Preventive Human Genome Editing and Enhancement: Candidate Criteria for Governance.

While somatic cell editing to treat disease is widely accepted, the use of human genome editing for "enhancement" remains contested. Scientists and policy-makers routinely cite the prospect of enhancement as a salient ethical challenge for human genome editing research. If preventive genome editing projects are perceived as pursuing human enhancement, they could face heightened barriers to scientific, public, and regulatory approval.

The public-private research ecosystem in the genome editing era.

Biomedical research in the US has long been conducted in a public-private (PP) "ecosystem." Today, especially with gene therapies and genome editing-based medicine, publicly funded researchers frequently hand off their research to the private sector for clinical development, often to small, venture capital-funded startups in which they have a financial interest. This trend raises ethical questions about conflicts of interest, effectiveness of regulatory oversight, and justice in therapy access, that we are addressing in a multi-year, multidisciplinary study of the evolving governance of genome editing.

"Death and Taxes": Why Financial Compensation for Research Participants is an Economic and Legal Risk.

In the US, research payments are technically taxable income. This article argues that tax liability is a form of possible economic and legal risk of paid research participation. Findings are presented from empirical research on Phase I healthy volunteer trials.

The Promise and Reality of Public Engagement in the Governance of Human Genome Editing Research.

This paper analyses the activities of five organizations shaping the debate over the global governance of genome editing in order to assess current approaches to public engagement (PE). We compare the recommendations of each group with its own practices. All recommend broad engagement with the general public, but their practices vary from expert-driven models dominated by scientists, experts, and civil society groups to citizen deliberation-driven models that feature bidirectional consultation with local citizens, as well as hybrid models that combine elements of both approaches.

Scientists' Views on Scientific Self-Governance for Human Genome Editing Research.

As research on human gene editing has grown, a variety of prominent international organizations are considering how best to govern such research. But what role do scientists engaged in genome editing think they should have in developing research governance? In this study, we present results from a survey of 212 U.S.

A New Governance Approach to Regulating Human Genome Editing.

For years, genomic medicine-medicine based on the growing understanding of the genetic contribution to many diseases and conditions-has been hailed as the future of medical treatment, but it has thus far had limited effect on day-to-day medical practice. The ultimate goal of genomic medicine has always been the ability not just to identify dangerous gene mutations, but to fix them. Now CRISPR and related genome-editing technologies may have the potential to provide a safe and effective way to repair dangerous mutations.

Hospital Policies During COVID-19: An Analysis of Visitor Restrictions.

Objective: In response to the COVID-19 pandemic, hospitals have developed visitor restriction policies in order to mitigate spread of infection. We reviewed hospital visitor restriction policies for consistency and to develop recommendations to highlight fair and transparent restrictions, exceptions, and appeals in policy development and implementation.

Design: Collection and analysis of public-facing visitor restriction policies during the first 3 months of the pandemic.

Reconsidering scarce drug rationing: implications for clinical research.

Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use.

Professionalism and Ethics: A Standardized Patient Observed Standardized Clinical Examination to Assess ACGME Pediatric Professionalism Milestones.

Introduction: The ethical skills fundamental to medical practice encompass a large portion of the Accreditation Council for Graduate Medical Education (ACGME) professionalism milestones. Yet many ethical practices are difficult to reduce to milestone frameworks given the variety of traditions of moral reasoning that clinician-trainees and their colleagues might properly employ.

Methods: We developed an observed standardized clinical examination (OSCE) simulation with standardized patients to assess the ethical skills captured in professionalism milestones in pediatrics.

Is Real-Time ELSI Realistic?

A growing literature has raised-skeptically-the question of whether cutting-edge scientific research can identify and address broader ethical and policy considerations in real time. In genomics, the question is: Can ELSI contribute to genomics in real time, or will it be relegated to its historical role of after-the-fact outsider critique? We address this question against the background of a genomic screening project where we participated as embedded, real-time ELSI researchers and observers, from its initial design through its conclusion. As part of the ELSI study design, the project included an ongoing reflexive ethnography in which the authors studied the process of its design and implementation.

Clarifying a Clinical Ethics Service's Value, the Visible and the Hidden.

Our aim in this article is to define the difficulties that clinical ethics services encounter when they are asked to demonstrate the value a clinical ethics service (CES) could and should have for an institution and those it serves. The topic emerged out of numerous related presentations at the Un-Conference hosted by the Cleveland Clinic in August 2018 that identified challenges of articulating the value of clinical ethics work for hospital administrators. After a review these talks, it was apparent that the field of clinical ethics may be at a crisis of sorts due to increased pressure to provide explicit measures to healthcare institutions to concretely demonstrate that CESs make a valuable difference in healthcare delivery.

Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events.

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of the adverse events (AEs) they experience during clinical trials.

Perils of the Hidden Curriculum: Emotional Labor and "Bad" Pediatric Proxies.

Today's medical training environment exposes medical trainees to many aspects of what has been called "the hidden curriculum." In this article, we examine the relationship between two aspects of the hidden curriculum, the performance of emotional labor and the characterization of patients and proxies as "bad," by analyzing clinical ethics discussions with resident trainees at an academic medical center. We argue that clinicians' characterization of certain patients and proxies as "bad," when they are not, can take an unnecessary toll on trainees' emotions.

Membership recruitment and training in health care ethics committees: Results from a national pilot survey.

Unlabelled: This pilot study reports on a survey regarding recruitment, appointment, and training of members for health care ethics committees (HCECs).

Background: Past studies have examined HCECs, but have focused on the roles of the committees and the broad makeup of membership. Thus, our study fills an important knowledge gap in trends of membership recruitment and appointment processes employed by HCECs to comprise their membership.

Transitions in Care for Infants with Trisomy 13 or 18.

 The scope of interventions offered to infants with trisomy 13 (T13) or trisomy 18 (T18) is increasing. We describe the spectrum of care provided, highlighting transitions in care for individual patients.  This is a single-center, retrospective cohort of infants with T13 or T18 born between 2004 and 2015.

Which Results to Return: Subjective Judgments in Selecting Medically Actionable Genes.

Background: Advances in genomics have led to calls for returning information about medically actionable genes (MAGs) to patients, research subjects, biobank participants, and through screening programs, the general adult population. Which MAGs are returned affects the harms and benefits of every genetic testing endeavor. Despite published recommendations of selection criteria for MAGs to return, scant data exist regarding how decision makers actually apply such criteria.

"Forward-Thinking" in U.S. Biobanking.

Aims: Do biobanks enact policies and plans that allow them to anticipate and respond to potential challenges? If a biobank has one such policy or plan, is it likely to have more? Using survey data from 456 U.S. biobanks, we assess four possible indicators of such "forward-thinking.

An Evaluation of the Middle East Research Training Initiative Tool in Assessing Effective Functioning of Research Ethics Committees.

The effective functioning of a research ethics committee (REC) can be evaluated using self-assessment tools. The Middle East Research Ethics Training Initiative (MERETI) tool can be used by one member, typically the Chair, to score an REC. The consistency of these scores across several members of an REC has never been evaluated.

Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

In genomics research, it is becoming common practice to return individualized primary and incidental findings to participants and several ongoing major studies have begun to automatically transfer these results to a participant's clinical medical record. This paper explores who should decide whether to place genomic research findings into a clinical medical record. Should participants make this decision, or does a researcher's duty to place this information in a medical record override the participant's autonomy? We argue that there are no clear ethical, legal, professional, or regulatory duties that mandate placement without the consent of the participant.