6 hours Ago By Sharyl Attkisson
There is a sea change in America’s framework for conducting experiments on humans. The biggest surprise is that you probably know little to nothing about it.It has to do with a provision tucked into a law, then implemented by the FDA.
It reverses decades of ethical tenets that were designed to prevent horrific abuses that have occurred in the past.“It’s a profound shift. These are people’s lives,” said James Lyons-Weiler, a scientist who heads the nonprofit, The Institute for Pure and Applied Knowledge, or IPAK.
He’s also an expert on informed consent.“An individual that’s enrolled in a clinical trial should know the potential benefits and the potential risks,” he said. “So informed consent includes accurate and understandable communication of the benefits and the risks.
And then it leaves the decision to the patient to enroll in the trial or not on the basis of their personal assessment of the risks and benefits themselves.”The concept of “informed consent” emerged from an American tragedy: the U.S.
government’s experiment on Black men with syphilis in Tuskegee, Alabama, in 1932.The unethical government research was exposed in 1972. An outcry led to the installment of core ethics in human research.
They required researchers to tell patients about the risks of being in a study and to get their explicit consent to take part. Also, ethics experts on Institutional Review Boards, or IRBs, must oversee the studies. And the studies have to potentially benefit the people taking part.
But many in the research community came together in a push to loosen the rules on informed consent. They finally got their wish, with a provision embedded in the 21st Century Cures Act. President Barack Obama signed it into law in his final full month in office.
“This clause allows individuals, without their knowledge, to be enrolled in clinical trials ...
if the people running the clinical trial have convinced themselves and an IRB that the patients enrolled in the trial are at minimal risk,” Lyons-Weiler said.The obvious problem is that what constitutes “minimal risk” relies on the honesty and judgment of researchers.Scientists, who frequently are paid to conduct studies for drug companies, say they’ve had increasing difficulty getting enough patients to enroll in studies when they’re told of the risks.
They argue that the greater good can’t be served if they can’t do their studies.Related ArticlesHealth | Harsh flu season has health officials worried about brain complications in childrenHealth | CDC report adds to evidence that HPV vaccine is preventing cervical cancer in US womenHealth | How to practice healthy fasting during RamadanHealth | The COVID ‘contrarians’ are in power. We still haven’t hashed out whether they were rightHealth | Texas says doctor illegally treated trans youth.
He says he followed the lawLyons-Weiler says under the new rules, researchers can even enroll you in a study without telling you at all. For example, your doctor could change your normal medication without disclosing to you that he’s doing it as part of a study.“So if they can hide the fact that you’re on a clinical trial without giving you prior knowledge about it, you, by definition, can’t make a free, prior informed decision,” he said.
Supporters of the loosened rules on informed consent say it will “bring new innovations and advances to patients who need them faster and more efficiently.” The FDA has said the changes will have “benefits in the form of health care advances” because studies that would not have been possible if patient consent were required — can now be done.“Full Measure with Sharyl Attkisson” airs at 10 a.
m. Sunday, WJLA (Channel 7) and WBFF (Channel 45)..
