Let’s Bring the Informed Consent Process Out of the Shadows

Misha Angrist

The disclosures researchers use to obtain consent in clinical trials are rarely shared with the public. They should be.

Since the long parade of ethics scandals that plagued biomedical research during the 20th century — from Nazi doctors’ experiments, to the Tuskegee Syphilis Study, to a Brooklyn hospital study that injected patients with live cancer cells — informed consent has been a hallmark of research on human beings … It enshrines the idea that we can’t experiment on people without first informing them of the risks and benefits and, obviously, getting their permission. The consent forms used in clinical trials, as dense and lawyerly as they might be, are meant to answer questions like: What is involved in the study? How long will it take? Will I get paid? What happens if it goes sideways?

But in many cases, few people outside of the researchers, participants, and the institutional review boards charged with approving a study ever see the language used in a trial’s consent form.

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