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.
You should also consider the elements or levels of:
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.
Researchers should provide detailed information in the IRB application about potential risks and benefits associated with the research, and provide information about the probability, magnitude and potential harms associated with each risk.
Generally you should not claim "there are NO risks."
There may be no anticipated risks; no foreseeable risks, or risks that are no greater than those ordinarily encountered in daily life or normal routines.
Benefits of research to individual participants are most important and most straightforward. Much more complicated are situations in which the relationship between risks to participants and benefits of broader knowledge resulting from the research must be weighed. In all situations, the researcher's first priority is to minimize risk and to protect the rights of the participant.
While risks and benefits to participants must both be considered, benefits must go beyond the potential absence of harm to research participants. Specific benefits of the research study to participants should be identified and, to the extent possible, quantified. In designing a study, one should overestimate risks and underestimate benefits.
Finally, a useful rule of thumb in considering benefits to research participants is to ask yourself: Would I honestly want someone I love to participate in this study? Would I participate in this study?
IRB will weigh the risks and benefits when considering a proposal. Where there is little risk there does not need to be great benefit so don’t be afraid to say that there are no direct benefits to the participant. If there are no benefits at all (to participant, society, or knowledge) the study is probably not worth doing.