Open Letter to Brown University Health Services

A Call for Ethical Integrity and Informed Consent

The Reconciliation, Mark Brody, and Bretigne

Aug 24, 2025

August 2025

Brown University Health Services

Brown Health Medical Group Obstetrics and Gynecology

Interested Members of the Brown Community

To Whom It May Concern:

We are writing as concerned healthcare practitioners and advocates for informed consent in response to your June 2025 article, "Pregnancy, Breastfeeding, Coronavirus, and COVID-19 Vaccine." (Perry et al). While we appreciate your efforts to guide patients during a complex public health landscape, we find the article’s lack of transparency and omission of informed consent principles unacceptable from a medical ethics perspective. These principles are not optional—they are the cornerstone of ethical medical practice, particularly for interventions affecting pregnant women, their infants, and future generations.

An honest look at COVID-19 vaccines for pregnant and breastfeeding women and children would include more disclosure, rather than the open-and-shut one-sided case presented in this article. Alerting families of the potential financial conflicts of interest in the organizations making these recommendations would also be a necessary ethical disclosure. A shared decision-making mindset must be adopted by Brown University Health, Brown Health Medical Group in Obstetrics and Gynecology, and affiliated medical organizations to take steps toward rebuilding public trust. Respect for the principles of informed consent would not only be appropriate but ethically mandatory in an article recommending medical treatment.

Disclosure about FDA and Legal Protections

Medical ethics require that pregnant women be informed that the safety of medical interventions in pregnancy and breastfeeding is a judgment call by medical doctors and professional organizations. Many of these doctors and organizations such as ACOG, receive federal funding to incentivize them to say the vaccines are safe. ACNM also received millions of dollars from the federal government as an influential mouthpiece (Redshaw, 2023). These financial biases are not being disclosed by the authors of the Brown article.

In the published article by Brown Health of June 2, 2025, the weighing of risks and benefits has been done for pregnant women and families—not by them—and does not necessarily reflect the important contribution made by personal values or beliefs of these families. The gatekeeping of information by aligned axis of government aid recipients must cease

Furthermore, women and families should know the truth about federal law 42 U.S.C. § 300aa-22, which provides unique legal protection to vaccine manufacturers and recommending professionals, shielding them from lawsuits over vaccine injuries. This stands in contrast to other pharmaceuticals, where adverse outcomes may result in legal recourse. Mention of this is entirely absent from the article.

Shared Decision-Making and Informed Consent

Informed consent from patients is mandated by federal law in the Patient Self-Determination Act of 1990. The tenets of informed consent include patients understanding to the best of their ability and highest point of satisfaction, the benefits, risks, alternatives to medical treatment offered to them, as well as what happens if they choose not to decide. It is crucial to highlight that leading professional bodies state that this is the mandate for professional conduct in communicating with patients about their medical options, including:

American College of Nurse-Midwives, ACNM, Position Statement: "Shared Decision Making in Midwifery Care" (2016):

“Shared decision making is a central tenet of the midwifery model of care. It includes respectful exchange of information and supports the individual’s autonomy in health decisions.”

This is echoed by the American Congress of Obstetricians and Gynecologists, ACOG, Committee Opinion No. 439, Informed Consent (reaffirmed 2021)

"Informed consent is a process of communication between the patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention."

And it is further elucidated in the ACNM Code of Ethics (2015):

“Midwives have a professional obligation to provide full and accurate information and to respect the informed choices of the individual receiving care, including choices that may differ from the midwife’s recommendations.”

And finally, ACOG Committee Opinion No. 664, Refusal of Medically Recommended Treatment During Pregnancy (June 2016), clearly states:

"Pregnant women should be supported in their decisions, and their autonomy should be respected. Coercive or punitive legal approaches to maternal decision making are not appropriate."

Informed consent is undergirded by the freedom to refuse or decline medical treatment without coercion, and without fear of retribution (such as having social services contacted for declining vaccinations). This guidance underscores that healthcare decisions must not be imposed through manipulation, pressure, or fear-based tactics (such as inability to enroll a child in day care or school). True consent cannot exist in the absence of freedom to decline. Coercion—whether implicit or explicit—violates ethical standards and undermines trust in the clinician-patient relationship.

In the context of mRNA vaccines in pregnancy, shared decision-making is not only legally and ethically appropriate but essential. Women deserve the right to receive complete, transparent information, including acknowledgment of unknowns, so they can make informed decisions consistent with their beliefs, values, and vision for their family.

Brown University should state unequivocally that they fully support women’s decisions about vaccination and reject on moral and ethical grounds practices such as social services consults for declining this or other vaccinations. While providing a one sided view of medical decision making may not be overtly coercive, doing so steers women towards the outcome desired by the practitioner, and does not guide women towards making their own personal decision. In short, it manipulates women and their families. Manipulation may not be identical to coercion, but it is a close cousin, unequivocally unethical, and a stark violation of informed consent principles.

Risks

Acknowledging Scientific Uncertainty

The mRNA COVID-19 vaccines, while authorized for emergency use, lack long-term safety data, especially in pregnant and pediatric populations. Similarly, the long-term adverse effects of COVID-19 injections were not fully understood initially. Now numerous research studies show that the vaccines are fraught with serious risks. The article’s assertion that mRNA vaccines are unequivocally safe in pregnancy overlooks these uncertainties and the wealth of data indicating harm. Both SARS-CoV-2 infection and mRNA vaccines introduce spike protein, which some studies have concluded has serious adverse effects, sometimes termed “spikeopathy” (Parry et al., 2023). Presenting vaccination as basically risk-free while highlighting infection risks creates an imbalanced narrative that undermines informed choice.

Transparent Risk Assessment

Severe COVID-19 outcomes in children and young adults are exceedingly rare, with a mortality risk near zero for healthy individuals under 18 (CDC, 2024). In contrast, mRNA vaccines carry documented risks, including myocarditis (1–2 cases per 10,000 in young males), and rare cases of anaphylaxis or Guillain-Barré Syndrome (Vaillant et al., 2023) and blood clots (Bergman, 2025). For pregnant women, short-term data suggest no significant increase in miscarriage or preterm birth (Nature Communications, 2022), yet long-term fetal outcomes remain unstudied. Other data dispute this, showing a far increase in miscarriage rates (Thorp, 2023), pointing to major flaws in research and potential oversights of data or even cover-ups. Families deserve a clear presentation of these trade-offs. Dismissing vaccine hesitancy as unscientific ignores the rational basis for caution with novel therapies during pregnancy.

Vaccination and use of novel therapies during pregnancy has, in the history of obstetrics been regarded as an unacceptable risk to both mother and developing baby. The reasons for the violation of this historically sacrosanct rule have not been explained in the article and, for informed consent to be applied properly, must be fully explained.

Alternatives to Vaccination

From the beginning of the pandemic, prevention as an intervention was often dismissed, including well-established nutrition-based immune support protocols. Safety concerns and pregnancy risks are paramount concerns when something as precious and sacred as a burgeoning human life is in balance, and the medical system has historically recognized this truth. Pregnant women should be informed how to naturally strengthen their immune systems, for example, by optimizing vitamin D levels, which are linked to reduced severity of viral infections (Aygun, 2022). Ferritin and hemoglobin levels should also be evaluated, as iron deficiency is common and associated with increased infection severity (Strauss, 1978).

Many people with COVID-19 reportedly benefited from hydroxychloroquine and zinc administration (Zelenko, et al, 2020). Hydroxychloroquine is among the most well-researched medications globally and has a long-standing history of use during pregnancy and lactation—unlike mRNA-based genetic vaccines, which are novel and lack longitudinal safety data. Hydroxychloroquine is actually prescribed during pregnancy complicated by autoimmune disorders of the mother to reduce complications such as preeclampsia. Furthermore, this drug is well studied and does not enter the breastmilk in sufficient amounts to cause problems for the nursing infant. Yet the Brown article completely avoids mention of any alternatives to vaccination.

The Valid Choice of Doing Nothing

Another medical option that goes unmentioned in the article is to proceed without medical intervention and allow nature to take its course. The absolute risk of COVID-19 causing severe harm to a developing baby is exceedingly low. The highest risk appears to occur when infection strikes late in pregnancy and leads to surgical delivery, which is a physician's preference rather than a clinical indication (Haphsey et al, 2021). These scenarios represent the worst outcomes for mother and baby.

Relative risk assessments may suggest that complications from COVID-19 vaccination may be more likely to affect the unborn child than the infection itself. Families need to be informed of this, and its omission is a flagrant violation of informed consent.

Respecting Personal Choice

Medical decisions are deeply personal and shaped by diverse values. Recommending that pregnant women vaccinate without acknowledging potential risks or respecting individual beliefs is unethical, especially in a climate where religious exemptions are well-recognized and completely legal in 46 out of 50 states. Shared decision-making requires full disclosure of known and unknown risks, empowering parents to make choices aligned with their values.

Recommendations

We urge Brown University Health Services to revise its guidance as follows:

1. Disclose any institutional conflict of interest -such as liability protection of vaccine manufactures and financial incentive to encourage vaccination.

2. Acknowledge the experimental nature of mRNA vaccines and the absence of long-term data in pregnancy and pediatric populations.

3. Disclose serious adverse events, such as myocarditis, Guillain-Barré syndrome, Bell's Palsy, anaphylaxis, and blood clots alongside potential benefits like maternal antibody transfer to infants.

4. Emphasize patient autonomy in the shared decision-making process and respect diverse values, providing assurance of non-retaliation and respect for autonomous decision-making.

5. Engage with patient advocacy groups and independent researchers to address public concerns and restore trust in the medical profession.

6. Retract their article on pregnancy, breastfeeding and the COVID-19 vaccination.

7. Publish a corrective article reflecting the many risks to pregnancy that some of the science suggests indicates is present for COVID-19 vaccination.

8. Publish an article showing the lack of evidence of COVID-19 vaccination’s benefits to pregnant women and their developing babies.

9. Respond to this letter within 14 days, indicating your willingness to take corrective action, and to avoid further action on this matter by the World Council for Health. We can be reached at wchusa.org@gmail.com

Conclusion

Ethical medical guidance requires honesty, transparency, and respect for patient autonomy. By presenting mRNA vaccine science as settled, Brown Health continues to undermine public trust. We call on Brown Health to revise its guidance, provide balanced information, and empower families with tools for informed decision-making. It is not only okay to trust women and families to make the best decision for their families - it is prohibited by medical ethical considerations around informed consent not to do so. Together, we can uphold the principles of ethical care and rebuild trust in healthcare institutions.

In Truth and Honor,

Sierra Hamm, RN, BSN

Mark Brody, CCH

Bretigne Schaffer

Lisa Lopes, M.S. NBC-HWC

The Reconciliation

Discussion about this post

Ready for more?