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 be.
