September 27, 2022

Justice needed for injured research subjects, says bioethicist

University of Minnesota bioethicist Carl Elliott has composed a handy primer on how to exploit a research subject in his blog: “Step 1: Design a risky, deceptive or scientifically worthless study. Step 2: Injure subjects. Step 3: Bankrupt the injured subjects by forcing them to pay for their medical care.”

University of Minnesota bioethicist Carl Elliott has composed a handy primer on how to exploit a research subject in his blog: “Step 1: Design a risky, deceptive or scientifically worthless study. Step 2: Injure subjects. Step 3: Bankrupt the injured subjects by forcing them to pay for their medical care.”

If rebuked for using the lowest form of humour, sarcasm, Dr Elliott would probably respond that he is deadly serious. He has just published a blistering “Perspective” article in the New England Journal of Medicine this week calling for justice for research subjects. Nearly every other developed country requires treatment or compensation for people who are injured by their participation in a trial, but not the US.

“If a research subject is seriously injured, neither the researcher nor the sponsor has any legal obligation to pay for that subject’s medical care. In fact, only 16% of academic medical centers in the United States make it a policy to pay for the care of injured subjects. If a subject is permanently disabled and unable to work, sponsors have no obligation to pay compensation for his or her lost income. If a subject dies, sponsors have no financial obligations to his or her family. Not a single academic medical center in the United States makes it a policy to compensate injured subjects or their families for lost wages or suffering. These policies do not change even if a subject is injured in a study that is scientifically worthless, deceptive, or exploitative.”

Why does the US treat research subjects so shabbily, even though this is an often discussed issue? Dr Elliott highlights three reasons: much of research oversight is secret; tort law has been ineffective in bringing about political change; and no “community” of research subjects exists to agitate for change.

What the US needs, he argues, is insurance for research subjects or at least agreement to indemnify subjects if something goes wrong. ~ NEJM, July 5

Michael Cook
Creative commons
clinical trials
research ethics