Patients as Research Subjects For COVID Vaccines: Catholic Moral Considerations

 BY: Dr. Ralph A. Capone, MD, FACP

Trust in American health care has ebbed over the past 50 years. From 1966 to 2012, the adults surveyed who expressed great confidence in medical profession leadership dropped from 73% to 34%.[i] The recent coronavirus pandemic has created new threats to trust.[ii]  The experimental mass COVID vaccination campaign is one of these. Trust is built upon patients’ belief that physicians steadfastly advocate for their best interests without interference from third parties such as employers, insurance companies, pharmaceutical corporations, and governments. Trust grows from the initial encounter between physicians and patients and increases over time. On their part, physicians earn trust by competent medical care in fulfilling their traditional mission to cure, to relieve, and to comfort. To care well for patients is a supreme act of respect for the life, health, and well-being of human persons. It is a praxis that tacitly recognizes the sanctity of each person’s life. Pope John Paul II wrote that physicians and other health care professionals are “guardians and servants of human life” (Evangelium vitae, no. 89).

As trust wanes, patients’ fears increase causing some to refrain from seeking early hospital care. This is novel in American health care. Deeply troubling, too, when physicians refuse to treat unvaccinated patients.[iv] (This was reminiscent of those physicians unwilling to attend to patients infected with HIV during the AIDS epidemic.) Most troubling of all was the undignified way in which individuals were “handled” in many health care settings, such as imposing virtual visits and preventing dying patients from seeing loved ones.

It is important to distinguish between medical and research professionals both of whom shared a spotlight during the Sars-CoV-2 pandemic. Physicians’ primary mission and sole focus is to promote the good of patients. Researchers, on the other hand, promote the common good by working to improve public health. They encounter persons not as patients but as human subjects who volunteer to participate in research. Professional obligations differ significantly in these roles.  Nevertheless, both ethical patient care and human research must explicitly acknowledge the respect due to all persons and the sanctity of each human life made in God’s image.

The USCCB’s Ethical and Religious Directives (ERDs) number 23 asserts:

The inherent dignity of the human person must be respected and protected regardless of the nature of the person’s health problem or social status.

 During COVID, a type of care emerged that established a perilous precedent. Clinics and offices became patient enrollment sites for experimental vaccine research. Historical vaccine development is often in the range of 10-15 years.[v] COVID vaccine development was severely foreshortened and was promoted and used

“(t)hrough an emergency access mechanism known as Emergency Use Authorization (EUA), (and) the products being rolled out (are) still technically investigational (author’s stress).”[vi] “Under ordinary circumstances, clinical trial authorizations oblige sponsors to disclose all risks to volunteers in order to formulate an informed and knowledgeable decision. This however has been subject to exceptions during the pandemic.”[vii] It’s not clear how many patients received adequate risk information or, further, that by their actual vaccination they became part of ongoing safety and efficacy studies. How many patients read or were encouraged to read the accompanying Factsheet stating “(t)here is no FDA approved vaccine to prevent COVID-19(.)”? [viii]  In a study of the serious risk of ADE (antibody-dependent enhancement) associated with COVID vaccines, the authors discovered “(t)his risk is sufficiently obscured in clinical trials protocols and consent forms for ongoing COVID-19 vaccine trials (and) that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.”[ix]

Some physicians, either knowingly or unknowingly, by promoting the use of investigational vaccines exchanged their traditional patient-centered role for one which promoted research and public health.  By prioritizing research goals and hoped-for public health benefits, these physicians failed in their principal duty toward patients. In some cases, medical professionals further undermined patient autonomy (self-governance) by discriminating against those refusing vaccination for reasons of conscience, personal values, or concern about possible adverse effects. It is true some (less than half) received vaccinations in pharmacies and clinics sponsored by large chain pharmacies and hospitals. Nonetheless, these other healthcare professionals share similar ethical obligations. Highlighting the failure to obtain informed consent should serve as a cautionary tale for the health care professions and the public.

Simply stated, patients are not research subjects. They only become one when they voluntarily consent to participate in clinical trials with full knowledge and understanding of risks and benefits. Complete and unedited disclosure of high-quality information must be given to patients before they are asked to volunteer to participate in research. This ensures they are properly informed and capable of making voluntary and uncoerced decisions.  For the most part, those who received COVID vaccines could not have been given informed and voluntary consent since full disclosure of known pre-marketing data listing potential side effects were withheld due to pandemic-related exemptions. “The duty of care (disclose all known and anticipated risks to participants) cannot be diminished due to the emergency.”[x] This constitutes a serious ethical breach in human clinical research.

In addition to informed consent, another key ethical principle involved in human research is the need to demonstrate a moral justification for the study, that is, that it addresses an essential public health need. The researcher also must consider the principle of distributive justice, that is, it must be designed to prevent any single group or class of subjects (racial, gender, age, clinic patient, etc.) from being unduly burdened by the study design. Finally, it is imperative that adequate animal studies have been already carried out which demonstrate safety (and reasonable risks) for human subjects.

Applying these ethical principles to the large-scale post-marketing vaccination trials that were carried out raises many questions. For example, was the mass experimental vaccination morally justified? Due to the nature of a viral pandemic, the initial pre-marketing studies of the COVID vaccines appear justifiable based on the known risks of respiratory infections, especially in the elderly and those with co-morbidities. However, the follow-up post-marketing trial of EUA vaccines appears unjustifiable since it lacked adequately documented animal safety studies. Finally, the widespread vaccine campaign added an undue burden to a large population of unsuspecting patients who entered their physicians’ offices for individual treatment and care but exited as generally uninformed subjects in a post-marketing drug trial. The Vaccine Adverse Events Reporting System (VAERS) continues to report increasing numbers of adverse events and deaths correlated with the administration of COVID vaccines.

The USCCB’s ERD number 31 adds:

No one should be the subject of medical or genetic experimentation, even if it is therapeutic, unless the person or surrogate first has given free and informed consent.

In an article published in the New England Journal of Medicine in 1966 (“Ethics and Clinical Research”), physician-researcher Henry K. Beecher stated:

(O)rdinary patients will not knowingly risk their health or their life for the sake of “science.” The ethical approach to medical research, according to this author, includes several components but especially important are two: “…the first being informed consent. …it is absolutely essential to strive (sic) for it for moral, sociological, and legal reasons…(t)he statement that consent has been obtained has little meaning unless the subject or his guardian is capable of understanding and unless all hazards are made clear…the subject (must know) that he is to be a participant in an experiment. Secondly, there is the more reliable safeguard provided by the presence of an intelligent, conscientious, compassionate, responsible investigator.

The Catechism of the Catholic Church, part 3, Respect for the Person and Scientific Research, number 2294 instructs:

It is an illusion to claim moral neutrality in scientific research and its applications. On the other hand, guiding principles cannot be inferred from simple technical efficiency, or from usefulness accruing to some at the expense of others or, even worse, from prevailing ideologies. Science and technology by their very nature require unconditional respect for fundamental moral criteria. They must be at the service of the human person, of his inalienable rights, of his true and integral good, in conformity with the plan and the will of God.

Moral guidelines for clinical research have been well-established since the mid-20^th century. These include the Nuremberg Code (1947 first articulation), the Declaration of Helsinki (World Health Organization, 1964), and the Belmont Report (USA, 1979.)

There are notable past examples of unethical research in the United States. Vigilance is essential to prevent additional occurrences. Heightened awareness of these abuses by physicians and patients is essential to prevent episodes. History is repeated if prior lessons are forgotten or never acknowledged.  These include the grave responsibility to obtain bona fide informed consent from their patients prior to administering experimental vaccines or drugs. Patients who choose to participate in research trials must be given details of the study’s design. These include the role, duties, and obligations of the researcher which, by necessity, are distinct from their personal physician’s role and obligations.  It is critically important for physicians who believe in and promote experimental treatments to formally enroll their patients into research trials so they might become eligible for those benefits provided to human subjects. These include study updates and any necessary health care follow-up. The principle of justice requires that all patients and research subjects’ autonomy and dignity must be protected.  During COVID the roles of researchers and physicians were not clearly demarcated.

In the COVID era, some physicians may have been unwilling participants in this country-wide post-marketing vaccine trial. An underappreciated problem facing physicians is the current employment model. Medical practices have transitioned over the past 30 years from the physician-owned private model to ownership by large third parties (e.g., hospital systems). Patients in a hospital-owned practice may be unaware of this dynamic. Pressures may emerge for physicians to place employer loyalty over their traditional role of patient-focused advocate.

In addition, physicians may have also encountered coercion from professional societies and licensing boards to conform to exclusive treatment protocols during the COVID pandemic. Repurposed drugs (off-label) used for early treatment of Sars-CoV-2 and found to be promising were absent from hospital and CDC COVID treatment algorithms. In the past, physicians were free to use such off-label therapies when patients were threatened with new and unusual diseases. Most patients were denied these potentially helpful therapies during the pandemic. If these re-purposed, off-label drugs were acknowledged as beneficial treatments, then the experimental COVID vaccines would not have obtained EUA status from the FDA. “There is inadequate availability of COVID-19 vaccine trial documents and data…(which) will not be available for months, perhaps years, for most vaccines.”[xiv] As these authors note, “(w)idespread use of interventions without full data transparency raises concerns over the rational use of COVID-19 vaccines.”[xv] Perhaps further detailed studies of the vaccines, especially while other potential treatments were available, would have diminished the risks to many ordinary patients of potentially serious adverse effects.

Enlisting patients in research without their knowledge or consent and without safeguards is a gross injustice and an offense against human dignity. To restore the medical profession to that noblest tradition as guardian of patients, Francis Peabody, in a commencement speech to the Harvard Medical class of 1927, stated best: “The secret of the care of the patient is in caring for the patient.”

[i] David W. Baker, “Trust in Health Care in the Time of Covid-19,” JAMA 2020;324(23)(December 15, 2020):2373-2375.

[ii] Ibid.

[iii] “Where are All the Patients? Addressing COVID-19 Fear to Encourage Sick Patients to Seek Emergency Care,” accessed June 4, 2022, http: Catalyst.nejm.org/doi/full/10.1056/CAT.20.0193

[iv] “COVID-19: Can Doctors Refuse to see Unvaccinated Patients?,” accessed June 4, 2022, https://www.mdedge.com/dermatology/article/247524/business-medicine/covid-19-can-doctors-refuse-see-unvaccinated-patients

[v] “Vaccine Development, Testing, and Regulation,” accessed June 4, 2022, https://historyofvaccines.org/vaccines-101/how-are-vaccines-made/vaccine-development-testing-and-regulation

[vi] Peter Doshi, “COVID-19 vaccines: In the Rush for Regulatory Approval, Do We Need More Data?, BMJ 2021;373:n1244 (May 18, 2021).

[vii] “COVID-19 Vaccines and their Pitfalls in Informed Consent,” https://repository.uchastings.edu/cgi/viewcontent.cgi?article=1104&context=hastings_science_technology_law_journal, accessed June 6, 2022.

[viii] Ibid.

[ix] Timothy Cardozo and Ronald Veazey, “Informed Consent disclosure to Vaccine Trial Subjects of Risk of COVID-19 Vaccines worsening Clinical Disease,” Int. J Clin. Pract 2021 March; 75(3):e13795. (Published online 2020 December 4. Doi:10.1111/ijcp.13795, accessed June 4, 2022.

[x] “COVID-19 Vaccines and their Pitfalls in Informed Consent,” see vii above.

[xi] “VAERS COVID Vaccine Adverse Event Reports,” https://openvaers.com/covid-data, accessed June 6, 2022.

[xii] “Ivermectin for COVID-19: Real-Time Metanalysis of 84 studies,” https://ivmmeta.com/, accessed June 4, 2022

[xiii] “HCQ (hydroxychloroquine) for COVID-19, Metanalysis of 347 studies, https://c19hcq.com/, accessed June 4, 2022.

[xiv] “Transparency of COVID-19 vaccine trials: decisions without data,” http://dx.doi.org/10.1136/bmjebm-2021111735, accessed June 6, 2022.

[xv] Ibid.