The sneaky bastards at the FDA did this a year ago, right under our noses. In January 2024, the FDA finalized a rule permitting Institutional Review Boards (IRBs) to waive or even alter informed consent requirements for clinical investigations deemed “minimal risk.” TTR guest author Jon Fleetwood, as always, brings us this news in his excellent reporting. Read his entire article here.
IRBs. Informed Consent. What does it all mean? If you don’t do research, you likely won’t know.
What is an IRB?
An Institutional Review Board (IRB) is a panel of individuals who review and oversee research studies that involve human participants. The IRB ensures that the studies are ethical and that they comply with all regulations. The IRB’s primary function is to protect the rights and welfare of the human research participants, making sure they are treated fairly, ethically and safely.
Anyone doing research must have an IRB, and that not only applies to direct human research (meaning the human is actually being given a drug or using a device), but also for indirect studies where the patient isn’t “touched” so to speak or actively involved. A direct example would be a clinical trial where a new drug is being tested. The human participants actually enroll in the trial and are given test doses of the medication. Even if a human participant is given a placebo, that research must be covered by an IRB to ensure the patients’ physical and psychological well-being. An example of an indirect study is one in which a company or other research entity is just using data from patients, with no direct patient interaction. In some cases an IRB is still needed to use data that may potentially identify who the subjects are.
The bottom line is that an IRB is needed for any drug, device assessment, survey or other study. And this is what makes the FDA’s ruling so unbelievable. Fleetwood says the implications are staggering, and he is absolutely right:
“Under this waiver, any person’s health data, biospecimens (such as blood or tissue samples), or medical records can be accessed and used for FDA-regulated research if it meets vague and highly subjective criteria.”
Hellbound and Down 