Ethical considerations for protecting the options of subjects in primary epidemic vaccine trials

Comments on an article by J. T. Monrad (see record 2020-61038-012). Monrad presented several issues about secondary vaccine trials. It lays out the case in which a vaccine has been tested through phases I-III and is being deployed. Subsequently, consideration is being given to conducting 'trials for another vaccine for the pathogen'. Monrad stated: 'In summary, we may say that researchers have strong prima facie reasons not to conduct a secondary vaccine trial.' Monrad discusses several factors meriting careful consideration about the need for developing and testing more than one vaccine: relative efficacy, length of immunity, adverse reactions (reactogenicity), ease of storage and administration, economic and logistical factors. What is not addressed are the ethical duties that exist when there are competing phase III vaccine candidates for COVID- 19. Ethically, a subject is allowed to quit a trial at any time. But how might this work in a vaccine trial with multiple candidates? If someone has received an experimental vaccine, they need to be informed of what to do should they wish to subsequently try an approved vaccine. But will companies and researchers with financial stakes in one vaccine readily disclose other options either initially or mid-trial? If a subject got experimental vaccine, there may be more of a chance of having an adverse immune reaction to an additional vaccine that is approved. So they may not wish to do anything. Thus, as part of all informed consents for phase three trials, participants need to be told that at the time some vaccine is approved, they will be told whether or not they received the test vaccine or the placebo so as to help participants make their decision as to whether to get another approved vaccine or not. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Erratum: Conducting clinical research in the era of the COVID-19 pandemic: Challenges and lessons for Speech-Language Pathology and Audiology research.

No abstract available.

Cell Therapy: cGMP Facilities and Manufacturing: Second Edition

This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility. © Springer Nature Switzerland AG 2009, 2022, Corrected Publication 2022.

Deploying Artificial Intelligence to Combat Covid-19 Misinformation on Social Media: Technological and Ethical Considerations

This paper reports on AI research into online misinformation pertaining to the COVID-19 pandemic within the Canadian context. This is part of our longer-term goal, i.e., development of a machine-learning tool to assist social media platforms, online service providers and government agencies in identifying and responding to misinformation on social media. We report on predictive accuracies accomplished by applying a combination of technologies, including a custom-designed web-crawler, The Dark Crawler, the Posit toolkit, and four different machine-learning models based on Naïve Bayes, Support Vector Machines, LibLinear and LibShortText. Overall, we found that Posit and LibShortText models showed higher levels of correlation to the pre-determined (manual and machine-driven) data classifications than the other machine-learning algorithms tested. We further argue that the harms associated with COVID-19 misinformation - e.g., the social and economic damage, and the deaths and severe illnesses - outweigh the right to personal privacy and freedom of speech considerations. © 2023 IEEE Computer Society. All rights reserved.

The Urgent Need for Healthcare Workforce Upskilling and Ethical Considerations in the Era of AI-Assisted Medicine.

This letter is in response to the article "Enhancing India's Health Care during COVID Era: Role of Artificial Intelligence and Algorithms". While the integration of AI has the potential to improve patient outcomes and reduce the workload of healthcare professionals, there is a need for significant training and upskilling of healthcare providers. There are ethical and privacy concerns related to the use of AI in healthcare, which must be accompanied by rigorous guidelines. One solution to the overburdened healthcare systems in India is the use of new language generation models like ChatGPT to assist healthcare workers in writing discharge summaries. By using these technologies responsibly, we can improve healthcare outcomes and alleviate the burden on overworked healthcare professionals.

TO BE fAIr: ETHICAL AND FAIR APPLICATION OF ARTIFICIAL INTELLIGENCE IN VIRTUAL LABORATORIES

In 1984, the film "The Terminator” predicted that a hostile Artificial Intelligence (AI) will threaten to extinguish humankind by 2029. Even though the real present is quite far from this post-apocalyptic scenario where AI rebels against its creator, a growing concern about the lack of ethical considerations in the use of AI is rapidly spreading, leading to the current "ethics crisis”. The lack of clear regulations is even more alarming considering that AI is becoming an integral part of new educational platforms. This follows the wave of digital transformation mainly induced by the Fourth Industrial Revolution, with advances in digitalization strategies, and the COVID-19 crisis, which forced education institutions worldwide to switch to e-learning. The appeal of AI is its potential to answer the needs of both educators and learners. For example, it can provide help grading assignments, enable tutoring opportunities, develop smart content, personalize and ultimately boost on-line learning. Although the "AI revolution” has great potential to improve and boost digital education, there are no clear regulations in place to ensure an ethical and fair use of AI. Therefore, this work aims to provide a comprehensive overview of the current concerns regarding fairness, accountability, transparency and ethics in AI applied to education, with specific focus on virtual laboratories. The main aspects that this work aims to discuss, and provide possible suggestions for, are: (i) ethical concerns, fairness, bias, equity, and inclusion;(ii) data transparency and digital rights, including data availability, collection, and protection;and, (iii) collaborative approach between disciplines. © 2022 SEFI 2022 - 50th Annual Conference of the European Society for Engineering Education, Proceedings. All rights reserved.

Sequential Vaccine Allocation with Delayed Feedback

In this work we consider the problem of how to best allocate a limited supply of vaccines in the aftermath of an infectious disease outbreak by viewing the problem as a sequential game between a learner and an environment (specifically, a bandit problem). The difficulty of this problem lies in the fact that the payoff of vaccination cannot be directly observed, making it difficult to compare the relative effectiveness of vaccination on different population groups. Currently used vaccination policies make recommendations based on mathematical modelling and ethical considerations. These policies are static, and do not adapt as conditions change. Our aim is to design and evaluate an algorithm which can make use of routine surveillance data to dynamically adjust its recommendation. We evaluate the performance of our approach by applying it to a simulated epidemic of a disease based on real-world COVID-19 data, and show that our vaccination policy was able to perform better than existing vaccine allocation policies. In particular, we show that with our allocation method, we can reduce the number of required vaccination by at least 50% in order to keep the peak number of hospitalised patients below a certain threshold. Also, when the same batch sizes are used, our method can reduce the peak number of hospitalisation by up to 20%. We also demonstrate that our vaccine allocation does not vary the number of batches per group much, making it socially more acceptable (as it reduces uncertainty, hence results in better and more interpretable communication). © 2022 International Joint Conferences on Artificial Intelligence. All rights reserved.

"Ethical considerations for epidemic vaccine trials": Correction

Reports an error in "Ethical considerations for epidemic vaccine trials" by Joshua Teperowski Monrad (Journal of Medical Ethics: Journal of the Institute of Medical Ethics, 2020[Jul], Vol 46[7], 465-469). In the original article, in a section the term 'white' should read 'non-white'. The correction is given in the erratum. (The following of the original article appeared in record 2020-61038-012). Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

CRISPR-Cas9: A History of Its Discovery and Ethical Considerations of Its Use in Genome Editing.

The development of a method for genome editing based on CRISPR-Cas9 technology was awarded The Nobel Prize in Chemistry in 2020, less than a decade after the discovery of all principal molecular components of the system. For the first time in history a Nobel prize was awarded to two women, Emmanuelle Charpentier and Jennifer Doudna, who made key discoveries in the field of DNA manipulation with the CRISPR-Cas9 system, so-called "genetic scissors". It is difficult to overestimate the importance of the technique as it enables one not only to manipulate genomes of model organisms in scientific experiments, and modify characteristics of important crops and animals, but also has the potential of introducing revolutionary changes in medicine, especially in treatment of genetic diseases. The original biological function of CRISPR-Cas9 system is the protection of prokaryotes from mobile genetic elements, in particular viruses. Currently, CRISPR-Cas9 and related technologies have been successfully used to cure life-threatening diseases, make coronavirus detection tests, and even to modify human embryo cells with the consequent birth of babies carrying the introduced modifications. This intervention with human germplasm cells resulted in wide disapproval in the scientific community due to ethical concerns, and calls for a moratorium on inheritable genomic manipulations. This review focuses on the history of the discovery of the CRISPR-Cas9 system with some aspects of its current applications, including ethical concerns about its use in humans.

Different patients, different preferences: A multicenter assessment of patients' personality traits and anxiety in shared decision making.

OBJECTIVE: Patient-centered care and shared decision making (SDM) are generally recognized as the gold standard for medical consultations, especially for preference-sensitive decisions. However, little is known about psychological patient characteristics that influence patient-reported preferences. We set out to explore the role of personality and anxiety for a preference-sensitive decision in bladder cancer patients (choice of urinary diversion, UD) and to determine if anxiety predicts patients' participation preferences. METHODS: We recruited a sample of bladder cancer patients (N = 180, primarily male, retired) who awaited a medical consultation on radical cystectomy and their choice of UD. We asked patients to fill in a set of self-report questionnaires before this consultation, including measures of treatment preference, personality (BFI-10), anxiety (STAI), and participation preference (API and API-Uro), as well as sociodemographic characteristics. RESULTS: Most patients (79%) indicated a clear preference for one of the treatment options (44% continent UD, 34% incontinent UD). Patients who reported more conscientiousness were more likely to prefer more complex methods (continent UD). The majority (62%) preferred to delegate decision making to healthcare professionals. A substantial number of patients reported elevated anxiety (32%), and more anxiety was predictive of higher participation preference, specifically for uro-oncological decisions (ß = 0.207, p < 0.01). CONCLUSIONS: Our findings provide insight into the role of psychological patient characteristics for SDM. Aspects of personality such as conscientiousness influence treatment preferences. Anxiety contributes to patients' motivation to be involved in pertinent decisions. Thus, personality and negative affect should be considered to improve SDM.

Conducting clinical research in the era of the COVID-19 pandemic: Challenges and lessons for Speech-Language Pathology and Audiology research.

BACKGROUND:  The novel coronavirus disease 2019 (COVID-19) presented new and unanticipated challenges to the academic training and performance of clinical research at undergraduate and postgraduate levels of training. This highlighted the need for reimagining research designs and methods to ensure continued generation of knowledge - a core function of a research-intensive university. Whilst adhering to government regulations geared towards protecting both the research participants and researchers, innovative research methods are required. OBJECTIVE:  The purpose of this scoping review is to explore published evidence on innovative clinical research methods and processes employed during COVID-19 and to document challenges encountered and lessons that the fields of Speech-Language Pathology and Audiology can learn. METHODS:  Electronic bibliographic databases including Science Direct, PubMed, Scopus, MEDLINE, ProQuest were searched to identify peer-reviewed publications, published in English, between 2019 and 2021, related to innovative clinical research methods and processes applied where in-person contact is regulated. RESULTS:  Significant challenges with conducting research in the COVID-19 era were identified, with important lessons learned and numerous opportunities that have relevance for this pandemic era and beyond. These findings are presented under 10 themes that emerged that highlight important considerations for research methods and processes during a pandemic and beyond. The findings of this study also raise implications for telehealth from which low- and middle-income countries (LMICs), where resource challenges exist, can benefit. CONCLUSION:  Challenges and opportunities identified in this review have relevance for the field of Speech-Language Pathology and Audiology as far as current and future (beyond COVID-19) clinical research planning is concerned.

Ethical Considerations of Distributed Participatory Design with Children

In this workshop, we invite researchers, practitioners and designers to reflect on ethical issues arising from Distributed Participatory Design (DPD) research with children. As participatory design research practices require rethinking and innovative adaptation in light of the COVID-19 pandemic, distributed, asynchronous and online (D)PD approaches may provide solutions to participation barriers. However, in light of this adaptation, additional ethical complexities may arise. Ongoing collaborative discussion is required to identify and address the different types of ethical issues which may arise when planning and conducting DPD projects with children. This workshop builds on previous workshops held at IDC 2021 and 2020, which provided insights into developing a protocol for a world-wide DPD project with children. © 2022 Owner/Author.

COVID-era sociolinguistics: introduction to the special issue

In the 18 months that have passed since COVID-19 was declared a global pandemic, linguists around the world have had to grapple with the practical and ethical issues that arose from trying to collect data in a safe and remote way while participants are experiencing an acute disaster. The current collection presents insights from a number of sociolinguistic research projects that were either initiated in response to the pandemic or that adjusted their research methods mid-trajectory. A concluding discussion article underscores that the honest reflections and concrete suggestions in this collection will remain relevant beyond the COVID-19 pandemic. They will be of value to any (socio)linguist who is navigating the ethics of fieldwork in uncertain or traumatic contexts, who is recruiting and retaining participants via remote means, or who is figuring out how to rapidly change their data collection methods.

Disparities in telemedicine during COVID-19.

BACKGROUND: Oncology rapidly shifted to telemedicine in response to the COVID-19 pandemic. Telemedicine can increase access to healthcare, but recent research has shown disparities exist with telemedicine use during the pandemic. This study evaluated health disparities associated with telemedicine uptake during the COVID-19 pandemic among cancer patients in a tertiary care academic medical center. METHODS: This retrospective cohort study evaluated telemedicine use among adult cancer patients who received outpatient medical oncology care within a tertiary care academic healthcare system between January and September 2020. We used multivariable mixed-effects logistic regression models to determine how telemedicine use varied by patient race/ethnicity, primary language, insurance status, and income level. We assessed geospatial links between zip-code level COVID-19 infection rates and telemedicine use. RESULTS: Among 29,421 patient encounters over the study period, 8,541 (29%) were delivered via telemedicine. Several groups of patients were less likely to use telemedicine, including Hispanic (adjusted odds ratio [aOR] 0.86, p = 0.03), Asian (aOR 0.79, p = 0.002), Spanish-speaking (aOR 0.71, p = 0.0006), low-income (aOR 0.67, p < 0.0001), and those with Medicaid (aOR 0.66, p < 0.0001). Lower rates of telemedicine use were found in zip codes with higher rates of COVID-19 infection. Each 10% increase in COVID-19 infection rates was associated with an 8.3% decrease in telemedicine use (p = 0.002). CONCLUSIONS: This study demonstrates racial/ethnic, language, and income-level disparities with telemedicine use, which ultimately led patients with the highest risk of COVID-19 infection to use telemedicine the least. Additional research to better understand actionable barriers will help improve telemedicine access among our underserved populations.

Be Careful Who You Follow: The Impact of the Initial Set of Friends on COVID-19 Vaccine Tweets

Although Twitter is regarded as one of the most potent sources of vaccine-related disinformation, relatively little is known about how Twitter constructs timelines for individual users. In this work, we examine the composition of the Twitter timeline conditioned on the initial selection of friends. We illustrate our method by analyzing how the initial selection of friends impacts the number of pro- and anti-vaccination information present in the timeline. Our experiment clearly shows the disproportionate prevalence of anti-vaccination content seeping into Twitter timelines even for accounts initialized with explicitly pro-vaccination friends. We also discuss ethical considerations of using automated bots for research purses in a social network environment. © 2021 ACM.

An overview of current COVID-19 clinical trials and ethical considerations editorial.

Not applicable.

[Comment] Ethical and practical considerations on cancer recommendations during COVID-19 pandemic.

National and international authorities and societies have recently published important cancer treatment recommendations in order to propose extra measures that should be taken during the COVID-19 pandemic, such as prioritisation of intend-to-cure treatments and younger patients, omission of non-urgent cases, and reduction of personnel present. These measures raise important ethical considerations, since they prioritise protection of Health Systems and Professionals without seemingly taking cancer patient feelings of stress into consideration. This could lead to an erosion of the physician-patient relationship, which is considered the core element of medical ethics. Moreover, they raise practical concerns about the continuous education of Health Professionals, the status of reference centres and the evaluation of the hitherto cancer treatments.