Eyal is correct that ethicists’ speculations about how the public may respond to human challenge trials are often made without a whisper of evidence.
This is not a new problem. The Institute of Medicine titled a 2001 monograph Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. One might think that a book with this title would demonstrate that the IRB system preserves public trust, but the title is merely an ornamental flourish. The book is devoted entirely to the accreditation of IRBs; public trust is neither analyzed in depth nor is there any attempt to show that accreditation improves trust.
We all agree that trust is important, which is what earns it one cheer. Assertions about its future trajectory merit additional applause only when they are are supported by evidence.
Cite: Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Subjects. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, D.C.: National Academy Press.
Smajdor and Räsänen's comparison of other human beings (those yet to be born) with pathogens or cancer has troubling historical antecedents. It reflects an undesirable coarsening of the debate around medical care in pregnancy, and does not reflect the lived experience of most women towards the children they bear.
Hospitality provides a far better metaphor for pregnancy than disease. It focuses on our duty to support those who are unexpectedly or even reluctantly in the position of accommodating someone else in need.
The article does not engage with the objections (published in this journal and also in response to the previous article by the same lead author) to the applicability of the ‘proportionality principle’ to ethical judgment when the considered intervention violates the right to life and discriminates on the basis of healthy, innate biological characteristics of the human race. In particular, the proportionality principle is irrelevant to coercive policies (mandates) if the associated procedure is known to kill a small percentage of people and therefore amounts to a mandated killing of a minority for the benefit of the majority. The right to life cannot be taken away in the interests of others, even if the majority would greatly benefit from the killing, without negating the very concept of human rights: if being born human is not a guarantee of the right to life, then there is no right to life. On this view, vaccination mandates can no longer be considered healthcare but democide.
We read with interest this risk-benefit and ethical analysis of the utility of SARS-CoV-2 vaccine boosters in university students. We have some major concerns about the choice of hospitalization as the primary measure of benefit. From the onset of the pandemic, healthcare providers, scientists, and public health experts in higher education have been learning from shared experiences, research, and evolving medical knowledge about the best way to safely populate college campuses with students, faculty, and staff. Hospitalizations averted is not the only marker of morbidity that is relevant to the college student population and given the rarity of severe disease requiring hospitalization in young, generally very healthy adults, hospitalization is not a good choice for a marker of COVID-19 related morbidity. We have also strived to minimize the risk of missed classes, severe illness, and need for prolonged medical leaves of absence given the potential adverse academic consequences of illness for students. Colleges and universities have been trying to balance infectious disease mitigation efforts with the need for in-person learning, social interactions, and the increased mental health challenges caused by some of these efforts that furthered the experience of isolation.
Much has changed since early 2020 and most schools have continued to evolve their protocols and policies to reflect new information and relevant data. We are dedicated to learning and contributing to th...
We read with interest this risk-benefit and ethical analysis of the utility of SARS-CoV-2 vaccine boosters in university students. We have some major concerns about the choice of hospitalization as the primary measure of benefit. From the onset of the pandemic, healthcare providers, scientists, and public health experts in higher education have been learning from shared experiences, research, and evolving medical knowledge about the best way to safely populate college campuses with students, faculty, and staff. Hospitalizations averted is not the only marker of morbidity that is relevant to the college student population and given the rarity of severe disease requiring hospitalization in young, generally very healthy adults, hospitalization is not a good choice for a marker of COVID-19 related morbidity. We have also strived to minimize the risk of missed classes, severe illness, and need for prolonged medical leaves of absence given the potential adverse academic consequences of illness for students. Colleges and universities have been trying to balance infectious disease mitigation efforts with the need for in-person learning, social interactions, and the increased mental health challenges caused by some of these efforts that furthered the experience of isolation.
Much has changed since early 2020 and most schools have continued to evolve their protocols and policies to reflect new information and relevant data. We are dedicated to learning and contributing to the continually growing literature related to COVID-19. We pay particular attention to the impact vaccination has on associated issues such as long COVID, worsening mental health, anosmia, postural orthostatic tachycardia syndrome, and other neurological sequela of infection for which data are still being gathered. We are also cautious about changing policy in reaction to a single study, although we are actively reviewing new information. As the authors allude to in their discussion of limitations, it was not possible to comprehensively address the impacts of the COVID-19 on mental health, time lost from academics, and other activities that are uniquely relevant to a college population.
"The will of the people shall be the basis of the authority of government".Article 21 of the United Nations' 1948 Universal Declaration of Human Rights
The most recent feature article by Bardosh et al opposes policies requiring vaccination with SARS Cov-2 mRNA vaccines in order to matriculate at universities in the United States (1). While the exposition put forward is thorough and cogent, the article raises a much larger question dealing with forced vaccination to prevent illness in our population. Vaccination has been enormously successful in dealing with a host of human diseases (2-4). One cannot overstate the huge benefits to humanity accruing from prevention of viral diseases including smallpox, rabies, yellow fever, measles, mumps, rubella, varicella and, of course, paralytic polio. Recently developed vaccines protect against hepatitis A and B. Human papilloma virus vaccine may succeed in reducing the cancer burden in women and also in men. Typhoid, tetanus, diphtheria, pertussis, hemophilus, meningococcus, and pneumococcus vaccines have been highly successful in dealing with these bacterial pathogens (5).
All states require children to be vaccinated against certain communicable diseases as a condition for school attendance
That is understandable since school brings together a large number of individuals in very close proximity. Certainly colleges with the inevitable crowded living conditions in dormitories promote a 24 hour expo...
"The will of the people shall be the basis of the authority of government".Article 21 of the United Nations' 1948 Universal Declaration of Human Rights
The most recent feature article by Bardosh et al opposes policies requiring vaccination with SARS Cov-2 mRNA vaccines in order to matriculate at universities in the United States (1). While the exposition put forward is thorough and cogent, the article raises a much larger question dealing with forced vaccination to prevent illness in our population. Vaccination has been enormously successful in dealing with a host of human diseases (2-4). One cannot overstate the huge benefits to humanity accruing from prevention of viral diseases including smallpox, rabies, yellow fever, measles, mumps, rubella, varicella and, of course, paralytic polio. Recently developed vaccines protect against hepatitis A and B. Human papilloma virus vaccine may succeed in reducing the cancer burden in women and also in men. Typhoid, tetanus, diphtheria, pertussis, hemophilus, meningococcus, and pneumococcus vaccines have been highly successful in dealing with these bacterial pathogens (5).
All states require children to be vaccinated against certain communicable diseases as a condition for school attendance
That is understandable since school brings together a large number of individuals in very close proximity. Certainly colleges with the inevitable crowded living conditions in dormitories promote a 24 hour exposure to whatever pathogens may achieve dominance in the community. The proponents of SARS-Cov-2 mRNA vaccine administration have placed the bivalent vaccine on the recommended list of childhood vaccinations, encouraging that this vaccine administration be required for children to be allowed to attend school. Such mandates are effective in compelling vaccination. The example of hepatitis A vaccination is noteworthy since it is not mandated in a significant number of states. In those states which have the longest history of compulsory hepatitis A vaccination for school attendance, the percentage of children so vaccinated is modestly higher than in those states which do not so require (6).
Bardosh et al have provided an extensive risk benefit analysis to claim that the mandatory administration of the SARS-Cov-2 mRNA vaccine is likely to produce more harm than benefit. Although we do not dispute their analysis, we would argue that the actual ethical issue is whether the general public, consisting of the governed population of the United States, has accepted the advisability of mRNA SARS-Cov-2 immunization in the face of uncertainty and confusion. At the present time as of the end of 2022, even among the highly vulnerable senior population, ages 65 and over, only about 36% have taken the bivalent booster (7). The willingness to accept the bivalent vaccine is far less than that among parents desiring to protect their school children. Furthermore, the FDA Vaccines Division, responsible for the approval of the mRNA vaccine, recently issued a remarkably candid appraisal, authored by Marks et al, acknowledging frustration at the rapidity with which mutations of SARS-Cov-2 result in rapidly waning benefit of mRNA vaccines (8). Just 6 months before, In June, 2022 there was a strong emphasis from that same FDA Vaccines Division on accelerating the preparation of mRNA vaccines against the BA4 and BA5 variants which were projected to have dominance in the fall (9). Pfizer and Moderna produced these mRNA products only to face the current reality that as of late October the BQ1 and BQ1.1 variants had replaced BA5 as the dominant variants with rapidly waning vaccine induced immunity and protection against symptomatic disease (10,11). A recent analysis of antibody classes elicited by repeated SARS-Cov-2 mRNA vaccination showed increasing levels of IgG4 tolerogenic antibodies, perhaps furnishing a partial explanation of waning immunity (12). Furthermore, animal models of repeated SARS-Cov-2 vaccination have recently been shown to induce humoral and cellular immune tolerance in animal models (13). Marks et al now state “Continuing along the current path of the generation and administration of variant-specific vaccine boosters is inadequate as a long-term strategy for addressing COVID-19 in populations globally” (8). This major shift at the FDA certainly does not convey confidence in a plan to mandate repeated vaccination and revaccination of the young population. If we consider the list of those vaccines previously mandated for school attendance, we realize that all have had extensive testing and years of experience. If these vaccines are mandated, it is only because the test of time has led to acquiescence by the population. Furthermore, exemptions are granted to parents who are opposed to vaccinating their children. Although exemptions could result in decreased herd immunity, that is not the case because few parents choose exemption from those vaccines which have achieved the confidence of our population. The most successful Covid vaccination campaign is in the small island nation of Cuba where three separate non-mRNA recombinant protein subunit vaccines administered at all ages from 2 years and over have yielded the most favorable results in the world in terms of Omicron infection and the lowest infection related mortality. These non mRNA vaccines have impressed their population to the extent that well over 90% have demonstrated confidence in the Cuban public health program and voluntarily chosen vaccination without mandates (14). A high level report by an international group has been issued recommending engagement and consideration of the use of the Cuban Covid vaccines worldwide (15).
In a comprehensive review of the challenges to development of effective vaccines against SARS-Cov-2 and other mucosally replicating respiratory viruses, Morens et al concluded “Durably protective vaccines against non-systemic mucosal respiratory viruses with high mortality rates have thus far eluded vaccine development efforts” (16). Marks et al now state “Simply updating the existing vaccine constructs with new variant sequences or even making trivalent or quadrivalent vaccines covering several variants is not likely to provide the depth and breadth of protection needed to interrupt viral transmission during a prolonged period” (8). They point out “However, the situation is far from hopeless because there are other approaches to future COVID-19 vaccine development currently under investigation”. We emphatically agree. In the face of uncertainty and confusion, as we attempt to protect segments of our population, we must not lose sight of the need for individuals to have the freedom to make their own educated choices. The best approach to vaccination is clearly that of education by government and the physician community so that there will be collective agreement as to benefit and absence of harm. Individuals should enjoy the dignity of choice. That policy is the venerable ideal of “consent by the governed” (17).
REFERENCES
1) Bardosh K, Krug A, Jamrozik E, et al. COVID-19 vaccine boosters for young adults: a risk benefit assessment and ethical analysis of mandate policies at universities. Journal of Medical Ethics Published Online First: 05 December 2022.
2) Greenwood B. The contribution of vaccination to global health: past, present and future. Philos Trans R Soc Lond B Biol Sci. 2014 May 12;369(1645):20130433.
3) Andre FE, Booy R, Bock HL, et al. Vaccination greatly reduces disease, disability, death and inequity worldwide. Bull World Health Organ. 2008 Feb;86(2):140-6.
4) Orenstein WA, Ahmed R. Simply put: Vaccination saves lives. Proc Natl Acad Sci U S A. 2017 Apr 18;114(16):4031-4033
5) Amanna IJ, Slifka MK. Successful Vaccines. Curr Top Microbiol Immunol. 2020;428:1-30
6) Nelson NP, Yankey D, Singleton JA, Elam-Evans LD. Hepatitis A vaccination coverage among adolescents (13-17 years) in the United States, 2008-2016. Vaccine. 2018 Mar 14;36(12):1650-1659
7) Baumgaertner E. As Covid Deaths Climb, Even Seniors Skip the Latest Booster https://www.nytimes.com/2022/12/21/health/covid-bivalent-booster-elderly...
8) Marks PW, Gruppuso PA, Adashi EY. Urgent need for next-generation COVID-19 Vaccines. JAMA. Published online December 09, 2022.
9) Marks P, Woodcock J, Califf R. COVID-19 Vaccination—Becoming part of the new normal. JAMA. 2022;327(19):1863–1864.
10) Rubin R. COVID-19 Boosters this fall to include omicron antigen, but questions remain about its value. JAMA. 2022;328(5):412–414
11) Rodriguez A, Weintraub K. BQ.1 and BQ.1.1 are now the dominant COVID variants. Here's what this means. https://www.usatoday.com/story/news/health/2022/11/20/new-covid-omicron-...
12) Irrgang P, Gerling J, Kocher K, et al. Class switch towards non-inflammatory, spike-specific IgG4 antibodies after repeated SARS-CoV-2 mRNA vaccination. Sci Immunol. 2022 Dec 22:eade2798.
13) Gao FX, Wu RX, Shen MY, et al . Extended SARS-CoV-2 RBD booster vaccination induces humoral and cellular immune tolerance in mice. iScience. 2022 Dec 22;25(12):105479
14) Gorry C. Vaccines and Public Trust: Containing COVID-19 in Cuba. MEDICC Rev. 2022;24(1):9-13
15) Osterholm MT, Rabadán-Diehl C, et al. FULL TECHNICAL REPORT Insights from Cuba's COVID-19 vaccine enterprise: Report from a high level fact-finding delegation to Cuba. MEDICC Rev. 2022 Oct 31;24(3-4):72-108
16) Morens DM, Taubenberger JK, Fauci AS. Rethinking next-generation vaccines for coronaviruses, influenzaviruses, and other respiratory viruses. Cell Host Microbe. 2023 Jan 11;31(1):146-157.
17) Cassinelli, CW. (1959). "The 'Consent' of the Governed". Political Research Quarterly. 1959 12 (2): 391–409
I read with interest the article titled “Ethics of college vaccine mandates, using reasonable comparisons” by Lam LL and Nichols T1, published on Mar 30, 2023, in the Journal of Medical Ethics.
I would like to comment on statements that the above authors made that COVID-19 vaccine-caused myocarditis cases are “generally mild” and “over 90% of the hospitalized vaccine-caused myocarditis cases fully recovered within days”, and that “approximately 10% of the hospitalised cases … may have some long-term consequences”.
Among individuals with COVID-19 vaccine-associated myocarditis, the majority develop cardiac MRI abnormalities including fibrosis, which persist on follow-up, as shown below2-4. The authors’ statements that vaccine-caused myocarditis is ‘mild’ and ‘fully recovered in 90% of cases’ with only ‘10% having long-term consequences’ are misleading, since development of myocardial fibrosis in most patients with vaccine-caused myocarditis refutes these statements. Consequently, any conclusions that the authors make relying on these inaccurate statements are not supported. To promote accuracy, a correction should be issued to the above authors’ statements.
Schauer J2 et al found that at 3-8 months’ follow-up, repeat cardiac MRI showed persistent late gadolinium enhancement, an indicator of cardiac injury and fibrosis, in 68.8% (11/15) of adolescents aged 12-17 years with COVID-19 vaccine–associated myocarditis.
I read with interest the article titled “Ethics of college vaccine mandates, using reasonable comparisons” by Lam LL and Nichols T1, published on Mar 30, 2023, in the Journal of Medical Ethics.
I would like to comment on statements that the above authors made that COVID-19 vaccine-caused myocarditis cases are “generally mild” and “over 90% of the hospitalized vaccine-caused myocarditis cases fully recovered within days”, and that “approximately 10% of the hospitalised cases … may have some long-term consequences”.
Among individuals with COVID-19 vaccine-associated myocarditis, the majority develop cardiac MRI abnormalities including fibrosis, which persist on follow-up, as shown below2-4. The authors’ statements that vaccine-caused myocarditis is ‘mild’ and ‘fully recovered in 90% of cases’ with only ‘10% having long-term consequences’ are misleading, since development of myocardial fibrosis in most patients with vaccine-caused myocarditis refutes these statements. Consequently, any conclusions that the authors make relying on these inaccurate statements are not supported. To promote accuracy, a correction should be issued to the above authors’ statements.
Schauer J2 et al found that at 3-8 months’ follow-up, repeat cardiac MRI showed persistent late gadolinium enhancement, an indicator of cardiac injury and fibrosis, in 68.8% (11/15) of adolescents aged 12-17 years with COVID-19 vaccine–associated myocarditis.
Cavalcante JL et al3 found that at approximately 3 months of follow-up, late gadolinium enhancement consistent with nonischemic fibrosis was still present in 80% (4/5) of adults aged 18-34 years with COVID-19 vaccine–associated myocarditis.
Kracalik I et al4 published data on outcomes at least 90 days after onset of COVID-19 vaccine- associated myocarditis in 519 adolescents and young adults aged 12–29 years. 54% of 151 patients with follow-up cardiac MRI’s had one or more abnormalities, including the presence of late gadolinium enhancement (in 47% of patients), inflammation or oedema, or wall motion abnormalities.
Finally, while the comment by Lam LL and Nichols T is available for free on the website of the Journal of Medical Ethics, the response by the authors of the original article by Bardosh K et al5 is not similarly available for free, which seems unusual.
Sincerely,
John J Jones
References:
1. Lam LL, Nichols T. Ethics of college vaccine mandates, using reasonable comparisons. J Med Ethics. 2023 Mar 30:jme-2022-108852. Online ahead of print.
2. Schauer J, Buddhe S, Gulhane A, et al. Persistent Cardiac Magnetic Resonance Imaging Findings in a Cohort of Adolescents with Post-Coronavirus Disease 2019 mRNA Vaccine Myopericarditis. J Pediatr. 2022;245:233-237.
3. Cavalcante JL, Shaw KE, Gössl M. Cardiac Magnetic Resonance Imaging Midterm Follow Up of COVID-19 Vaccine-Associated Myocarditis. JACC Cardiovasc Imaging. 2022;15:1821-1824.
4. Kracalik I, Oster M, Broder K, et al. Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study. Lancet Child Adolesc Health. 2022;6:788-798.
5. Bardosh K, Krug A, Jamrozik E, et al. Covid-19 vaccine boosters for young adults: a risk benefit assessment and ethical analysis of mandate policies at universities. J Med Ethics. 2022 Dec 5;jme-2022-108449. Online ahead of print.
Trust, Review, Response and Ethical control
Hinpetch Daungsupawong1; Viroj Wiwanitkit2
1. Private Academic Consultant, Phonhong, Lao People's Democratic Republic ORCID: 0009-0002-5881-2709
2. Adjunct professor, Chandigarh University, India ORCID 0000-0003-1039-3728 Correspondence
Hinpetch Daungsupawong
Private Academic Consultant, Phonhong, Lao People's Democratic Republic
Email: hinpetchdaung@gmail.com
Post Publication correspondence Professor Viroj Wiwanitkit Chandigarh University, India Eamil: wviroj@yahoo.com
Authors’ contribution
HD 50 % ideas, writing, analyzing, approval
VW 50 % ideas, supervision, approval Page 2 of 6 https://mc.manuscriptcentral.com/medethics Journal of Medical Ethics
Conflict of interest : Authors declare no conflict of interest
Acknowledgement: none
Dear Editor, the article “Trust and the Goldacre Review: why trusted research environments are not about trust” give many concerns in the current practice [1]. The article highlights the significance of trust and trustworthiness in the exchange of health data. It emphasizes the importance of carefully considering where confidence is appropriate and desirable in different elements of data sharing, such as people, institutions, and data platforms. Because of the complexiti...
Trust, Review, Response and Ethical control
Hinpetch Daungsupawong1; Viroj Wiwanitkit2
1. Private Academic Consultant, Phonhong, Lao People's Democratic Republic ORCID: 0009-0002-5881-2709
2. Adjunct professor, Chandigarh University, India ORCID 0000-0003-1039-3728 Correspondence
Hinpetch Daungsupawong
Private Academic Consultant, Phonhong, Lao People's Democratic Republic
Email: hinpetchdaung@gmail.com
Post Publication correspondence Professor Viroj Wiwanitkit Chandigarh University, India Eamil: wviroj@yahoo.com
Authors’ contribution
HD 50 % ideas, writing, analyzing, approval
VW 50 % ideas, supervision, approval Page 2 of 6 https://mc.manuscriptcentral.com/medethics Journal of Medical Ethics
Conflict of interest : Authors declare no conflict of interest
Acknowledgement: none
Dear Editor, the article “Trust and the Goldacre Review: why trusted research environments are not about trust” give many concerns in the current practice [1]. The article highlights the significance of trust and trustworthiness in the exchange of health data. It emphasizes the importance of carefully considering where confidence is appropriate and desirable in different elements of data sharing, such as people, institutions, and data platforms. Because of the complexities of public views and behaviors, deliberate techniques of accessing and surveying the public on health data sharing are required. According to the authors, the concept of "building public trust" may need to develop, because data sharing should ideally be accompanied with assurances and guarantees about data storage, sharing, and use. To protect data security and enhance trustworthiness, good governance structures, regulation, and external limitations are emphasized. While trust may still be required in cases where data access and use cannot be directly monitored, constant monitoring, audits, and security assurances can help to lessen the requirement for trust. However, trust may be required in circumstances where judgment is still required. The issue of trust becomes critical in the setting of an author with a famous "big name" and quality control to certify the code of conduct. In this circumstance, trust entails not only the author's reputation and reliability, but also the assurance that they adhere to ethical norms and follow a code of behavior. To solve this, quality control measures that verify and certify the author's adherence to the code of conduct should be put in place. This can include stringent peer review processes, transparent evaluation criteria, and ethical guidelines that writers must follow. To achieve impartiality, quality control measures should be independent, impartial, and carried out by professionals in the subject. Transparency and accountability are also important in developing confidence. Any conflicts of interest or unethical activities should be acknowledged and handled, and the author's actions and behaviors should be scrutinized. This can assist readers and the broader academic community build trust. It is also critical to foster a culture of responsible research and publishing. Institutions and publishers should encourage and enforce ethical behavior, give research integrity training, and establish clear criteria for authors to follow. This can include rules for data sharing, proper citation standards, and adherence to professional organizations' ethical guidelines. Finally, a combination of quality control methods, transparency, responsibility, and a culture of responsible research can aid in the establishment and maintenance of trust in the work of researchers. In the current era of widespread AI use, such as chatbots, the issue of fictitious authoring becomes more significant as it can undermine trust in the information provided [2]. Quality control measures should be implemented to verify the authenticity and credibility of authors in AI systems, ensuring that they adhere to ethical standards and follow a code of conduct. Transparency and accountability are crucial to build trust in AI-generated content and to prevent the dissemination of fictitious information. Transparency is also essential in developing trust. Users should be made aware of the AI system's nature and limits, as well as any potential involvement of human operators in the content generating process. Users can make educated decisions and understand the level of trust they can place in the information presented if it is clear whether the content is generated exclusively by AI or if there is human involvement. Accountability is another important part of establishing confidence in AI systems. Concerns or complaints concerning bogus authoring should be addressed through procedures. This can include reporting mechanisms, inquiry, and appropriate sanctions for any unethical practices or misuse of AI systems. Trust may be built by keeping authors and operators accountable for their activities. Finally, post-publication ethical control is critical for preserving research trust by monitoring and addressing any ethical violations, errors, or fraudulent practices that may have occurred during the publication process [3]. It ensures the scientific literature's integrity and fosters transparency and accountability among researchers and authors. To maintain trust in the scientific community, post-publication ethical control must be prioritized. Continuous monitoring, discovery, and correction of ethical violations, errors, and fraudulent practices in published research is required. It is critical to create and implement ethical principles and standards, foster transparency and responsibility, and promote a culture of responsible research conduct in order to preserve trust. Journals and publishers should develop robust peer review processes, provide means for reporting concerns, and take action in cases of misconduct as soon as possible. Furthermore, collaboration among researchers, professional organizations, and regulatory agencies is critical for establishing best practices, sharing information, and cultivating a collective commitment to preserving ethical norms. The scientific community may safeguard the integrity and reliability of research papers by prioritizing post-publication ethical control. Enhancing transparency through clear disclosure of cnflicts of interest, data sharing, and full technique explanations are among the recommendations for strengthening post-publication ethical control. Journals should implement post-publication review systems and encourage the scientific community to actively participate in examining and replicating study findings. Collaboration between researchers, peer reviewers, and editors can help to identify ethical infractions and inaccuracies. Furthermore, funding agencies and institutions should prioritize research integrity and, when appropriate, provide support for investigations and retractions. By implementing these guidelines, the scientific community may strengthen trust in research and uphold the highest ethical standards throughout the study process, including the postpublication phase, which is little acknowledged.
Reference
1. Graham M, Milne R, Fitzsimmons P, Sheehan M. Trust and the Goldacre Review: why trusted research environments are not about trust. J Med Ethics. 2023 Oct;49(10):670-673.
2. Koga S. The Integration of Large Language Models Such as ChatGPT in Scientific Writing: Harnessing Potential and Addressing Pitfalls. Korean J Radiol 2023;24:924- 925. 3. Stebbing J, Sanders DA. The importance of being earnest in post-publication review: scientific fraud and the scourges of anonymity and excuses. Oncogene. 2018 Feb 8;37(6):695-696.
I had difficulty with the Goldacre report, when it starts with the apparent contradiction of dismissing trust (in no uncertain terms). yet then proposing these TREs. (Trusted research environments). Where do the authors actually stand?
I agree that personal autonomy does not of itself invalidate medical mandates.
I note that I do not conclude that vaccine mandates are wrong just because they violate body autonomy of vaccine refusers. Rather, ‘mandatory vaccination, immunity passports, or any other form of discrimination on the basis of the vaccination status are defeasible not because they limit basic freedoms and rights but because they discriminate against (and thus devalue) the innate constitution of all human beings.’ Moreover, the premise that vaccine mandates are justified by the value of human autonomy is logically inconsistent: ‘We must, first of all, value our kind ’as it is’ in order to bestow worth on what we ‘ought to become’, and to pursue any ontological transformation by devaluing the innate constitution of other members of the kind would, paradoxically, negate the value of our own judgement.’ https://blogs.bmj.com/medical-ethics/2021/03/01/discrimination-on-the-ba...
It seems the authors interpret the healthy, innate human constitution that includes our immune system - an act of nature that determines our objective identity - as an act of socia...
I agree that personal autonomy does not of itself invalidate medical mandates.
I note that I do not conclude that vaccine mandates are wrong just because they violate body autonomy of vaccine refusers. Rather, ‘mandatory vaccination, immunity passports, or any other form of discrimination on the basis of the vaccination status are defeasible not because they limit basic freedoms and rights but because they discriminate against (and thus devalue) the innate constitution of all human beings.’ Moreover, the premise that vaccine mandates are justified by the value of human autonomy is logically inconsistent: ‘We must, first of all, value our kind ’as it is’ in order to bestow worth on what we ‘ought to become’, and to pursue any ontological transformation by devaluing the innate constitution of other members of the kind would, paradoxically, negate the value of our own judgement.’ https://blogs.bmj.com/medical-ethics/2021/03/01/discrimination-on-the-ba...
It seems the authors interpret the healthy, innate human constitution that includes our immune system - an act of nature that determines our objective identity - as an act of social coercion, which I contend is a category mistake.
For the sake of clarity, I summarise the three strongest arguments against the ethical permissibility of vaccine mandates:
1. Vaccine mandates imply that all humans are born in a defective, inherently harmful state that must be biotechnologically augmented to allow our unrestricted participation in society, which amounts to discrimination on the basis of healthy, innate characteristics of the human race. This devaluation of the innate human constitution is not only universally dehumanising, but it perverts the very concept of human rights; discrimination against the unvaccinated implies that being born human is no longer a guarantee of full human rights.
2. The right to free, uncoerced medical consent is not negotiable, under any circumstances, because without it we have no guaranteed rights at all; every other right can be subverted by medical coercion. Crucially, by accepting any medical treatment imposed by coercion we would be acquiescing to the taking away of the right to free medical consent not only from ourselves but from our children and from future generations, and we do not have the moral right to do this. Acquiescence to medical coercion is therefore always unethical, even if the mandated intervention were a placebo.
3. Vaccines are known to occasionally cause deaths of healthy people. When an employee is required to receive vaccination as a condition of employment, that employee is economically coerced to participate in an activity where a percentage of employees are expected to die ‘in the course of employment’ as a direct result of the mandated activity. It may be objected that infectious pathogens also kill people, but these two categories of deaths are not ethically equivalent. Infection with a pathogen is not mandated, whereas deaths resulting from mandatory vaccination are mandated deaths, a legalised killing of some people for the prospective benefit of the majority. Critically, any discrimination against the unvaccinated amounts to a violation of the right to life, because a small percentage of the targeted population are expected to die as a result of this coercive treatment. By refusing to acquiesce to mandated vaccines we take an ethical stance in defence of the right to life.
In the U.S. a parent has a fundamental right to raise their child as they see fit, but this not an absolute right. Parents must act in the best interest of their child. The right to know your genetic identity is supported by ethical principles and existing legal frameworks. Denying individuals access to their genetic information violates their autonomy, privacy, and dignity. Lack of access to genetic identity information from birth also significantly increases the likelihood of physical and mental health issues.
Medical history and genetic makeup play an essential role in identifying health risk factors. An accurate medical history provides relevant information to the genetic information stored in our DNA. Family health history is a significant factor in determining the likelihood of developing certain diseases we carry in our DNA. Family medical history includes the types of health conditions family members have been diagnosed with, age of diagnosis, and relevant environmental or lifestyle factors. Common health conditions often included in a family medical history are heart disease, cancer, stroke, diabetes, high blood pressure, and mental health disorders.
A thorough understanding of medical history can help identify early signs of conditions that may otherwise go undetected. People base their health habits on their parents’ medical history which could, if incorrect, lead to medical conditions that might have been prevented, delays in diagnosis, or unnece...
In the U.S. a parent has a fundamental right to raise their child as they see fit, but this not an absolute right. Parents must act in the best interest of their child. The right to know your genetic identity is supported by ethical principles and existing legal frameworks. Denying individuals access to their genetic information violates their autonomy, privacy, and dignity. Lack of access to genetic identity information from birth also significantly increases the likelihood of physical and mental health issues.
Medical history and genetic makeup play an essential role in identifying health risk factors. An accurate medical history provides relevant information to the genetic information stored in our DNA. Family health history is a significant factor in determining the likelihood of developing certain diseases we carry in our DNA. Family medical history includes the types of health conditions family members have been diagnosed with, age of diagnosis, and relevant environmental or lifestyle factors. Common health conditions often included in a family medical history are heart disease, cancer, stroke, diabetes, high blood pressure, and mental health disorders.
A thorough understanding of medical history can help identify early signs of conditions that may otherwise go undetected. People base their health habits on their parents’ medical history which could, if incorrect, lead to medical conditions that might have been prevented, delays in diagnosis, or unnecessary medical procedures. Slow diagnosis due to lack of information may lead to death or long term health problems that could have been avoided. Unnecessary procedures, office visits, and surgeries may be performed due to lack of an accurate medical history.
Knowing your genetic identity plays a role in your sense of connection to the past and cultural heritage and helps people understand and embrace their unique identity and place in the world. The development of a sense of self is influenced by genetic makeup, family dynamics, culture, peer relationships, and life experiences.
A key challenge for someone being raised in non-genetic families, even if it is only one parent, can be on the development of their self-concept. As someone grows and develops, individuals often look to their family for cues about their identity, including physical traits, personality characteristics, and values. For those not genetically related to their family, these cues are not available, leading to a sense of disconnection or confusion about identity. “Genetic bewilderment” is a term coined by geneticist Richard Lewontin and is the feeling of “otherness” rooted in a break in the continuity of genetic heritage. Essentially a personal sense of security and belonging to the family group is undermined which affects development. Individuals in these instances often blame themselves for this lack of genetic mirroring resulting in potential self-esteem issues, insecurity, and genetic bewilderment.
Parents are not acting in the best interest of their child when they choose not to tell their child they are donor conceived. Infertility is a deeply distressing experience that can cause intense feelings of loss, grief, and shame. The emotional intensity of infertility trauma may lead to the parent unconsciously dissociating from the child’s origins as a coping mechanism. The child’s origin is buried so deep in the parent’s subconscious, they no longer remember the truth.
Avni, Chen et al. "Discovering Your Presumed Father Is Not Your Biological Father: Psychiatric Ramifications of Independently Uncovered Non-Paternity Events Resulting from Direct-to-Consumer DNA Testing." Psychiatry Research, vol. 323, 2023.
Klugman-Rabb, Jodi. “A Qualitative Study on the Effect of Misattributed Parentage Experiences.” Dissertation, Touro University Worldwide, 2023.
Lawton, Bessie et al. “Experiences of Misattributed Parentage Communities: Impacts of Discovering New Familial Kinships.” Journal of Family History, vol. 46, no. 2, 2021, pp. 117-136.
Lewontin, Richard. "The Triple Helix: Gene, Organism, and Environment." Harvard University Press, 2001.
Eyal is correct that ethicists’ speculations about how the public may respond to human challenge trials are often made without a whisper of evidence.
This is not a new problem. The Institute of Medicine titled a 2001 monograph Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. One might think that a book with this title would demonstrate that the IRB system preserves public trust, but the title is merely an ornamental flourish. The book is devoted entirely to the accreditation of IRBs; public trust is neither analyzed in depth nor is there any attempt to show that accreditation improves trust.
We all agree that trust is important, which is what earns it one cheer. Assertions about its future trajectory merit additional applause only when they are are supported by evidence.
Cite: Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Subjects. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, D.C.: National Academy Press.
Smajdor and Räsänen's comparison of other human beings (those yet to be born) with pathogens or cancer has troubling historical antecedents. It reflects an undesirable coarsening of the debate around medical care in pregnancy, and does not reflect the lived experience of most women towards the children they bear.
Hospitality provides a far better metaphor for pregnancy than disease. It focuses on our duty to support those who are unexpectedly or even reluctantly in the position of accommodating someone else in need.
The article does not engage with the objections (published in this journal and also in response to the previous article by the same lead author) to the applicability of the ‘proportionality principle’ to ethical judgment when the considered intervention violates the right to life and discriminates on the basis of healthy, innate biological characteristics of the human race. In particular, the proportionality principle is irrelevant to coercive policies (mandates) if the associated procedure is known to kill a small percentage of people and therefore amounts to a mandated killing of a minority for the benefit of the majority. The right to life cannot be taken away in the interests of others, even if the majority would greatly benefit from the killing, without negating the very concept of human rights: if being born human is not a guarantee of the right to life, then there is no right to life. On this view, vaccination mandates can no longer be considered healthcare but democide.
http://dx.doi.org/10.1136/medethics-2020-107026
https://gh.bmj.com/content/7/5/e008684.responses#fundamental-values-cann...
We read with interest this risk-benefit and ethical analysis of the utility of SARS-CoV-2 vaccine boosters in university students. We have some major concerns about the choice of hospitalization as the primary measure of benefit. From the onset of the pandemic, healthcare providers, scientists, and public health experts in higher education have been learning from shared experiences, research, and evolving medical knowledge about the best way to safely populate college campuses with students, faculty, and staff. Hospitalizations averted is not the only marker of morbidity that is relevant to the college student population and given the rarity of severe disease requiring hospitalization in young, generally very healthy adults, hospitalization is not a good choice for a marker of COVID-19 related morbidity. We have also strived to minimize the risk of missed classes, severe illness, and need for prolonged medical leaves of absence given the potential adverse academic consequences of illness for students. Colleges and universities have been trying to balance infectious disease mitigation efforts with the need for in-person learning, social interactions, and the increased mental health challenges caused by some of these efforts that furthered the experience of isolation.
Much has changed since early 2020 and most schools have continued to evolve their protocols and policies to reflect new information and relevant data. We are dedicated to learning and contributing to th...
Show More"The will of the people shall be the basis of the authority of government".Article 21 of the United Nations' 1948 Universal Declaration of Human Rights
Show MoreThe most recent feature article by Bardosh et al opposes policies requiring vaccination with SARS Cov-2 mRNA vaccines in order to matriculate at universities in the United States (1). While the exposition put forward is thorough and cogent, the article raises a much larger question dealing with forced vaccination to prevent illness in our population. Vaccination has been enormously successful in dealing with a host of human diseases (2-4). One cannot overstate the huge benefits to humanity accruing from prevention of viral diseases including smallpox, rabies, yellow fever, measles, mumps, rubella, varicella and, of course, paralytic polio. Recently developed vaccines protect against hepatitis A and B. Human papilloma virus vaccine may succeed in reducing the cancer burden in women and also in men. Typhoid, tetanus, diphtheria, pertussis, hemophilus, meningococcus, and pneumococcus vaccines have been highly successful in dealing with these bacterial pathogens (5).
All states require children to be vaccinated against certain communicable diseases as a condition for school attendance
That is understandable since school brings together a large number of individuals in very close proximity. Certainly colleges with the inevitable crowded living conditions in dormitories promote a 24 hour expo...
I read with interest the article titled “Ethics of college vaccine mandates, using reasonable comparisons” by Lam LL and Nichols T1, published on Mar 30, 2023, in the Journal of Medical Ethics.
I would like to comment on statements that the above authors made that COVID-19 vaccine-caused myocarditis cases are “generally mild” and “over 90% of the hospitalized vaccine-caused myocarditis cases fully recovered within days”, and that “approximately 10% of the hospitalised cases … may have some long-term consequences”.
Among individuals with COVID-19 vaccine-associated myocarditis, the majority develop cardiac MRI abnormalities including fibrosis, which persist on follow-up, as shown below2-4. The authors’ statements that vaccine-caused myocarditis is ‘mild’ and ‘fully recovered in 90% of cases’ with only ‘10% having long-term consequences’ are misleading, since development of myocardial fibrosis in most patients with vaccine-caused myocarditis refutes these statements. Consequently, any conclusions that the authors make relying on these inaccurate statements are not supported. To promote accuracy, a correction should be issued to the above authors’ statements.
Schauer J2 et al found that at 3-8 months’ follow-up, repeat cardiac MRI showed persistent late gadolinium enhancement, an indicator of cardiac injury and fibrosis, in 68.8% (11/15) of adolescents aged 12-17 years with COVID-19 vaccine–associated myocarditis.
Cavalcante JL et al3 found that at...
Show MoreTrust, Review, Response and Ethical control
Hinpetch Daungsupawong1; Viroj Wiwanitkit2
1. Private Academic Consultant, Phonhong, Lao People's Democratic Republic ORCID: 0009-0002-5881-2709
2. Adjunct professor, Chandigarh University, India ORCID 0000-0003-1039-3728 Correspondence
Hinpetch Daungsupawong
Private Academic Consultant, Phonhong, Lao People's Democratic Republic
Email: hinpetchdaung@gmail.com
Post Publication correspondence Professor Viroj Wiwanitkit Chandigarh University, India Eamil: wviroj@yahoo.com
Authors’ contribution
HD 50 % ideas, writing, analyzing, approval
VW 50 % ideas, supervision, approval Page 2 of 6 https://mc.manuscriptcentral.com/medethics Journal of Medical Ethics
Conflict of interest : Authors declare no conflict of interest
Acknowledgement: none
Dear Editor, the article “Trust and the Goldacre Review: why trusted research environments are not about trust” give many concerns in the current practice [1]. The article highlights the significance of trust and trustworthiness in the exchange of health data. It emphasizes the importance of carefully considering where confidence is appropriate and desirable in different elements of data sharing, such as people, institutions, and data platforms. Because of the complexiti...
Show MoreI had difficulty with the Goldacre report, when it starts with the apparent contradiction of dismissing trust (in no uncertain terms). yet then proposing these TREs. (Trusted research environments). Where do the authors actually stand?
I thank the authors for critically engaging with my paper “Ethics of vaccine refusal”. http://dx.doi.org/10.1136/medethics-2020-107026
I agree that personal autonomy does not of itself invalidate medical mandates.
I note that I do not conclude that vaccine mandates are wrong just because they violate body autonomy of vaccine refusers. Rather, ‘mandatory vaccination, immunity passports, or any other form of discrimination on the basis of the vaccination status are defeasible not because they limit basic freedoms and rights but because they discriminate against (and thus devalue) the innate constitution of all human beings.’ Moreover, the premise that vaccine mandates are justified by the value of human autonomy is logically inconsistent: ‘We must, first of all, value our kind ’as it is’ in order to bestow worth on what we ‘ought to become’, and to pursue any ontological transformation by devaluing the innate constitution of other members of the kind would, paradoxically, negate the value of our own judgement.’ https://blogs.bmj.com/medical-ethics/2021/03/01/discrimination-on-the-ba...
It seems the authors interpret the healthy, innate human constitution that includes our immune system - an act of nature that determines our objective identity - as an act of socia...
Show MoreIn the U.S. a parent has a fundamental right to raise their child as they see fit, but this not an absolute right. Parents must act in the best interest of their child. The right to know your genetic identity is supported by ethical principles and existing legal frameworks. Denying individuals access to their genetic information violates their autonomy, privacy, and dignity. Lack of access to genetic identity information from birth also significantly increases the likelihood of physical and mental health issues.
Medical history and genetic makeup play an essential role in identifying health risk factors. An accurate medical history provides relevant information to the genetic information stored in our DNA. Family health history is a significant factor in determining the likelihood of developing certain diseases we carry in our DNA. Family medical history includes the types of health conditions family members have been diagnosed with, age of diagnosis, and relevant environmental or lifestyle factors. Common health conditions often included in a family medical history are heart disease, cancer, stroke, diabetes, high blood pressure, and mental health disorders.
A thorough understanding of medical history can help identify early signs of conditions that may otherwise go undetected. People base their health habits on their parents’ medical history which could, if incorrect, lead to medical conditions that might have been prevented, delays in diagnosis, or unnece...
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