Hi everybody, Cheryl Ackison here. Welcome to another edition of Full Measure After Hours.

Today, Uninformed Consent, a disturbing change in medical ethics that nobody's probably told you about.

There's been a quiet but dramatic shift in longstanding medical ethics in the

United States. The federal government recently loosened the traditional rules that required

researchers to get what's called informed consent before people get a treatment or agree to be in a study.

This is a sea change in medical ethics, and I'll bet you probably heard little to nothing about it

until now. Sunday, January 19th, on my TV show Full Measure, I'll be looking at this issue,

and today in this podcast you'll hear from James Lyons

Weiler, who heads up the nonprofit Institute for Pure and Applied Knowledge, IPAC, and opposes

this change.

The 21st Century's Cures Act, just before it was signed into law, there was a clause that

was added called the Minimal Risk Clause.

This clause allows individuals without their knowledge to be enrolled in clinical trials.

These are experimental clinical trials, prospective clinical trials.

If the people running the clinical trial have convinced themselves and an IRB that patients enrolled in the trial are at minimal risk.

Obviously, that begs questions of definitions, but it also, most importantly, reverses

116 years, I believe it was, or so, of learned protections.

And that I came up with this morning, learned protections, reviewing the

history, and I sent you a paper, an article on it, reviewing the history of informed consent.

We have these things in play, these protections in place, specifically to protect the patients from individuals who, for reasons other

than the patient's personal benefit might break the rules or take shortcuts.

Can you describe, well, let me give a little background first. I think informed consent in this country got a great deal of attention after the Tuskegee syphilis experiments. When it turned out the government had been experimenting on black men with syphilis without giving them full consent as to what they were doing. And even after penicillin was deemed to be a treatment for it,

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