A Cross Sectional Survey of Recruitment Practices, Supports, and Perceived Roles for Unaffiliated and Non-scientist Members of IRBs.

BACKGROUND: Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members' roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs. METHODS: We distributed a self-administered REDCap survey of members of the Association for the Accreditation of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members. RESULTS: 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials. CONCLUSIONS: Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members.

COVID-19 Ethics Debrief: Pearls and Pitfalls of a Hub and Spoke Model.

A hub and spoke model offers an effective and efficient approach to providing informed guidance to those who need it. The National Center for Ethics in Health Care (NCEHC) at the Veterans Health Administration, Department of Veterans Affairs, is the largest known hub and spoke healthcare ethics delivery model. In this article, we describe ways NCEHC's hub and spoke configuration succeeded during the COVID-19 pandemic, as well as limitations of the model and possible improvements to inform adoption at other healthcare systems.

Between Usual and Crisis Phases of a Public Health Emergency: The Mediating Role of Contingency Measures.

Much of the sustained attention on pandemic preparedness has focused on the ethical justification for plans for the "crisis" phase of a surge when, despite augmentation efforts, the demand for life-saving resources outstrips supply. The ethical frameworks that should guide planning and implementation of the "contingency" phase of a public health emergency are less well described. The contingency phase is when strategies to augment staff, space, and supplies are systematically deployed to forestall critical resource scarcity, reduce disproportionate harm to patients and health care providers, and provide patient care that remains functionally equivalent to conventional practice. We describe an ethical framework to inform planning and implementation for COVID-19 contingency surge responses and apply this framework to 3 use cases. Examining the unique ethical challenges of this mediating phase will facilitate proactive ethics conversations about healthcare operations during the contingency phase and ideally lead to ethically stronger health care practices.

How Should Clinicians Respond to International Public Health Emergencies?

This case analysis examines obligations health care workers have to support relief efforts when an infectious disease outbreak could impact us all. How clinicians, institutions, and local communities ought to balance increased need for global solidarity in response to global disease outbreaks with concerns of local stakeholders is one specific tension this article investigates. We explore how emphasizing global health solidarity in the face of highly hazardous communicable diseases can help mitigate global risk.

Finding Common Ground and Advancing Engagement in Citizen Science.

Citizen science, a diverse enterprise involving multiple processes, participants, and projects, challenges conventional approaches to thinking about science and the issues it raises. This commentary explores three key themes identified in the accompanying narratives. (1) Motivated volunteers may serve as novel resources for science, allowing projects to proceed in ways that are cheaper and more accessible than previously considered. (2) Traditional scientific approaches may be insufficient to even identify research questions, much less attempt to address issues. Citizen science may fill that gap. (3) Ethical concepts may have unique applications in this burgeoning field, both due to the emergence of novel ethical issues and to new categories of people, places, and things inherent in the conduct of citizen science. The commentary closes with suggestions for moving forward as citizen science becomes the norm rather than the exception.

Using a Scoring Rubric to Assess the Writing of Bioethics Students.

Educators in bioethics have struggled to find valid and reliable assessments that transcend the "reproduction of knowledge" to target more important skill sets. This manuscript reports on the process of developing and grading a minimal-competence comprehensive examination in a bioethics master's degree program. We describe educational theory and practice for the creation and deployment of scoring rubrics for high-stakes performance assessments that reduce scoring inconsistencies. The rubric development process can also benefit the program by building consensus among stakeholders regarding program goals and student outcomes. We describe the Structure of the Observed Learning Outcome taxonomy as a mechanism for rubric design and provide an example of how we applied that taxonomy to define pass/fail cut scores. Details about domains of assessment and writing descriptors of performance are also presented. Despite the laborious work required to create a scoring rubric, we found the effort to be worthwhile for our program.

Incorporating Spirituality into Health Sciences Education.

Researchers are beginning to collect empiric data about coping mechanisms of health science students. Yet, there is an important aspect of coping with stress that is only partially addressed in health sciences curricula: students' spiritual well-being. In this essay, we describe a course in spirituality and health care that we offered to fourth-year medical students, as well as a small empirical study we conducted to assess students' spiritual needs and practices. We then offer reflections on the broad applicability of this work to students in the health sciences more generally, including suggestions for curriculum interventions that may ensure students' success.

Examining ethics - developing a comprehensive exam for a bioethics master's program.

Assessing mastery of bioethics in a graduate program requires careful attention not simply to the content knowledge and skill development of students but also to the principles of sound assessment processes. In this article, we describe the rationale, development process, and features of the comprehensive exam we created as a culminating experience of a master's program in bioethics. The exam became the students' opportunity to demonstrate the way they were able to integrate course, textual, and practical knowledge gained throughout the experience of the program. Additionally, the exam assessed students' proficiency in the field of bioethics and their ability to critically and constructively analyze bioethical issues. In this article, we offer tips to other exam creators regarding our experiences with question and answer development, scoring of the exam, and relationships between coursework and exam preparation and completion. We also include a sample rubric for others to see how we determined which student answers were satisfactory.