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)).

What kinds of risks are often encountered by research subjects?
Risks are usually classified as physical, psychological, social, and/or economic.

• Physical Harms: e.g., pain, discomfort, or injury
• Psychological Harms: undesired changes in thought processes and emotion (e.g., depression, confusion, or hallucination); stress, guilt, loss of self-esteem;
• Social/Economic Harms: embarrassment within one's business or social group; loss of employment; criminal prosecution

Check appropriate risk category for your research:

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

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

R3. __ The risk(s) represents a minor increase over minimal risk, or

R4. __ The risk(s) represents more than a minor increase over minimal risk.

What is a Benefit?
A valued or desired outcome; an advantage. 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 (value to society). 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 your research:

B1. __no prospect of benefit (a study with no prospect of benefit is probably not worth doing!)

B2. __no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge of value to the Discipline (this could include the training of future researchers)

B3. __ no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge to further society's understanding of the topic under study

B4. __ the research involves the prospect of direct benefit to individual subjects.

How do your risks and benefits compare?
Are risks reasonable in relation to the benefits to subjects? If your risk # is higher than your benefit #, you may need to rethink your project.