Consent For Vaccination Research Articles

Vaccine uptake and consent: what has changed since COVID-19?

Vaccine uptake and consent: what has changed since COVID-19?

Lowering the Age of Consent for Vaccination to Promote Pediatric Vaccination: It's Worth a Shot.

This paper challenges historically preconceived notions surrounding a minor's ability to make medical decisions, arguing that federal health law should be reformed to allow minors with capacity as young as age 12 to consent to their own Centers for Diseases Control and Prevention (CDC)-approved COVID-19 vaccinations. This proposal aligns with and expands upon current exceptions to limitations on adolescent decision-making. This analysis reviews the historic and current anti-vaccination sentiment, examines legal precedence and rationale, outlines supporting ethical arguments regarding adolescent decision-making, and offers rebuttals to anticipated ethical counterarguments.

Minor Consent for Vaccination: Ethically Justified, Politically Fraught.

Policies allowing some minors to consent to receive recommended vaccines are ethically defensible. However, a policy change at the federal level expanding minor consent for vaccinations nationwide risks triggering a political backlash. Such a move may be perceived as infringing on the rights of parents to make decisions about their children's health care. In the current post-COVID environment of heightened anti-vaccination activism, changes to minor consent laws may be unadvisable, and policy makers should proceed with caution.

Feline Injection-Site Sarcoma and Other Adverse Reactions to Vaccination in Cats.

Vaccine-associated adverse events (VAAEs), including feline injection-site sarcomas (FISSs), occur only rarely but can be severe. Understanding potential VAAEs is an important part of informed owner consent for vaccination. In this review, the European Advisory Board on Cat Diseases (ABCD), a scientifically independent board of feline medicine experts, presents the current knowledge on VAAEs in cats, summarizing the literature and filling the gaps where scientific studies are missing with expert opinion to assist veterinarians in adopting the best vaccination practice. VAAEs are caused by an aberrant innate or adaptive immune reaction, excessive local reactions at the inoculation site, an error in administration, or failure in the manufacturing process. FISS, the most severe VAAE, can develop after vaccinations or injection of other substances. Although the most widely accepted hypothesis is that chronic inflammation triggers malignant transformation, the pathogenesis of FISS is not yet fully understood. No injectable vaccine is risk-free, and therefore, vaccination should be performed as often as necessary, but as infrequently as possible. Vaccines should be brought to room temperature prior to administration and injected at sites in which FISS surgery would likely be curative; the interscapular region should be avoided. Post-vaccinal monitoring is essential.

Vaccination in pregnancy: Healthcare provider attitudes and practices.

To assess provider attitudes and practices regarding vaccination in pregnancy to discern strategies to increase vaccination rates in pregnancy, given that in the USA, various healthcare organizations recommend that pregnant individuals be vaccinated against influenza, pertussis, and SARS-CoV-2, but vaccination rates among gravidas remain suboptimal across these vaccines. An Institutional Review Board-approved survey was disseminated to obstetric healthcare providers by email from June through October 2021. Questions assessed provider demographics, attitudes, and practices surrounding vaccination in pregnancy. A total of 192 providers consented, 179 initiated the survey, and 153 completed it entirely. Statistical software (SAS) was used to perform descriptive statistics. All providers strongly agreed/agreed that all pregnant individuals should receive vaccines in pregnancy. Following patient vaccination consent, 13% reported needing to refer patients to alternative sites for vaccine administration. Following patient vaccination decline, 13% did not determine reasons for refusal, 30% did not re-counsel at subsequent visits, and 92% did not ask another staff member to counsel the patient. Despite provider support for maternal immunization, uptake of vaccines in gravidas remains suboptimal, demonstrating a gap between provider recommendations and patient uptake. These data highlight opportunities for intervention regarding counseling and vaccine availability to increase vaccine uptake in pregnancy.

Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management.

Informing patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was evident when the medical personnel at the vaccination centers were provided with informed consent forms that did not respect the existing legal requirements. In addition, the protocol for persons seeking vaccination stated that the patient was supposed to receive the informed consent form from the receptionist in order to read and sign it. We analyzed the legal implications and the malpractice litigation risk associated with this practice. Due to essential deficiencies and in the absence of an official enactment of new regulations, we conclude that the vaccination consent process did not comply with the legal requirements. Implications include medical personnel's legal liability, loss of malpractice insurance coverage, and public mistrust that may have contributed to a low vaccination rate. Given the potential of future pandemics or other health crises, this may be a valuable lesson for developing better legal strategies.

香港抗疫的倫理焦點

LANGUAGE NOTE | Document text in Chinese; abstract also in English.
 本文回顧及討論2021年1月至2022年4月COVID-19疫情期間香港抗疫中曾在公共領域提出或引起關注的倫理問題。新型的傳染病是複雜和具有不確定的挑戰，COVID-19全球大流行引起的倫理問題有普世的性質，但亦必須結合本地具體的情況討論。作者對其中的倫理焦點提出觀察分析，包括接種COVID-19疫苗的知情同意程序及其局限性，以及為精神上無行為能力的老年人接種疫苗決定的特殊挑戰。
 This article reviews and discusses ethical issues that emerged in the public realm in the first two years of the COVID-19 pandemic in Hong Kong, between January 2021 and March 2022. Emerging infectious diseases are complex and bring about uncertain challenges. Although many of the ethical issues during the pandemic were universally experienced, it is important to understand them within the local contexts in which they arose. The paper reports on observations related to some of these ethical issues, namely, the process of informed consent for COVID-19 vaccination and its limitations, and the challenge of arriving at vaccination decisions for mentally incapacitated elders.

Analysis of the Implementation of Informed Consent COVID-19 Vaccination in the Semarang City Region

Background : In the data analysis report it was found that in more than 80 countries the number of deaths due to COVID-19. The vaccine in Semarang City has been carried out, the Semarang City Health Service noted, there are 1,216,650 people who have received the first and second doses of the COVID-19 vaccine. The use of informed consent in the COVID-19 vaccine is still very low. It was found that 80% of COVID-19 vaccines used incomplete informed consent in every medical action. The purpose of this study was to determine the implementation of informed consent for COVID-19 vaccination in the Semarang City Region.
 Materials and Methods: The carried out by means of a sampling non-probability sampling technique wasusing purposive sampling, namely a sampling technique with certain considerations made by the researchers themselves, based on characteristics, namely that they had already done a second dose of vaccine and also with the characteristics of the population that had been previously known. The sample is 100 people.
 Results: Informed consent was explained to the patient, not all were informed, because there were still things that had not been explained, such as procedures for action, previous medical history. Informed consent of the COVID-19 vaccine was not given in the first and second doses. However, the majority are given in the first dose. The information provided by health workers at the time of vaccinating COVID-19 did not provide a complete explanation. The explanation to the patient is enough to explain what is important and more orally.
 Conclusion: The implementation of COVID-19 vaccination can be carried out on men and women aged 18-60 years, the implementation of informed consent for COVID-19 vaccination is not in accordance with the applicable laws and regulations, namely the place is not in the right place. give informed consent for the COVID-19 vaccination, the information in the informed consent is still incomplete, so it has not been fully informed to patients. It is recommended to evaluate the implementation of informed consent to see the suitability of its implementation with the laws and regulations.

Importance of human papillomavirus vaccination leaflets focusing on the safety profile targeted pediatricians in Japan

ObjectivesTo investigate the association between providing leaflets to support pediatricians in explaining the safety of the human papillomavirus (HPV) vaccine and mother’s decision to vaccinate their daughters in Japan. MethodsIn this cross-sectional study, we conducted a survey of mothers to evaluate the effect of leaflets that were created to support pediatricians in explaining the safety profile of the HPV vaccine. Mothers who provided consent for vaccination before receiving an explanation were excluded from the study. The primary outcome was the mother’s decision to vaccinatetheir daughters with the HPV vaccine after receiving an explanation from pediatricians using our leaflets. ResultsAmong 161 eligible mothers, 101 decided on HPV vaccination (decided group) and 60 did not (decided against group). There was no difference in the maternal background between the 2 groups. The decided group had a significantly more positive impression of the leaflets than the undecided group. In multivariable logistic regression analysis, a detailed explanation for possible adverse events and specific solutions to them was associated with the mother's decision to have their daughters vaccinated (odds ratio 2.35, 95% confidence interval 1.02–5.44), but not the pathology of cervical cancer and the HPV vaccination process. ConclusionLeaflets emphasizing an explanation of adverse events may contribute to mothers’ decision making for HPV vaccination.

Diminished capacity to make treatment decision for COVID-19 vaccination in schizophrenia.

Recent evidence suggests that people with schizophrenia are at high risk for severe COVID-19 and should be prioritized for vaccination. However, impaired decision-making capacities could negatively affect the uptake of COVID-19 vaccination in this population. Capacity to consent to COVID-19 vaccination was assessed in 80 outpatients with schizophrenia. Using the MacArthur Competence Assessment Tool for Treatment, 56.3% of the sample were classified as having diminished capacity to consent to the vaccination. Diminished capacity to consent to COVID-19 vaccination was associated with lower vaccination rates, poorer cognition and higher level of psychotic symptoms. Developing interventions for enhancing informed consent for vaccination is urgent within this population.

State Versus Adolescent Override for Parental Refusals to Vaccinate Against COVID-19.

State Versus Adolescent Override for Parental Refusals to Vaccinate Against COVID-19.

COVID-19 Vaccine Hesitancy Among Deployed Personnel in a Joint Environment.

ABSTRACTIntroductionIn the United States, vaccine hesitancy has been identified as a major barrier to vaccination against COVID-19, but attitudes toward COVID-19 vaccination among military personnel are not well understood. We evaluated the prevalence and correlates of COVID-19 vaccine consent or refusal among deployed personnel in a joint environment.Materials and MethodsDeidentified data were retrospectively extracted from the electronic medical record of the Military Health System in May 2021. All personnel currently assigned to the deployment area of operations were included in the analysis if their choice to receive the vaccine was known. Personnel characteristics were compared by vaccine acceptance status using chi-square tests, Fisher’s exact tests, or correlation coefficients. This analysis was exempted from Institutional Review Board review.ResultsThe sample included 1,809 individuals, primarily members of the Army (72%) and members of Reserve (53%) or National Guard (27%) units. In the overall sample, 61% accepted the vaccine, with vaccine acceptance rates being lowest among Black or African American personnel (54%; P = .03 for comparison across racial groups) and members of Reserve or National Guard units (59%; P < .001 for comparison by component). No differences in vaccine acceptance were found according to sex or health status (including prior COVID-19 infection).ConclusionsOverall vaccine acceptance was greater among deployed military personnel than that reported in the U.S. population as a whole. However, lower vaccine acceptance among personnel from marginalized populations suggests a need to ensure that all service members have sufficient opportunities to have a frank and ongoing discussion with health care providers to address concerns related to vaccination. Additionally, lower vaccine acceptance among Reserve and National Guard personnel indicates a need for innovative educational approaches to counter vaccine hesitancy in the premobilization phase of deployment.

Clinical ethics: consent for vaccination in children

The prospect of vaccinating children and young people against COVID-19 raises questions that apply more widely to vaccination in children. When can children or adolescents consent, on their own, for...

Parental consent for vaccination of minors against COVID-19

As of May 2021, emergency use authorization (EUA) for Pfizer’s COVID-19 (COVID) vaccine applies to minors at least 12 years of age—some 25 million adolescents across the United States [1], [2]. While this change marks a critical step towards herd immunity and return to normality in everyday life, it also raises a host of questions concerning parental consent for vaccination of minors in pandemic times, most notably: should parental consent be required for COVID vaccine administration?

The Impact of a Digital Vaccine Consent Form in a Large Community Pharmacy Chain.

Background: A large community pharmacy chain implemented a new digital platform to eliminate the need for patients to fill out a traditional vaccine consent form in the pharmacy. The new digital vaccine consent form allowed patients to complete the form online, where it was transmitted directly to the pharmacy's network. Objectives: To identify the characteristics of patients who used an online digital vaccine consent form to receive vaccinations and to evaluate patient satisfaction and confidence in utilizing the digital vaccine consent form to receive pharmacy services. Methods: This three-month prospective study was conducted in the Mid-Atlantic division of a large community pharmacy chain. A 16-question survey was developed using information from the literature to collect demographic information and patient confidence and satisfaction with the digital vaccine consent form. An email was sent to pharmacy staff containing instructions on the procedure for posting a recruitment flyer, distributing the survey post-vaccination, and how to return completed surveys. Univariate and bi-variate analysis were conducted. Results: Thirty-six participants responded to the survey, majority of participants were female (56%). Two patients used the digital vaccine consent form; both used because it was more convenient and were likely to use the form again. For those who did not use the digital vaccine consent form, 32% feel somewhat unconfident in using digital technologies for pharmacy services. A majority of patients prefer to be notified about new online services by email (39%) or advertisements in the pharmacy (31%). When asked the likelihood of using the digital vaccine consent form in the future, majority stated unlikely (34%) or neutral (25%). Conclusions: Most participants did not utilize the new digital vaccine form. This provides an opportunity to further engage patients on the availability and use of the digital vaccine consent form in order to advance digital technologies for pharmacy services.

COVID-19 Vaccination of HCWs in the First Phase of a Large-Scale Mass Vaccination Program within a Healthcare System

Background: The approval of the first SARS-COV-2 vaccines for COVID-19 were accompanied by unprecedented efforts to provide vaccination to healthcare workers and first responders. More information about vaccine uptake in this group is needed to better refine and target educational messaging. Methods: HCA Healthcare used federal guidance and internal experience to create a systemwide mass vaccination strategy. A closed point-of-dispensing (POD) model was developed and implemented. The previously developed enterprise-wide emergency operations strategy was adapted and implemented, which allowed for rapid development of communications and operational processes. A tiering strategy based on recommendations from the National Academies was used in conjunction with human resources data to determine vaccine eligibility for the first phase of vaccination. A comprehensive data and reporting strategy was built to connect human resources and vaccine consent data for tracking vaccination rates across the system. Results: Vaccination of employed and affiliated colleagues began December 15, 2020, and was made available based on state-level release of tiers. Within the first 6 weeks, in total, 203,544 individuals were eligible for vaccine based on these criteria. Of these, 181,282 (89.1%) consented to and received vaccine, 19,788 (9.7%) declined, and 2,474 (1.2%) indicated that they had already been vaccinated. Of those eligible, the highest acceptance of vaccine was among the job codes of specialists and professionals (n = 7,914 total, 100% consent), providers (n = 23,335, 99.6%,), and physicians (n = 3,218, 98.4%). Vaccine was most likely to be declined among job codes of clerical and other administrative (n = 12,889 total, 80.1% consent), clinical specialists and professionals (n = 22,853, 81.0%,) and aides, orderlies and technicians (n = 17,803, 82.6%,). Registered nurses made up the largest eligible population (n = 56,793), and 89.5% of those eligible consented to receive vaccination. Average age among those who consented was slightly older (48.3 years) than those that declined (44.7 years), as was length of employment tenure (6.9 vs 5.0 years). Conclusion: A large-scale, closed POD, mass vaccination program was able to vaccinate nearly 200,000 healthcare workers for SARS-CoV-2 in 6 weeks. This program was implemented in acute-care sites across 20 different US states, and it was able to meet the various state-level requirements for management of processes, product, and required reporting. The development of a standardized strategy and custom, centralized monitoring and reporting facilitated insight into the characteristics of early vaccine adopters versus those who decline vaccination. These data can aid in the refining and targeting of educational materials and messaging about the SARS-CoV-2 vaccine.Funding: NoDisclosures: None

Communicating with patients and the public about COVID-19 vaccine safety: recommendations from the Collaboration on Social Science and Immunisation.

Communicating with patients and the public about COVID-19 vaccine safety: recommendations from the Collaboration on Social Science and Immunisation.

Recruiting for research on sensitive topics in schools: an experience with Vaxcards, a collectable vaccine card game

Undertaking recruitment for research in schools is an effective way to recruit young people for research participation but it is not without its challenges. Gaining access and coordinating many levels of different organisations and stakeholders whose cooperation and approval are crucial all add time and sometimes logistical challenges for the research team. In addition, recruiting around sensitive research topics can elicit additional barriers to successful research.The research team aimed to conduct a pragmatic cluster randomised controlled trial involving schools in a local government region in Victoria, Australia, to assess the effect of a vaccination-based educational card game called “Vaxcards” on vaccine consent returns. Schools were contacted via phone and email to determine which staff member would best be a contact point for a face-to-face meeting to discuss the methods and purpose of the study. Email follow-ups were scheduled to follow up non-responsive schools and consent forms. The minimum required sample size was 13.Of 31 eligible schools, 13 were recruited. The research team encountered several unanticipated challenges before achieving the recruitment target. The most common reasons for non-participation were being too busy with other commitments, concerns regarding the topic of vaccination being too sensitive, and concerns that key stakeholders in the school would not approve of the research topic of vaccination. One school required a review by a private research ethics board that rejected the study. Significant hesitancy and misinformation about vaccine science was observed that affected engagement with a small number of schools.This paper highlights the challenges of recruiting schools in the context of public anxieties about vaccines and has several important learning lessons for successful recruitment about sensitive topics. This includes navigating approval processes for research in schools, the importance of local champions, dealing with misinformation and the importance of strong relationships and organisational trust.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001753246. Prospectively registered on 25 October 2018 8:24:21 AM

Nursing Home and Vaccination Consent: The Italian Perspective.

Since the beginning of the Covid-19 pandemic, many countries have begun vaccination campaigns, with different methods and timelines, with the goal of vaccinating over 75% of the population and thus achieving herd immunity. Initially it was necessary to identity the categories of citizens who should be the first to receive the vaccines, on the basis of scientific evidence. On the basis of this information, elderly residents in nursing homes and the staff who care for them should be the highest priority subjects for vaccination. In this context, obtaining informed consent to Covid-19 vaccination presents a considerable challenge, as the advanced age and frequent comorbidities of a significant number of the residents may mean that they are incapable of expressing consent themselves. The legislation of various Western nations substantially agrees on the general principle that those capable of judgement must be asked for their consent for healthcare services, and that even those with psychological weaknesses that limit their full ability to decide must be involved in these decision-making processes. The article can help systematize the processes to be implemented to protect the health of individuals as members of a close and fragile community.

Implications and advice on getting COVID-19 vaccine consent

Implications and advice on getting COVID-19 vaccine consent