I am grateful to Sam Bushman and the team at Liberty Roundtable for the opportunity to discuss an issue that is rapidly becoming one of the most important and least examined questions in modern medicine.
Informed consent does not exist if a patient cannot choose what enters their bloodstream.
Blood transfusion medicine has long operated on trust in screening systems, infectious disease testing, and regulatory oversight. What has changed since 2020 is not the importance of those safeguards, but the biological variables introduced into the donor population and the lack of transparent evaluation of how those variables may affect transfusion recipients.
Background: Why the Question Arose
I shared my experience in Hong Kong at the beginning of the COVID crisis and my academic background in the history of science. History repeatedly shows that during periods of institutional pressure, scientific caution can be replaced by narrative management. This does not negate all public health action, but it does mean that dissenting data, early warnings, and minority hypotheses can be suppressed. Similar dynamics were documented during the early years of the HIV blood contamination crisis of the 1980s, where delays in policy change had lethal consequences for transfusion recipients, including hemophiliacs and surgical patients. These events are well documented in medical history and regulatory reviews.
The 1995 review commissioned by HHS, entitled “HIV and the Blood Supply: An Analysis of Crisis Decisionmaking” concluded that blood organizations delayed action despite mounting evidence, that blood industry conflicts of interest were under appreciated, and that an over reliance on establishing scientific certainty of harm eclipsed commonsense mitigation of risk.
That historical precedent informs our present concern. The introduction in 2021 of a novel mRNA platform at global scale created new biological exposures. Yet transfusion systems continue to treat all donor blood as equivalent, without regard to donor exposure or reaction after exposure.
Mitigating Risk
The mRNA platforms used during the COVID era rely on lipid nanoparticle delivery and intracellular production of spike protein. Peer reviewed studies have documented:
Transient detection of vaccine derived mRNA in plasma compartments following injection.
Circulating spike or spike associated signals beyond the immediate injection window in certain contexts.
Biodistribution beyond the injection site, including lymphatic and vascular compartments.
The presence of DNA plasmids and SV40 promoter linked to cancers
These findings establish a scientifically legitimate question: what persists in donors, in what quantities, for how long, and with what effect on vulnerable recipients such as surgical patients, the elderly, the immunocompromised, or newborns?
A responsible medical system investigates such questions rather than dismissing them as irrelevant.
These findings establish a legitimate patient interest in mitigating risk. Currently, the only options for mitigating these risks are:
Directed donations (patient-directed matching with compatible donors)
Autologous donation (self-donation ahead of time)
Autotransfusion (the Cell Saver system used to recycle blood during surgery)
Autologous donation is especially relevant for expectant mothers, who can store a unit of their own blood ahead of delivery. Mothers delivering at home also can do so through the local hospital designated for transfer should an emergency occur. Expectant mothers should consult with their care provider to allow sufficient time blood replenishment between donation and delivery.
Taking action on these concerns are evidence of responsibility and scientific awareness among patients that must not be dismissed or hindered by healthcare providers.
Clinical Case Documentation
Part of my work with Dr. James Thorp involves collecting documented case histories in which individuals with no prior mRNA injection history experienced severe clinical events following transfusion. These events included unexpected clotting phenomena, cardiac complications, myocarditis, pericarditis, and others ranging from severe harm to death. Such cases justify both patient interest in mitigating risk and systematic scientific investigation, just as early AIDS era transfusion cases justified urgent changes in blood screening policy and the option of a patient’s supplying a preferred donor (directed donation) as an undeniable patient right.
Medicine advances through signal detection. When signals emerge, the response should be measurement, transparency, and risk mitigation.
Microscopic Blood Observations
The origins of SafeBlood are linked to clinicians in Europe, such as SafeBlood’s founder Georg Della Pietra, who routinely examine blood using dark field microscopy. They reported structural and aggregation differences in samples from individuals after mRNA injection compared with prior observations in their practices. While microscopy findings alone do not define disease, they contributed to a broader hypothesis that the developing concerns about the blood supply warranted an mRNA-free alternative.
The Path Forward
First and foremost, the right to directed and autologous donations must be protected.
This means protecting these fundamental medical freedoms at the state level and in national policy. Several states have advanced legislation and are expected to do so again this year. Most recently, Oklahoma and Iowa have also put forward bills.
At the national level, the FDA must to correct a misleading statement dissuading directed donations on the grounds of a misapplied study over ten years old. This statement was posted in 2023, during the FDA period of suppression of COVID therapeutics and mRNA adverse event reporting. This has encouraged some hospitals and blood banks in different states to restrict access to directed and autologous donations.
Blood donor mRNA vaccine status must be tracked by the blood banks and disclosed to transfusion recipients. Without this there cannot be informed consent.
This is also necessary to make non-mRNA-donor blood available for emergency medicine. Non-mRNA-vaccinated donor blood must be reserved to be available. For non-emergency planned surgeries blood from COVID unvaccinated donors can be arranged by directed donations.
When the technology becomes available for accurate, rapid, and cost effective testing of blood for vaccine component, this testing must be made available to patients and their advocates.
With these measures, organizations like SafeBlood can work with the medical system and health agencies to meet the total blood need.
Ongoing research is crucial to this process:
Quantitative studies on persistence of vaccine associated components in donors.
Analysis of transfusion outcomes stratified by donor exposure history.
Transparent reporting systems.
Until those data exist, a precautionary approach that respects patient choice is essential.
The discussion at Liberty Roundtable reflects a broader public recognition that trust in medicine depends on openness. History shows that when institutions resist acknowledging emerging risks, parallel systems arise. SafeBlood is one such system, built not from ideology but from the principle that patients have the right to know and to choose.
Science progresses through questioning. Ethics progresses through consent. Both demand transparency.
Ethical Core: Donor Choice and Informed Consent
The central issue is not exclusion. It is choice.
Directed donations and autologous donations have long existed in transfusion medicine. Patients request known donors for religious reasons, rare blood types, prior reactions, or personal preference. The post-2020 environment introduced a new variable: exposure to mRNA platforms. Denying patients the ability to request blood consistent with their risk tolerance raises ethical concerns under the principle of informed consent.
Regulatory guidance discouraging directed donation solely on the basis of mRNA exposure status has further limited patient agency. Historically, during the HIV crisis, failure to adapt transfusion policy quickly led to preventable harm. That history should caution us against repeating delays in risk acknowledgment.
That hospital and blood bank policies informed by blood-industry self-interest have in a number of instances over-ruled doctor-patient decision making and informed consent raises significant ethical concerns.
Why SafeBlood Exists
SafeBlood does not operate as a blood bank. We do not store or distribute blood products. We facilitate directed donor matching by location, allowing individuals to establish donor networks before emergencies arise. This model mirrors earlier eras of transfusion medicine where family and community donors were common.
Importantly, this service is relevant not only to unvaccinated individuals but also to those who have received injections and now wish to avoid additional exposure. Risk tolerance varies. Medicine must respect that diversity of judgment.
Dr. R. Clinton Ohlers, PhD is Vice President and Director of Media Relations for SafeBlood Donation. He holds a PhD from the University of Pennsylvania and taught and conducted research at the University of Hong Kong, returning to the US during the early COVID outbreak. His work focuses on blood safety, medical ethics, and informed consent, with an emphasis on restoring transparency and patient choice in transfusion medicine.
About SafeBlood
SafeBlood Donation is a global initiative dedicated to protecting informed consent in blood transfusions.
Our core principle is simple:
If you cannot choose your donor, you do not have informed consent.
A Note to Readers
This publication exists to examine these issues carefully, without slogans and without coercion. If you value detailed scientific analysis, ethical discussion, and continued investigation into blood safety and transfusion biology, you may wish to upgrade to a paid subscription.
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Science advances through inquiry. Medicine advances through informed choice.
