Tag: Adverse events

According to regulatory guidelines, researchers must report specific new information to an Institutional Review Board (IRB) to protect human subjects. This is a critical component of ethical research, ensuring that any unforeseen issues are promptly addressed by the governing body. This guide explains the core concept of RNI and its vital role in research compliance.

Fatal adverse events, a specific type of Reportable New Information (RNI), must be reported to the IRB within 24 hours of discovery. This critical component of ethical oversight defines what is RNI in clinical research, ensuring the protection of human subjects throughout a study.

Over 70% of Americans take some form of dietary supplement, many of which are considered nutraceuticals. While often perceived as inherently safe due to their natural origin, a crucial question remains: do nutraceuticals have side effects, or are they completely without risk? The answer is nuanced, depending on dosage, product quality, and individual health factors.

Consuming excessive amounts of highly caffeinated products can have severe consequences, with medical experts warning against such practices. A single extra-strength 5-hour Energy shot contains as much as 242 mg of caffeine, making the act of drinking 5'5 hour energies a potentially life-threatening overdose.

According to the FDA, dietary supplements are regulated as a category of food, not as drugs, which fundamentally changes the way the agency oversees them. This key distinction helps explain why the FDA does not approve dietary supplements before they are sold to the public, and clarifies what are FDA supplements in the context of federal law.