What is the definition of "minimal risk" in research?

The definition of "minimal risk" in research is characterized by a situation where the likelihood and severity of harm that participants may face are not greater than those encountered in their everyday lives. This standard is crucial for ensuring that studies involving human subjects are ethically justified, particularly in ensuring participant safety and welfare.

When research is classified as involving minimal risk, it allows researchers to pursue studies while adhering to ethical guidelines designed to protect participants. This classification can influence the design of studies, the consent process, and the level of oversight required from Institutional Review Boards (IRBs). By establishing that the risks are comparable to those experienced in daily life, researchers can proceed with studies that might address important social, medical, or psychological questions without imposing undue risk on participants.

The emphasis on "likelihood and severity" being aligned with daily experiences is essential in determining whether certain research protocols can be approved without more stringent oversight. Additionally, ethical standards compel researchers to minimize risks as much as possible, but as long as they remain within that threshold of minimal risk, they can maintain compliance with ethical research practices.