Ethics to inform decision making

Ethical considerations are an important part of decision-making processes at each stage of an infectious disease emergency. This chapter introduces the notion that ethical thinking begins with a process of clarification of the values and moral principles at work in decision-making, and evolves a set of procedures to reason morally in each decision-making context. Certain moral concepts are necessary to highlight in the ethics of infectious disease emergencies, particularly ideas of autonomy, beneficence, and justice. The chapter then works through the different phases of emergency response, introducing the key ethical issues and questions at each phase. Ethical thinking does not provide single ideal answers, but enables decision-makers to identify and articulate the value components of decisions, so as to balance, for example, considerations of individual liberties with public health outcomes in an emergency. Elaborate processes of consideration and consultation are often in tension with the challenges of making critical decisions rapidly and under uncertainty. That is why trustworthy institutions and continued community engagement are crucial, particularly in culturally diverse settings. The chapter concludes by emphasising the need for ongoing ethical reflection and preparedness to better manage future outbreaks, advocating for a sustained social conversation on the balance between protecting public health and respecting individual rights

Comparative Assessment of Efficiency and Obturation Quality of Kedo-S Plus and Kedo-SH Files During Pulpectomy in Primary Mandibular Molars: An Observational Study

Aim: This research aims to evaluate and compare the efficiency and obturation quality of Kedo-S plus and Kedo-SH files during pulpectomy in deciduous molars. Materials and Methods: The study involved children aged 4–8 years who required pulpectomy for thirty deciduous lower molars. They were randomly divided into two groups: Group I used Kedo-SH files, and Group II used Kedo-S Plus files. A stopwatch recorded the instrumentation time, while Coll and Sadrian criteria assessed the obturation quality. Statistical analysis was performed with the independent t-test and Chi-square test. Results: The mean instrumentation time for Group I was 190.1 seconds, significantly longer than Group II's 110.1 seconds, with a p-value of < 0.0001. However, no statistically significant differences were found in obturation quality between the two groups. Conclusion: The Kedo-S Plus group demonstrated reduced instrumentation time compared to the Kedo-SH group while maintaining comparable obturation quality

Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023

Earlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten years we have seen a vast expansion of the number of countries in Africa performing CHIM studies, as well as a growing number of different challenge organisms being used. Community and public engagement with assiduous ethical and regulatory oversight has been central to successful introductions and should be continued, in more community-led or community-driven models. Valuable initiatives for regulation of CHIMs have been undertaken but further capacity building remains essential

What information and the extent of information research participants need in informed consent forms: a multi-country survey

Background: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. Methods: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). Results: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be \u27moderately important\u27 to \u27very important\u27 for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). Conclusions: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF

Ethics preparedness for infectious disease outbreaks research in India: A case for novel coronavirus disease 2019

In the past decade, India has witnessed several outbreaks/epidemics (such as H1N1, H5N1, avian influenza, Ebola, SARS, Zika and Nipah) which were successfully tackled with appropriate research[1]. India with its 1.3 billion population residing in densely populated areas in resource-constrained environments is at constant risk for any emerging outbreaks that can cause rapid spread of infection. There have been considerable investments in preparedness for rapid responses and to create a conducive environment to undertake therapeutic or disease prevention research. Research is needed when the outbreak is ongoing or after it has subsided