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BACKGROUND: Clinical ethics consultants support mental health professionals in identifying and analyzing moral problems in clinical practice. OBJECTIVE: Presentation of key ethical concepts and normative theories that are relevant for clinical ethics consultation in mental healthcare. MATERIAL AND METHODS: Conceptual and ethical analyses. RESULTS: After distinguishing between morality, ethics and law, moral problems are differentiated from other types of problems encountered in clinical practice. Subsequently, key ethical concepts and the concept of moral distress are clarified. In relation to the normative framework a distinction is made between philosophical ethical theories and medical ethical theories, such as principlism and the ethics of care. Finally, justification tests for ethical decision-making in situations of danger to self or others based on the harm principle and soft paternalism are proposed. CONCLUSION: Knowledge of key ethical concepts and normative theories is important for the identification and analysis of moral problems in mental healthcare and should be given greater weight in the training of clinical ethics consultants.

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Drawing on the authors' own ethnographic research, this article discusses the importance of developing polymedia literacy as a key step toward ethical online research on social networking sites (SNS). Polymedia literacy entails the ability to critically analyze the vast landscape of SNS, their affordances, and users' social motivations for choosing specific SNS for their interactions. Internet researchers face several ethical challenges, including issues of informed consent, "public" and "private" online spaces, and data protection. Even when research ethics committees waive the need for a formal ethics approval process, researchers of online spaces need to ensure that their studies are conducted and presented in an ethical and responsible manner. This is particularly important in research contexts that pertain to vulnerable populations in online communities.

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Background: COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs' responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods: The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members.The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results: A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions: Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

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OBJECTIVES: Good Clinical Practices (GCP) are essential for patient-centric research. The standard bioethics and GCP training emphasizing a "one-size-fits-all" approach may not adequately equip ethics committee members, especially the lay and social scientist members, towards their critical role in reviewing clinical trials and related documentation. This article explores a patient-centered, patient advocates-driven training program focused on raising awareness about research ethics and GCP among patients, advocates and ethics committee members. METHODS: A patient advocates-driven program called Patient Advocates for Clinical Research (PACER) conducted trainings focused on GCP for patient-centric research for patients, advocates and ethics committee members. Pre- and post-workshop questionnaires were used to assess the participants' knowledge of GCP. RESULTS: The workshop was attended by 116 participants. Of these 91 consented to participate in questionnaire evaluation that assessed participants' knowledge on ethics committee (EC) functionality, research ethics and data confidentiality. Pre-workshop evaluations highlighted knowledge gaps. Only 16.5% were familiar with the primary ethical consideration for vulnerable populations and 69.2% were knowledgeable about data governance. Post-workshop evaluations demonstrated significant overall response improvement of 5.4% (𝜒2=13.890; p<0.001). The understanding of ethical considerations for vulnerable populations rose by 15.4% (p=0.007), and knowledge of data privacy regulations improved by 11.0% (p=0.041). CONCLUSION: The workshop under PACER initiative highlighted the knowledge gaps in understanding the EC functionality, research ethics and data confidentiality. The workshop effectively fostered participants' understanding of ethical research practices.

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BACKGROUND: Qualitative Humanities research is perturbed by ethical review processes that routinely invoke epistemological assumptions skewed towards positivistic or deductive research, giving rise to several concerns, including increased risk aversion by University Research Ethics Committees (URECs) and the evaluation of qualitative research designs according to STEM standards. METHODS/MATERIALS: This paper presents findings from an AHRC-funded research network built to better understand how research ethics frameworks and processes might be reformed to more appropriately fit ethically challenging qualitative methodologies. RESULTS: There remains dissatisfaction with the current processes for awarding ethical approval and the subsequent management of ethical dimensions of projects. In spite of recent developments, UREC frameworks remain seriously flawed, with a wide divergence in the quality of expertise, procedures, and practices, leading to inconsistency in ethical approval awards. CONCLUSIONS: These factors downgrade UK Higher Education research power in the Humanities and undermine our commitments to the researched. We propose a series of recommendations for reform.

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One Health research has gained attention over the past few decades due to its potential to improve health challenges across the globe. However, obtaining ethics approvals for timely implementation of One Health research is a challenge in some contexts. Our study was undertaken to describe various challenges faced by researchers, research ethics committees (RECs) and members of regulatory bodies in Africa. An online survey was conducted between March and June 2021. The effect of predictors, including respondents' role (e.g., REC member, regulator and/or One Health researcher), sex, education, age, and country, on the perception of challenges and opportunities when conducting and reviewing One Health research, was investigated using multivariable linear regression models. Participants with different roles did not perceive any of the examined challenges differently during review of One Health-related research; but female participants (p = 0.026) and those with ten or more years of experience (p = 0.0325) perceived insufficient One Health knowledge as less of a challenge. Professional role was an important predictor (p = 0.025) for the perception of the establishment of a mandatory One Health review system. Respondents with multiple roles perceived the creation of ad hoc committees for review of One Health research under emergency situations to be less important (p = 0.02); and REC members perceived the creation of such committees to be less feasible (p = 0.0697). Our study showed that perceptions of the importance and feasibility of opportunities for improvement of One Health research ethics review under emergency and non-emergency situations varied across professional roles. This emphasizes the need to consider such improvement strategies; and the need for continuous and timely evaluation for improvement of ethics review of One Health and emergency research in Africa.

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BACKGROUND: Involving and engaging the public in scientific research and higher education is slowly becoming the norm for academic institutions in the United Kingdom and elsewhere. Driven by a wide range of stakeholders including regulators, funders, research policymakers and charities public involvement and public engagement are increasingly seen as essential in delivering open and transparent activity that is relevant and positively impacts on our society. It is obvious that any activities involving and engaging members of the public should be conducted safely and ethically. However, it is not clear whether conducting activities ethically means they require ethical approval from a research ethics committee. MAIN BODY: Although there is some guidance available from government organisations (e.g. the UK Health Research Authority) to suggest ethical approval is not required for such activities, requests from funders and publishers to have ethical approval in place is commonplace in the authors' experience. We explore this using case studies from our own institution. CONCLUSION: We conclude that any public-facing activity with the purpose to systemically investigate knowledge, attitudes and experiences of members of the public as research and as human participants requires prior approval from an ethics committee. In contrast, engaging and involving members of the public and drawing on lived experience to inform aspects of research and teaching does not. However, lack of clarity around this distinction often results in the academic community seeking ethical approval 'just in case', leading to wasted time and resources and erecting unnecessary barriers for public involvement and public engagement. Instead, ethical issues and risks should be appropriately considered and mitigated by the relevant staff within their professional roles, be it academic or a professional service. Often this can involve following published guidelines and conducting an activity risk assessment, or similar. Moving forward, it is critical that academic funders and publishers acknowledge the distinction and agree on an accepted approach to avoid further exacerbating the problem.

Involving and engaging members of the public is recognised best practice in university research and teaching. Involvement and engagement activities (for instance, working with the public to design a research study) continue to increase in priority and are an important part of an academic's role. However, there is often confusion amongst researchers and educators around whether involving the public in these activities requires prior ethical approval, similar to what would be the case when inviting members of the public to participate in a clinical research study, or to donate samples such as blood for experiments. As an example, sometimes researchers are asked for ethical approval by scientific journals when trying to publish the findings from their public involvement and engagement work, when in fact this is not needed. The ongoing uncertainty about the difference between actual research on one hand and public involvement and engagement on the other hand wastes precious time and resources, and is a barrier for scientists to working with the public. We have developed guidance for academic staff on when ethical approval is and is not required, using examples from our own experience. We wrote this article to bring awareness to this problem; share our views with the wider academic community; encourage discussion around the problem and possible solutions; and ultimately contribute to educating on when research ethics approval is needed, and when not.

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O assentimento infantil é uma exigência ética em pesquisas com crianças, porém sua comunicação eficaz tem sido um desafio. Neste relato, descrevemos a construção teórica e metodológica de um termo de assentimento infantil em formato de história em quadrinhos. A experiência foi realizada em uma escola municipal de Teresina, Piauí, com 32 crianças entre oito e dez anos. As etapas consistiram no estudo das questões éticas envolvidas, na construção da arte sequencial, na observação participante, em ajustes na história em quadrinhos e na aplicação e assinatura do termo de assentimento. A experiência resultou em um termo com legibilidade de Flesch de 91,81 sobre as questões éticas na pesquisa com crianças. O assentimento infantil em formato de história em quadrinhos apresentou linguagem acessível, lúdica e legibilidade adequada para comunicar pesquisa com crianças.

Child assent is an ethical requirement in research with children, however effective communication has been a challenge. In this report we describe the theoretical and methodological construction of a child assent term in comic book format. The experience was carried out in a municipal school of Teresina-Piaui with 32 children between eight and ten years old. The steps consisted of the study of ethical issues, the construction of sequential art, in participant observation, in adjustments to the comic strip and in the application and signature of the assent term. The experience resulted in a term with Flesch readability of 91.81 on ethical issues in research with kids. The childish nod in comic book format presented accessible, playful language and adequate legibility to communicate research with children.

El asentimiento infantil es una exigencia ética en investigaciones con niños. Sin embargo, la comunicación eficaz ha sido un desafío. En este relato describimos la construcción teórica y metodológica de un término de asentimiento infantil en formato de cómics. La experiencia ha sido realizada en una escuela municipal de Teresina, Piauí, con 32 niños entre ocho y diez años. Las etapas consistieron en el estudio de las cuestiones éticas, en la construcción del arte secuencial, en la observación participante, en ajustes en los cómics y en la aplicación y firma del término de asentimiento. La experiencia resultó en un término con legibilidad de Flesch de 91,81 sobre las cuestiones éticas en la investigación con niños. El asentimiento infantil en formato de cómics presentó lenguaje accesible, lúdica y legibilidad adecuada para comunicar investigación con niños.

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The Research Ethics Committee (CEP) has become an essential mechanism for social control in Brazilian research involving human subjects, contributing to the development of studies guided by ethical standards and to the protection of research participants. This article analyzes the performance of CEP in Western Amazonian institution, its history, operating conditions, trends, and different aspects between 2018 to 2022. The theoretical framework addresses the history of research involving human subjects, the origins and evolution of bioethics in the international context, bioethics in Brazil, and regulations on the ethical analysis of research. The data were collected through the Brazil Platform and reports from the institution's CEP. The CEP evaluated 865 research protocols, most of which were from Health Sciences. Additionally, it was observed that during 2018 to 2022 the covid-19 pandemic had a negative impact on the number of projects submitted for evaluation to the CEP. The 57% drop in the number of projects registered during 2020/2022 reveals the negative impact of this event on the execution of projects with human participants.

El Comité de Ética en Investigación (CEP) se ha convertido en un mecanismo esencial para el control social en la investigación brasileña con seres humanos, contribuyendo al desarrollo de estudios guiados por normas éticas y a la protección de los participantes en la investigación. Este artículo analiza el desempeño del CEP en la institución amazónica occidental, su historia, condiciones de funcionamiento, tendencias y diferentes aspectos entre 2018 y 2022. El marco teórico aborda la historia de la investigación con seres humanos, los orígenes y la evolución de la bioética en el contexto internacional, la bioética en Brasil y la normativa sobre el análisis ético de la investigación. Los datos se recogieron a través de la Plataforma Brasil y de informes del CEP de la institución. El CEP evaluó 865 protocolos de investigación, la mayoría de los cuales eran de Ciencias de la Salud. Además, se observó que durante 2018 a 2022 la pandemia de covid-19 tuvo un impacto negativo en el número de proyectos presentados para evaluación al CEP. La caída del 57% en el número de proyectos registrados durante 2020/2022 revela el impacto negativo de este evento en la ejecución de proyectos con participantes humanos.

Os Comitês de Ética em Pesquisa (CEPs) tornaram-se um mecanismo essencial para o controle social em pesquisas brasileiras envolvendo sujeitos humanos, contribuindo para o desenvolvimento de estudos regido por padrões éticos e para a proteção de participantes de pesquisas. Esse artigo analisa o desempenho de CEP em instituição da Amazonia Ocidental, sua história, condições operativas, tendências e diferentes aspectos entre 2018 e 2022. O enquadre teórico visa a história da pesquisa envolvendo sujeitos humanos, as origens e evolução da bioética no contexto internacional, bioética no Brasil e regulamentos de análise ética de pesquisa. Os dados foram coletados através da Plataforma Brasil e relatórios do CEP da instituição. O CEP avaliou 865 protocolos de pesquisa, a maioria deles de Ciências da Saúde. Adicionalmente, foi observado que de 2018 a 2022 a pandemia da covid-19 teve um impacto negativo no número de projetos submetidos para avaliação do CEP. A queda de 57% no número de projetos registrados em 2020/2022 revela o impacto negativo desse evento na execução de projetos com participantes humanos.

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INTRODUCTION: Research with young people (YP) is ethically challenging and bound in a complex maze of issues relating to power, voice and representation. Such sensitivities mean that the challenges raised in researching marginalised YP are often hard to navigate. This paper reports on research carried out with YP to explore links between mental health, school exclusion and involvement in criminal gangs. It aims to provide a practical guide to negotiating some of the methodological and ethical challenges experienced. METHOD: In-depth interviews conducted with 28 YP (aged 14-24 years) who were gang involved or seen to be at risk of gang involvement. Research was conducted in youth clubs, alternative provision and youth justice settings. RESULTS: OBSERVATIONS/REFLECTIONS: We reflect on how navigating ethics can create barriers to involving YP as primary informants in research. We consider why it is important to overcome these hurdles and how public engagement work with recognised gatekeepers and the use of creative interview methods can facilitate meaningful encounters, where YP feel able to share valuable insights into their lives. CONCLUSION: Alongside a number of specific learning points, the paper reflects on theories behind research with YP, including the need for recognition of power imbalances and reflexivity. It concludes with thoughts on the practical realities of achieving meaningful participation or an 'authentic voice' with marginalised groups and the importance of this in informing policy and practice. PATIENT OR PUBLIC CONTRIBUTION: The focus of this work was to collect experiences of YP who are recognised as gang-involved or at risk of being so, with a view to informing health and education policies. The scoping study for the project involved extensive public engagement work with YP exploring and trialling suitable methods of accessing, recruiting and ultimately interviewing this target group. This is central to the discussion within the body of the paper.

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Bioethical dilemmas can emerge in research and clinical settings, from end-of-life decision-making to experimental therapies. The COVID-19 pandemic raised serious ethical challenges for healthcare organizations, highlighting the need to conduct needs assessments of the bioethics infrastructures of healthcare organizations. Clinical ethics committees (CECs) also create equitable policies, train staff on ethics issues, and play a consultative role in resolving the difficulty of complex individual cases. The main objective of this project was to conduct a needs assessment of the bioethics infrastructure within a comprehensive hospital system. A cross-sectional anonymous online survey, including quantitative and qualitative formatted questions. The survey was sent to five key leaders from the organization's hospitals. Survey questions focused on the composition, structure, function, and effectiveness of their facilities' bioethics infrastructure and ethics-related training and resources. Positive findings included that most facilities have active CECs with multidisciplinary membership; CECs address critical issues and encourage team members to express clinical ethics concerns. Areas of concern included uncertainty about how CECs function and the process for resolving clinical ethics dilemmas. Most reported no formal orientation process for CEC members, and many said there was no ongoing ethics education process. The authors conclude that if CECs are a critical institutional resource where the practice of medicine and mission intersect, having well-functioning ethics committees with trained and oriented members demonstrates an essential commitment to the mission. The survey revealed that more needs to be done to bolster the bioethics infrastructure of this institution.

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Background: Ethics Committee accreditation is a process to assess the performance against a set of standards. Very few studies have shown that process of accreditation results in the improvement of the overall functioning of ECs. in terms of quality and governance. Hence, the present study was planned to evaluate the impact of accreditation on registered EC in terms of quality and governance and to compare functioning of accredited versus non accredited EC in terms of quality and governance. Materials and Methods Study Design: This was a cross sectional, observational, questionnaire-based survey conducted on 28 registered Ethics Committee in India after approval from the Institutional Ethics Committee. Results: Accredited EC's (n = 12) were compared for NABH standard for accreditation before and after accreditation in terms of percentage. It was found that majority of the standards related to structure and composition, adherence to specific policies , completeness of review and after approval process were met by majority of EC's after accreditation. Only a few EC 's fulfilled some of the criteria before accreditation. There was a statistically significant difference with reference to adherence to specific policies by accredited and non-accredited EC's like updating SOP according to changing requirements (P < 0.0237), process for preparing SOP (P < 0.0237), categorization of review process mentioned in SOP (P < 0.0237) procedure to be followed for vulnerable population (P < 0.0103) , process of handling issues related to complaints by participants and other stakeholders violation (P < 0.0103) etc. Conclusion: Accreditation results in improving of EC functioning in terms of quality and governance.

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BACKGROUND: The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). METHODS: We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. RESULTS: Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. CONCLUSIONS: There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.

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Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

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The ethics in Catholic hospitals are guided by the Ethical and Religious Directives for Catholic Health Care Services, which provide direction on many topics, including family planning. Previous research has demonstrated there is variability in the availability of prohibited family planning services at Catholic hospitals. This study aims to research a potential source of variability in interpretation and application of the directives through interviewing ethics committee members. Participants were recruited from two different hospitals on the east coast with a total sample size of eight. Ethics committee members were asked questions regarding their personal approach to ethics, their hospital's approach to ethics, and the permissibility of specific family planning methods at their hospital. Most ethics committee members stated that the Catholic faith and/or directives were important in their hospitals' approach to ethics. Most participants stated that they had instances in which their personal approach to ethics conflicted with their hospital's approach, citing women's health and end-of-life care as common causes of conflict. All but one ethics committee member stated that hormonal contraception was forbidden under the directives; however, many members stated that this was either a gray area or permissible under certain circumstances. Reproductive health issues rarely came before the ethics committee at either site with one participant referring to them as "black and white issues." This research suggests that ethics committee members did not see the directives governing family planning services to be ambiguous. However, given the low frequency in which these issues come to the attention of the ethics committee, it is difficult to determine whether the opinions expressed by our participants contribute to the variability between Catholic hospitals when it comes to reproductive healthcare provision. An interesting topic for future research would be interviewing executives at Catholic hospitals to determine where this variability arises.

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BACKGROUND: Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government's pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020-February 2021) and the second phase (March 2021-February 2023) for long-term preparedness. RESULTS: The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week: the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training). CONCLUSION: As a result of South Korea's commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.

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Research ethics committees exist internationally to review research proposals to protect the rights and safety of human participants and researchers involved in research. These committees recruit a panel of expert and lay members, mostly on an unpaid voluntary basis, with relevant scientific experience to appraise these studies. Contemporary data in the UK show that women and people over 55 years old are overrepresented in these committee panels in the Health Research Authority, suggesting that there are potential barriers to inclusivity and participation. A variety of global approaches to tackle these barriers include targeting specific populations, such as faith or community leaders, or implementing quotas have been adopted. Further research is needed to understand likely barriers preventing participation in research ethics committees in the UK and how they may be overcome.

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This is a qualitative examination of ethics consultation requests, outcomes, and ethics committee recommendations at a tertiary/quaternary pediatric hospital in the U.S. The purpose of this review of consults over an 18-year period is to identify specific trends in the types of ethical dilemmas presented in our pediatric setting, the impact of consultation and committee development on the number and type of consults provided, and any clinical features and/or challenges that emerged and contributed to the nature of ethical situations and dilemmas. Furthermore, in reviewing clinical ethics consultation trends for nearly two decades, we can identify topic areas for further ethics education and training for ethics consultants, ethics committee members, and pediatric healthcare teams and professionals based on our experiences. Our study with nearly two decades of data prior to the COVID-19 pandemic can serve as groundwork for future comparisons of consultation requests and ethics support for pediatric hospitals prior to, during, and following a pandemic.

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BACKGROUND: We have examined the number and types of stipulations received following the submission of surgical study protocols to the Institutional Review Boards (IRBs) for review, and their effect on turnaround time for approval. This analysis will enable our organization to improve the quality of applications and design of study protocols, which can streamline the approval process and increase efficiency of the startup phase for clinical research. METHODS: IRB stipulations for 48 surgical studies were analyzed. Various factors were assessed: surgical specialty, type of study by design, clinical trial phase, type of investigational product, type of IRB utilized (local or centralized), study complexity score, type of review (e.g., exempt, expedited, or full board), turnaround time, and number of stipulations received. Statistical analyses were performed to examine associations between the number/type of stipulations received during the IRB review process and any of the aforementioned study-related factors. RESULTS: For analyzed surgical studies, the number of stipulations allotted to a study and time taken for approval had moderate association with the complexity of the study. The turnaround time for approval was the highest for randomized, controlled trials and studies undergoing full board review. CONCLUSION: This study elucidates characteristics that are associated with increased time for IRB approval. Analysis of IRB stipulations can help improve the turnaround time for the approval process, increase efficiency of startup phase, and transition to execution phase faster, which will allow more time for enrollment of research subjects, and increase return on investment made into research and development programs.

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Purpose and Aim: In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. Subject and Methods: The study was conducted as a retrospective audit. After exemption from ethics review, the data were collected from the IEC office situated in KEM Hospital and were segregated into four domains: structure, review process, outcomes, and administration. The data were analyzed using descriptive statistics. Mann-Whitney U-test was used to compare the turnover time for approval of projects between the two study periods at 5% level of significance. SPSS software version 22 was used to analyze the data. Results: Constitution changed , more protocols pertaining to COVID 19 studies were reviewed, meetings frequency doubled, and Standard Operating Procedures was amended to incorporate the changes faced during pandemic. Significant decrease in turnover time was noticed with respect to submission to query letter and study completion. There were more protocol deviations. Financial burden and expenditure decreased due to less paperwork and meetings being held online. Conclusion: The ethics committee infrastructure and functioning had to undergo a paradigm shift to adapt to the various changes and overcome the various hurdles occurring during the COVID-19 pandemic.