Assessing Risks and Benefits

How do I evaluate the balance between the risks and benefits to the subjects in my study?

What is Risk?
The regulatory 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 appropriate risk category:

R1. __ The research involves no more than minimal risk to subjects.

R2. __ The research involves more than minimal risk to subjects.

R2a __ The risk(s) represents a minor increase over minimal risk, or

R2b __ The risk(s) represents more than a minor increase over minimal risk.

What is a Benefit?
A research benefit is considered to be something of 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 participation in research is not considered to be a benefit, but rather compensation for research-related inconveniences.

Check appropriate benefit category:

B1. __ no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition (mainly for patient subjects);

B2. __ no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge to further society's understanding of the disorder or condition under study (mainly for healthy volunteers); or

B3. __ the research involves the prospect of direct benefit to individual subjects.