Federal regulations, based on the ethical principle of beneficence, require that risks associated with research are reasonable in relation to the anticipated benefits. Subjects must be informed about the potential risks of a study.
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
When assessing risk, bear in mind there are five major types of risk:
Risk/Benefit Assessment Checklist
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 (h) (i)).
Check the appropriate risk category of your research:
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:
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