The capacity to designate a surrogate is distinct from decisional capacity: normative and empirical considerations.

The capacity to designate a surrogate (CDS) is not simply another kind of medical decision-making capacity (DMC). A patient with DMC can express a preference, understand information relevant to that choice, appreciate the significance of that information for their clinical condition, and reason about their choice in light of their goals and values. In contrast, a patient can possess the CDS even if they cannot appreciate their condition or reason about the relative risks and benefits of their options. Patients who lack DMC for many or most kinds of medical choices may nonetheless possess the CDS, particularly since the complex means-ends reasoning required by DMC is one of the first capacities to be lost in progressive cognitive diseases (eg, Alzheimer's disease). That is, patients with significant cognitive decline or mental illness may still understand what a surrogate does, express a preference about a potential surrogate, and be able to provide some kind of justification for that selection. Moreover, there are many legitimate and relevant rationales for surrogate selection that are inconsistent with the reasoning criterion of DMC. Unfortunately, many patients are prevented from designating a surrogate if they are judged to lack DMC. When such patients possess the CDS, this practice is ethically wrong, legally dubious and imposes avoidable burdens on healthcare institutions.

Human Biospecimens Come from People.

Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive.

Death by Neurological Criteria: Caring for Families amid Tragedy.

When a patient is declared dead using neurological criteria, intense emotional and ethical challenges can follow. In our experience as clinical ethicists, consults surrounding the declaration of "brain death" can be some of the most difficult. In what follows, we describe some best practices related to death by neurological criteria (DNC). We begin with important policies hospitals need to have in place to ensure that death is properly understood by all members of the clinical team and place some limits on the authority of families to demand continued "treatment" for deceased patients. Next, we explain how best to prepare families for the diagnosis. We then discuss how to talk to families when breaking the news concerning DNC. Finally, we describe how to approach a family that is resisting the determination of death. SUMMARY: This article advises clinicians on how to talk to families about brain death.

Biobanks and the Moral Concerns of Donors: A Democratic Deliberation.

Do members of the public believe that biobanks should accommodate the moral concerns of donors about the types of research done with their biospecimens? The answer to this question is critical to the future of genomic and precision medicine, endeavors that rely on a public willing to share their biospecimens and medical data. To explore public attitudes regarding the requirements of consent for biobank donations, we organized three democratic deliberations involving 180 participants. The deliberative sessions involved small group discussions informed by presentations given by experts in both biobank research and ethics. We found that participants had a sophisticated understanding of the ethical problems of biobank consent and the complexity of balancing donor concerns while promoting research important to the future of health care. Our research shows how deliberative methods can offer policy makers creative ideas for accommodating the moral concerns of donors in the biobank consent process.

Effect of deliberation on the public's attitudes toward consent policies for biobank research.

In this study, we evaluate the effect of education and deliberation on the willingness of members of the public to donate tissue to biobank research and on their attitudes regarding various biobank consent policies. Participants were randomly assigned to a democratic deliberation (DD) group, an education group that received only written materials, and a control group. Participants completed a survey before the deliberation and two surveys post-deliberation: one on (or just after) the deliberation day, and one 4 weeks later. Subjects were asked to rate 5 biobank consent policies as acceptable (or not) and to identify the best and worst policies. Analyses compared acceptability of different policy options and changes in attitudes across the three groups. After deliberation, subjects in the DD group were less likely to find broad consent (defined here as consent for the use of donations in an unspecified range of future research studies, subject to content and process restrictions) and study-by-study consent acceptable. The DD group was also significantly less likely to endorse broad consent as the best policy (OR = 0.34), and more likely to prefer alternative consent options. These results raise ethical challenges to the current widespread reliance on broad consent in biobank research, but do not support study-by-study consent.

Reframing Professionalism: The Virtuous Professional.

This article was migrated. The article was marked as recommended. In response to prevalent unprofessional behaviors during the 1990s, the medical school administration at Michigan State University's College of Human Medicine developed a student curriculum for professional development, called "The Virtuous Student Physician." However, as students adopted these professional aspirations and attributes, they noted that faculty members were not being held to the same standards. The medical school's senior associate dean for faculty affairs and development convened a task force to reframe professionalism for all faculty, residents, and students. Our first step was to survey our faculty regarding their awareness of the student professionalism curriculum and their own perceived professional weaknesses. This survey showed the following: most faculty members were aware of "The Virtuous Student Physician" curriculum, that faculty members identified social responsibility as the most difficult attribute to achieve, and that the most difficult behavior identified was working to resolve problem behaviors with colleagues. The task force then developed a new curriculum "The Virtuous Professional: A System of Professional Development for Students, Residents, and Faculty." The task force identified three core virtues (Courage, Humility, and Mercy) and reframed the professional attributes encompassed by these virtues to be aspirational for the entire learning community. The faculty of the College subsequently adopted the new principles and practices, including the use of routine, anonymous student evaluation of faculty professionalism. We are currently collecting data from student evaluations of their clinical faculty members. We plan to use this feedback to guide faculty development and recognize those who model exemplary professionalism as well as to address those who engage in unprofessional behavior.

Competence in Plain English.

Like many other bioethicists, I often give talks on clinical topics that may touch on the patient's right of autonomy with regard to medical treatment and, from there, may move to questions about whether said patient has the capacity to exercise said right. When I get to that subject, I might ask, "Is this person competent to refuse treatment?" A stunned silence falls over the room, until finally a hand shoots up. "'Competent' is a legal term," I am instructed. "Don't you mean to ask whether he has the capacity to make decisions for himself?" The tone suggests that I'm being helped to make a very important distinction. But it's not a very important distinction; and it's misleading to boot.

Understanding the Public's Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey.

Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket-or broad-consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using "real-time"-or study-by-study-consent, but this policy places a significant burden on biobanks. In order to better understand the public's preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

The moral concerns of biobank donors: the effect of non-welfare interests on willingness to donate.

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 (in June 2014) 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.

Respecting donors to biobank research.

The most common way for people to consent to research with their banked biological material is through signing a blanket consent, which allows any future use, giving the donor no information or control. This does not respect the donor or the philosophy if donation.