The CDC has just announced it will fund a $1.6M study of HBV vaccination in West Africa. The exact details of the study have been witheld but in essence the study will compare the five year outcomes of HBV vaccination at birth compared to vaccination at 6 weeks in a nation with a very high prevalence of chronic HBV infection. The study purports to be looking for “nonspecific effects”. The grant was awarded to researchers from the University of South Denmark with a well established track record of poorly done research critical of vaccination.
Many have raised concerns about this study. That is an understatement. This study is unethical and racist. It is shades of the infamous Tuskeegee experiment. Here’s why.
https://www.nature.com/articles/s41467-025-67796-0
The Tuskegee Experiment, formally called the Tuskegee Study of Untreated Syphilis in the Negro Male, is one of the most infamous ethical violations in U.S. medical history.
What it was
Type: Observational study (non-therapeutic)
Conducted by: U.S. Public Health Service (USPHS), later involving the CDC
Location: Macon County, Alabama
Years: 1932–1972 (40 years)
Who was studied
600 Black men, mostly poor sharecroppers
399 had syphilis
201 did not (controls)
Participants were told they were being treated for “bad blood” (a vague local term), not syphilis
What actually happened
No informed consent
Effective treatment deliberately withheld
Even after penicillin became the standard, curative treatment in 1947
Participants were actively prevented from receiving treatment elsewhere
Painful diagnostic procedures (e.g., lumbar punctures) were falsely described as “special treatment”
The men were followed until death, autopsy, or study termination
Harms caused
Preventable deaths
Severe complications of untreated syphilis:
Neurosyphilis
Cardiovascular syphilis
Transmission to wives
Congenital syphilis in children
Profound, lasting distrust of the medical system in Black communities
Exposure and aftermath
1972: Study exposed by journalist Jean Heller
Public outrage → study terminated
1974: National Research Act passed
Institutional Review Boards (IRBs) mandated
Belmont Report (1979) established core ethical principles:
Respect for persons
Beneficence
Justice
1997: President Bill Clinton issued a formal apology on behalf of the U.S. government
Why it still matters
It is a foundational case in:
Medical ethics education
Research regulation
Informed consent standards
Frequently (and sometimes incorrectly) cited in discussions of:
Vaccine hesitancy
Medical mistrust
Important distinction:
Tuskegee was not a case of experimentation with treatment — it was the intentional denial of known, effective therapy
Key ethical violations (summary)
No informed consent
Deception
Withholding effective treatment
Exploitation of a vulnerable population
Racial injustice
Violation of physician duty to treat
I am describing the proposed CDC-funded randomized trial in Guinea-Bissau in which some newborns would not receive the hepatitis B (HBV) vaccine at birth (i.e., delayed to later), to evaluate outcomes including alleged “non-specific” effects / adverse effects. That reporting is real and recent. AP News+2CIDRAP+2
Below is a careful comparison to Tuskegee, focusing on what’s genuinely similar vs what’s fundamentally different—and the key ethical fault lines.
What’s similar to Tuskegee (the uncomfortable parallels)
1) Vulnerable population + power imbalance
Tuskegee: Poor Black men in Alabama, recruited with deception and limited access to care.
Guinea-Bissau trial: Extremely resource-limited setting; newborns/parents may have limited bargaining power and limited alternatives if the study becomes the main route to care.
This is the classic “structural vulnerability” problem that makes exploitation easier even without overt malice. The Guardian+1
2) Withholding a proven preventive intervention
Tuskegee: Withheld effective treatment (penicillin) after it became standard.
HBV trial: Randomizing some infants to not receive the birth dose (a proven prevention strategy), at least initially.
Ethically, withholding standard-of-care prevention in a high-burden region is exactly why critics are using the Tuskegee analogy. AP News+2The Guardian+2
3) “We’re studying safety/other effects” while participants bear the risk
Tuskegee framed harmful procedures as “special treatment.” Here, critics argue the “non-specific effects / adverse effects” rationale is not a sufficient justification for exposing some babies to preventable infection risk when safety/effectiveness are already well established. CIDRAP+1
What’s different (and why it’s not a 1:1 match)
1) Deception vs consent
Tuskegee: Deliberate deception + no informed consent.
HBV trial (as described): It’s being planned as a formal clinical trial, which should include consent, oversight, DSMB, stopping rules, etc. (Whether the oversight is adequate is part of the controversy; some reporting says the award process bypassed typical pathways.) AP News+1
2) Intent and design
Tuskegee: Observational “watch what happens if we don’t treat.”
HBV trial: Interventional RCT comparing birth dose vs delayed dose (not “never vaccinate”), aiming to measure broader outcomes (mortality/morbidity/developmental outcomes are mentioned). CIDRAP+1
3) Standard-of-care ambiguity (the crux)
Ethically, the key question is: What is the locally accepted standard of care right now?
Reporting says Guinea-Bissau’s current practice is first HBV dose at ~6 weeks and that universal birth dose implementation is projected later; the trial would compare birth dose to that existing schedule. STAT+1
That matters because research ethics often permits trials that compare to the local standard—but only if participants are not being denied care they’re otherwise entitled to and if the study doesn’t exploit the gap.
The ethical “make-or-break” issues for the HBV newborn trial
A) Clinical equipoise
Is there genuine uncertainty that justifies randomization?
For HBV prevention, global consensus supports the birth dose as effective and important in high-burden settings (and CDC itself has historically promoted birth dose in Africa). The Guardian+1
If the trial’s real aim is to find “adverse/non-specific effects,” many ethicists argue equipoise is weak because the vaccine’s safety record is already extensive. ABC News+1
B) Risk/benefit to the child
Newborns can’t consent; ethics requires minimal risk unless there’s prospect of direct benefit.
The birth dose can prevent lifelong chronic infection when transmission occurs around birth/early infancy.
If randomization increases any infant’s chance of HBV acquisition, critics argue the risk is not justified by the knowledge gain. AP News+1
C) Justice and “ethics dumping”
Would this study be considered acceptable in the U.S. or Denmark?
If not, doing it in a poorer country because it’s “easier” is the modern version of the Tuskegee power dynamic—often called ethics dumping or neocolonial research practice. The Guardian+1
D) Safeguards that would reduce (not erase) the ethical concern
If this proceeds, the minimum ethical protections people will look for include:
Verified maternal HBsAg testing and prophylaxis pathways
Immediate rescue vaccination if risk factors emerge
Independent IRB/ethics approval in-country + internationally
DSMB with hard stopping rules (HBV infections, severe outcomes)
True community engagement and transparent consent language
A plan that improves local access to birth dose long-term (not just data extraction)
Some reporting suggests the process and rationale are themselves contested, which is why the backlash is so strong. AP News+2Undark Magazine+2
Bottom line comparison (plain language)
Tuskegee was a long-running, deceptive project that denied treatment to Black men to observe harm.
The Guinea-Bissau HBV trial (as reported) is a modern RCT that may still be ethically problematic because it would intentionally delay a proven preventive measure in a vulnerable population—raising justice and exploitation concerns that echo Tuskegee even if the mechanics (consent/oversight) differ. AP News+2The Guardian+2
Below is a concise ethics argument memo, written in a style suitable for an IRB, ethics committee, hospital MEC, or professional policy discussion.
ETHICS ARGUMENT MEMO
Subject: Ethical Analysis of Proposed Neonatal Hepatitis B Vaccine Withholding Trial in Africa
Comparison Reference: Tuskegee Syphilis Study
Executive Summary
The proposed randomized controlled trial that withholds or delays the hepatitis B (HBV) birth-dose vaccine in neonates in a low-resource African setting raises serious ethical concerns under established international research ethics standards. While procedurally different from the Tuskegee Syphilis Study, the trial risks repeating its core ethical failure: exposing a vulnerable population to preventable harm in order to generate knowledge that would not be ethically pursued in higher-resource settings.
Ethical Framework
This analysis applies the Belmont Report principles:
Respect for Persons
Beneficence / Nonmaleficence
Justice
1. Respect for Persons (Informed Consent & Autonomy)
Neonates cannot consent; therefore, heightened protections apply.
In settings of poverty, low literacy, and limited healthcare access, formal consent does not guarantee meaningful informed consent.
Parents may perceive trial participation as the only way to receive medical care, creating implicit coercion.
This mirrors Tuskegee’s exploitation of structural vulnerability, even without explicit deception.
Conclusion: Consent under these conditions is ethically fragile and insufficient to justify added risk.
2. Beneficence / Nonmaleficence (Risk–Benefit Balance)
The HBV birth dose is a proven, safe, and globally recommended intervention that prevents:
Perinatal and early childhood HBV transmission
Chronic HBV infection
Cirrhosis and hepatocellular carcinoma decades later
Withholding or delaying the birth dose predictably increases risk of irreversible harm.
The stated scientific aim (evaluating “non-specific” or adverse effects) does not establish true clinical equipoise, given the extensive global safety data.
The research benefit is speculative; the risk to individual infants is real.
Conclusion: The trial violates the obligation to minimize harm and lacks a favorable risk–benefit ratio.
3. Justice (Fair Subject Selection & Exploitation)
The trial is proposed in a population that:
Has higher infectious disease burden
Has fewer healthcare alternatives
Has limited ability to refuse participation
A study that would not be ethically acceptable in the U.S. or Europe is being conducted in a poorer country.
This constitutes ethics dumping—the modern analogue of Tuskegee’s racial and socioeconomic injustice.
Conclusion: The burdens of research are unfairly placed on a disadvantaged population for the benefit of others.
Comparison to Tuskegee (Key Point)
Tuskegee: Withheld known effective treatment without consent.
HBV trial: Withholds known effective prevention with consent that may be ethically compromised.
Common core failure: Accepting preventable harm to a vulnerable population as an acceptable research cost.
This is not identical misconduct, but it is ethically rhyming misconduct.
Ethical Bottom Line
Even if the trial meets technical regulatory requirements, it fails ethical justification because:
It withholds a proven standard-of-care preventive intervention
It exposes neonates to avoidable lifelong risk
It exploits global inequities in healthcare access
It violates the Belmont principles of beneficence and justice
Ethical research must not depend on lowered moral standards for poorer populations.
Recommendation
The study should not proceed as designed.
US taxpayers should not be forced to pay for unethical experimentation on African babies
Any research on HBV vaccination timing must:
Ensure universal birth-dose access
Use non-inferiority or observational designs
Avoid intentional exposure to preventable disease
Provide durable benefit to the host community
