What does 'minimal risk' mean in the context of human subjects research?

In the context of human subjects research, 'minimal risk' refers specifically to the level of risk that is not greater than what participants would encounter in their everyday lives, such as during routine physical examinations or common activities. This definition helps ensure that research involving human subjects adheres to ethical standards and does not expose participants to unnecessary harm.

Identifying risk levels is crucial for the IRB’s review process, as it informs the ethical consideration of research protocols. By defining 'minimal risk' in relation to everyday experiences, regulatory guidelines can help protect participants while allowing research to progress under manageable risk levels. This concept is particularly significant for determining which studies may qualify for expedited review, as those presenting minimal risk can often be processed more quickly than those with higher risks.

The distinction between this definition and other options highlights that 'minimal risk' cannot be an arbitrary assessment based on individual experience, nor can it overlook context or focus solely on risks associated with specific types of studies, such as those involving experimental drugs. Understanding this classification is essential for researchers when designing studies and for IRBs when evaluating the ethical implications of proposed research involving human subjects.