and patient communities are essential for achieving biobanking goals and benefits for precision medicine and future patients. (shrink)

Volume 19, Issue 5, May 2019, Page 45-47.

In their latest contribution to a series of important joint papers on informed consent, Joseph Millum and Danielle Bromwich analyze and reject what they call the “standard view” on informed...

Volume 19, Issue 5, May 2019, Page 38-40.

Volume 19, Issue 5, May 2019, Page 34-36.

Volume 19, Issue 5, May 2019, Page 22-24.

Volume 19, Issue 5, May 2019, Page 20-22.

Volume 19, Issue 5, May 2019, Page 24-26.

Volume 19, Issue 5, May 2019, Page 31-33.

In the spirit of full disclosure, I have been a member of the Delphi panels discussed in this article (Beskow and Weinfurt 2019) since their inception and was one of the people who was recently int...

Beskow and Weinfurt (2019) present an excellent and timely discussion of how to respond to evidence that individuals do not fully understand a biobank consent form. We faced similar challenges afte...

Volume 19, Issue 5, May 2019, Page 27-28.

Volume 19, Issue 5, May 2019, Page 36-38.

Studies of patient decision‐making use many different measures to evaluate the quality of decisions and the decision‐making process, partly to determine whether the ethical goals of informed consent, patient autonomy, and shared decision‐making have been achieved. We describe these measures, grouped under three main approaches, and review their limitations, leading to three conclusions. First, no measure or combination of measures can provide a complete assessment of decision quality. Second, the quality of a decision is best characterized vaguely, for instance as (...) “good,” “satisfactory,” or “poor,” and these categorizations depend on qualitative judgments that go beyond quantitative measures. Third, bioethicists should focus on identifying and addressing poor or problematic decisions, rather than trying to incrementally increase decision quality, quantified by a measure. Decision‐quality measures can be useful in research and in advancing important goals of bioethics, as long as the challenges of defining and measuring decision quality are recognized. (shrink)

Volume 19, Issue 5, May 2019, Page 41-42.

Background Biobank participants often do not understand much of the information they are provided as part of the informed consent process, despite numerous attempts at simplifying consent forms and improving their readability. We report the first assessment of biobank enrollees’ comprehension under an "integrated consent” process, where patients were asked to enroll in a research biobank as part of their normal healthcare experience. A number of healthcare systems have implemented similar integrated consent processes for biobanking, but it is unknown how (...) much patients understand after enrolling under these conditions. Methods: We recruited patients who enrolled in a biobank while in a healthcare setting when receiving ordinary care. We assessed knowledge of consent materials using 11 true/false questions drawn from a well-known biobank knowledge test. After reviewing the results from 114 participants, we revised the consent form and repeated the knowledge assessment with 144 different participants. Results: Participants scored poorly on the knowledge test in both rounds, with no significant differences in overall scores or individual items between the rounds. In Phase 1, participants answered 53% of the questions correctly, 25% incorrectly, and 22% “I don’t know.” In Phase 2, participants answered 53% of questions correctly, 24% incorrectly, and 23% “I don’t know.” Participants scored particularly poorly on questions about data sharing and accessing medical records. Conclusions: Enrollees under an integrated consent model had significant misunderstandings that persisted despite an attempt to improve information specifically about those topics in a consent form. These results raise challenges for current approaches that attribute misunderstanding to overly complex consent forms. They also suggest that the pressures of the clinic may compound other problems with patient understanding of biobank consent. As health systems increasingly blend research and care, they may need to rethink their approach to educating patients about participation in a biobank. (shrink)

The article covers electronic informed consent from different dimensions so that practitioners might understand the history, regulation, and current status of eIC. It covers the transition of informed consent to electronic screens and the implications of that transition in terms of design, costs, and data analysis. The article explores the limits of regulation mandating eIC for mobile application research, and addresses some of the broader social context around eIC.

Background The literature on the ethics of biobanking often overlooks the practical operations of biobanks. The ethics of stewardship requires that biobank resources are used to conduct beneficial science. Networked biobanks have emerged to increase the scientific benefit of biobank resources, but little is known about whether and how operations of networking may accomplish this goal.Methods As part of a larger study on the ethical, legal, and social implications (ELSI) of networked biobanking, we conducted 38 interviews with representatives of 31 (...) networked biobanks. Interviews explored operations of the networks. We used thematic analysis to examine how respondents describe three topics associated with stewarding biobank resources—funding, utilization, and sustainability.Results Our results highlight that funding, utilization, and sustainability are critical not only to the operation of biobanks, but also to the ethical obligations that biobankers owe to stakeholders to steward the resources. Based on prior research, we hypothesized that respondents would describe networking as beneficial to increasing funding, utilization, and sustainability of the network. Respondents generally found value in networked biobanking, but networking did not necessarily increase funding, utilization, and sustainability.Conclusion The results presented here support inclusion of funding, utilization, and sustainability as topics of ethical concern in the practice of biobanking and networked biobanking. These issues are rooted in the stewardship obligations that biobankers feel to their partners, client investigators, and participants. The goal of promoting stewardship through networking requires significant time and effort to build governance models that honor the obligations of each individual biobank to their donors and advance the collective goals of the network. We conclude with suggestions offered by respondents to address improving these aspects of stewardship. (shrink)