IRBs must determine that risks to the subjects are justified in relationship to the anticipated benefits. They must also determine that risks are managed to the extent possible consistent with sound research design.

Defining Risk

The federal regulations offer the following definition of risk:

"The probability of harm or injury (physical, psychological, social, or economic) occurring as the result of participation in a research study."

The regulations also define 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."

Behavioral research does not usually involve risks to a person's health or physical well being, but there are, nevertheless, risks which must be considered by the researcher and the IRB.

Breach of Confidentiality
A breach of confidentiality is often the greatest risk to participants in behavioral and social sciences research. Reputations may be damaged, or employment or insurance coverage may be jeopardized if confidentiality is not maintained.

Information about subjects' activities may place them at risk of legal action. For example, if a researcher asks parents how they discipline their children, information about child abuse may be obtained and must
be reported. Similarly, if subjects divulge information about illegal activities or stigmatized activities, any disclosure of that information could place the subjects at risk of significant harm.

The kind and level of risk is determined by context. For example, research regarding political activism in some countries may put subjects in serious jeopardy, while it would not in other countries.

Risk Resulting from Study Procedures
Another category of risk that might occur in research in the social and behavioral sciences is psychological stress caused by the research questions or procedures. Perhaps questions raise painful memories or unresolved issues.
Interviews of survivors of personal or state violence, for example, may be very stressful. Questions about at-risk behaviors may cause embarrassment or feelings of guilt when that behavior is generally stigmatized

Most psychological risks are minimal and transitory, but investigators must be aware of the potential for
serious psychological harm.

Managing Risk

In many cases risk can be eliminated or reduced by careful procedures for ensuring confidentiality. Psychological support and referrals can be built
into studies when emotional distress may be an outcome. Consent forms describing the kinds of questions the researcher will ask allow participants to choose whether they wish to divulge certain types of information or
explore certain issues.

Benefits

Potential benefits for individual subjects may be easy to define in studies offering interventions for behavioral or psychological problems. However, research is often conducted as part of a faculty member or graduate student investigation into a specialized field of study. The research may provide no direct benefit to the subjects.

Furthermore, it may be many years before the results of the research are promulgated and made useful to society or to groups of people.

Vague promises to benefit science or society are not adequate descriptions of benefit. When there is no direct
benefit to subjects, they must be told what the researcher is trying to learn and why. (The only exception would be a study in which deception is a necessary element of the design.)

Compensation to subjects is not considered a benefit in the risk/benefit analysis, nor is the fact that participants may find it rewarding to be helpful.