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. This article addresses the gap in guidance by presenting an ethical framework and practical guidelines for the enrollment of invested parties. Drawing from experiences with the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large multisite observational cohort study, we argue that invested parties should not be categorically excluded from enrollment in their own research studies if certain criteria are met and appropriate safeguards are in place. We underscore the need to balance inclusion with fairness, promote valid voluntary informed consent, ensure data privacy, protect scientific validity, and mitigate unique risks to invested parties as participants. Additionally, we recommend regular reporting and empirical assessment to evaluate the impact of enrolling invested parties on participants and study outcomes.

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. We therefore decided to perform a secondary coding of the transcripts to examine equity-related issues systematically. METHODS: We conducted a process of secondary coding and analysis of interviews with research staff involved in recruitment for pediatric clinical research. Through consensus we identified codes relevant to equity and developed a conceptual framework including 5 stages of research. RESULTS: We analyzed 28 interviews and coded equity-related items. We report 6 implications of our findings. First, inequitable access to clinical care is an upstream barrier to research participation. Second, there is a need to increase research opportunities where underserved and under-represented populations receive care. Third, increasing research team diversity can build trust with patients and families, but teams must ensure adequate support of all research team members. Fourth, issues related to consent processes raise institutional-level opportunities for improvement. Fifth, there are numerous study procedure-related barriers to participation. Sixth, our analysis illustrates that individuals who speak languages other than English face barriers across multiple stages. CONCLUSIONS: Research staff members identified equity-related concerns and recommended potential solutions across 5 stages of the research process, which may guide those endeavoring to improve research recruitment for pediatric patients from minoritized and underserved populations.

Inclusive, engaged, and accountable institutional review boards.

In February 2023, the U.S. Government Accountability Office (GAO) released another report acknowledging that we still lack meaningful, validated, widely-accepted measures for evaluating institutional review board (IRB) quality and effectiveness. This challenge is well known to the Consortium to Advance Effective Research Ethics Oversight (www.AEREO.org), a collaborative group of human research protection (HRP) professionals, researchers, and research ethicists founded in 2018 to do precisely what GAO recommends: examine approaches for measuring IRB effectiveness in protecting human subjects, and implement the approaches as appropriate. Two underlying tenets have been central to AEREO's as approach to thinking about IRB quality and effectiveness: (1) IRBs exist to protect participants and thus the participant perspective should be central to all IRBs do; and (2) because IRBs are tasked with applying subjective ethical and regulatory standards about which people may disagree, their approach and decisions should at least meet the basic standard of reasonableness in terms of accounting for relevant perspectives, considering key factors, and providing defensible justifications. Critical to each of these tenets, IRBs should include diverse perspectives in their deliberations, find ways to meaningfully engage with relevant communities about their views regarding ethical research and appropriate participant protections, and be accountable to the public.

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.

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. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team's larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious wrongdoing by physicians.

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. METHODS: We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside expertise is most frequently requested. RESULTS: The survey response rate was 18.4%, with 55.4% of respondents reporting their institution's IRB uses outside experts. Nearly all respondents who reported using outside experts indicated they do so less than once a month, but occasionally each year (95%). The most common method of identifying an outside expert was securing a previously known subject matter expert (83.3%). Most frequently, respondents sought consultation for scientific expertise not held by current members (69.6%). Almost all respondents whose IRBs had used outside experts reported an overall positive impact on the IRB review process (91.5%). CONCLUSIONS: Just over half of the IRBs in our sample report use of outside experts; among them, outside experts were described as helpful, but their use was infrequent overall. Many IRBs report not relying on outside experts at all. This raises important questions about what type of engagement with outside experts should be viewed as optimal to promote the highest quality review. For example, few respondents sought assistance from a Community Advisory Board, which could address expertise gaps in community perspectives. Further exploration is needed to understand how to optimize IRB use of outside experts, including how to recognize when expertise is lacking, what barriers IRBs face in using outside experts, and perspectives on how outside expert review impacts IRB decision-making and review quality.

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. The capacity IRBs have to fulfill their mission of protecting research participants without unduly hindering research is influenced by IRBs' access to and use of the right type of expertise to review challenging research ethics, regulatory, and scientific issues. Through a review of the regulations and standards permitting IRBs to draw on the competencies of outside experts and through examination of the needs, strategies, challenges, and concerns related to doing so, we identify critical gaps in the existing literature and set forth an agenda for future empirical research.

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. Staff were eligible if they conducted participant recruitment, consent, and/or enrollment for clinical research. We developed our semi-structured interview guide based on a framework for trusting researcher-community partnerships. Results: We interviewed 28 research staff, with a median age of 28 years (range 22-50) and a median of 5 years of experience (range 1-29). Interviewees identified factors relevant to relationship building across three levels: the individual staff member, the relational interaction with the family, and the institutional or other structural backdrop. Individual factors included how staff developed recruitment skills, their perceived roles, and their personal motivations. Relational factors spanned four stages of recruitment: before the approach, forming an initial connection with a family, building the connection, and following up. Structural factors were related to access and diversity, clinical interactions, and the COVID-19 pandemic. Conclusions: Research staff discussed tensions and supports with various actors, challenges with the integration of research and clinical care, the importance of voluntariness for building trust, and multiple contributors to inequities in research. These findings reveal the importance of ensuring research staff have a voice in institutional policies and are supported to advocate for patients and families.

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. METHODS: Structured data requests were sent to members of the Consortium to Advance Effective Research Ethics Oversight directing Human Research Protection Programs (HRPP). RESULTS: Fourteen of the 32 HRPP director members responded to a questionnaire about their approach to review and oversight during COVID-19. Eleven of the 14 provided summary data on COVID-19-specific protocols and six of the 11 provided protocol-related documents for our review. All respondents adopted at least one additional COVID-19-specific step to their usual review process. The average turnaround time for convened and expedited IRB reviews was 15 calendar days. In our review of the documents from 194 COVID-19-specific protocols (n = 302 documents), we identified only a single review that raised ethical concerns unique to COVID-19. CONCLUSIONS: Our data provide a snapshot of how HRPPs approached the review of COVID-19-specific protocols at the start of the pandemic in the USA. While not generalizable to all HRPPs, these data indicate that HRPPs can adapt and respond quickly response to a pandemic and likely need little novel expertise in the review and oversight of COVID-19-specific protocols.

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. To better understand physician and trainee views about displaying emotion in front of patients, we conducted a mixed-methods study using vignettes, closed-, and open-ended questions to explore the current attitudes of medical students, residents, and physicians at one academic medical center regarding whether or not it is appropriate for a physician to cry with a patient. Quantitative analyses investigated the effects that vignette constructs, level of training, gender, and history of crying at work within the last six months had on respondents' opinions regarding the appropriateness of physicians crying. An open-ended question, "Describe a situation in the hospital during which you felt like crying," was analyzed for key themes.

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. In this study, we sought to evaluate and address bias through the use-case of our classifier. We demonstrated the presence of biased unhealthy alcohol use risk underestimation among Hispanic compared to Non-Hispanic White trauma inpatients, 18- to 44-year-old compared to 45 years and older medical/surgical inpatients, and Non-Hispanic Black compared to Non-Hispanic White medical/surgical inpatients. We further showed that intercept, slope, and concurrent intercept and slope recalibration resulted in minimal or no improvements in bias-indicating metrics within these subgroups. Our results exemplify the importance of integrating bias assessment early into the classifier development pipeline.

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

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' Ethical and Religious Directives for Health Care Services (ERDs) address collaborations between US Catholic healthcare providers and other entities, the ERDs 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. This article describes ethical and social problems observed in recent patient data-sharing collaborations with AI companies and analyzes them in light of the guiding principles of the ERDs as well as the 2020 Rome Call to AI Ethics (RCAIE) document recently released by the Vatican. While both the ERDs and RCAIE guiding principles can inform future collaborations, we suggest that the next revision of the ERDs should consider addressing data-sharing and AI more directly. SUMMARY: Electronic health record data-sharing with artificial intelligence developers presents unique ethical and social challenges that can be addressed with updated United States Catholic Conference of Bishops' Ethical and Religious Directives and guidance from the Vatican's 2020 Rome Call to AI Ethics.