Ethics committees in the time of COVID-19.

BACKGROUND: ethics committees (ECs) protect the rights, safety, and well-being of research participants and ensure the scientific correctness of clinical research. COVID-19 pandemic and the lockdown from 9 March to 16 May 2020 have potentially influenced several activities, including ECs. OBJECTIVES: to assess the impact of COVID-19 outbreak on Italian ECs and their performance during the lockdown. DESIGN: cross-sectional survey. SETTING AND PARTICIPANTS: the survey was conducted in mid-June 2020 in Italy contacting all the 90 local ECs. MAIN OUTCOME MEASURES: amount and kind of activities performed during the lockdown, characteristics of submitted studies and adoption of standard protocols of evaluation of research applications during the pandemic. Chi-square test was used to estimate the differences between territories with higher incidence (HI) and lower incidence (LI) of COVID-19. RESULTS: 258 questionnaires were collected from 46 ECs that participated in the study. Ten were excluded due to missing substantial data. Responses were divided into two groups according to location of EC: the HI (125 responses) and the LI (123 responses). Seventy-five percent of the HI describe an increase in the number of studies submitted, while 53% of the LI does not (p=0.001). Due to the pandemic and its effects on research, the 15% of participants belonging to HI territories reported that consideration and respect of research-related and general ethical principles could have decreased, as well the adoption of standard protocols of evaluation of research applications. EC secretariats located in HI Regions moved to smart working more than in LI ones (75% vs 59%; p=0.001). Where the EC workload increased significantly, it was reported that it was impossible to perform an accurate analysis of the submitted documentation, with the effect of providing a favorable opinion to studies of not excellent quality, though always ensuring the respect of ethical principles and patients' safety. CONCLUSIONS: COVID-19 impact on ECs has been heavier in HI territories, but smart working has been effective in ensuring EC activities and the subsequent activation of clinical studies potentially useful to face the pandemic. Clear differences arise between ECs belonging to the Italian Regions that have recorded a HI of COVID-19 cases compared to those located in Regions with a LI of cases. In some EC members' perception, the high number of studies in the most affected Regions together with the emergency experienced during the lockdown may have exposed ECs to the risk of decreasing the adoption of ethical principles and standard protocols of evaluation of research applications.

Issues of gender in sport leadership: reflections from Sub-Saharan Africa

Globally, a gender gap in sport leadership exists despite global reforms, leadership and key strategic actions. This paper reports on the leadership dimension of the 2021 follow-up study to the 2014 baseline study on gender leadership and participation in sport within southern Africa. It reports on changes over time in selected sports (athletics, basketball, boxing, football, and judo as recorded in the 2014 study, with the addition of netball in the 2021 research) and within five countries (Lesotho, Malawi, South Africa, Zambia and Zimbabwe). A purposively selected sample group completed an online survey (N = 41), followed by structured interviews conducted with 45 decision makers from relevant government entities and national sport organisations. Findings indicate that Covid-19 had little effect on leadership composition across organisational types. Government entities spearheaded ‘gender reform' with 47.7% female representation at the executive level. National Olympic Committees had 24.1% women in leadership and national sport federations 27.7% with the latter showing an increase of 6.7% since 2014. Men dominated in sub-committees (62.2%) and emerged as leaders in netball – a sport featuring 98% female participation. Key recommendations address the gender gap in sport leadership from the regional level.

Assessing University Governance and Policies in Relation to the COVID-19 Pandemic

In response to the COVID-19 pandemic, universities around the globe have taken numerous extraordinary measures and implemented many changes to their strategic, operational, and academic activities. Currently, there is a transformation taking place from the emergency decision-making in the early stages of the pandemic towards reflection and resolution on how the past months can shape governance and strategy. Higher education institutions have been facing challenges with the alignment of their university governance for their strategic and operational plans. Presently, university leaders have prioritized risk management and financial management over all else. Unfortunately, due to these priorities, university responses to the pandemic took the top-down approach of management, rejecting the shared governance structures and collegial practices of the institutions. The pandemic has accelerated the openness to change by creating an emergency or steering response team led by university presidents and provosts, with sub-teams focusing on operations and other academic advisory groups working together to deal with the fast-rising scenarios. The consequence is a clear flow of information and strong communication across the institution, which sequentially builds on mechanisms to respond to the secondary effects of the pandemic. Moreover, higher education institutions are continuously facing challenges with their strategic alignment of business objectives in order to have a diverse educational system in response to the pandemic. "Assessing University Governance and Policies in Relation to the COVID-19 Pandemic" presents the latest research and studies investigating information on university governance and adapting previous, existing, and proposed models for the current pandemic. This book is comprised of chapters contributed by various leading international authors to discuss and analyze all aspects of university governance in relation to their impact on strategies in finance, sustainability, academic issues, research, faculty and students, leadership, campus, employment and recruitments, and more. This is an essential text for university presidents, strategic planning authorities in universities, college deans and academic department chairpersons, government authorities and policymakers, researchers, students, and academicians.

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.

A Survey on Methodological Issues of Clinical Research Studies Reviewed by Independent Ethic Committees during the COVID-19 Pandemic in Italy.

The struggle for information and the hasty search for answers caused by the COVID-19 pandemic threatened the possibility of lowering study quality, as well as ethical committees' review standards during the outbreak. Our investigation aimed to assess the impact of COVID-19 on the quality of clinical research studies submitted to Italian Ethics Committees in the period between April and July 2020. All 91 Italian ethics committees were contacted via email in order to collect anonymized information on the type and quality of COVID-19-related studies submitted to each committee during the study period. The present study summarizes the characteristics of the 184 study applications collected, pointing out, especially, how the quality of the study population and statistical analysis are crucial variables in determining the study approval. Nevertheless, despite the need for high-quality and open scientific information, especially exacerbated by this particular historical period, only a minority of the ethics committees (20.9%) agreed to share their data; such scarce participation, beyond biasing the representativeness of the results obtained by the present study, more importantly, hinders the broader goal of creating trust between researchers and the general public.