INSIGHTS: Our way of thinking about informed consent has evolved over the last century. In a world of human guinea pigs, does it need to evolve further?

By Guest Opinion

The IJB report on so-called “professional guinea pigs,” people who loan their bodies to clinical research organizations (CROs) in Canada in exchange for the money they need to live. These test subjects often lie to get into clinical studies, and hide painful side effects that could get them kicked out of a study. 

The private companies that recruit these human test subjects are not required to share their participant enrollment data with the federal government, or with other provinces, allowing participants to enroll in back to back trials. Violating the “washout period” impacts both subject health, and the strength of the data gathered by the trials.

The Investigative Journalism Bureau sat down with Moreno to understand how clinical trials with human subjects, and notions of informed consent, have evolved since the post-war era.

“I’ve been in loose contact with this community for 30 years, what used to be called the guinea pig zero world.” Moreno, an American bioethicist and philosopher, told me of the IJB’s [LINK] investigation into how marginalized people are enticed to participate in clinical trials for handsome financial rewards. 

Moreno spent his career examining how humanity can conduct medical experiments while preserving human dignity. He brings a unique lens to how experiments can be ethically conducted on humans. His father J.L. Moreno, who founded the Beacon Hill Sanitarium in New York, was a pioneer of psychotherapy; he studied under, and later criticized, Sigmund Freud. 

“I grew up in a mental hospital,” said Moreno of his childhood accompanying his father to work, even participating in research as a subject. He went on to become a bioethicist and served on three U.S. presidential commissions and the UNESCO bioethics committee, amongst other notable career contributions . 

“I think there is a longstanding undercurrent of mistrust of experts that goes well before even the current era, post World War II,” he explained. “People have long-standing reservations about people who are doing things to them and who have fancy degrees and white coats.”

The concept of ‘informed consent’ from human subjects was born as a consequence of Nazi war crimes in 1947 when Allied powers established the Nuremberg Code, 10 basic rules for the conduct of human experiments.  While the Nuremberg Code established a rules-based order for acceptable experimentation, it was unenforceable by law. 

The core principle of the Nuremberg Code is voluntary consent: research subjects must not experience “any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion” . Research participants must also be informed of “the effects upon his health or person which may possibly come from the experiment”. 

The IJB’s investigation found that the underground society of these professional clinical trial participants are being lured by private contract research organizations — paid by pharmaceutical companies — with cash, referral bonuses, loyalty points, and other perks. But those who experience adverse reactions to the study drugs must leave the trial early, often forfeiting remuneration. 

Leveraging money to gain participation from economically desperate subjects undermines the kind of free and informed consent envisioned by the Nuremberg Code. 

Moreno recalls in his career many times where the idea of informed consent blurred in instances where compensation was offered to subjects in exchange for their participation in potentially deadly studies. 

In his time serving on U.S. president Bill Clinton’s Advisory Committee on Human Radiation Experiments, he recalled an experiment done in partnership with Quaker Oats where, “if you were among the orphans at a couple of schools, then you were given trace amounts of radiation to see where the breakfast cereal protein goes.” 

There was mostly no consent requirement in these experiments, but instead incentives were offered.“You could be a part of a special club called the Science Club, and go to a baseball game, and you get a special diet,” said Moreno. 

Even among doctors in training, incentives can be considered before side effects. 

“I used to ask my medical students when I was at the University of Virginia, have you ever been in a clinical trial?” said Moreno. “A third of them maybe had… a substantial number.”

“Why? It was money,” he explained. When he asked them what they remembered from their informed consent form, they often could recall just one thing. But when asked how much they were paid? “That they remembered,” said Moreno. 

“What is an undue influence? Something you couldn’t turn down. Ultimately, it’s a matter of intuition and fairness.”