An Open Discussion of the Impact of OpenNotes on Clinical Ethics: A Justification for Harm-Based Exclusions from Clinical Ethics Documentation.

The OpenNotes (ON) mandate in the 21st Century Cures Act requires that patients or their legally authorized representatives be able to access their medical information in their electronic medical record (EMR) in real time. Ethics notes fall under the domain of this policy. We argue that ethics notes are unique from other clinical documentation in a number of ways: they lack best-practice guidelines, are written in the context of common misconceptions surrounding the purpose of ethics consultation, and often answer questions of a different nature than other documentation. Thus, we believe the clinical ethics community would benefit from clarification on when the withholding of ethics notes is justified. We provide recommendations for excluding information from ethics documentation based on the likelihood and magnitude of harm that may occur with particular disclosures and suggest approaches to decrease the potential harms that may occur. We define and explain six types of reasons to exclude information from ethics notes based on significant harms that are not addressed in the ON policy: (1) harmful revelations from a protected chart note; (2) negative emotional effects on patients or families; (3) the purpose of the consultation is undermined by harmful consequences; (4) avoidable negative impact on interpersonal dynamics; (5) inappropriate labeling or disclosure of medical, social, or financial information; and (6) inclusion of biasing or otherwise unfair information. We also suggest approaches to mitigate harm when excluding, including, reframing, or delaying release of information that is perceived to be relevant to an ethics case. Overall, we hope our analysis and recommendations will initiate a much-needed discussion about the impact of the ON mandate on clinical ethics documentation.

The Top 10 Questions Facing the Field of Clinical Ethics in 2020: Reflections on the Evolving Clinical Ethics UnConference.

Evolving Clinical Ethics: A Working UnConference, held 5 through 7 February 2020 in Houston, Texas, brought together 91 participants from a variety of institutions, many of whom are engaged in clinical ethics work. The event followed the success of the first Clinical Ethics UnConference hosted by the Cleveland Clinic Center for Bioethics in 2018, and offered an opportunity for ethicists to share both their challenges and their solutions to clinical ethics issues. In this article we explore the emerging themes of the second UnConference and identify the top 10 questions currently faced by the field. We address both unresolved issues and areas of agreement and highlight new collaborations that have been developed to work toward greater standardization in our field.

Variation in Clinical Ethics Fellowship Programs: Lessons from the Field.

Given the enduring debate over what constitutes quality, and therefore appropriate training, in clinical ethics consultation, it is unsurprising that there is variation in the structure and content of clinical ethics fellowship programs. However, this variation raises questions about the value of fellowship training when the ethicists that emerge from these programs might be quite different. The specifics of fellowship programs are largely internal. As such, the extent of variation and whether such variation is problematic remains unclear. In this article, we summarize lessons learned from discussions between fellows, their mentors and program directors at the 2020 Clinical Ethics UnConference, and outline some possible ways to advance the conversation about variation in fellowship programs and training. We argue for the more open sharing of training specifics in order to help break down the siloed nature of fellowship programs. Greater transparency could, firstly, allow for more robust reflection on and refinement of training practices and, secondly, allow us to better balance professionally appropriate consistency with unavoidable or desirable variation based on local norms, culture and leadership.

What the HEC-C? An Analysis of the Healthcare Ethics Consultant-Certified Program: One Year in.

Efforts to professionalize the field of bioethics have led to the development of the Healthcare Ethics Consultant-Certified (HEC-C) Program intended to credential practicing healthcare ethics consultants (HCECs). Our team of professional ethicists participated in the inaugural process to support the professionalization efforts and inform our views on the value of this credential from the perspective of ethics consultants. In this paper, we explore the history that has led to this certification process, and evaluate the ability of the HEC-C Program to meet the goals it has set forth for HCECs. We describe the benefits and weaknesses of the program and offer constructive feedback on how the process might be strengthened, as well as share our team's experience in preparing for the exam.

Dueling Definitions of Abortifacient: How Cultural, Political, and Religious Values Affect Language in the Contraception Debate.

Contraception works by preventing fertilization of an egg or preventing implantation of a fertilized embryo. For those who believe pregnancy begins at implantation, contraceptives preventing implantation are not abortifacient. However, for those who assert that pregnancy begins at fertilization, any agent causing the intentional loss of an embryo, even prior to implantation, is abortifacient, both morally and for lack of a different term to describe the postfertilization, preimplantation loss. In the debate on this topic, much of the discourse on both sides wrongly focuses on the opposing side's perceived ignorance in denying scientifically proven definitions rather than on the substance of the conflict. Indeed, both sides accuse the other of prioritizing its "subjective" views over "objective" facts. In this essay, we unpack the scientific, cultural, and religious factors that underlie this debate. We argue that the only way to move forward is to clarify our terminology and engage with the substance of the argument, rather than merely the rhetoric.

Pumilol, a Diterpenoid with a Rare Strobane Skeleton from Pinus pumila (Pinaceae).

Pumilol (1), a strobane diterpenoid, reported herein for the first time, was isolated from the bark of Pinus pumila (Pall.) Regel (Siberian Dwarf Pine or Japanese Stone Pine), along with 17 known compounds including serratane triterpenoids, not previously reported from this species, and four ferulate derivatives. The absolute configuration of pumilol was established using HR-ESI-MS, NMR, the DP4+ probabilities and by comparison of the experimental and calculated electronic circular dichroism (ECD) spectra. Labda-8(17),13-dien-15-oic acid (4), bornyl (E)-4-hydroxycinnamate (14) and bornyl (E)-ferulate (15) showed activity against S. aureus and/or E. faecalis with MIC90 values 12.5 - 50 µm.

A surrogate's secrets are(n't) safe with me: patient confidentiality in the care of a gestational surrogate.

Gestational surrogacy relies on a legal agreement between the surrogate and the intended parents to define the roles and responsibilities of the parties, including explicit consent by the surrogate to allow the physician to release all pregnancy-related medical information to the intended parents. In the event of surrogate misconduct, however, physicians may feel conflicted if the surrogate asks the physician to withhold information about potentially dangerous behaviour in pregnancy from the intended parents. While the American Society for Reproductive Medicine guidelines may support disclosure over the objections of the surrogate, the authors argue that such disclosure is a violation of the surrogate's rights and the physician's ethical and professional duties. A surrogate's confidentiality must be maintained as it is an essential element of the physician-patient relationship.

Can civil lawsuits stem the tide of direct-to-consumer marketing of unproven stem cell interventions.

The sale of unproven stem cell interventions (SCIs) by commercial entities has proliferated in highly developed countries, most notably in the USA. Yet, there have been few criminal prosecutions and regulatory enforcement actions against providers who have violated laws and best practice standards due to the lack of resources and legal ambiguity. While the stem cell research community has invested much in protecting patients and preventing the growth of this industry, some patients are seeking remedies under civil law to hold stem cell clinics responsible for fraudulent practices. Several patients have filed lawsuits against providers demanding compensation for physical injuries caused by unproven treatments and financial losses due to fraud and false advertising. Lawsuits can be used as a tool not only to compensate plaintiffs but also to achieve positive public health and policy outcomes. In this paper, we explore the value of a public health litigation strategy as a countermeasure against the exploitative practices of the unproven SCI industry by analyzing stem cell lawsuits and comparing them with other major public health litigation efforts. We argue that stem cell lawsuits complement other approaches to reining in unsafe practices. In particular, stem cell lawsuits could intensify publicity and raise awareness of the harms of unproven treatments, set legal precedent, reshape the media narrative from one focused on the right to try or practice to one highlighting the need for adequate safety and efficacy standards, and encourage authorities to turn their attention to policy reform and enforcement.