How Post-Tuskegee Research Protections Were Exploited to Make Molecular HIV Surveillance Possible
Internal CDC documents reveal a disturbing connection between The Tuskegee Syphilis Study and Molecular HIV Surveillance.
The Tuskegee Syphilis Study, conducted by the U.S. Public Health Service (USPHS) from 1932 to 1972, involved observing the progression of untreated syphilis in hundreds of African American men without their informed consent, despite the wide availability of effective treatments such as penicillin during the course of the experiment. The research participants were never told they had syphilis, never given educational counseling to help prevent further transmission to their wives and children, discouraged from seeking effective treatment outside of the study, denied proper medical care and were instead misled with ineffective remedies, constituting a profoundly cruel breach of medical ethics. After forty years, the experimentation was eventually terminated, but only after news of the study was leaked to the press.
Once those horrific cruelties came to light and ignited justifiable outrage, the self-evident ethical failures and human rights violations sparked sweeping reforms in medical research ethics. The public outcry following revelations of the study's operation led to the establishment of the National Research Act in 1974, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which in turn produced the Belmont Report in 1979. The Belmont Report laid out fundamental ethical principles for research involving human subjects: respect for persons, beneficence, and justice. Core elements of those three principles involve the need for informed consent, transparency on the part of researchers, and patient autonomy in medical research. These principles became the cornerstone of federal regulations and requirements for Institutional Review Boards (IRBs) that oversee and approve research involving human subjects, ensuring ethical practices in all federally funded research.
Although The Tuskegee study has become infamous in exemplifying cruel and opportunistic medical science that harms already-vulnerable black communities, it is by no means the only instance. For example, from 1909 to 1979, California's forced sterilization program disproportionately targeted marginalized populations, especially women of color. An estimated 20,000 women were sterilized without their informed consent and in many cases without their knowledge.
Reverberations of Tuskegee continue to echo throughout our collective consciousness, especially in the world of HIV treatment and care. Black people continue to experience a disproportionately high rate of HIV infection in the U.S. While they constitute roughly 12% of the total population, they account for roughly 40% of both new diagnoses and those living with HIV, and they are less likely to utilize PrEP for the prevention of new HIV acquisition. They also have some of the lowest rates of viral suppression and retention in care. Systemic racism, severe inequities, and socioeconomic factors such as limited educational and employment opportunities, reduced access to healthcare, and stigma surrounding sexual health are among the many drivers that increase vulnerability to HIV and hinder access to prevention and treatment services. Study after study has demonstrated a reluctance among Black communities to engage with HIV-related public health efforts due to medical distrust that is deeply rooted in the legacy of Tuskegee racism.
WHY TUSKEGEE MATTERS WITHIN A CONTEXT OF MOLECULAR HIV SURVEILLANCE
It is impossible to conduct a literature review about the ethical, medical and legal implications of molecular HIV surveillance without encountering repeated references to the Tuskegee study. It's mentioned in the resolution passed by President's Advisory Council on HIV and AIDS that calls for the CDC to place a moratorium on MHS. It appears in policy papers and position statements about MHS issued by organizations such as the Center for HIV Law and Policy, Positive Women's Network, Sero Project, and the U.S. Caucus of People Living With HIV. The discourse surrounding Tuskegee isn't just limited to academic theory or policy experts' analysis. It also routinely manifests in focus group conversations and community feedback sessions intended to solicit input about MHS, like the following quote cited by the Washington State Department of Public Health's Molecular HIV Surveillance Community Engagement Report released in 2023:
“I can speak specifically about being a Black woman: Tuskegee is still something that traumatizes us. And what happened in Tuskegee? They didn’t tell the people in that study what was really going on. With molecular analysis, they’re not telling us what’s going on. It’s scary. People are still traumatized about something that happened decades ago—and why? Because it’s still happening today. They’re still not telling us what they’re doing with our data and our medical information.”
Data released earlier this year by the CDC indicate southern states are subjected to molecular HIV surveillance more than twice as much as other regions of the United States, and the rate at which people of color are surveilled closely mirrors the disproportionate rates of new infections experienced by Black communities, making a bad situation that much worse.
LEGAL LOOPHOLES AND DANGEROUS PRECEDENT
Upon reviewing internal CDC documents that chronicle a history of the origin and evolution of molecular HIV surveillance as we know it today, I was surprised to discover a direct connection between the Tuskegee syphilis study and the birth of molecular HIV surveillance. And it's appalling. CDC officials actually exploited a legal loophole in federal regulations intended to protect vulnerable populations from the very harms it now replicates.
The public health practice of CDC-mandated molecular HIV surveillance is an adaptation of something previously called the VARHS Study (Variant, Atypical, and Resistant HIV Surveillance). VARHS was a multi-site research project investigating the impact and emergence of HIV mutations that either diminish the effectiveness of antiviral medications or in some cases confers a protective mechanism by which replication of some viral strains is further inhibited in the presence of specific medications. It was coordinated by over a dozen major universities across the country and a Stanford University laboratory that performed all of the genetic analysis for the study sites. The CDC funded those institutions directly, and research participants were protected by strict ethical guidelines, overseen and subject to approval by well-established Institutional Review Boards. VARHS required careful consideration and approval by IRBs to keep everything ethical, consensual, and adherent to the Belmont Principles. That is, until 2004.
On June 24th, 2004, Dr. Andrew Vernon, the Associate Director for Science at the CDC's National Center for HIV, STD, and Tuberculosis Prevention at that time, signed a document that re-classified VARHS from research to non-research and thus exempt from ethical review for the protection of human research subjects as it had in the past. In doing so, VARHS became a routine disease surveillance activity with informed consent and other ethical "recommendations" rather than requirements that went largely ignored. It is clear from reviewing subsequent CDC documents over time how those initial recommendations became increasingly diluted until they were eventually abandoned entirely.
The CDC justified this decision by invoking legal authority granted by federal law – specifically, 45 CFR Part 46 Subpart A (c) which states "Department or agency heads retain final judgment as to whether a particular activity is covered by this policy [meaning the requirement for institutional review board (IRB) approval of research involving human subjects] and this judgment shall be exercised consistent with the ethical principles of the Belmont Report." Unfortunately, 45 CFR Part 46 Subpart A (c) falls woefully short in identifying any process for evaluating, challenging, and in some cases, reversing the exercise of a single individual's judgment in its faithful adherence to the Belmont principles.
Effective July 1st, 2004, the VARHS project, which would later be renamed Molecular HIV Surveillance, was no longer required to undergo IRB approval for the protection of human research subjects as it had in the past. Along with that shift, the CDC expanded the scope of the initiative even further to include the routinized collection of increasingly sensitive data from already-vulnerable populations, and the rebranding as "Molecular HIV Surveillance" (MHS) obscured its experimental research origins. From there, it evolved over the years to encompass widespread interventions involving the identification and tracking of individuals both living with HIV and at risk of acquiring HIV, using a combination of demographic, behavioral, medical and genetic data computed with social network analyses and predictive risk algorithms.
At the same time, the CDC ended its contract with Stanford University to create a firewall between its oversight and direct involvement with accessing personally identifying information. This was part of a larger strategy to exploit regulatory and legal loopholes surrounding what counts as research, avoiding any potential re-determination of their work as research activity that could impose restrictive ethical constraints and accountabilities precluding its very practice. To that end, state health departments were newly vested with the responsibility of collecting HIV genetic data from public and private labs.
With the stroke of a pen, a single person who is an appointed government official can implement Tuskegee-like experimentation all over again in an entirely legal way by invoking a loophole created by legislation intended to prevent such a thing from ever happening again. It goes without saying how such a dangerous precedent could be further abused by agency appointees in the midst of the current Presidential administration: the ability to weaponize any form of medical scientific research by simply reclassifying it as routine public health practice for mass deployment nationwide, stripped of any and all ethical constraints. That is an enormous and dangerous amount of power for any one government official to subjectively wield without accountability or recourse. It’s even worse this is coming from the CDC, which is part of the USPHS — the same entity that conducted the horrific Tuskegee Study.
At the time of this writing in 2025, MHS has now been underway for more than twenty years, and outrage surrounding it is typically met with tepid responses from its proponents such as, "It's too late. We have already implemented it. The MHS train has already left the station. There is no turning back now." Efforts to hold the CDC accountable for consistency with the Belmont Report have been repeatedly dismissed, minimized and subverted by propaganda campaigns accentuating the many tactical advantages of deploying genetic surveillance as a necessary tool in "getting to zero."
As the voices of HIV advocacy groups have grown louder and angrier with public criticism of this government surveillance, the CDC re-re-branded MHS once again as "Cluster Detection and Response" (CDR) in 2018. This coincided with the inclusion of CDR in the U.S. National Strategy for Ending the Epidemic and the CDC began requiring all states and territories to implement the practice as a requirement to continue receiving federal HIV funding. At various times the CDC has cited additional reasons for the non-research exemption, including alignment with its own Policy 557 used to inform such a determination, the technical specificity of how it uses de-identified codes assigned to biospecimens for information collection, the intentionally structured absence of direct oversight of the labs and medical providers legally required to provide genetic sequence information, patient medical records housed by intermediary state departments of health, and more.
A number of pervasive themes begin to emerge in any analysis of controversies surrounding molecular HIV surveillance, such as whether or not it constitutes research, and the problematic historical context of how it came into existence. Black communities are deservedly alarmed by how quickly government-sanctioned human experimentation on vulnerable people, without their awareness or consent, has reemerged so quickly since the universal denouncement of Tuskegee. Equally disheartening is the apparent ease of subverting, even exploiting, "never again" protections meant to safeguard the world from a recurrence of such atrocities. And loyalties are divided among those with a once-shared goal of ending HIV by "getting to zero" as the realization sets in that such a goal is only possible at this time if we are willing to make significant concessions to the protection of human rights related to privacy, informed consent, bodily autonomy, social justice and equity for all.
HIV-related research and medicine is wholly dependent on the public’s trust, and betrayals of that trust, especially among BIPOC communities, creates lasting damage that harms everyone.