The level of review for human subject research is determined by the risk of harm to the participants and the vulnerability of the participants. Vulnerable populations include children, prisoners, pregnant women and fetuses, and mentally disabled persons. The types of risk include
- Psychological, emotional, or sociological risk such as stress, anxiety, guilt, invasion of privacy, breach of confidentiality, harassment, and lessening of an individual’s identity.
- Risk of physical injury or pain.
- Risk of legal difficulties to a community or a group of individuals.
- Risk of economic harm or other inconveniences such as those that would affect the participant’s financial standing, employability, insurability, or reputation.
The first step in determining the level of review is classifying the risk to the participants of the research as less than minimal, minimal, or greater than minimal.
Less-than-minimal risk: The research has no known risk.
Minimal risk: The research presents only the kinds of risk encountered in daily life by most people (e.g. moderate exercise testing, psychological testing producing only minor stress, surveys involving sensitive topics such as society’s illegal activities or sexual practices).
Greater-than-minimal risk: The risk presents the kinds of risk beyond those normally encountered in daily life (e.g. maximal exercise testing, stressful psychological testing, questions about the participants illegal activities or sexual practices).