Federal regulations define minimal risk as “… 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 of the general population or during the performance of routine physical or psychological examinations or tests.”
When the IRB evaluates risk in a protocol application, they:
- review the probability and magnitude of harm or discomfort in research that are not greater in and of themselves than those ordinarily encountered in daily life
- put an emphasis on risks associated with research procedures that may lead to emotional, psychological, social, physical, or financial harm
- evaluate risks associated with a specific population (vulnerable people, such as children, older persons, cognitively impaired) who may experience different types of risk
The loss of confidentiality is another type of risk. Confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the participant to do otherwise. The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data.
Risks may be eliminated by using research procedures or data collection necessary only for the research. Examples include recording data without identifiers, collecting the minimum data necessary for the research and performing procedures only necessary to achieve the study objectives.
The IRB cannot approve research in which the risks are judged unreasonable in relation to the anticipated benefits.