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5 Unethical Medical Experiments Brought Out of the Shadows of History

Prisoners and other vulnerable populations often bore the brunt of unethical medical experimentation.

By Allison Futterman
January 11, 2021 5:30 PM
Source: Discover Magazine

medical instruments on a table - shutterstock
Source: Discover Magazine
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(Credit: PanatFoto/Shutterstock)

Most people are aware of some of the heinous medical experiments of the past that violated human rights. Participation in these studies was either forced or coerced under false pretenses. Some of the most notorious examples include the experiments by the Nazis, the Tuskegee syphilis study, the Stanford Prison Experiment, and the CIA’s LSD studies.

But there are many other lesser-known experiments on vulnerable populations that have flown under the radar. Study subjects often didn’t — or couldn’t — give consent. Sometimes they were lured into participating with a promise of improved health or a small amount of compensation. Other times, details about the experiment were disclosed but the extent of risks involved weren’t.

This perhaps isn’t surprising, as doctors who conducted these experiments were representative of prevailing attitudes at the time of their work. But unfortunately, even after informed consent was introduced in the 1950s, disregard for the rights of certain populations continued. Some of these researchers’ work did result in scientific advances — but they came at the expense of harmful and painful procedures on unknowing subjects.

Here are five medical experiments of the past that you probably haven’t heard about. They illustrate just how far the ethical and legal guidepost, which emphasizes respect for human dignity above all else, has moved.

Learn more about Informed Consent

The Prison Doctor Who Did Testicular Transplants

From 1913 to 1951, eugenicist Leo Stanley was the chief surgeon at San Quentin State Prison, California’s oldest correctional institution. After performing vasectomies on prisoners, whom he recruited through promises of improved health and vigor, Stanley turned his attention to the emerging field of endocrinology, which involves the study of certain glands and the hormones they regulate. He believed the effects of aging and decreased hormones contributed to criminality, weak morality, and poor physical attributes. Transplanting the testicles of younger men into those who were older would restore masculinity, he thought.  

Stanley began by using the testicles of executed prisoners — but he ran into a supply shortage. He solved this by using the testicles of animals, including goats and deer. At first, he physically implanted the testicles directly into the inmates. But that had complications, so he switched to a new plan: He ground up the animal testicles into a paste, which he injected into prisoners’ abdomens. By the end of his time at San Quentin, Stanley did an estimated 10,000 testicular procedures.

The Oncologist Who Injected Cancer Cells Into Patients and Prisoners

During the 1950s and 1960s, Sloan-Kettering Institute oncologist Chester Southam conducted research to learn how people’s immune systems would react when exposed to cancer cells. In order to find out, he injected live HeLa cancer cells into patients, generally without their permission. When patient consent was given, details around the true nature of the experiment were often kept secret. Southam first experimented on terminally ill cancer patients, to whom he had easy access. The result of the injection was the growth of cancerous nodules, which led to metastasis in one person.

Next, Southam experimented on healthy subjects, which he felt would yield more accurate results. He recruited prisoners, and, perhaps not surprisingly, their healthier immune systems responded better than those of cancer patients. Eventually, Southam returned to infecting the sick and arranged to have patients at the Jewish Chronic Disease Hospital in Brooklyn, NY, injected with HeLa cells. But this time, there was resistance. Three doctors who were asked to participate in the experiment refused, resigned, and went public.

The scandalous newspaper headlines shocked the public, and legal proceedings were initiated against Southern. Some in the scientific and medical community condemned his experiments, while others supported him. Initially, Southam’s medical license was suspended for one year, but it was then reduced to a probation. His career continued to be illustrious, and he was subsequently elected president of the American Association for Cancer Research.

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The Aptly Named ‘Monster Study’

Pioneering speech pathologist Wendell Johnson suffered from severe stuttering that began early in his childhood. His own experience motivated his focus on finding the cause, and hopefully a cure, for stuttering. He theorized that stuttering in children could be impacted by external factors, such as negative reinforcement. In 1939, under Johnson’s supervision, graduate student Mary Tudor conducted a stuttering experiment, using 22 children at an Iowa orphanage. Half received positive reinforcement. But the other half were ridiculed and criticized for their speech, whether or not they actually stuttered. This resulted in a worsening of speech issues for the children who were given negative feedback.

The study was never published due to the multitude of ethical violations. According to The Washington Post, Tudor was remorseful about the damage caused by the experiment and returned to the orphanage to help the children with their speech. Despite his ethical mistakes, the Wendell Johnson Speech and Hearing Clinic at the University of Iowa bears Johnson’s name and is a nod to his contributions to the field.

The Dermatologist Who Used Prisoners As Guinea Pigs

One of the biggest breakthroughs in dermatology was the invention of Retin-A, a cream that can treat sun damage, wrinkles, and other skin conditions. Its success led to fortune and fame for co-inventor Albert Kligman, a dermatologist at the University of Pennsylvania. But Kligman is also known for his nefarious dermatology experiments on prisoners that began in 1951 and continued for around 20 years. He conducted his research on behalf of companies including DuPont and Johnson & Johnson.

Kligman’s work often left prisoners with pain and scars as he used them as study subjects in wound healing and exposed them to deodorants, foot powders, and more for chemical and cosmetic companies. Dow once enlisted Kligman to study the effects of dioxin, a chemical in Agent Orange, on 75 inmates at Pennsylvania’s Holmesburg Prison. The prisoners were paid a small amount for their participation but were not told about the potential side effects.about:blankabout:blank

In the University of Pennsylvania’s journal, Almanac, Kligman’s obituary focused on his medical advancements, awards, and philanthropy. There was no acknowledgement of his prison experiments. However, it did mention that as a “giant in the field,” he “also experienced his fair share of controversy.”

The Endocrinologist Who Irradiated Prisoners

When the Atomic Energy Commission wanted to know how radiation affected male reproductive function, they looked to endocrinologist Carl Heller. In a study involving Oregon State Penitentiary prisoners between 1963 and 1973, Heller designed a contraption that would radiate their testicles at varying amounts to see what effect it had, particularly on sperm production. The prisoners also were subjected to repeated biopsies and were required to undergo vasectomies once the experiments concluded.

Although study participants were paid, it raised ethical issues about the potential coercive nature of financial compensation to prison populations. The prisoners were informed about the risks of skin burns, but likely were not told about the possibility of significant pain, inflammation, and the small risk of testicular cancer.

Despite your doctors accolades what is their professional history? How do you feel about their history? Is there anything controversial in their history?

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Immigrant Women File Lawsuit Against ICE And Georgia Doctor Alleging Medical Abuse

WOMEN 12/22/2020 03:24 pm ET 
Updated Dec 23, 2020
Source: Huff Post

More than 30 women say they were subject to non-consensual invasive medical procedures.

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By Rowaida Abdelaziz
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We have people who love us and are waiting on us, is a comment we have often heard from those who have suffered medical abuse, negligence and violence while under forced medical care. After being given a cocktail of medications this particular female patient woke stripped down to her undergarments in the middle of the night with no answers or explanations for medical professionals who seem unconcerned and remove from her situation.

By Rowaida Abdelaziz

More than 30 women filed a class-action lawsuit on Monday against a Georgia gynecologist and the U.S. Immigration and Customs Enforcement agency, alleging they were subject to medical abuse and retaliation while in ICE custody.

The women, all of whom were detained at Irwin County Detention Center in Ocilla, Georgia, allege they underwent non-consensual invasive procedures ― including hysterectomies, birth control shots, and medically unindicated gynecological procedures that amounted to sexual assault ― at the hands of Dr. Mahendra Amin, who was working as an obstetrician-gynecologist authorized by ICE to provide medical services to detainees. The immigrant women also accuse ICE and LaSalle Corrections employees of retaliating against them for speaking out against Amin. (LaSalle Corrections, a private prison company, operates the detention center.)

Amin’s lawyer, who did not respond to HuffPost’s request for comment, has previously denied any wrongdoing on behalf of his client. An ICE spokesperson told HuffPost that they could not comment on pending litigation but that the agency was “fully cooperating” with the investigation by the Department of Homeland Security’s Office of Inspector General.

The women filed the 160-page complaint in the U.S. District Court for the Middle District of Georgia with the help of several organizations and law firms including the National Immigration Project of the National Lawyers Guild, Atlanta’s Dreyer Sterling, and New York’s Morningside Heights Legal Services.

“We are seeking an immediate end to the egregious retaliation against the women who spoke out against the abuse, release of the women who have suffered medical abuse, and compensation for the harms that the survivors suffered,” said Azadeh Shahshahani, legal and advocacy director at Atlanta-based Project South and co-counsel on the lawsuit. “It is high time for this facility rife with human rights violations to be shut down and for ICE and LaSalle to be held accountable.”

News of ICE detainees receiving unwanted and unnecessary hysterectomies first came out in September after a nurse blew the whistle. More detained women have since spoken out to say they endured medical neglect or were forced to undergo surgeries performed by Amin that they never approved of. An independent inquiry by a team of medical experts in October uncovered a troubling pattern of incorrect diagnoses and failure to secure informed consent for medical surgeries on detainees at the Irwin County Detention Center.

The immigrant women included in Monday’s suit came from a range of countries including Mexico, Bolivia, Senegal and Kenya. Some of the women have since been released while others have been deported. Last month, the Trump administration agreed to freeze the deportations of the women who alleged abuse at the Georgia facility.

In the complaint, women say they faced a range of retaliatory actions after speaking out against Amin, including physical assault, solitary confinement, loss of money from their commissary accounts, limited access to phones, and delayed delivery of medications and medical records. 

At a virtual press conference on Tuesday hosted by the National Immigration Project of the National Lawyers Guild, one of the accounts of abuse came from Elizabeth, a 21-year-old detainee who was born in Guadalajara, Mexico, and has lived in the U.S. since she was brought to the country at 8 years old. (She is being identified solely by her middle name due to sensitive details of her story.) Elizabeth alleged that she did not receive a six-week postpartum checkup after giving birth and that she sought medical help after experiencing pain. ICE sent her to Amin.

Upon arrival at her appointment, Elizabeth said that she was handcuffed and shackled at her ankles and waist. She alleged that Amin conducted a vaginal ultrasound and gave her a Depo-Provera birth control shot without explaining the procedures. She said that she only found out what the shot entailed after speaking to another immigrant who had received the same shot and that she did not consent to receiving the birth control.

“I just feel like I have no control over my body anymore,” Elizabeth said.

At the doctor’s office, she said she was forced to sign paperwork that she never had the chance to read. And following the visit, she said she bled for two months, gained 15 pounds and was frequently depressed.

“The people that we trust, the medical staff that is here, we can’t trust them anymore,” she said. “We don’t know what they are doing with our bodies.”

Elizabeth said she hopes to receive justice for the medical mistreatment and to be released from the detention center while she pursues her immigration case to stay in the U.S. The young mother couldn’t celebrate Thanksgiving and will likely miss out on celebrating Christmas with her newborn daughter. 

“We have kids. We have people that love us that are waiting for us,” she said.

Out of greed or wrath many so called medical professionals commit atrocities to ‘patients’ often never explaining what they have done to their bodies. These people often suffer years with unexplained illnesses. These ‘medical professionals’ following them with no more permission than they had the first time. Looking for bodies they can commit their atrocities to, not to mention the required informed consent — by true medical professionals. They often attempt to cover their tracks by using prisoners, immigrants, fraud, mis-diagnosis, mis-informing, harassing, post voluntary election into medical trails along with many other methods and means. What should be done? What other populations do thee doctors exploit? What other methods and means have you seen?

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Do it yourself? When the researcher becomes the subject

Poldrack in scanner
Stanford psychologist Russell Poldrack, shown here in his 105th MRI scanning session during an 18-month experiment, is one of a number of researchers who are enlisting as subjects in their own studies. TIM LAUMANN
Source: Science Magazine
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By Esther LandhuisDec. 5, 2016 , 12:30 PM
Source: Science Magazine
Photos Source: Science Magazine

Some scientists analyze fruit flies. Others use zebrafish. Many conduct studies with mice. But occasionally, researchers choose to experiment on a different animal: themselves. Consider the medical officer who in the early 1800s fed himself spoiled sausage to determine the source of foodborne botulism. Or the physician who in 1929 performed the world’s first cardiac catheterization on himself, and the young doctor who in 1984 guzzled Helicobacter pylori broth to prove that the bacterium causes ulcers. The latter two went on to win Nobel Prizes, but others haven’t been as fortunate. During the Spanish–American War, when yellow fever was killing thousands of U.S. soldiers, physician Jesse Lazear died after intentionally exposing himself to infected mosquitoes.

Medical martyrdom is rarer these days, in part due to increased regulation of human subject research after World War II, and fewer researchers dying for their work can only be a good thing. Nonetheless, autoexperimentation continues. The access to the subject is matchless, and the allure of big data and personalized medicine seems to be some nudging self-experimenters toward new types of studies. However, the regulatory environment remains somewhat vague, leaving it up to researchers to weigh practicality against ethical considerations. But if care and diligence accompany the appetite for adventure, scientists can responsibly conduct self-experimentation studies that help advance science—and potentially offer some fun and personal benefit to boot.

Balancing ease with ethics

For scientists whose work isn’t particularly risky, it’s hard to beat a prime motivation for self-experimentation: convenience. “It’s easy to draw your own blood and analyze it,” says Laura Stark, a bioethics historian at Vanderbilt University in Nashville. “You don’t have to worry about someone suing you or deciding you can’t use their sample.”

That was a key factor when Lawrence David, a Ph.D. student at the Massachusetts Institute of Technology at the time, and his adviser, bioengineer Eric Alm, sought to monitor how daily activities influenced the human gut and oral microbiomes over the course of a year. They needed to determine feasibility limits—for example, how frequently samples could be collected and how many variables could be measured. When the researchers couldn’t immediately find participants, they decided to enroll themselves. “We thought that by participating, we’d gain firsthand understanding of those limits,” says David, now an assistant professor of molecular genetics and microbiology at Duke University in Durham, North Carolina.

Each day, the two researchers saved spit samples and pooped into sterile bags. They used an iPad app to log their weight and everything they did and ate. Several months into the study, David went to Bangkok for a few weeks but stuck with the regimen, shipping home 3 to 5 pounds of stool on dry ice. That commitment eventually paid off when the results were published.

Russell Poldrack, a psychologist at Stanford University in Palo Alto, California, also had an ambitious study plan that required more than what the average participant would tolerate. That’s what led him to climb into an MRI machine every Tuesday and Thursday morning for 18 months to get his brain scanned. The idea started simmering years before, when Poldrack’s studies to understand psychiatric disorders stalled because they lacked a good control for normal brain function variability over time. At some point, he recalls, while he was directing the Imaging Research Center at the University of Texas (UT) at Austin, artist-in-residence Laurie Frick “really started pushing me, saying, ‘You’ve got this MRI scanner. Why aren’t you getting in there and scanning yourself?’”

While Poldrack was mulling over this possibility, Stanford geneticist Michael Snyder published a 2012 paper describing an “integrative Personal Omics Profile” of a 54-year-old male volunteer—himself. Snyder’s genome was sequenced and analyzed, and over 14 months, the research team made more than 3 billion measurements of his blood, saliva, mucus, urine, and feces. During the study—conducted as a proof of principle and to learn what a baseline “healthy” state looks like—Snyder discovered that he was genetically at risk for type 2 diabetes. With that information and the accompanying data, he was able to investigate biological pathways that kicked in as he developed signs of disease, which could have implications beyond Snyder’s individual health. Seeing Snyder’s work made Poldrack think that his crazy brain study might “not just be a goofy boutique project; it could actually have some scientific impact.”

He was right: His 18-month ordeal produced the most detailed map of functional brain connectivity in a single person to date.

Despite the potential advantages of using oneself as a subject, scientists contemplating this approach should consider research ethics guidelines. In the United States, the National Institutes of Health enacted policies in 1954 that restrict the use of employees as research subjects. The National Research Act, passed by Congress in 1974, requires research involving human subjects to be vetted by an institutional review board (IRB). Current rules, which date from 1981, outline additional protections for vulnerable groups, including pregnant women, children, and prisoners. U.S. federal law does not, however, explicitly address self-experimentation by a scientist or physician, says Jonathan Moreno, a bioethicist at the University of Pennsylvania. As Stark explains, it is “a blind spot in the current human subjects regulations.” That means that, at least for now, it is up to researchers to decide whether they’re comfortable experimenting on themselves and whether they need to seek IRB approval.

Conducting research in this vague regulatory environment can create confusion, even when researchers do everything they can to make sure they’re proceeding according to regulations and requirements. Before Poldrack started his brain study, for example, he submitted a proposal to the IRB at UT Austin, where he worked at the time. The board said that it did not consider his project to be human subjects research and therefore it did not require approval, so Poldrack got started collecting his scans without worrying about any further paperwork.

About 6 months after Poldrack started collecting data, however, the situation became more complicated. Researchers at Washington University School of Medicine in St. Louis learned of the study and wanted to use some of Poldrack’s data. When they checked with their IRB to see whether a formal protocol was required, they hoped the IRB would say it was unnecessary. After all, it was data being collected at a different institution that hadn’t required IRB approval—“essentially just a data transfer from our point of view,” says M.D.-Ph.D. student Tim Laumann, one of the researchers interested in accessing the data. However, the Washington University IRB did require a protocol to be written and approved—a process that took about a month even when expedited, Laumann says.

Looking back, Poldrack suspects that things could have gone more smoothly if he had gotten IRB approval from his institution to begin with. “It would have made data sharing much easier because the data would not have been living in an ethical gray zone”—although, he adds, other aspects of the study, such as the fact the data cannot be de-identified, “might also have raised issues even with IRB approval.” In the absence of hard-and-fast rules for self-experimentation, researchers wishing to study themselves should trust their best judgment while allowing for hiccups that could arise in this less-chartered realm.

The power of doing it yourself

Beyond administrative challenges, self-experimentation studies can raise questions about whether analyses of just a few individuals are scientifically valid. Self-monitoring experiments are not randomized or blinded like traditional human studies, and the experimenter’s personal involvement and motivations could make the research seem less objective.

Despite these concerns and caveats, there are scenarios where self-experimentation may be not only acceptable but optimal. Studies such as Poldrack’s, which aim to correlate hard-to-describe personal experiences such as mood or emotion with concrete measurements, for example, are among them because the researchers have particular expertise that makes them ideal subjects. Researchers “know the categories used to describe feelings and side effects and can articulate them in a way that translates easily into scientific language,” Stark says. Self-experimentation, therefore, can offer a way to calibrate tools and technologies that are otherwise hampered by relying on an individual’s subjective experience.

And for University of California, San Francisco, neuroscientist Adam Gazzaley, who develops video games to help improve brain function, the small sample size is exactly what he wants. The video games automatically adjust their difficulty based on the user’s performance, creating a personalized digital therapy, which is a key part of his lab’s effort to shift “away from just focusing on large populations and focusing more on the individual, the n of 1,” Gazzaley says. “We’re looking to understand more about how to make meaningful statements about data from a single person.”

<p>Adam Gazzaley underwent various measurements, including EEGs, as a participant in his own studies.</p>
Adam Gazzaley underwent various measurements, including EEGs, as a participant in his own studies. JO GAZZALEY
Source: Science Magazine
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Every once in a while, when Gazzaley gives talks about the project, someone from the audience would ask him whether he played the games himself. His answer was “no” until the summer of 2015, when Gazzaley decided to put his time where his mouth is and became a research participant. For 2 months he played an hour of Body Brain Trainer, a physical and cognitive fitness game, three mornings a week. He also did 30 minutes of a meditation game called Meditrain on weeknight evenings, and for 3 weeks he played the newest game, Neurodrummer, which aims to improve cognition through rhythm training. He also had to get numerous measurements taken via saliva and blood samples, MRIs, EEGs, sleep tracking, heart rate monitoring, and more.

“Playing games I helped invent and being in studies I helped design and validate, but doing it from the perspective of a participant, was really helpful,” Gazzaley says. Experiencing firsthand the challenges of compliance, especially for something “not as quick as a pill,” has inspired Gazzaley to develop ways to not only push people to work harder during the game but also to sustain motivation over the long haul.

As for whether he plans to publish the data collected on himself, he says he might play the games again, perhaps annually, “to get a more longitudinal view.” For now, though, the personal reasons for self-experimentation could be just as strong as the scientific motivation. Now in his late 40s, Gazzaley says he is “approaching the age range of the adults we treat in some of our older studies. We know middle-aged folks have declining cognitive control. This seemed a great way for me to try and get out in front of it.”

Regardless of why scientists engage in self-experimentation, they should be transparent, making a public statement—perhaps a paragraph in the manuscript—explaining why they’re doing a study on themselves and what they hope to learn by conducting the research this way, Moreno says. “It says the researcher isn’t just using patients as guinea pigs.” Time will tell whether these types of studies establish worth that goes beyond provocative one-offs. Then again, with certain research questions, he adds, “if you don’t give it a shot, you may never know.”

doi:10.1126/science.caredit.a1600160

Esther Landhuis

Esther Landhuis is a freelance science journalist based in the San Francisco Bay area.

Why don’t more doctors and scientist use themselves as subjects since they have confidence in their trails? Why don’t patients know about informed consent? Why don’t doctors and scientist get it? Why are clinical trials infamous for their fines? Are unethical medical experiments really a thing of the past? Why are there so many modern day instances of unethical medical experiments?

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You Might Be in a Medical Experiment and Not Even Know It

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By Alice Dreger, January 31, 2017 1:34 PM
Source: Discover Magazine
Feature Photo Source: Unsplash, Hush Naidoo 

In the long view, modern history is the story of increasing rights of control over your body – for instance, in matters of reproduction, sex, where you live and whom you marry. Medical experimentation is supposed to be following the same historical trend – increasing rights of autonomy for those whose bodies are used for research.

Indeed, the Nuremberg Code, the founding document of modern medical research ethics developed after the Second World War in response to Nazi medical experiments, stated unequivocally that the voluntary, informed consent of the human subject is essential. Every research ethics code since then has incorporated this most fundamental principle. Exceptions to this rule are supposed to be truly exceptional.

Yet today, more and more medical experimenters in the United States appear to circumvent getting the voluntary, informed consent of those whose bodies are being used for research. What’s more, rather than fighting this retrograde trend, some of the most powerful actors in medical research are defending it as necessary to medical progress.about:blankabout:blank

A few years ago, I fell in with a growing group of professionals in medicine and allied fields such as bioethics who have mobilised to defend the right to informed consent in medical experimentation. As a historian of medicine, I had worked since 1996 with intersex rights activists on improving care for children born with bodies in between the male and female types. In 2009, colleagues alerted me that a group of parents judged ‘at risk’ of having a child born with a particular genetic intersex condition appeared to be unwitting subjects in a medical experiment.

A major researcher and physician was promoting the prenatal use of a drug (dexamethasone) aimed at preventing intersex development. Targeting would-be parents who knew they had this condition running in their families, the researcher told them that the ‘treatment’ had been ‘found safe for mother and child’.

In fact, the US Food and Drug Administration (FDA) has not approved dexamethasone for preventing intersex development, much less found it ‘safe’ for this use. Indeed, the FDA has noted dexamethasone causes harm in foetal animals exposed to it. No one seems to have told the parents that this ‘treatment’ had not gone through anything like the normal route of drug approval: there has been no animal modelling of this use, no blinded control trial for effectiveness, and no long-term prospective safety trials in the US, where thousands of foetuses appear to have been exposed.

Shockingly, at the same time that this researcher was pushing the ‘treatment’ as ‘safe’, she was obtaining grants from the US National Institutes of Health (NIH) to use the same families in retrospective studies to see if it had been safe. A Swedish research group has recently confirmed – through fully consented, prospective studies – that this drug use can cause brain damage in the children exposed prenatally.

As I sought allies in defending the rights of these families, I discovered that, while this was an especially egregious case of failure to obtain informed consent to what amounted to a medical experiment, the lapse was not unique. Public Citizen’s Health Research Group, a Washington-based NGO, has been leading the work in tracking cases where medical researchers fail in their obligations to obtain informed consent.about:blankabout:blank

Recently, Public Citizen, together with the American Medical Student Association, sounded an alarm about two clinical trials, one called iCOMPARE, the other FIRST. In these studies, researchers extended the working hours of newly trained physicians to see if these physicians and their patients were better or worse off with the most inexperienced doctors working longer, more tiring shifts.

The young doctors used in these studies were not given the option of not participating. If their residency programmes participated, they were in. More concerning, their patients were never informed that they were experimental subjects, even though a primary research goal was to see if patients treated by residents working longer shifts would experience higher rates of harm.

Some studies tracked by Public Citizen reveal downright bizarre ethical mistakes. A recent study funded by the US Department of Health and Human Services, led by a US Department of Veterans Affairs researcher, sought to determine whether, if brain-dead kidney donors’ bodies were cooled after brain death, living recipients of the transplanted kidneys did better. The researchers decided they didn’t need to get voluntary consent to the experiment from the living kidney recipients. They simply maintained the dead donors were the experimental subjects.

The largest contemporary fight over failure to obtain informed consent has been over the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (or SUPPORT). This was a large NIH-funded study meant to determine, in part, whether higher or lower levels of oxygen after birth provided very premature babies with benefit or harm. The consent forms for this study did not inform the parents that the experiment’s purpose was to see if, by being randomly assigned to one of two experimental oxygen ranges, babies end up more likely to be blind, neurologically damaged or die.

Most parents also weren’t informed that the researchers would use experimental measuring devices meant to ‘blind’ professional caregivers to the babies’ real oxygen levels to try to make the study more rigorous. Researchers told many parents that the study involved no special risks because all the procedures in the research were supposedly standard of care. This was a demonstrably untrue claim.

In this case, the US Office for Human Research Protections (OHRP) – an agency meant to protect the rights of people in federally funded research – agreed with Public Citizen and an allied group of more than 40 of us in medicine and bioethics that the informed consent for this trial was seriously inadequate. But in a series of emails meant to stay private, top NIH officials pressured the OHRP to back off its criticisms. OHRP is supposed to oversee NIH’s work, not the other way around!

NIH leaders also partnered with the editor of The New England Journal of Medicineto publicly defend this study. The journal’s editor-in-chief tried actively to limit the ability of us critics to respond. Meanwhile, the parents were never officially informed of what happened to their babies.

Those defending these troubling studies often argue that elaborate consent procedures can get in the way of obtaining important scientific results. They say that subjects might encounter the risks of the experiment even in ‘normal’ patient care, so we might as well engage them in studies without scaring them off through frightening research consent forms.

It is true that the current research ethics system in the US is cumbersome, inefficient and dysfunctional. Researchers often find themselves confused and frustrated by the bureaucracies of research ethics systems.

But that is no excuse not to vigorously maintain the first principle of the Nuremberg Code: the voluntary consent of the subject is essential. We can’t afford the risk to medical research that sloppy ethics entail; when the public finds out about the circumvention of informed consent – as in the case of the infamous US Public Health Service syphilis study at Tuskegee – the damage to the integrity and authority of the medical research community is inevitably significant and long-lasting.about:blank

The tenets of the Nuremberg Code were not meant only for Nazis. If Nazis presented the only danger to people being used for medical experiments, eliminating the Nazis would have solved our problems. The Nuremberg Code was written to guide all of us, because good intentions are not enough.

This article was originally published at Aeon and has been republished under Creative Commons.

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THE NUREMBERG CODE AND ITS IMPACT ON CLINICAL RESEARCH

Posted by Natalie Jarmusik on Tue, Apr 9, 2019
Source: IMA Research

Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects. 

What Is the Nuremberg Code?

When World War II ended in 1945, the victorious Allied powers enacted the International Military Tribunal on November 19th, 1945.  As part of the Tribunal, a series of trials were held against major war criminals and Nazi sympathizers holding leadership positions in political, military, and economic areas.  The first trial conducted under the Nuremberg Military Tribunals in 1947 became known as The Doctors’ Trial, in which 23 physicians from the German Nazi Party were tried for crimes against humanity for the atrocious experiments they carried out on unwilling prisoners of war.  Many of the grotesque medical experiments took place at the Auschwitz concentration camp, where Jewish prisoners were tattooed with dehumanizing numbers onto their arms; numbers that would later be used to identify their bodies after death.

The Doctors’ Trial is officially titled “The United States of America v. Karl Brandt, et al.,” and it was conducted at the Palace of Justice in Nuremberg, Bavaria, Germany.  The trial was conducted here because this was one of the few largely undamaged buildings that remained intact from extensive Allied bombing during the war.  It is also said to have been symbolically chosen because it was the ceremonial birthplace of the Nazi Party.  Of the 23 defendants, 16 were found guilty, of which seven received death sentences and nine received prison sentences ranging from 10 years to life imprisonment. The other 7 defendants were acquitted. 

The verdict also resulted in the creation of the Nuremberg Code, a set of ten ethical principles for human experimentation. 

What Are The Nuremberg Code’s Ethical Guidelines For Research?

The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 elements of the code are: 

  1. Voluntary consent is essential
  2. The results of any experiment must be for the greater good of society
  3. Human experiments should be based on previous animal experimentation
  4. Experiments should be conducted by avoiding physical/mental suffering and injury
  5. No experiments should be conducted if it is believed to cause death/disability
  6. The risks should never exceed the benefits
  7. Adequate facilities should be used to protect subjects
  8. Experiments should be conducted only by qualified scientists
  9. Subjects should be able to end their participation at any time
  10. The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur

Want to learn more about the history of clinical research? Take a minute to watch the video and explore our History of Clinical Research timeline for more detail.

The History of Clinical Research Timeline by IMARC Research

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Source: IMA Research
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The Significance Of The Nuremberg Code

The Nuremberg Code is one of several foundational documents that influenced the principles of Good Clinical Practice (GCP)

Good Clinical Practice is an attitude of excellence in research that provides a standard for study design, implementation, conduct and analysis. More than a single document, it is a compilation of many thoughts, ideas and lessons learned throughout the history of clinical research worldwide.

Several other documents further expanded upon the principles outlined in the Nuremberg Code, including the Declaration of Helsinki, the Belmont Report and the Common Rule. 

Although there has been updated guidance to Good Clinical Practice to reflect new trends and technologies, such as electronic signatures, these basic principles remain the same. The goal has always been—and always will be—to conduct ethical clinical trials and protect human subjects. 

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‘Unchecked’ Experiments on People Raise Concern

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Source: The New York Times
By Sheryl Gay Stolberg
Featured Photo Source: Unsplash, Philipp Wuthrich

On the outskirts of the nation’s capital, tucked away on the sixth floor of a suburban office building, there is a little-known computer data base: a state-by-state accounting of the experiences of every cat, dog, hamster, guinea pig, chimpanzee, rabbit or farm animal used in a laboratory experiment.

Here in the Government’s Division of Animal Care, one can discover precisely how many guinea pigs were subjected to biomedical research in 1995 (333,379). Or how many chimpanzees felt pain during research but were comforted with medication (19,712). Civil servants have compiled such numbers for 31 years, ever since Congress passed the Animal Welfare Act.

But there are no comparable figures for people. ”We have better information about animal experiments than we do about human experiments,” said R. Alto Charo, of the President Clinton’s National Bioethics Advisory Commission.

More than two decades after the Federal Government issued regulations to protect human subjects of medical experiments, the research landscape has changed so much that many doctors and scientists are not necessarily covered by the rules. For example, an entire area of study, embryo research, has grown in the private sector over the last 20 years.

The regulations were the direct legacy of the notorious Tuskegee study, which was halted 25 years ago, amid revelations that the Government had withheld treatment for syphilis to black men in Tuskegee, Ala., without their consent.

The Federal regulations were aimed at establishing the twin pillars of ethical research for subjects of federally-financed studies: the assurance that patients would be warned of risks and that an independent panel would evaluate the experiment before it was conducted.

But as President Clinton prepares to issue a formal apology to the subjects of the Tuskegee study on Friday, there is mounting concern that the Government’s protections do not go far enough.

On Capitol Hill, Representative Christopher Shays, Republican of Connecticut, convened a hearing last week to determine the scope of lapses and violations of ethics in experiments. He was startled by the testimony, including accounts of ethics panels, institutional review boards, or I.R.B.’s, set up as profit-making ventures to evaluate proposed experiments for research groups that pay them.

”I found it amazing,” Mr. Shays said. ”I am struck by the fact that we have I.R.B.’s that can be created by anyone, that we don’t even know how many there are. I think the more we get into this the more we are going to realize how casual this process really is.”

Moreover, certain privately financed research is not bound by the rules. The loophole means some people — no one knows how many — are participating in studies that are wholly unregulated. When there are complaints, there is nothing the Government can do.

”There is unchecked human experimentation taking place,” said Dr. Gary B. Ellis, director of the Federal Office for Protection from Research Risks. How much is impossible to determine. But documents obtained from the research protection agency revealed several examples of possible lapses, though the names of those making the complaints were withheld.

In one instance, the parents of a 3-year-old boy with a rare genetic disease enrolled him in an experimental bone marrow transplant program in 1990, at a state university hospital. The parents said their son emerged from the treatment with profound brain damage, unable to walk, talk or feed himself. There was no way to know if the treatment caused the damage, but in a 1991 letter to the protection agency, his parents said that the consent form they had signed had not fully explained the risks of the procedure.

”Had we been informed of this risk we would not have consented to the transplant,” the couple wrote. ”We are now faced with the expense and challenge of caring for a brain-damaged child who will now live a much longer life span because they corrected his disease.”

In another case, an Oregon breast cancer patient complained that the hospital in which she had received chemotherapy had released information from her medical records to researchers without her consent.

In both cases the research was privately financed, so Dr. Ellis could not investigate. ”We have incident after incident where we get to the point where we determine that we don’t have the authority,” he said. ”It’s very frustrating.”

Senator John Glenn, Democrat of Ohio, has been seeking to close this gap. He introduced a bill, the Human Research Subject Protections Act of 1997, that would require informed consent and board review of all experiments, regardless of who paid for them. The bill also would create criminal penalties for violators — a provision that has drawn criticism from the Pharmaceutical Research and Manufacturers Association of America, which often finances private research.

”We believe in informed consent and our companies bend over backwards when we deal with patients,” said Mark Grayson, the group’s spokesman. But criminal penalties were unwarranted, he said.

Dr. William E. Gibbons, who directs research on genetic testing of embryos at the Jones Institute for Reproductive Medicine in Norfolk, Va., was also skeptical, saying his scientists already follow Federal guidelines.

”How bad a problem do we actually have?” Dr. Gibbons asked. Replied Senator Glenn: ”One violation is too much.”

Experts point out that the debate over ethics in human experiments is occurring at a time when medical research is safer than it has ever been. History is dotted with scientific horrors beyond the Tuskegee study, notably the gruesome Nazi experiments of World War II and human radiation experiments financed by the Government during the cold war.

These low points in the annals of medicine gave rise to the current system. The concept of informed consent, that patients must be told in advance about how the experiment might help or hurt them, is rooted in the Nuremberg Code by which the Nazi experiments were judged in postwar trials. But it was not until 1974, two years after the Tuskegee study was disclosed, that the Fedeal Government enacted a set of comprehensive rules designed to protect volunteers for research.

Informed consent was one cornerstone of the new rules. The creation of institutional review boards was the other. Today, these provisions are so universally accepted they are referred to as the Common Rule.

The Common Rule applies to three research categories: studies supported by 17 Federal agencies that adhere to it, including the Department of Defense; experiments to prove the efficacy of a new medicine or device and gain the Food and Drug Administration’s approval, and research paid for with private money but conducted by academic researchers whose employers have signed agreements with the Government. About 450 universities now require that their scientists to adhere to the Common Rule.

Although it has been updated six times in the past 23 years (there are now specific provisions for children, prisoners and pregnant women) many ethics experts say the nature of research has changed so dramatically since the Common Rule was drafted that a thorough re-examination is in order.

”The old model presumes that you would do research to find out some important new basic facts about health,” said Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. ”Current research might be for a pharmaceutical company to put a new drug on the market to compete with the five ones that are already there for, say, insomnia or weight loss. The risks and benefits may be different.”

In addition, Dr. Caplan said, the boom in research paid for by private industry has created a new phenomenon: commercial review boards that have generated a wave of what Dr. Caplan called ”I.R.B. shopping” by researchers.

At last week’s Congressional hearing, Dr. Benmjamin Wilfond, a pediatrician who sits on the review board at the University of Arizona, recalled how one proposal was shopped around.

Not long ago, he said, his board rejected a plan by a university researcher to test a new anti-inflammatory treatment for childhood asthma. The experiment, which was to be paid for by the company seeking approval of the new drug, called for half of the children to receive the new treatment and the other half to receive a placebo. Some of the children given the placebo were to have discontinued their current therapy; the univeristy board thought that was unethical.

Later, Dr. Wilfond said, he learned that the same experiment was being conducted by a private doctor who had submitted the plan to an ethics panel in another state.

What, if anything, Congress can do about lapses is unclear; Government has traditionally been loath to interfere with the private practice of medicine, and no regulatory system is foolproof. ”The situation that we have created is generally effective,” Dr. Harold Varmus, director of the National Institutes of Health, told Representative Shays last week. ”But it’s not perfect.”

But Ms. Charo, of the bioethics commission, said she believed that expanding the Common Rule to cover all research would be a good first step. At least, she said, regulators might then be able to gather basic statistics for humans as they do for other species. After all, she added wryly: ”I’m an animal too.”A version of this article appears in print on May 14, 1997, Section A, Page 1 of the National edition with the headline: ‘Unchecked’ Experiments on People Raise Concern. 

Is medical treatment or care without ‘informed consent’ even when experimental ever ethical? What should the laws that govern informed consent look like? Why?

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The Largest Unethical Medical Experiment in Human History – Georgia Institute of Technology

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Source: Georgia Institute of Technology
This monograph describes the largest unethical medical experiment in human history: the implementation and operation of non-ionizing non-visible EMF radiation (hereafter called wireless radiation) infrastructure for communications, surveillance, weaponry, and other applications. It is unethical because it violates the key ethical medical experiment requirement for “informed consent” by the overwhelming majority of the participants. The monograph provides background on unethical medical research/experimentation, and frames the implementation of wireless radiation within that context. The monograph then identifies a wide spectrum of adverse effects of wireless radiation as reported in the premier biomedical literature for over seven decades. Even though many of these reported adverse effects are extremely severe, the true extent of their severity has been grossly underestimated. Most of the reported laboratory experiments that produced these effects are not reflective of the real-life environment in which wireless radiation operates. Many experiments do not include pulsing and modulation of the carrier signal, and most do not account for synergistic effects of other toxic stimuli acting in concert with the wireless radiation. These two additions greatly exacerbate the severity of the adverse effects from wireless radiation, and their neglect in current (and past) experimentation results in substantial under-estimation of the breadth and severity of adverse effects to be expected in a real-life situation. This lack of credible safety testing, combined with depriving the public of the opportunity to provide informed consent, contextualizes the wireless radiation infrastructure operation as an unethical medical experiment.

Indeed, at the hart of many unethical medical experiments is the lack of informed consent and the loss of consent. Would you recognize an unauthorized and unethical medical experiment if you saw one? What would it look like? How would one report it? In fact in the past some governments have been apart of unethical experiments. The most widely known of these in recent history were the experiments conducted by the Nazis.

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Ethical or exploitative—should prisoners participate in COVID-19 vaccine trials?

Source: Science Mag
Photos Source: Science Mag
By Eli Cahan Sep. 14, 2020 , 1:50 PM

Science’s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

As 38 clinical trials seek tens of thousands of volunteers to receive doses of experimental vaccines, researchers are discussing how to find and recruit participants effectively and ethically. Some people who are especially vulnerable to COVID-19 have not been well represented in studies—or represented at all. Prisoners, for instance, have borne a heavy burden of COVID-19, with more than 125,000 U.S. prisoners infected, and more than 1000 dead. But prisoners have also been excluded from the trials out of concern that they might be coerced into participating or exploited if they do.

Now, some researchers argue that including prisoners in studies could offer outsize health benefits. Correctional facilities have experienced many COVID-19 outbreaks and are structurally unsuited to social distancing (among other precautions). And so, the researchers argue, like other people at high risk of catching the disease, prisoners should be allowed to participate in clinical trials. 

ScienceInsider spoke with George Annas, a lawyer and bioethicist at Boston University, whose research addresses ethics and human rights in clinical trials, and Lauren Brinkley-Rubinstein, a sociologist and epidemiologist at the University of North Carolina, Chapel Hill, who studies management of infectious disease and substance abuse in incarcerated people. Both have published about health and ethics in holding facilities during the pandemic: In July, Annas wrote in The New England Journal of Medicine about inhumane medical practices in immigrant detention centers and, and in August, Brinkley-Rubinstein and colleagues argued in JAMA that prisoners should be included in vaccine trials.

This interview has been edited for brevity and clarity.

Q: What clinical research has been done historically in correctional facilities? Has it been done well?

George Annas: The history is pretty dark. It’s a history of research done without consent, without oversight, and without consequences. It starts in some respects with the Nazis, since Holocaust research—or pretend research, really—was done in prisoners to get scientific information for the German state. Another famous experience was John Charles Cutler’s 1940s experiments in Guatemalan prisons. In those experiments, prisoners were deliberately infected with gonorrhea, syphilis, and chancroid.

Lauren Brinkley-Rubinstein: There are lots of instances of prisoners being intentionally infected with diseases in order to develop new drugs, including malaria and hepatitis C. Horrible things happened at San Quentin [State Prison], including giving prisoners experimental testicular transplants. I think dark is the right word.

Q: Is any COVID-19 vaccine research taking place in correctional facilities? Has anyone put forward serious proposals to do such research?

L.B.R.: There was some conversation at the federal level at the initiation of large vaccine trials to include people involved in some way with the criminal justice system. My colleagues and I had a couple of phone calls with people involved in running those trials to see if it was something they’d entertain. There was some openness to it. But ultimately, including incarcerated populations felt too cumbersome. Between the ethical risks and the operational obstacles to actually get the sites up and running, it would have required a lot of extra effort.

G.A.: Up until recently, there’s really been no excuse to do research in these settings. But it’s a strange and perhaps intriguing group to study, because they’re almost definitely going to be exposed to the virus. So, it could give you answers you may not get if you trial the general population—who may not ever be exposed. That’s why we’re looking again. I’m not a big fan of prison research, but I am a big fan of science, so I think we should look at all these things again.

L.B.R.: Still, I think part of this conversation should be focused on people on probation or parole—the high-risk population that is criminal justice involved, but not presently incarcerated.

G.A.: Yeah. I’d be much more amenable to efforts to bring people on probation or parole into trials. They would be unshackled, literally, from some of the risks of exploitation we think about for prisoners who receive perks for “good” behavior and punishment for “bad” behavior.

Q: Could this kind of research actually benefit incarcerated people if they participate?

L.B.R.: It definitely could, assuming the vaccine works. Incarcerated people do have different risks, in terms of the barriers they face to getting certain elements of routine health care along with their potential to be exploited. But they also potentially would gain more from vaccination, given these settings are extreme amplifiers of infection.

G.A.: But the risk if an experimental vaccine doesn’t work is that these individuals won’t only be disappointed, but they’ll feel they were lied to or exploited.

L.B.R.: Another big part about why understanding these contexts is important is that we do eventually want vaccines to be made available to these populations. But there are lots of implementation issues that are very particular to jails and prisons. How do we store the vaccines under potentially very specific conditions? How do we monitor patients for side effects after injections? How we manage any needed follow-up, like a booster shot? We need to get expertise to optimize these programs when vaccines are eventually deployed. I don’t think that alone is justification to do a trial, but it is such a big part of vaccines being effective once they are approved. It’s something we’ll have to figure out.

Q: Could there be broader public health advantages for doing COVID-19 vaccine research in correctional facilities? Would experimental use of vaccines in correctional facilities benefit staff, neighboring communities, and more distant ones?

L.B.R.: If the experimental vaccines work, then the public health benefit of focusing vaccine resources—even during trials—on correctional facilities cannot be overemphasized. We’ve already seen that jail churn plays a tremendous role in community transmission.

G.A.: To me, it’s a different experiment. You can’t use community results to justify research on individuals. The risk-benefit analysis needs to come out right for the individual before they can consent to being in the trial.

Q: If such research is undertaken, how will we know whether ethical safeguards did enough to protect participants’ rights?

George Annas (left) and Lauren Brinkley-Rubinstein (right) GEORGE ANNAS AND LAUREN BRINKLEY-RUBINSTEIN

G.A.: There probably is no replacement for asking the participants themselves. Did they feel exploited? Did they feel used? Did they feel fulfilled? Did they feel part of something bigger?

L.B.R.: This is really at the crux of the issue. We’d have to ask, but also to appoint oversight boards that have prisoner representation. And we’d have to adopt other safeguards to ensure we are doing things ethically.

Q: Would giving prisoners the option to participate in a vaccine trial set a precedent for future research? What about continuing to withhold access?

G.A.: I think the question of “if not now, when?” is a very good one. We have a worldwide pandemic with a giant prisoner population that’s very susceptible to the disease and is dying from it. If we’re not going to permit research in that circumstance, we’re never going to permit it.

L.B.R.: Also, if we can figure out how to do this right—given the stakes right now—that could give back some element of power or respect that is otherwise not present in these places.

G.A.: It’s a question of whether we treat prisoners as human beings with agency, who are allowed to participate in something for the public good.

L.B.R.: Our approach to experimentation in prisons has been very binary: a history of serious abuses of power when we have run trials, versus the decision to completely avoid including prisoners in trials. We have to ask ourselves whether there’s a middle path.

G.A.: And considering a middle path, but then deciding it’s too much work—that would be an extreme position, too.

Q: As the prospect of an approved vaccine nears, fierce debate surrounds who should receive it first. According to current Centers for Disease Control and Prevention guidance, prisoners are not considered separate from the general population, putting them last in line. In contrast, a draft proposal released this month by the National Academies of Sciences, Engineering, and Medicine said prisoners should get vaccinated after health care workers, but before the general population. Where do you think incarcerated people belong on the priority list?

L.B.R.: Based on the evidence have about outbreaks, incarcerated people should be at the top tier. There’s a clear connection between what happens in these institutions and what happens in the community. When we have infections that spread in jails or prisons like wildfire, and staff going in and out and in and out, we’re making COVID infection more likely everywhere. If the only thing you cared about was your own health, you would still make the decision to prioritize them.

G.A.: People at the highest risk should receive the treatment first. That includes prisoners. It’s that simple, really. 

doi:10.1126/science.abe7861

As we are in the midst of the only Pandemic in recent history desperately in search of a vaccine, one must question the ethics employed in medical trails and the medical industries murky and dark history with experimentation not to mention fraud and scams. Without a current doubt those who find an effective vaccine will reap financial benefit. Every country on the globe is interested. Are you willing to take a vaccine? A health professional once stated, there is no profit in health. The profit is in disease. As many are trying to decided who should have the vaccine first and reporting in those population most affected by the corona virus, one must ask if these populations should also bare the brunt of clinical trials as well. Are clinical trials on unknowing and those not asked ever ethical and permissible?

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