Category: Clinical trials

Millions of health articles are published annually, with randomized controlled trials (RCTs) sitting atop the evidence hierarchy for assessing interventions. The reason randomized controlled trials are considered the gold standard of nutrition research is their unique ability to reduce bias and provide the strongest evidence for cause-and-effect relationships between dietary interventions and health outcomes.

A 2012 meta-analysis of randomized controlled trials found that dietary protein intake was associated with significant reductions in systolic and diastolic blood pressure. This evidence highlights the potential of dietary protein supplementation as a non-pharmacological strategy for hypertension management and prevention, leading to further investigation into the specific effects of various protein types.

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.