Minimal Risk

Minimal Risk: "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 or psychological examinations or tests" (from 45 CFR 46.102(i)).

When making a decision about minimal risk of research:

1. Consider both magnitude and likelihood of risk
   A more serious event may be permissible if its probability is extremely low;
   Example: Airplane flight carries a risk of death, but it occurs only once in some millions of passenger miles.
2. Risks of ordinary, non-invasive diagnostic tests are OK
   Examples: routine blood draws in adults, general physical exams, pen-and-paper tests, ultrasound exams(at accepted levels)
3. Minimal risk may be age- or context- dependent
   Example: Blood draw may be minimal risk for someone old enough to give consent, but not for a small and needle-shy child
4. Remember that risks need not be "physical" in order to be "more than minimal"
   Examples: A serious privacy risk, confidentiality risk, informational risk or risk of embarassment may be enough to push a study into the "greater than minimal risk" category and thus to full committee review