A guide to establishing, implementing, and optimizing diversity, equity, inclusion, and accessibility (DEIA) committees.

Diversity, equity, inclusion, and accessibility (DEIA) efforts are increasingly recognized as critical for the success of academic institutions. These efforts are facilitated mainly through the formation of dedicated DEIA committees. DEIA committees enhance professional development and create a more inclusive environment, which benefits all members of the institution. Although leadership and faculty membership have recognized the importance and necessity of DEIA, the roles of DEIA committees may be more ambiguous. Although leadership and faculty may seek to support DEIA at their institutions, they may not always fully understand the necessity of these committees or how to successfully create a committee, foster and promote its success, and sustain its impact. Thus, here, we offer a background rationale and guide for strategically setting up DEIA committees for success and impact within an academic institution with applicability to scientific societies.

Current practices and perspectives on clerkship grading in obstetrics and gynecology.

BACKGROUND: Clerkship grades in obstetrics and gynecology play an increasingly important role in the competitive application process to residency programs. An analysis of clerkship grading practices has not been queried in the past 2 decades in our specialty. OBJECTIVE: This study aimed to investigate obstetrics and gynecology clerkship directors' practices and perspectives in grading. STUDY DESIGN: A 12-item electronic survey was developed and distributed to clerkship directors with active memberships in the Association of Professors of Gynecology and Obstetrics. RESULTS: A total of 174 of 236 clerkship directors responded to the survey (a response rate of 73.7%). Respondents reported various grading systems with the fewest (20/173 [11.6%]) using a 2-tiered or pass or fail system and the most (72/173 [41.6%]) using a 4-tiered system. Nearly one-third of clerkship directors (57/163 [35.0%]) used a National Board of Medical Examiners subject examination score threshold to achieve the highest grade. Approximately 45 of 151 clerkship directors (30.0%) had grading committees. Exactly half of the clerkship directors (87/174 [50.0%]) reported requiring unconscious bias training for faculty who assess students. In addition, some responded that students from groups underrepresented in medicine (50/173 [28.9%]) and introverted students (105/173 [60.7%]) received lower evaluations. Finally, 65 of 173 clerkship directors (37.6%) agreed that grades should be pass or fail. CONCLUSION: Considerable heterogeneity exists in obstetrics and gynecology clerkship directors' practices and perspectives in grading. Strategies to mitigate inequities and improve the reliability of grading include the elimination of a subject examination score threshold to achieve the highest grade and the implementation of both unconscious bias training and grading committees.

Insights from Preventability Assessments Across 42 State and City Maternal Mortality Reviews in the United States.

BACKGROUND: The rising trend in maternal mortality over the past three decades sets the United States (U.S.) apart from all other high-income countries. Multidisciplinary state and city Maternal Mortality Review Committees (MMRCs) conduct comprehensive reviews of maternal deaths, including assessments of preventability and contributing factors. OBJECTIVE(S): Assess preventability of and contributing factors to maternal mortality in the U.S. STUDY DESIGN: This study is a secondary analysis of cross-sectional, population-based data from the most recent, publicly available MMRC data from 40 state and 2 cities in the U.S. Preventability was analyzed among all deaths during pregnancy or within one year postpartum from any cause (pregnancy-associated deaths, PAD) and deaths during pregnancy or within one year postpartum from causes related to pregnancy or its management, but not from accidental causes (pregnancy-related deaths, PRD). We also explored preventability by cause-of-death and contributing factors grouped as community, patient-family, provider, facility, and health system factors. RESULTS: Of deaths that occurred after 2010, between 53%-93.8% of PADs and 45%-100% of PRDs were deemed preventable across the 42 states and cities. Across the ten states reporting PRD preventability by cause-of-death, MMRCs deemed preventable >90% of deaths from preeclampsia-eclampsia and mental health conditions, >80% of deaths from hemorrhage and cardiovascular conditions, about 70% of deaths from infection and thrombotic embolism, and about 40% of deaths from amniotic fluid embolism and stroke. A total of 3,345 contributing factors were described in MMRC reports from 14 states in relation to 739 PRDs. While collectively patient-family and provider factors were most frequently noted as contributing to PRDs, the contribution of such factors varied between 6%-56% and 18%-42.3%, respectively, across the states. Based on data from 20 MMRCs with available information, racism or discrimination were noted in relation to 37.7% of PRDs. CONCLUSIONS: A large proportion of PADs and PRDs in the U.S. are preventable. However, likely due to differences in MMRC membership, available data, and judgement employed to determine preventability, wide variation exists in the proportion of deaths deemed preventable and factors identified as contributing to such deaths across states. There is need to reevaluate the definitions, structure, and outputs for maternal death preventability assessments currently employed by a majority MMRCs to adequately inform state and national programming and policies.

Critical dialogue method of ethics consultation: making clinical ethics facilitation visible and accessible.

In clinical ethics consultations, clinical ethicists bring moral reasoning to bear on concrete and complex clinical ethical problems by undertaking ethical deliberation in collaboration with others. The reasoning process involves identifying and clarifying ethical values which are at stake or contested, and guiding clinicians, and sometimes patients and families, to think through ethically justifiable and available courses of action in clinical situations. There is, however, ongoing discussion about the various methods ethicists use to do this ethical deliberation work. In this paper, we make visible and accessible seven steps of facilitation used in the critical dialogue method of ethics consultation.We describe how the facilitation techniques serve two overall purposes. First, to identify ethically justified responses to ethical questions. Second, to assist participants to gain greater moral clarity, understanding and confidence to respond to ethical challenges as independent moral agents.By describing in detail facilitation steps for clinical ethics consultation, we aim to advance the scholarship of 'clinical ethics facilitation methods' and to demystify the ethical deliberation work undertaken by clinical ethicists.

Is the UN receiving ethical approval for its research with human participants?

This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors' experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not received appropriate ethical oversight. It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight?

Future pandemics and the urge to 'do something'.

Research with enhanced potential pandemic pathogens (ePPP) makes pathogens substantially more lethal, communicable, immunosuppressive or otherwise capable of triggering a pandemic. We briefly relay an existing argument that the benefits of ePPP research do not outweigh its risks and then consider why proponents of these arguments continue to confidently endorse them. We argue that these endorsements may well be the product of common cognitive biases-in which case they would provide no challenge to the argument against ePPP research. If the case against ePPP research is strong, the views of professional experts do little to move the needle in favour of ePPP research.

Clinical Ethics Fellowship Programs in the U.S. and Canada: A Descriptive Study of Program Characteristics and Practices.

To address the current lack of knowledge about clinical ethics fellowship programs (CEFPs), we surveyed all 36 programs in the U.S. and Canada. The number of CEFPs has grown exponentially over the last 40 years and far exceeds previous estimates. Commonalities among CEFPs include: 88.8% require an advanced degree or rarely accept applicants without one; 91.7% of programs do not restrict applicants to a specific background such as medicine or philosophy; and 88.9% of programs compensate fellows. CEFPs vary widely on numbers of fellows trained in the last 3 years (1-111), numbers of consultations performed by each fellow (0-450), and salaries paid ($0-$95,000). Less than half of programs meet CEFP standards established by ABPD. Nonpaying programs and larger programs tend to have lower admission standards and lower expectations for fellows. We hope these data will help inform CEFP standards that promote quality and consistency without stifling desirable diversity and innovation.

Which Benefits Can Justify Risks in Research?

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs.

Ethical regulation of biomedical research in Brazil: a quality improvement initiative.

BACKGROUND: Q-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil's national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project. METHODS: An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies. RESULTS: In 2019-2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs. CONCLUSIONS: Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world's largest research ethics evaluation systems.

Behind the scenes of research ethics committee oversight: a qualitative research study with committee chairs in the Middle East and North Africa region.

BACKGROUND: Research cites shortcomings and challenges facing research ethics committees in many regions across the world including Arab countries. This paper presents findings from qualitative in-depth interviews with research ethics committee (REC) chairs to explore their views on the challenges they face in their work with the oversight of research involving human populations. METHODS: Virtual in-depth interviews were conducted with chairs (n = 11) from both biomedical and/or social-behavioral research ethics committees in six countries, transcribed, coded and subject to thematic analysis for recurring themes. RESULTS: Two sets of recurring themes impede the work of the committees and pose concerns for the quality of the research applications: (1) procedures and committee level challenges such as heavy workload, variations in member qualification, impeding bureaucratic procedures, member overwork, and intersecting socio-cultural values in the review process; (2) inconsistencies in the researchers' competence in both applied research ethics and research methodology as revealed by their applications. CONCLUSIONS: Narratives of REC chairs are important to shed light on experiences and issues that are not captured in surveys, adding to the body of knowledge with implications for the region, and low- and middle-income countries (LMICs) in other parts of the world. International research collaborations could benefit from the findings.

Level of readiness of employees of Systems Plus College Foundation (SPCF) on Disaster Risk-Reduction Management (DRRM).

OBJECTIVE: To determine the level of readiness on disaster risk-reduction management among employees of an educational institution. METHODS: The descriptive, evaluative study was conducted from March to April 2022 at 6 branches of Systems Plus College Foundation, Philippines, in Balibago, Rizal, Miranda, San Fernando, Caloocan and Cubao after approval from the ethics review committee of the Our Lady of Fatima University, Philippines, and comprised employees who were associated with the college for at least 6 months. Data was collected using Google Forms, and a validated tool was used to assess the disaster risk-reduction management readiness. The responses were categorised into 5 groups, ranging from 'very much ready' to 'not ready'. Gathered data was analysed by using SPSS version 20. Mean results were derived and presented with standard deviation. RESULTS: The responses suggested moderate readiness regarding structural safety codes 3.02±0.98, non-structural safety codes 3.02±1.04, availability of emergency supplies and equipment 2.84±1.09, and servicing and maintenance 2.85±1.03. CONCLUSIONS: Increasing the level of readiness related to disaster risk-reduction management must be given priority to ensure the safety of the employees in a higher education institution.

Use of animals for scientific and educational purposes by Mexican institutions.

In Mexico, it is not known which institutions use animals for scientific purposes. This work reports, based on data requested from the National Institute of Transparency, Access to Information and Protection of Personal Data (INAI), the types of institutions that use animals for research and how many of these have an ethics committee. Research centres, colleges, hospitals, national institutes, technical colleges, and public universities are the types of institutions that report using animals for experimentation. Only 54% of institutions have ethics committees. Mexican institutions from 2015 to 2021 used a total of 2,112,786 animals. Mammals are the most widely used animal group. The scientific purposes for using animals depend on the type of institution that uses them. In Mexico, it is necessary to update the regulations in order to regulate the use, protection and the care of laboratory animals.

En México se desconoce cuáles son las instituciones que utilizan animales con fines científicos. Se reporta, a partir de datos solicitados al Instituto Nacional de Transparencia, Acceso a la Información y Protección de Datos Personales (INAI), los tipos de instituciones que usan animales y cuántas poseen un comité interno para el cuidado y uso de los animales de laboratorio. Los centros de investigación, colegios, hospitales, institutos nacionales, tecnológicos y universidades públicas son los tipos de instituciones que reportaron usar animales. El 54% de las instituciones poseen comités de ética. Un total de 2,112,786 animales fueron usados por instituciones del 2015 al 2021. Los mamíferos es el grupo animal más utilizado. El uso de los animales se encuentra en función del tipo de institución que los utiliza. En México, es necesario actualizar la normatividad, con el fin de regular el uso, la protección y el cuidado de los animales de laboratorio.

Enhancing Epidemiology's Impact on Policy: Mediation by Expert Committees.

Epidemiologic evidence is often a key source of information used by expert committees to guide policy decisions, yet epidemiologists rarely consider this audience for their research. For a better understanding of the pipeline from epidemiologic research to expert committee assessment to policy, several reports from the National Academies of Sciences, Engineering, and Medicine were reviewed and discussed with staff and committee members. The topics of these consensus committee assessments included health behaviors, medical care, and military exposures. The focus was often on emerging issues of immediate concern for which there was little relevant research available but a need for prompt action. Committees generally sought a comprehensive assessment of potential health effects of a given product or exposure, which often included social and behavioral health outcomes that are rarely addressed by epidemiologists. To enhance epidemiology's contribution to societal decisions, the choice of research topics should expand to consider emerging societal concerns. Research funding agencies need to be engaged as mediators between committee needs and the research community to stimulate contributory research. Improved communication of research needs to the epidemiology community would be beneficial to researchers aspiring to have an impact and to those who use epidemiologic information to help guide policy decisions.

Twenty-five years of novel drug approvals in rheumatology.

The field of rheumatology has experienced dozens of novel drug approvals in the past two and a half decades, but the regulatory mechanisms underpinning these decisions are not well understood. In the USA, the Food and Drug Administration (FDA) evaluates the safety and efficacy of novel drugs through the New Drug Application (NDA) process. When additional content expertise is required to evaluate scientific or technical matters, the FDA may convene Human Drug Advisory Committees. To better understand the landscape of rheumatology NDAs and the FDA use of advisory committees, we performed a review of all rheumatic disease drug applications from 1996 to 2021 that were granted approval by the FDA. Our review identified 31 NDAs, seven of which utilized an advisory committee. The indications for using advisory committees and their influence on ultimate approvals was not clear. Recommendations to improve transparency and increase public trust in FDA decisions are provided.

Bringing data monitoring committee charters into the sunlight.

Clinical trials investigating novel or high risk interventions, or studying vulnerable participants, often use a data monitoring committee to oversee the progress of the trial. The data monitoring committee serves both an ethical and a scientific function, by protecting the interests of trial participants while ensuring the integrity of the trial results. A data monitoring committee charter, which typically describes the procedures by which data monitoring committees operate, contains details about the data monitoring committee's organizational structure, membership, meeting frequency, sequential monitoring guidelines, and the overall contents of data monitoring committee reports for interim review. These charters, however, are generally not reviewed by outside entities and are rarely publicly available. The result is that a key component of trial oversight remains in the dark. We recommend that ClinicalTrials.gov modify its system to allow uploading of data monitoring committee charters, as is already possible for other important study documents and that clinical trialists take advantage of this opportunity to voluntarily upload the data monitoring committee charter for trials that have one. The resulting cache of publicly available data monitoring committee charters should provide important insights for those interested in a particular trial, as well as for meta-researchers who wish to understand and potentially improve how this important component of trial oversight is actually being applied.

Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov.

BACKGROUND: Data monitoring committees advise on clinical trial conduct through appraisal of emerging data to ensure participant safety and scientific integrity. While consideration of their use is recommended for trials performed with vulnerable populations, previous research has shown that data monitoring committees are reported infrequently in publications of pediatric randomized controlled trials. We aimed to assess the frequency of reported data monitoring committee adoption in ClinicalTrials.gov registry records and to examine the influence of key trial characteristics. METHODS: We conducted a cross-sectional data analysis of all randomized controlled trials performed exclusively in a pediatric population and registered in ClinicalTrials.gov between 2008 and 2021. We used the Access to Aggregate Content of ClinicalTrials.gov database to retrieve publicly available information on trial characteristics and data on safety results. Abstracted data included reported trial design and conduct parameters, population and intervention characteristics, reasons for prematurely halting, serious adverse events, and mortality outcomes. We performed descriptive analyses on the collected data and explored the influence of clinical, methodological, and operational trial characteristics on the reported adoption of data monitoring committees. RESULTS: We identified 13,928 pediatric randomized controlled trial records, of which 39.7% reported adopting a data monitoring committee, 49.0% reported not adopting a data monitoring committee, and 11.3% did not answer on this item. While the number of registered pediatric trials has been increasing since 2008, we found no clear time trend in the reported adoption of data monitoring committees. Data monitoring committees were more common in multicenter trials (50.6% vs 36.9% for single-center), multinational trials (60.2% vs 38.7% for single-country), National Institutes of Health-funded (60.3% vs 40.1% for industry-funded or 37.5% for other funders), and placebo-controlled (47.6% vs 37.5% for other types of control groups). Data monitoring committees were also more common among trials enrolling younger participants, trials employing blinding techniques, and larger trials. Data monitoring committees were more common in trials with at least one serious adverse event (52.6% vs 38.4% for those without) as well as for trials with reported deaths (70.3% vs 38.9% for trials without reported deaths). In all, 4.9% were listed as halted prematurely, most often due to low accrual rates. Trials with a data monitoring committee were more often halted for reasons related to scientific data than trials without a data monitoring committee (15.7% vs 7.3%). CONCLUSION: According to registry records, the use of data monitoring committees in pediatric randomized controlled trials was more frequent than previously reported in reviews of published trial reports. The use of data monitoring committees varied across key clinical and trial characteristics based on which their use is recommended. Data monitoring committees may still be underutilized in pediatric trials, and reporting of this item could be improved.

Involving parents in paediatric clinical ethics committee deliberations: a current controversy.

In cases where the best interests of the child are disputed or finely balanced, Clinical Ethics Committees (CECs) can provide a valuable source of advice to clinicians and trusts on the pertinent ethical dimensions. Recent judicial cases have criticised the lack of formalised guidance and inconsistency in the involvement of parents in CEC deliberations. In Manchester University NHS FT v Verden [2022], Arbuthnot J set out important procedural guidance as to how parental involvement in CEC deliberations might be managed. She also confirmed substantive guidance on the role of parental views in determining the child's best interests. We agree that it is good practice to ensure that the patient voice is heard in ethics processes, but how that is achieved is controversial. Surely it is best that what matters most to a patient and their family, whether facts or values, is conveyed directly to those considering the moral issues involved, rather than via a prism of another party. The approach suggested in the Verden case has much in common with the process used by our CEC. In this article, we commend Arbuthnot J's approach, provide an example of its effective operation and consider what it might mean for ethics processes.

If it walks like a duck : Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is research.

Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is an ethical framework developed by the WHO for using unproven interventions in public health emergencies outside the context of medical research. It is mainly intended for use when medical research would be impracticable, but there is still a need to systematically gather data about unproven interventions. As such, it is designed as something of a middle ground between clinical and research ethical frameworks.However, I argue that MEURI does not truly lie at the intersection of clinical care and research. Due to its intent, structure and oversight requirements, it takes on most of the crucial features of research, to the point that it is best understood as a form of research. As a result, cases where MEURI could practicably be applied should instead make use of existing research frameworks. For those circumstances where research is truly impracticable, a more straightforward oversight system than MEURI is needed. While existing practices of compassionate use have some applicability, proposals to make use of clinical ethics committees to oversee unproven interventions may help achieve the right balance in acting in a patient's best interests when the relevant evidence base is weak.

Beyond regulatory approaches to ethics: making space for ethical preparedness in healthcare research.

Centralised, compliance-focused approaches to research ethics have been normalised in practice. In this paper, we argue that the dominance of such systems has been driven by neoliberal approaches to governance, where the focus on controlling and individualising risk has led to an overemphasis of decontextualised ethical principles and the conflation of ethical requirements with the documentation of 'informed consent'. Using a UK-based case study, involving a point-of-care-genetic test as an illustration, we argue that rather than ensuring ethical practice such compliance-focused approaches may obstruct valuable research. We call for an approach that encourages researchers and research communities-including regulators, ethics committees, funders and publishers of academic research-to acquire skills to make morally appropriate decisions, and not base decision-making solely on compliance with prescriptive regulations. We call this 'ethical preparedness' and outline how a research ethics system might make space for this approach.

UK Research Ethics Committee's review of the global first SARS-CoV-2 human infection challenge studies.

This paper describes the UK Research Ethics Committee's (REC) preparations and review of the global first SARS-CoV-2 human infection challenge studies. To frame our review, we used the WHO guidance and our UK Health Research Authority ethical review framework. The WHO criteria covered most issues we were concerned about, but we would recommend one further criterion directing RECs to consider alternative research designs. Could research questions be equally well answered by less intrusive studies? The committee met virtually, ensuring broad representation across the UK nations and also ensuring applicants could attend easily. We worked in collaboration with the applicants but while we recognise that such proximity might raise the accusation of 'collusion', we made every effort to maintain 'moral distance' and all decisions were made by the committee alone. Prior existing processes and policy facilitated training and review but even with this preparation, review took time and this could have hindered a rapid response to the emergency. Review for the various follow-on studies will now be speedier and once the pandemic has subsided, our group could be reconvened in future emergencies. In conclusion, we have tried to make decisions in good faith. We know there is controversy and disagreement and reasonable people may feel we have made the wrong decision. A more detailed analysis, built on the WHO guidance, is provided in online supplemental material.