Scientists express concerns over FDA provisions regaring human subject testing
The rules and ethics behind scientific testing on human subjects have changed drastically, with JustTheNews calling it a "sea change" in the world of human testing.
The outlet reported that a provision "tucked into a law" that was implemented by the Food and Drug Administration (FDA) "reverses decades of ethical tenets that were designed to prevent horrific research abuses that have occurred in the past."
It was reported that the new changes sparked concerns of "the Tuskegee Syphilis Experiments" that were conducted on Black males in the 1950s.
At the time, scientists failed to tell the test subjects that a treatment for syphilis had been discovered and, instead, observed as the disease ravaged the men who were part of the experiment.
What happened?
Ever since those experiments, the rules around "informed consent" emerged as a measure to protect test subjects from enduring such horrific circumstances.
JustTheNews noted:
Ever since the Tuskegee case, U.S. scientists have been required to obtain “informed consent” from research subjects. Among other things, that means they must be told about, and sign off on, all risks of being part of the research.
James Lyons-Weiler, a scientist in charge of the nonprofit Institute for Pure Applied Knowledge or IPAK, is also an expert in informed consent, and explained his view on the situation.
"An individual that's enrolled in a clinical trial should know the potential benefits and the potential risks,” Lyons-Weiler explained.
He added, "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."
However, the 21st Century Cures Act, which Obama signed into law during his time in office, changed the situation.
"Minimal Risk Clause"
Lyons-Weiler explained the "Minimal Risk Clause."
"In the 21st Century Cures Act, just before it was signed into law, there was a clause that was added called 'the Minimal Risk Clause.'”
He continued, "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.’”
Only time will tell how the new law affects the scientific community.