What does "minimal risk" refer to in human research studies?

"Minimal risk" in human research studies refers to situations where the likelihood and seriousness of potential harm or discomfort to participants are no greater than what they would encounter in their daily lives. This concept is essential in ethical research practices as it helps determine the level of oversight and regulatory requirements for a study.

When the risks are considered minimal, it indicates that while there might be some potential risks involved, they are minor and do not exceed what individuals might typically face during daily activities such as routine physical or psychological challenges. Thus, the risk assessment focuses on both the probability and the intensity of possible negative outcomes.

Other options present considerations that do not accurately reflect the definition of minimal risk. The assertion that a study poses no risk to participants implies a total absence of risk, which does not hold true, as even the most benign studies may entail some level of risk. The idea that minimal risk equates solely to non-invasive procedures overlooks studies that might present minimal risk through other means. Lastly, the claim that minimal risk studies require no oversight from an IRB is incorrect, as institutional review boards (IRBs) still play a critical role in ensuring that ethical considerations are upheld, even in studies assessed as minimal risk.