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Russia’s coronavirus vaccine trials have a few key problems

Source: Meduza

In May and June 2020, news stories began popping up about Russia’s attempts to test or begin testing a coronavirus vaccine. First the state-owned banking company “Sberbank” suggested that its employees take part in vaccine trials; then reports emerged that researchers at the Gamaleya National Research Institute of Epidemiology and Microbiology had become the test subjects of a coronavirus vaccine that had yet to undergo any other human trials. Then on June 2, the Russian Defense Ministry announced that a coronavirus vaccine is being tested on “military personnel volunteers.” All of these announcements have elicited mixed reactions from the scientific community — provoking questions about the ethics and legality of carrying out these experiments. 

Problem #1: Vaccine trials are drawing in subjects who are “administratively vulnerable” 

In a nutshell: Sberbank has suggested that its employees become coronavirus vaccine test subjects, while the Gamaleya National Research Institute of Epidemiology and Microbiology has already tested COVID-19 vaccines on its staff members in Moscow; the Defense Ministry is testing on military personnel; and the Moscow Health Department is testing on doctors. All of these test subjects are dependent on their superiors at work, making them prone to “administrative vulnerability.” 

Like many countries, Russia has adopted best practices for carrying out clinical trials. In this case, the Russian Health Ministry is bound by GOST’s technical standards on “Clinical investigations. Good clinical practice.” These guidelines specifically refer to conditions for testing on vulnerable populations, including those who fall under the umbrella of “administrative vulnerability.” This is defined as a vulnerability that applies to “members of groups with a hierarchical structure,” including, for example, university students, hospital staff and laboratory personnel, paid employees, prisoners, and military personnel.

Officially, people belonging to vulnerable groups should only participate in clinical research in Russia if there are no other available test subjects, and even then they must be afforded additional protections.

Nevertheless, Russia regularly sees clinical trials carried out on vulnerable people, even when there are other groups who could serve as test subjects. Most recently, reports emerged that the Moscow Health Department was carrying out research on the controversial drug hydroxychloroquine as a preventative medicine against the coronavirus (it is typically used as a malaria medication and known to cause serious side effects). Medical workers from Moscow were involved in the trials, and according to an open letter from the non-profit Association of Clinical Research Organization (AOKI), not all of them participated voluntarily. “AOKI received direct complaints from clinic staff about pressure from the administration and required registration in the program,” the letter says.

Problem #2: People are being used as test subjects in unregistered clinical trials

In a nutshell: Moscow’s Health Department has officially named what appears to be a clinical study a “prevention program.” As such, it is not actually registered as a clinical trial and its participants are not being afforded adequate legal protection.

Pressure on test subjects can also be indirect, which is why experts emphasize the importance of free and informed consent, as well as the protection of trial participants. This, in turn, requires the development of special rules, and independent expert councils to monitor compliance. To make all of this possible, a clinical trial needs some sort of official status. 

Russian law stipulates that conducting a clinical study requires permission from the Health Ministry. As outlined in GOST’s technical standards, registering planned research trials involving human subjects in a public database is also a requirement of the World Medical Association’s Helsinki Declaration on the ethical principles of human experimentation; this should “protect the rights and ensure the safety and well-being of people.”

That said, these rules don’t apply if you don’t register your study. And so one potential loophole is to pass a clinical trial off as something else. 

According to AOKI Executive Director Svetlana Zavidova, unregistered coronavirus treatment trials are a relatively new development (registered studies have been going on for some time). Zavidova also points to the Moscow Health Department’s so-called “prevention program” (that’s its official name) as a prime example: it’s not registered as a clinical study (in Russian, “klinicheskoe issledovanie”), even though the word “study” (“issledovanie”) is used on its website.

While an officially registered clinical trial is legally required to protect the life and health of its participants, in this case, these laws won’t apply. “The term ‘prevention program’ is not a legally defined concept, therefore participants in the hydroxychloroquine prevention program do not have adequate legal protection [in relation to] the risk they are facing,” AOKI’s open letter warns. “The organizers are not required to protect the life and health of the prevention program’s participants, and we do not know that they are doing this [taking part in the study] voluntarily.”

Problem #3: Scientists are testing treatments on themselves unchecked

In a nutshell: Staff members at the Gamaleya National Research Institute were vaccinated against the coronavirus. Apparently this is not very legal and, in fact, not very safe.

Researchers at Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology were inoculated with a coronavirus vaccine that had yet to undergo any other human trials. As it turns out, this experiment was not registered as a clinical study either. In an interview with Interfax, the institute’s director, Alexander Ginzburg, claimed that the “researchers were not so much testing on themselves as protecting themselves, so that they can continue development during the pandemic.” “Accordingly, everyone involved in the development [of the vaccine] was protected,” he said.

Under Russian law, a clinic trial is defined as the study of the properties of a drug in the course of its use on a person, with the goal of gathering evidence of its safety, effectiveness, and so on. Theoretically, if an experiment does not have any of these aims — like the Gamaleya Institute’s vaccination drive aimed at “protecting” its researchers — then it’s not technically a clinical trial.

That said, not everyone agrees that this was legal. The AOKI, for example, takes up this position in its open letter. Since it wasn’t registered as a clinical trial, the staff were vaccinated unofficially. And according to medical law consultant Polina Gabay, this is a breach of regulations: “All laboratory procedures are strictly standardized and outlined in [Standard Operating Procedures]. It’s actually unbelievable that the employees could violate regulations in such a way. In any case, I don’t see any legal basis for this kind of vaccine trials on employees outside of the defined framework of the law,” she explained in a letter to Meduza. 

Problem #4: Some trials can go forward legally, even without official registration

In a nutshell: The Russian government has greatly simplified bureaucratic processes for testing drugs previously registered as treatments for other diseases as potential coronavirus medications. This is very beneficial for pharmaceutical companies. 

“The speed with which permits are now being issued for studies [of coronavirus medications] is surprising,” says AKOI’s Svetlana Zavidova. “The Health Ministry is issuing permits within a week, and maybe, sometimes faster. Now it’s not a problem to get permission to study COVID-19 drugs in Russia.” She also said that previously, receiving permission to conduct this type of study could take up to three months.

That said, regardless of expedited procedures, Russia has a total of just 17 clinical trials for coronavirus treatments. For comparison, the United States has 272 such studies, Spain has 116, and France has 104. 

Russia is, however, testing a greater number of treatments, including through the aforementioned unofficial methods, and in full accordance with new legislation. In April, the Russian government issued decree No. 441, which stipulates that pharmaceuticals already registered for the prevention and treatment of other diseases can also be studied for use against COVID-19. Under this model of “minimally interventional research,” it’s enough for trials to give notice to the Health Ministry and Russia’s Federal Healthcare Supervisory Agency (Rosdravnadzor), and then provide a report to the Health Ministry after the fact.

Testing on these types of drugs do not require a third-party assessment of the ethics and safety of human trials. What’s more, the document says that these tests can form the basis for changes to the instructions for prescribing the medications in question. Naturally, pharmaceutical companies are very interested in such bureaucratically unburdened trials. 

As a result, the provisions of decree No. 441 are being actively put into practice. For example, according to documents made available to Meduza by AOKI, Russia’s Federal Medical-Biological Agency has started to test the malaria medication Mefloquine on patients on this exact basis (while some specialists believe that Mefloquine could be effective against COVID-19, this is not a popular opinion among global experts, as there has been only one Mefloquine trial so far).

“The feeling is that now, in such troubled times, the pandemic is revealing all sores, including in our science,” says Svetlana Zavidova. 

The Russian Health Ministry and Rosdravnadzor have yet to respond to Meduza’s questions regarding clinical trials in Russia.