To qualify for an exemption or for expedited review, research activities must be no more than minimal risk. If research activities are determined to be more than minimal risk, a study must be reviewed by the convened IRB.
Minimal risk. As defined in the federal regulations, 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(i)).
For research involving prisoners, the regulations at 45 CFR part 46 subpart C define minimal risk as follows:
Minimal risk is the probability and and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of health persons (45 CFR 46.303(d)).
For research involving children as research participants, the IRB must consider the potential benefits, risks, and discomforts of the research to children and assess the justification for their inclusion in the research. In assessing the risks and potential benefits, the IRB should consider the circumstances of the children to be enrolled in the study--for example their health status, age, and ability to understand what is involved in the research--as well as potential benefits to subjects, other children with the same disease or condition, or society as a whole.
When considering what types of risks research subjects might encounter, consider the following:
- Physical Risks: These risks include physical discomfort, pain, injury, or illness brought about by the methods and procedures of the research.
- Psychological Risks: Psychological risks may be experienced during participation in the research and/or afterwards as a result of participating in the research. These risks include anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, and/or altered behavior.
- Social/Economic Risks: Social risks include alterations in relationships with others that are to the disadvantage of the subject, and may involve embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and status in relation to others. Economic risks include payment by subjects for procedures, loss of wages or income, and/or damage to employability or insurability.
- Legal Risks: Legal risks include risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally liable.
- Loss of Confidentiality: Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks from breach of confidentiality include invasion of privacy, as well as the social, economic and legal risks outlined above. Loss of confidentiality is the most common type of risk encountered in social and behavioral science research.