What Are the Potential Risks?

The Common Rule defines minimal risk as: "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical, medical or psychological examinations or tests."

Note that the probability of harm should be distinguished from the magnitude of harm. It is virtually certain that we will suffer minor transient harms in normal every-day life (transportation delays; inclement weather; embarrassment; fatigue; etc.). Such high-probability, low-magnitude harms are within the definition of "minimal-risk" research. Researchers should consider what the probability of transient harm occurring is; whether the harm is likely to be lasting in any way; and what steps will be taken to ameliorate the harm.

• More than minimal risk means that the degree of physical or psychological discomfort is above that which is ordinarily encountered in daily living or during the performance of routine physical or psychological examinations or tests. This could include disclosure of confidential information to individuals who could use that information to harm a subject in some way.
• The Common Rule defines potentially damaging information as (i) information ....recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation."