COVID-19 Vaccination: Guidance for Ethical, Informed Consent in a National Context.

This Guidance addresses the essential elements of informed consent to novel, provisionally registered COVID-19 vaccines which conform to the current definition of an investigational vaccine namely, lacking requirements for approval for full registration. 1 First, it addresses the ethical obtaining of informed consent in a setting of short and long term knowns and unknowns, by structuring the personal nature of informed consent into its twelve component parts. Second, as a guidance for family physicians, it explores reasonable medical concerns arising for individuals from both knowns and unknowns about COVID-19 disease and vaccines.Where there are waves of pandemic pressure impelling political, economic, social and public health forces to promote vaccination to health care providers and their patients, the necessary constituents of valid informed consent can be sublimated and possibly forfeited. This context of informed consent for COVID-19 vaccines is not unique to Australia. The analysis and presentation of international data by Australian Government agencies is a process occurring in all countries. Therefore, the Australian experience of consenting for vaccination is relevant to informed consent across the globe.The purpose of this Guidance is to assist personalised risk-benefit assessment for the informed consent of the vaccinee. Its aim is not to give a therapeutic guide nor to draw conclusions which can only rightly be drawn pertaining to each individual recipient in discussion with a health care provider. This is especially true in the setting of incomplete research where the many unknowns may be more significant for some than others. Since data is changing over time, national tables have not been used for specifics which the vaccine provider should access at the time of consultation.While we recommend the Guidance be read in conjunction with Government issued information, this Guidance will address specific fields relevant to informed consent which may not be addressed in those communications, but which a consenting individual as a person with their own values and experiences may wish to know. Aim: To address the requirements of ethical informed consent of the individual adult in the context of reasonable concerns pertaining to the unknowns and incomplete research attending novel, provisionally registered COVID-19 vaccines. Methodology: To elucidate what might be reasonable concerns for individuals considering vaccination, Public Assessment Reports of regulatory authorities (Food and Drug Administration and Therapeutic Goods Administration) and published trials of currently available vaccines were reviewed. International Covid-19 vaccine safety discussions were observed for peer-reviewed and, if necessary, pre-print references base. These references were studied for potential relevance to vaccine recipients. Vaccine Development Guidelines were also reviewed for pre-clinical requirements and compared with pre-clinical data presented at licensing. Missing information was requested from the Therapeutic Goods Administration (TGA).Pertinent unknowns were thereby identified as issues potentially relevant to fully informed consent, and compared with the content of standard Government-issued vaccine consent advice forms. Disparities were selected as relevant unknowns or reflecting incomplete research.Pertinent issues were incorporated into a twelve point structure for reasonable consideration to guide ethical inform consent. Paediatric COVID disease and vaccination are mentioned briefly due to paediatric vaccination being unapproved in Australia at the time of writing in under 12-year-olds, and exclusion of minors from phase III safety and efficacy trials. Conclusion: The provision of ethically obtained, fully informed consent is very pertinent to an investigational vaccine notwithstanding the pandemic context. To ascertain informed consent to the best of our ability, the gap between officially delivered information and reasonable concerns generated by knowns and relevant unknowns, can be addressed in a structured manner by physicians. Consent should not be coerced but be free of inducements and reprisals, respecting declarations of human rights, particularly given the investigational nature of COVID-19 vaccines. Each recipient requires adequate information to make their own judgment. The process of validly informed consent will therefore include discussion of concerns and of relevant information we do and do not yet have. Ethical informed consent should address those concerns as best is possible.

COVID-19 infection is related to differences in the use of personal protective equipment by orthopaedic specialist trainees caring for hip fracture patients during the second surge of COVID-19 in the North West of England.

INTRODUCTION: Personal protective equipment (PPE) may protect health-care workers from COVID-19 infection and limit nosocomial spread to vulnerable hip fracture patients. METHODS: We performed a cross-sectional survey amongst orthopaedic trainees to explore PPE practice in 19 hospitals caring for hip fracture patients in the North West of England. RESULTS: During the second wave of the pandemic, 14/19 (74%) hospitals experienced an outbreak of COVID-19 amongst staff or patients on the orthopaedic wards. An FFP3 respirator mask was used by doctors in only 6/19 (32%) hospitals when seeing patients with COVID-19 and a cough and in 5/19 (26%) hospitals when seeing asymptomatic patients with COVID-19. A COVID-19 outbreak was reported in 11/13 (85%) orthopaedic units where staff wore fluid resistant surgical masks compared to 3/6 (50%) units using an FFP3 respirator mask (RR 1.69, 95% CI 0.74-3.89) when caring for symptomatic patients with COVID-19. Similarly, a COVID-19 outbreak was reported in more orthopaedic units caring for asymptomatic patients with COVID-19 where staff wore fluid resistant surgical masks (12/14 (86%)) as compared to an FFP3 respirator mask (2/5 (40%)) (RR 2.14, 95% CI 0.72-6.4). CONCLUSION: Urgent re-evaluation of PPE use is required to reduce nosocomial spread of COVID-19, amongst highly vulnerable patients with hip fracture.

Safety of "hot" and "cold" site admissions within a high-volume urology department in the United Kingdom at the peak of the COVID-19 pandemic.

OBJECTIVES: To determine the safety of urological admissions and procedures during the height of the COVID-19 pandemic using "hot" and "cold" sites. The secondary objective is to determine risk factors of contracting COVID-19 within our cohort. PATIENTS AND METHODS: A retrospective cohort study of all consecutive patients admitted from March 1 to May 31, 2020 at a high-volume tertiary urology department in London, United Kingdom. Elective surgery was carried out at a "cold" site requiring a negative COVID-19 swab 72-hours prior to admission and patients were required to self-isolate for 14-days preoperatively, while all acute admissions were admitted to the "hot" site.Complications related to COVID-19 were presented as percentages. Risk factors for developing COVID-19 infection were determined using multivariate logistic regression analysis. RESULTS: A total of 611 patients, 451 (73.8%) male and 160 (26.2%) female, with a median age of 57 (interquartile range 44-70) were admitted under the urology team; 101 (16.5%) on the "cold" site and 510 (83.5%) on the "hot" site. Procedures were performed in 495 patients of which eight (1.6%) contracted COVID-19 postoperatively with one (0.2%) postoperative mortality due to COVID-19. Overall, COVID-19 was detected in 20 (3.3%) patients with two (0.3%) deaths. Length of stay was associated with contracting COVID-19 in our cohort (OR 1.25, 95% CI 1.13-1.39). CONCLUSIONS: Continuation of urological procedures using "hot" and "cold" sites throughout the COVID-19 pandemic was safe practice, although the risk of COVID-19 remained and is underlined by a postoperative mortality.