Abstract
During the mid-20th century, a number of studies were conducted that involved vulnerable populations, particularly incarcerated individuals. Among the most notable figures in this context was the US dermatologist Albert Kligman, who is credited with originating the term “Corneotherapy.”
Kligman’s research forms part of these studies, which took place during a period when ethical standards in biomedical, dermatological and cosmetic research were markedly different from those upheld today.
Documented practices from this era included questionable approaches to informed consent, especially among populations with limited autonomy. These methods are now widely recognised as unethical.
The International Association for Applied Corneotherapy (I.A.C.) unequivocally does not endorse or support such actions, reaffirming its commitment to contemporary ethical standards in research and practice, but feel that we should acknowledge this controversial chapter in modern skin care development.
Human subjects in cosmetic product development
Experiments involving human subjects have played a central role in the development and validation of modern cosmetic products globally. Unlike purely laboratory-based testing, these studies allow researchers to evaluate how formulations interact with real skin under everyday conditions—providing insight into safety, tolerability, and visible efficacy.
Historically, human testing in cosmetics expanded significantly during the mid-20th century, particularly as concerns about ingredient safety grew following events such as the Thalidomide tragedy. While that incident was pharmaceutical rather than cosmetic, it led to stricter global expectations for testing standards and ethical oversight across all personal care sectors.
Modern cosmetic trials with human participants typically fall into several categories:
Patch testing is widely used to assess irritation or sensitisation potential by applying small amounts of a product to the skin under controlled conditions.
Use tests (or consumer trials) involve participants applying products over days or weeks to evaluate real-world performance—such as hydration, wrinkle reduction, or barrier repair. Increasingly, these studies are supported by non-invasive bioengineering tools, including corneometry (for hydration), TEWL measurements (for barrier function), and high-resolution imaging.
Ethical governance is now fundamental to all human-based cosmetic research. International frameworks such as the Declaration of Helsinki [1] establish guidelines for informed consent, participant safety, and scientific integrity. In addition, regulatory bodies like the European Commission enforce strict rules—most notably the ban on animal testing for cosmetics in the European Union, which has increased reliance on human volunteer studies and advanced in vitro methods.
Today, cosmetic experiments involving human subjects are designed to minimise risk while maximising relevance. When conducted responsibly, they provide essential evidence that supports both product claims and consumer safety, bridging the gap between laboratory science and real-world skin health.
Historical context
The use of prisoners in human testing is one of the most controversial chapters in the history of biomedical and cosmetic research. While it did occur, especially in the mid-20th century, it is now heavily restricted or effectively prohibited in most countries due to serious ethical concerns.
From the 1950s through the 1970s, some researchers and companies conducted experiments on incarcerated individuals. A well-known example is the work carried out at Holmesburg Prison in the United States. [2] Under the direction of Albert M. Kligman [3], prisoners across a number of ethnicities and genetic traits participated in dermatological studies that tested cosmetics, pharmaceuticals, and chemical agents on the skin.
These studies often included:
• Application of experimental creams, deodorants, and lotions
• Exposure to irritants to study skin reactions
• Testing of ingredients later used in consumer products
Participants were typically paid small sums, which at the time was framed as voluntary participation.
Why prisoners were used
Researchers were drawn to prisons because they offered:
• A stable, confined population for long-term observation
• Easier monitoring and follow-up
• Lower costs compared to recruiting from the general public
However, these practical advantages came at the cost of ethical integrity, particularly regarding coercion and informed consent. [4]
Ethical issues
Despite being described as “voluntary,” prisoner testing raised major ethical concerns:
• Coercion and power imbalance: Incarcerated individuals have limited freedom, making true informed consent questionable.
• Inadequate disclosure: Participants were not always fully informed about risks.
• Exploitation of vulnerable populations: Prisoners were often selected because they were easily accessible and economically disadvantaged.
These concerns became more widely recognized alongside broader ethical reckoning following events such as the Tuskegee Syphilis Study, which exposed systemic abuses in human research. [5]
Other uses of controlled environments for human experimentation
Research involving incarcerated people was not limited to the work of Albert M. Kligman and others. Across the mid-20th century, a range of academic researchers, government programs, and private companies used prisons as controlled environments for human experimentation—often under conditions that would not meet today’s ethical standards.
Pharmaceutical and dermatological testing programs
At Stateville Correctional Centre in the US, researchers conducted malaria experiments during the 1940s, deliberately infecting prisoners to test antimalarial drugs. These studies were linked to wartime efforts and involved collaboration between universities and pharmaceutical interests. [6]
Similarly, multiple pharmaceutical companies—including Dow Chemical Company and Johnson & Johnson [7] - have been associated with prison-based trials, where products such as skin treatments, antiseptics, and chemical compounds were tested on inmates.
While some participants consented, the broader context of incarceration raised ongoing concerns about the validity of that consent.
Government-sponsored experiments
During the Cold War era, certain U.S. government programs also involved prisoners. Under projects such as MKUltra [8], individuals—including some who were incarcerated—were exposed to psychoactive substances like LSD to study behavioural effects.
In another example, chemical exposure studies linked to Dow Chemical Company included testing of substances such as dioxins on prison populations, again raising serious ethical questions about risk disclosure and long-term harm. [9]
Infectious disease and vaccine trials
Infectious disease research also used prison populations. For example, studies on hepatitis transmission and vaccines were conducted in U.S. prisons during the 1950s and 1960s. These experiments aimed to understand disease spread and immunity but often involved deliberate exposure to pathogens.
Regulatory changes
By the 1970s, public scrutiny and policy reform led to significant restrictions:
• The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research established stricter guidelines.
• The Belmont Report [10] introduced core principles: respect for persons, beneficence, and justice.
• Regulations in the United States (under the “Common Rule”) now impose strict limits on research involving prisoners, allowing only minimal-risk studies with clear ethical justification.
These historical examples illustrate how both commercial and government-backed research once relied on incarcerated individuals—and why modern ethical frameworks now place strong protections around vulnerable populations.
Current perspective
Today, the cosmetic industry does not rely on prisoner testing. Instead, it uses:
• Consenting volunteers from the general population
• In vitro (lab-based) testing
• Advanced imaging and non-invasive measurement techniques
Research involving prisoners is now considered a highly sensitive area, subject to strict ethical oversight, and is rarely permitted outside narrowly defined conditions.
In short, while prisoner-based testing contributed to some early dermatological knowledge, it is now widely viewed as ethically problematic and incompatible with modern standards of human research.
Following reforms like the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research) [10] and stricter oversight rules, research involving prisoners is tightly controlled and limited to minimal-risk studies with clear benefit and voluntary participation.
References
[1] https://www.wma.net/policies-post/wma-declaration-of-helsinki/
[2] https://en.wikipedia.org/wiki/Holmesburg_Prison
[3] https://en.wikipedia.org/wiki/Albert_Kligman
[4] https://www.ncbi.nlm.nih.gov/books/NBK430827
[5] https://www.cdc.gov/tuskegee/about/index.html
[6] https://en.wikipedia.org/wiki/Stateville_Penitentiary_Malaria_Study
[7] https://www.bmj.com/content/376/bmj.o681
[8] https://en.wikipedia.org/wiki/MKUltra
[9] https://www.nytimes.com/1983/07/17/us/dioxin-tests-conducted-in-60-s-on-70-philadelphia-inmates-now-unknown.html
[10] https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
