With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

BackgroundThe Life Extension Medical Decision law enacted on February 4, 2018 in South Korea was the first to consider the suspension of futile life-sustaining treatment, and its enactment caused a big controversy in Korean society. However, no study has evaluated whether the actual implementation of life-sustaining treatment has decreased after the enforcement of this law. This study aimed to compare the provision of patient consent before and after the enforcement of this law among cancer patients who visited a tertiary university (...) hospital's emergency room to understand the effects of this law on the clinical care of cancer patients.MethodsThis retrospective single cohort study included advanced cancer patients aged over 19 years who visited the emergency room of a tertiary university hospital. The two study periods were as follows: from February 2017 to January 2018 (before) and from May 2018 to April 2019 (after). The primary outcome was the length of hospital stay. The consent rates to perform cardiopulmonary resuscitation (CPR), intubation, continuous renal replacement therapy (CRRT), and intensive care unit (ICU) admission were the secondary outcomes.ResultsThe length of hospital stay decreased after the law was enforced from 4 to 2 days (p = 0.001). The rates of direct transfers to secondary hospitals and nursing hospitals increased from 8.2 to 21.2% (p = 0.001) and from 1.0 to 9.7%, respectively (p < 0.001). The consent rate for admission to the ICU decreased from 6.7 to 2.3% (p = 0.032). For CPR and CRRT, the consent rates decreased from 1.0 to 0.0% and from 13.9 to 8.8%, respectively, but the differences were not significant (p = 0.226 and p = 0.109, respectively).ConclusionAfter the enforcement of the Life Extension Medical Decision law, the length of stay in the tertiary university hospital decreased in patients who established their life-sustaining treatment plans in the emergency room. Moreover, the rate of consent for ICU admission decreased. (shrink)

From its inception, genomics has been a speculative endeavor, fixated on a far-off horizon that would deliver on the promise of targeted diagnostics and individualized therapeutics (Fortun 2008). M...

BackgroundAttention deficit hyperactivity disorder is clinically diagnosed; however, quantitative analysis to statistically analyze the symptom severity of children with ADHD via the measurement of head movement is still in progress. Studies focusing on the cues that may influence the attention of children with ADHD in classroom settings, where children spend a considerable amount of time, are relatively scarce. Virtual reality allows real-life simulation of classroom environments and thus provides an opportunity to test a range of theories in a naturalistic and (...) controlled manner. The objective of this study was to investigate the correlation between participants’ head movements and their reports of inattention and hyperactivity, and to investigate how their head movements are affected by different social cues of different sensory modalities.MethodsThirty-seven children and adolescents with and without ADHD were recruited for this study. All participants were assessed for diagnoses, clinical symptoms, and self-reported symptoms. A virtual reality-continuous performance test was conducted under four conditions: control, no-cue, visual cue, and visual/audio cue. A quantitativecomparison of the participants’ head movements was conducted in three dimensions using a head-mounted display in a VR classroom environment. Task-irrelevant head movements were analyzed separately, considering the dimension of movement needed to perform the VR-CPT.ResultsThe magnitude of head movement, especially task-irrelevant head movement, significantly correlated with the current standard of clinical assessment in the ADHD group. Regarding the four conditions, head movement showed changes according to the complexity of social cues in both the ADHD and healthy control groups.ConclusionChildren and adolescents with ADHD showed decreasing task-irrelevant movements in the presence of social stimuli toward the intended orientation. As a proof-of-concept study, this study preliminarily identifies the potential of VR as a tool to understand and investigate the classroom behavior of children with ADHD in a controlled, systematic manner. (shrink)

Jonathan Edwards was a preacher, theologian, and missionary to the Native Americans. This book asserts that Jonathan Edwards stood firmly on the Reformed tradition in the doctrine of justification.

Public investments in genomic and precision medicine have begun to yield clinically useful interventions, most recently, for example, two new, FDA-approved gene therapies for sickle cell disease (F...

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...) In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

Background Researchers engaged in the study of the ethical, legal, and social implications (ELSI) of genetics and genomics are often publicly funded and intend their work to be in the public interest. These features of U.S. ELSI research create an imperative for these scholars to demonstrate the public utility of their work and the expectation that they engage in research that has potential to inform policy or practice outcomes. In support of the fulfillment of this “translational mandate,” the Center for (...) ELSI Resources and Analysis (CERA), funded by the National Human Genome Research Institute (NHGRI), aims to facilitate community-informed, ELSI research results synthesis and dissemination. However, little is known about how ELSI research scholars define the goals of translation and imagine the intended users of their research findings.Methodology We distributed a Qualtrics survey to ELSI scholars that aimed to determine: (1) researchers’ expectations for their research findings in relation to policy or practice outcomes, (2) the stakeholder groups researchers believe could benefit from their research findings, and (3) the methods researchers use to foster the uptake of their findings by those stakeholders.Results Most ELSI researchers surveyed thought there were stakeholders that could benefit from their research findings, including health care professionals, at-risk individuals, patients, and their family members, policy-makers, and researchers/scientists, and expected their research findings to inform the creation or revision of laws, policies, or practice guidelines. Most researchers planned to disseminate findings directly to relevant stakeholders, with fewer expecting dissemination support from research funders, universities, or other entities.Conclusion The broad range of research topics, disciplines, and set of potential end users represented in ELSI reseach complicate the work of a knowledge broker. Nonetheless, the CERA can play an important role in disseminating ELSI results to relevant stakeholders. Further research should explore outreach mechanisms. (shrink)

The expansion of the higher education system and the rationalization of universities in South Korea, while broadly following the global patterns, reflect the characteristics of the national political system. We show the rapid growth of universities and document core organizational changes among universities: the elaboration of faculty performance evaluation rules, the expansion and differentiation of central administrations, and the emergence of engagement in vision statements. These changes, constructing universities as organizational actors, parallel the changes in higher education systems elsewhere. However, (...) the uniqueness of the Korean experience lies with the role of the state as a catalyst guiding the overall direction and the structure and strategy of universities. We discuss the implications of our research for the rationalization of universities in a highly centralized system. (shrink)

With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process and (...) evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital’s Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. Investigator reply rates gradually increased, except for the first year. The studies were graded as “critical,” “major,” “minor,” and “not a finding”, based on findings and number of deficiencies. The auditors’ decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being “major” or “critical”. Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants’ personal information were associated with higher audit grade. We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in “non-responding” and “critical” studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits. (shrink)

This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics.

BackgroundAlthough the Life-Sustaining Treatment (LST) Decision Act was enforced in 2018 in Korea, data on whether it is well established in actual clinical settings are limited. Hospital-acquired pneumonia (HAP) is a common nosocomial infection with high mortality. However, there are limited data on the end-of-life (EOL) decision of patients with HAP. Therefore, we aimed to examine clinical characteristics and outcomes according to the EOL decision for patients with HAP.MethodsThis multicenter study enrolled patients with HAP at 16 referral hospitals retrospectively from (...) January to December 2019. EOL decisions included do-not-resuscitate (DNR), withholding of LST, and withdrawal of LST. Descriptive and Kaplan–Meier curve analyses for survival were performed.ResultsOf 1,131 patients with HAP, 283 deceased patients with EOL decisions (105 cases of DNR, 108 cases of withholding of LST, and 70 cases of withdrawal of LST) were analyzed. The median age was 74 (IQR 63–81) years. The prevalence of solid malignant tumors was high (32.4% vs. 46.3% vs. 54.3%, P = 0.011), and the ICU admission rate was lower (42.9% vs. 35.2% vs. 24.3%, P = 0.042) in the withdrawal group. The prevalence of multidrug-resistant pathogens, impaired consciousness, and cough was significantly lower in the withdrawal group. Kaplan–Meier curve analysis revealed that 30-day and 60-day survival rates were higher in the withdrawal group than in the DNR and withholding groups (log-rank P = 0.021 and 0.018). The survival of the withdrawal group was markedly decreased after 40 days; thus, the withdrawal decision was made around this time. Among patients aged below 80 years, the rates of EOL decisions were not different (P = 0.430); however, mong patients aged over 80 years, the rate of withdrawal was significantly lower than that of DNR and withholding (P = 0.001).ConclusionsAfter the LST Decision Act was enforced in Korea, a DNR order was still common in EOL decisions. Baseline characteristics and outcomes were similar between the DNR and withholding groups; however, differences were observed in the withdrawal group. Withdrawal decisions seemed to be made at the late stage of dying. Therefore, advance care planning for patients with HAP is needed. (shrink)

Lest we take Zhu Xi merely as a grand synthesizer who, in the words of Wing-tsit Chan, made "Neo-Confucianism truly Confucian" by countering and assimilating Buddhist and Daoist influences, this volume urges us to regard him as a profound philosopher who brought metaphysical and cosmological insights to bear on ethical cultivation and social praxis. The twelve essays assembled in Returning to Zhu Xi: Emerging Patterns within the Supreme Polarity, edited by David Jones and Jinli He, examine the manifold aspects of (...) Zhu's philosophy, including its contemporary resonance. The anthology functions on the whole as a general but thoroughly scholarly reference to the wide-ranging thought of Zhu Xi. What distinguishes the... (shrink)

Big data and artificial intelligence (“AI”) promise to transform virtually all aspects of biomedical research and health care (Matheny et al. 2019), through facilitation of drug development, diagno...

Ethically challenging situations routinely arise in the course of illness and healthcare. However, very few studies have surveyed patients and family members about their experiences with ethically challenging situations. To address this gap in the literature, we surveyed patients and family members at three hospitals. We conducted a content analysis of their responses to open-ended questions about their most memorable experience with an ethical concern for them or their family member. Participants described 219 unique ethical experiences that spanned many of (...) the prevailing themes of bioethics, including the patient-physician relationship, end-of-life care, decision-making capacity, healthcare costs, and genetic testing. Participants focused on relational issues in the course of experiencing illness and receiving medical care and concerns regarding the patient-physician encounters. Many concerns arose outside of a healthcare setting. These data indicate areas for improvement for healthcare providers but some concerns may be better addressed outside of the traditional healthcare setting. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)