To use the checklist for assessing risk, begin with the federal regulatory definition of minimal risk. Once
you have completed the checklist, refer to the type of IRB review your research will require.
When assessing risk, bear in mind there are five major types of risk:
- physical risk (for example, pain, bruising and infection associated with venipuncture, muscle soreness and pain as a consequence of exercise testing, heart attack induced by maximal exercise tests)
- psychological risk (for example, stress associated with experiments and testing, feelings of guilt or discomfort because of sensitive survey topics)
- social risk (for example, invasion of privacy, loss of community standing)
- legal risk (for example, criminal prosecution or revocation of parole)
- economic risk (for exmaple, loss of employment, loss of potential monetary gain)
Definition of minimal risk: Minimal risk means that 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 (45 CFR 46.102
Check the appropriate risk category of your research:
- ___ The research involves no more than minimal risk to subjects.
- ___ The research involves minimal risk to subjects.
- ___ The research involves more than minimal risk to subjects.
a. ___The risk(s) represents a minor increase over minimal risk, or
b. ___The risk(s) represents more than a minor increase over minimal risk, or
c. ___The risk(s) represents a major increase over minimal risk.
Definition of benefit: A research benefit is considered to be something of a health-related, psychosocial,
or other value to an individual research subject, or something that will contribute to the acquisition of
generalizable knowledge. Money or other compensation for participating in research is not considered
to be a benefit. A great deal of research in the social and behavioral sciences offers little potential
for direct benefits to the subjects themselves. Rather, the benefits often encompass the importance
of the knowledge to be gained, and/or to the contributions the research makes to science or society.
Check the appropriate benefits category (ies) of your research:
- ___ The research provides no prospect of direct benefit to individual subjects, but likely will yield
generalizable knowledge about subject’s disorder or condition.
- ___ The research provides no prospect of direct benefits to individual subjects, but likely will yield
generalizable knowledge to further society’s understanding of the disorder or condition under
- ___ The research provides the prospect of direct benefits to individual subjects.
- ___ The research provides no prospect of direct benefits to individual subjects, to science, or to
If you checked numbers 1 or 2 under Risks Categories, and numbers 1, 2, or 3, in the Benefits Categories,
your protocol will generally be reviewed as Exempt unless the research involves one of the categories of
vulnerable subjects; refer to children, prisoners, mentally disabled persons, economically or educationally
disadvantaged persons, pregnant women, fetuses and neonates.
If you checked number 3.a or 3.b under Risks Categories, and numbers 1, 2, or 3, in the
Benefits Categories, your protocol will be reviewed as Expedited or require a full-board review.
If you checked number 3.c under Risks Categories, and/or number 4, in the Benefits Categories,
your protocol will not receive IRB approval, and you will be unable to conduct your research.