Ethical Considerations for Enrolling "Invested Parties" in Large-Scale Clinical Studies: Insights from the RECOVER Initiative.

Research institutions often lack policies addressing the risks and benefits of enrolling "invested parties" such as investigators, research staff, and patient, caregiver, and community representatives (groups most affected by a disease or intervention) in studies where they have direct involvement. Invested parties may have both strong motivations to study the condition or intervention and to participate as study subjects. More guidance is needed to promote appropriate access to research participation and mitigate potential risks.

Equity Concerns Across Pediatric Research Recruitment: An Analysis of Research Staff Interviews.

Background And Objectives: Difficulty recruiting individuals from minoritized and underserved populations for clinical research is well documented and has health equity implications. Previously, we reported findings from interviews with research staff about pediatric research recruitment processes. Respondents raised equity concerns related to recruitment and enrollment of participants from minoritized, low resourced, and underserved populations.

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.

Relationship building in pediatric research recruitment: Insights from qualitative interviews with research staff.

Introduction: Clinical research staff play a critical role in recruiting families for pediatric research, but their views are not well described. We aimed to describe how pediatric research staff build trusting research relationships with patients and their families.

Methods: We interviewed research staff at one pediatric research institution and its affiliated academic medical center between November 2020 and February 2021.

What Can State Medical Boards Do to Effectively Address Serious Ethical Violations?

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public.

Institutional Review Board Use of Outside Experts: A National Survey.

Background: Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts.

Bias Assessment and Correction in Machine Learning Algorithms: A Use-Case in a Natural Language Processing Algorithm to Identify Hospitalized Patients with Unhealthy Alcohol Use.

Unhealthy alcohol use represents a major economic burden and cause of morbidity and mortality in the United States. Implementation of interventions for unhealthy alcohol use depends on the availability and accuracy of screening tools. Our group previously applied methods in natural language processing and machine learning to build a classifier for unhealthy alcohol use.

Institutional Review Board Use of Outside Experts: What Do We Know?

Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the primary focus of any published literature or empirical study to date. These issues have important implications for IRB quality.

A snapshot of U.S. IRB review of COVID-19 research in the early pandemic.

Background/objective: Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating strict public health measures and a workforce largely relegated to working from home. Our objectives were to measure adjustments to standard IRB review processes, IRB turnaround time and document and any novel ethical issues encountered.

Crying with a Patient: A Pilot Study of the Attitudes of Physicians and Physicians-in-Training.

Physicians are taught to maintain emotional distance. However, limited research suggests that many have cried in the hospital setting. How physicians understand and manage their emotions is an understudied topic, and public displays of emotion are not adequately addressed in medical education.

Patient Data-Sharing for AI: Ethical Challenges, Catholic Solutions.

Unlabelled: Recent news of Catholic and secular healthcare systems sharing electronic health record (EHR) data with technology companies for the purposes of developing artificial intelligence (AI) applications has drawn attention to the ethical and social challenges of such collaborations, including threats to patient privacy and confidentiality, undermining of patient consent, and lack of corporate transparency. Although the United States Catholic Conference of Bishops' () address collaborations between US Catholic healthcare providers and other entities, the do not adequately address the novel concerns seen in EHR data-sharing for AI development. Neither does the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.

C3(H2O) prevents rescue of complement-mediated C3 glomerulopathy in Cfh-/- Cfd-/- mice.

Therapeutic complement inhibition is a major focus for novel drug development. Of upstream targets, factor D (FD) is appealing because it circulates in plasma at low concentrations and has a single function: to cleave factor B to generate C3 convertase of the alternative pathway (AP). Mice with a targeted deletion of factor H (FH; Cfh-/- mice) develop C3 glomerulopathy (C3G) due to uncontrolled AP activity.

Priority Populations Toolkits: Enhancing researcher readiness to work with priority populations.

The National Center for Advancing Translational Sciences has called for more comprehensive research with priority populations to reduce disparities and for the development of additional resources to assist researchers in implementing these recommendations. Here we report the development and initial evaluation of five Priority Populations Toolkits, which are resources developed by the University of Illinois Center for Clinical and Translational Science to meet these goals. Three aims guide the content: increasing knowledge, facilitating communication, and improving research design.

Preventing Egregious Ethical Violations in Medical Practice: Evidence-Informed Recommendations from a Multidisciplinary Working Group.

This article reports the consensus recommendations of a working group that was convened at the end of a 4-year research project funded by the National Institutes of Health that examined 280 cases of egregious ethical violations in medical practice. The group reviewed data from the parent project, as well as other research on sexual abuse of patients, criminal prescribing of controlled substances, and unnecessary invasive procedures that were prosecuted as fraud. The working group embraced the goals of making such violations significantly less frequent and, when they do occur, identifying them sooner and taking necessary steps to ensure they are not repeated.

Serious Ethical Violations in Medicine: A Statistical and Ethical Analysis of 280 Cases in the United States From 2008-2016.

Serious ethical violations in medicine, such as sexual abuse, criminal prescribing of opioids, and unnecessary surgeries, directly harm patients and undermine trust in the profession of medicine. We review the literature on violations in medicine and present an analysis of 280 cases. Nearly all cases involved repeated instances (97%) of intentional wrongdoing (99%), by males (95%) in nonacademic medical settings (95%), with oversight problems (89%) and a selfish motive such as financial gain or sex (90%).