Biobank Participants' Attitudes toward Requiring Understanding for Biobank Consent.

Biobank participants often do not understand the information they are provided during the informed consent process. Ethicists and other stakeholders have disagreed, however, on the appropriate response to these failures in understanding. This paper describes an attempt to address this issue by conducting knowledge tests with 22 recent biobank enrollees, followed by in-depth, semistructured interviews about the goal of understanding in biobank consent.

Biobank Participants' Attitudes Toward Data Sharing and Privacy: The Role of Trust in Reducing Perceived Risks.

Biobank participants are often unaware of possible uses of their genetic and health information, despite explicit descriptions of those uses in consent forms. To explore why this misunderstanding persists, we conducted semi-structured interviews and knowledge tests with 22 participants who had recently enrolled in a research biobank. Results indicated that participants lacked understanding of privacy and data-sharing topics but were mostly unconcerned about associated risks.

Hybrid theories, psychological plausibility, and the human/animal divide.

A hybrid theory is any moral theory according to which different classes of individuals ought to be treated according to different principles. We argue that some hybrid theories are able to meet standards of psychological plausibility, by which we mean that it's feasible for ordinary human beings to understand and act in accord with them. Insofar as psychological plausibility is a theoretical virtue, then, such hybrid theories deserve more serious consideration.

Collecting Biospecimens and Obtaining Biobank Consent From Patients in an Academic Health Care Setting: Practical and Ethical Considerations.

Academic health centers and health systems increasingly ask patients to enroll in research biobanks as part of standard care, raising important practical and ethical questions for integrating biobank consent processes into health care settings. This article aims to assist academic health centers and health systems considering implementing these integrated consent processes by outlining the 5 main issues-and the key practical and ethical considerations for each issue-that Indiana University Health and the Indiana Biobank faced when integrating biobank consent into their health system, as well as the key obstacles encountered. The 5 main issues to consider include the specimen to collect (leftover, new collection, or add-ons to clinical tests), whether to use opt-in or opt-out consent, where to approach patients, how to effectively use digital tools for consent, and how to appropriately simplify consent information.

Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues.

Research biobanks that enroll minors face important practical, ethical, and regulatory challenges in reconsenting participants when they reach the age of 18. Federal regulations governing research in the United States provide minimal guidance and allow for a range of practices, including waiving the requirement to obtain reconsent. Some commentators have argued that institutional review boards should indeed grant such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18.

In Defence of Forgetting Evil: A Reply to Pilkington on Conscientious Objection.

In a recent article for this journal, Bryan Pilkington (2019) makes a number of critical observations about one of our arguments for non-traditional medical conscientious objectors' duty to refer. Non-traditional conscientious objectors are those professionals who object to indirectly performing actions-like, say, referring to a physician who will perform an abortion. In our response here, we discuss his central objection and clarify our position on the role of value conflicts in non-traditional conscientious objection.

Incorporating Biobank Consent into a Healthcare Setting: Challenges for Patient Understanding.

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.

Conflicting roles for humans in learning health systems and AI-enabled healthcare.

The goals of learning health systems (LHS) and of AI in medicine overlap in many respects. Both require significant improvements in data sharing and IT infrastructure, aim to provide more personalized care for patients, and strive to break down traditional barriers between research and care. However, the defining features of LHS and AI diverge when it comes to the people involved in medicine, both patients and providers.

Genetic Data Aren't So Special: Causes and Implications of Reidentification.

Genetic information is widely thought to pose unique risks of reidentifying individuals. Genetic data reveals a great deal about who we are and, the standard view holds, should consequently be treated differently from other types of data. Contrary to this view, we argue that the dangers of reidentification for genetic and nongenetic data-including health, financial, and consumer information-are more similar than has been recognized.

Protecting health privacy even when privacy is lost.

The standard approach to protecting privacy in healthcare aims to control access to personal information. We cannot regain control of information after it has been shared, so we must restrict access from the start. This 'control' conception of privacy conflicts with data-intensive initiatives like precision medicine and learning health systems, as they require patients to give up significant control of their information.

Expanded FDA regulation of health and wellness apps.

This paper argues that the Food and Drug Administration's (FDA) policy for health and wellness apps is ethically problematic. Currently, the FDA does not regulate health and wellness apps that are not intended for medical use. As a result of this hands-off policy, preventing harm to consumers is left primarily to developers and app marketplaces.

Forget Evil: Autonomy, the Physician-Patient Relationship, and the Duty to Refer.

Aulisio and Arora argue that the moral significance of value imposition explains the moral distinction between traditional conscientious objection and non-traditional conscientious objection. The former objects to directly performing actions, whereas the latter objects to indirectly assisting actions on the grounds that indirectly assisting makes the actor morally complicit. Examples of non-traditional conscientious objection include objections to the duty to refer.

Communicating Identifiability Risks to Biobank Donors.

Recent highly publicized privacy breaches in healthcare and genomics research have led many to question whether current standards of data protection are adequate. Improvements in de-identification techniques, combined with pervasive data sharing, have increased the likelihood that external parties can track individuals across multiple databases. This article focuses on the communication of identifiability risks in the process of obtaining consent for donation and research.