Court sides with professor who tested experimental drug on himself

A professor who injected himself with an experimental anticancer virus developed in his lab was acquitted in a rare ruling that questioned the boundaries of clinical trial regulations.

“The defendant conducted a self-experiment to assess the drug’s effects based on the need to understand how it works in cancer patients,” ruled the Ulsan District Court. “This was a justifiable act of considerable legitimacy by social norms and does not constitute a crime.”

The ruling, handed down in the appellate trial of Hwang Tae-ho, a professor of clinical pharmacology at Pusan National University Yangsan Hospital, was finalized after prosecutors chose not to appeal.

Why did this unusual ‘self-experiment’ go to trial?

Hwang was reported to authorities after injecting himself with OTS-412, an oncolytic vaccinia virus being developed in his lab, in January 2022, according to legal sources on Wednesday. Over two weeks, he collected blood samples to observe dynamic T cell immune responses.

OTS-412 is a genetically engineered, attenuated form of the vaccinia virus used in smallpox vaccines. It targets and destroys cancer cells selectively, offering potential treatment for patients unresponsive to conventional therapies.

At the time, Hwang was seeking approval for clinical trials of OTS-412 in both Korea and the United States. He reported the results of his self-experiment to the Ministry of Food and Drug Safety, but was subsequently charged with violating the Pharmaceutical Affairs Act, which mandates prior ministry approval for administering investigational drugs to humans.

Experts in the medical community say it's highly unusual for a researcher to face legal action over a self-experiment.

Hwang initially received a 1 million won ($720) summary fine. He requested a formal trial, and the lower court ruled in September 2024 that while he had violated the law, the infraction was minor. It issued a stay of adjudication, meaning he would be considered not guilty if he committed no further offenses for two years.

Believing he had broken no law, Hwang appealed.

“OTS-412 was already at a stage where it could be administered to cancer patients in clinical trials. I conducted the test safely after consulting with fellow researchers,” he said.

Hwang’s self-experiment was conducted before receiving Drug Safety Ministry approval for his submitted phase 1 trial protocol — which did not include the self-injection. Some in the medical field argued that the act may have raised ethical concerns due to its timing.

Hwang defended the necessity of the experiment. “The immune response immediately after OTS-412 administration is critical data for clinical comparisons,” said Hwang. “But collecting large volumes of blood over a short period is difficult in cancer patients, who are already weakened. That’s why I chose to test it on myself.”

Why did the appeals court overturn the earlier ruling?

The appellate court sided with Hwang’s argument that the experiment posed no public health risk and was not conducted for personal gain.

Like the lower court, the appellate panel deemed the act to fall under clinical trial regulations. However, it emphasized that unregulated self-testing could set a precedent of accepting harm to individuals for perceived collective benefit.

Still, the court ultimately ruled that the illegality of the act was negated.

“The defendant did not appear to be acting out of personal interest or attempting to bypass regulations,” said the court. “The self-experiment raised no significant public safety or ethical concerns. As the lead researcher, he made the decision after thorough ethical reflection. Therefore, the original ruling is overturned, and the defendant is acquitted.”

U.S., Korean authorities green light clinical trials

In September 2023, while the case was ongoing, the U.S. Food and Drug Administration approved a phase 1 clinical trial for OTS-412. Korea’s Drug Safety Ministry granted approval more recently.

“I am grateful to the court and regulatory agencies for allowing this research to proceed,” Hwang said.

He added that the therapy is being developed to treat solid tumors such as breast and skin cancers that have not responded to existing treatments. Phase 1 trials involving around 20 patients are scheduled to begin later this year at Pusan National University Hospital and Dong-A University Hospital.

“Although I was acquitted, that doesn’t mean the experiment was ethically flawless,” Hwang acknowledged. “With that in mind, I will focus on advancing immunotherapy drug development.”

Typically, clinical trials for new drugs must undergo rigorous approval processes. Trial sponsors must submit detailed protocols to both the ministry and Institutional Review Boards at participating hospitals. Approval for phase 1 trials generally takes about 30 days, although it can take longer if supplemental data are requested.

If an unapproved trial is conducted, or if the study deviates from the approved protocol and causes harm, legal consequences may follow. However, cases like Hwang’s — where the researcher self-administers the drug — are exceedingly rare and legally ambiguous.

“This was an exceptional case and not ideal,” said Lee Myung-jin, founding chairman of the Korean Society for Medical Ethics. “But I don’t believe it’s something that should be legally punished. There was no harm to others, and he made the decision voluntarily to help others — so it did not stray far from medical ethics.”

This article was originally written in Korean and translated by a bilingual reporter with the help of generative AI tools. It was then edited by a native English-speaking editor. All AI-assisted translations are reviewed and refined by our newsroom.

BY KIM MIN-JU, JUNG JONG-HOON [[email protected]]