Challenges for ethics committees in biomedical research governance: Illustrations from China and Australia

In this paper, the evolution of the ethics committees for health research, their history, membership, and function in China and Australia is described. Investigators in each country compared the history and governance of their ethical systems based on the published evidence rather than personal opinions. Similarly, examples of challenges were selected from the literature. In both countries, the aim was to maximize the social benefits of research and minimize the risk imposed on the participants. Common challenges include maintaining independence, funding and delivering timely ethical reviews of the research projects. These challenges can be difficult where research ethics committees rely on voluntary contributions and lack a strong resource base. They must adapt to the increasingly rapid pace of research as well as the technological sophistication. Population health research can challenge the conventional views of consent and privacy. The principles of the sound ethical review are common in both countries; governance arrangements and operational procedures, however, can differ, reflecting the cultural values and norms of their host countries and in respect of legal environments. By studying the evolution and function of ethics committees in the two countries, we established the differences in the governance and health systems, while similar ethical objectives helped sustain collaborative research.

Experience of the surgical team in COVID-19 in a tertiary care hospital in Pakistan.

Objective: To analyse experience of the surgical team in COVID-19 in a tertiary care hospital in Pakistan. Study Design: Analytical Observational study. Setting: Department of Surgery, Tertiary Care Hospital Sialkot, Pakistan. Period: March to September 2020. Material & Methods: After the permission of ethical review committee (ERC/12/2020), data was collected by all four groups surgeons, Resident and internees, paramedical staff and other staff of surgical teams. A simple, 6 question-questionnaire, manually typed, was distributed to all members willing to complete and return the questionnaire. Data was analyzed by using SPSS-23. Results: Majority (91.27%) of the surgical team members got satisfactory training to handle with Covid-19 Cases. The 80 % was in fear to contract the disease while working in isolation and COVID-19 wards and about (76%) were well adjusted to their newly assigned duties. About 85% of surgical team members experienced prolong duty hours (12 hours a day) related stress and similar percentage participated in the management of surgeries done during this period. Conclusion: Surgical Team participated and adapted to meet the newly assigned duties to lookafter the isolation and COVID-19 wards. Team members experienced stress and fear of contracting disease was a matter of concern. However, it has taken care of all trauma, life-threatening emergencies and oncological cases adhering to use of principles of use of PPEs.

IMMUNOEXPRESSION OF CD-10 IN BASAL CELL CARCINOMA AND SQUAMOUS CELL CARCINOMA OF HEAD AND NECK

Objective: To compare the expression of CD-10 in basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Study Design: Comparative cross-sectional study. Place and Duration of Study: Armed Forces Institute of Pathology, Rawalpindi, from Jun 2016 to Jun 2017. Methodology: After taking ethics approval from the ethical review committee AFIP, previously diagnosed, thirty-eight cases of each basal cell carcinoma and squamous cell carcinoma were taken from the histopathology department of Armed Forces Institute of Pathology, Rawalpindi. CD-10 was applied according to standard protocol. The intensity of the CD-10 expression is assessed and categorized into three groups. CD-10 expression less than 10% in the tumour cell was taken as negative (-), 10 to 50% staining was taken as positive (+) and greater than 50% staining in tumour cells was taken as strong positive (++). Results: Out of the total 76 cases included in the study, 9 (24%) were strongly positive (++) whereas 20 (52.6%) were positive (+) and 9 (23.7%) were negative (-) for CD-10 expression. Out of the total 38 cases of SCC 4 (11%) cases showed positive CD-10 expression and 34 (89%) showed negative (-) results. A significant association (p-value <0.001) was seen when CD-10 expression in BCC was compared with SCC. Conclusion: CD-10 expression was higher in basal cell carcinoma when compared to squamous cell carcinoma in which CD-10 expression was very low/absent, hence CD-10 can serve as a useful adjunct marker in differentiating between basal cell carcinoma and squamous cell carcinoma in problematic cases.

The Canadian COVID-19 Experiences Survey: Study Protocol

Introduction: Vaccine hesitancy remains a significant challenge even through the second year of the COVID-19 pandemic, even in the most well-supplied countries. In Canada, despite high vaccine uptake of the first wave of vaccinations, there are signs of declining uptake of vaccine boosters. Likewise, recommended COVID-19 mitigation behaviors such as mask wearing, distancing, and hand hygiene have been challenging to sustain over the pandemic. The aim of the Canadian COVID-19 Experiences Survey (CCES) is to use a variety of social-cognitive and neurocognitive variables to predict the uptake and sustaining of vaccinations, boosters, and COVID-19 mitigation behaviors across the Canadian population through the second and third years of the pandemic. Methods and analyses: Vaccine hesitant and fully vaccinated adults (N=1,958) were recruited to the 35-minute CCES web survey, using quota sampling, with sampling weights being applied to ensure representativeness of the Canadian population. In Wave 1, conducted between 28 September and 21 October, 2021, 43.3% (n=848) reported not having received any vaccinations, 50.2% (n=983) reported being fully vaccinated, and 6.5% (n=127) reported having had one vaccination with no intention of having a second dose. Social cognitive variables being measured include intentions, beliefs, reasons, and attitudes. Neurocognitive variables being measured include executive dysfunction, delay discounting, and temporal orientation. Other key variables being measured include trust in science, political orientation, mood, and long-COVID symptoms. Ethics and dissemination: The CCES has received ethical review and approval by the University of Waterloo Office of Research Ethics. Findings will be disseminated through peer-reviewed publications and presentations at scientific meetings.

An ethical review on the search for performance: evidence-based nutrology and the use without indication of anabolic steroids

This study aimed to evaluate what is new in the controversial use of testosterone, as an indication in pathologies such as hypogonadism or its use by athletes and bodybuilders in search of performance. Much is said about the subject and many myths were created without any scientific foundation, one of the objectives of the monograph is to show that when there is a precise clinical indication, testosterone is necessary and extremely beneficial to the patient. It was evaluated in current literature through books and articles, advances in physiology, regulation, treatment of late adult hypogonadism, incidence of use and the most common analogues used by athletes, the harms and benefits expected from the use of the hormone and especially what we have again on cardiovascular safety in testosterone use. After an extensive review, it is still not possible to affirm all the benefits and harms of using the hormone, many old studies are disputed in new studies and even presented results opposite to what was previously believed.

The Royal Bay Bakery

Theoretical basis There are a range of business evaluation methods that can be applied to determine the value of a business. Ultimately, the valuation of a business is what someone will pay for it when the sale transaction is completed. When determining the value of their own business, business owners are often influenced by how hard they have worked to start and build up the business, what the business represents and their projections for the future (Hawkey, 2017). This case provides an opportunity for students to consider exit strategy planning and how to establish a fair market price for a business, how to consider the value of good will and, in particular, the value associated with running an environmentally conscious bakery operation. The trend toward environmental responsibility and green practices in the small business community has started to have an impact on the value of small companies (Inc. 2021). Finally, the case raises the issue of the personal values of the owners and the related implication of finding a buyer with similar values and interests for a bakery business. Research methodology This case was field researched and the company and individuals are not disguised. One of the authors interviewed the two owners of The Royal Bakery. There were three interviews over a six-month period. The interviews were audio recorded. An ethical review for this research was completed at the co-authors’ institution, and a case release was signed. Case overview/synopsis The Royal Bay Bakery presents Dave Grove and Gwen Snyder who, with over 30 years in the bakery business, had started to consider next steps toward retirement. Royal Bay Bakery was profitable and growing. As they prepared to retire and sell the business, they were unsure about how to maximize the value of the business. They also wanted to find a buyer who would recognize and continue their business commitment to environmental and social sustainability. Complexity academic level This case may be taught in a class on exit strategies for small family businesses in the context of a small business course. This case is appropriate for both undergraduate seniors and graduate students. The case may be used to help students understand small business valuation, family ownership and exit strategies and environmental practices in small businesses. Instructors may choose to emphasize specific conceptual tools, including SWOT analysis, and business valuation. The case may also be used to reinforce applications of exit strategy for small, family-owned businesses.

The Ethics of Innovation: Ethical Decision-Making and Review for Field Studies and Projects Targeting Dogs and Cats

To date, independent ethical oversight of many companion animal welfare initiatives has been limited and, in some instances, inadequate. Beyond a blurred line between “innovation” and “research,” the nature of the work conducted in animal welfare projects is often poorly aligned with established institutional ethical review structures, which are designed for research involving humans or research involving animals and are also focused on industry and academic institutions. This commentary details the struggle of one United States-based nonprofit organization to find ethical guidelines and support for conducting non-traditional field-based animal welfare studies, and subsequent experience establishing an Ethical Review Board to evaluate organizational initiatives. The commentary discusses member selection, materials and processes, and lessons and learnings from the creation and use of an Ethical Review Board. Sharing content of the ethical review process, as well as challenges and learnings from it, is intended to support other organizations and individuals seeking to ensure that innovation for animal welfare consistently meets high ethical standards.

Tb-practecal: Study Protocol for a Randomised, Controlled, Open-label, Phase II-III Trial to Evaluate the Safety and Efficacy of Regimens Containing Bedaquiline and Pretomanid for the Treatment of Adult Patients With Pulmonary Multidrug Resistant Tuberculosis

BackgroundGlobally rifampicin-resistant tuberculosis disease affects around 460 000 people each year. Current recommended regimens are 9-24 months duration, have poor efficacy and carry significant toxicity. A shorter, less toxic and more efficacious regimen would improve outcomes for people with rifampicin-resistant tuberculosis. MethodsTB-PRACTECAL is an open-label, randomised, controlled, phase II/III non-inferiority trial evaluating the safety and efficacy of 24 week regimens containing bedaquiline and pretomanid to treat rifampicin resistant tuberculosis. Conducted in Uzbekistan, South Africa and Belarus, patients aged 15 and above with rifampicin resistant pulmonary tuberculosis and requiring a new course of therapy are eligible for inclusion irrespective of HIV status. In the first stage, equivalent to a phase IIB trial, patients are randomly assigned one of four regimens, stratified by site. Investigational regimens include oral bedaquiline, pretomanid and linezolid. Additionally, two of the regimens also include moxifloxacin (arm 1) and clofazimine (arm 2) respectively. Treatment is administered under direct observation for 24 weeks in investigational arms and 36 to 96 weeks in the standard of care arm. The second stage of the study is equivalent to a phase III trial, investigating the safety and efficacy of the most promising regimen/s. The primary outcome is the percentage of unfavourable outcomes at 72 weeks post randomisation. This is a composite of early treatment discontinuation, treatment failure, recurrence, lost to follow up and death. The study is conducted in accordance with ICH-GCP and full ethical approval was obtained from Médecins sans Frontières ethical review board, London School of Hygiene and Tropical Medicine ethical review board as well as ERBs and regulatory authorities at each site. DiscussionTB-PRACTECAL is an ambitious trial using adaptive design to accelerate regimen assessment and bring novel regimens that are effective and safe to patients quicker. The trial took a patient-centred approach, adapting to best practice guidelines throughout recruitment. The implementation faced significant challenges from the COVID-19 pandemic. The trial was terminated early for efficacy on the advice of the DSMB and will report on data collected up to end of recruitment and additionally, the planned final analysis at 72 weeks after end of recruitment. Trial registrationClinicaltrials.gov registration number NCT02589782