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Greater than minimal risk research involves studies that expose participants to risks exceeding those encountered in daily life or during routine physical or psychological evaluations. Because they pose an elevated level of potential harm—such as the potential to cause psychological distress or harm that is more than minor and temporary—these studies do not qualify for exempt or expedited review. Instead, their research protocols must undergo a rigorous, comprehensive review by the full institutional review board (IRB).

Greater Than Minimal Risk Research

When a study poses more than minimal risk, such as having the potential to emotionally upset participants, it requires correspondingly greater benefits to be ethically justified. In such cases, it is crucial that the research is rigorously designed to either answer a scientifically interesting question or provide clear practical implications that outweigh the elevated risks.

Justifying Greater Than Minimal Risk Research

What is the primary characteristic that classifies a study as 'greater than minimal risk' research?

What type of Institutional Review Board (IRB) review is required for a research study that exposes participants to risks exceeding those encountered in daily life?

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