HHS regulations found in Subpart A (46.102) desribe risks in human subjects (participants) research 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 or during the performance of routine physical or psychological examinations or tests.” With research performed at UMBC, risks are classified as physical, psychological, social/economic and legal. Below are illustrations of such risks including:
Physical risks include physical discomfort, pain,or injury resulting from a method or procedure in a research study. Examples include noise, electric shock, heat, or cold.
Psychological risks are those that may bring about anxiety, depression, guilt, shock and loss of self-esteem and altered behavior. Deception or mental stresses are examples of psychological risks
Social risks result from potential changes in relationships with others including embarrassment, loss of respect of others, or diminishing opportunities that impact relationships with others.
Economic risks include loss of wages or other income and any other financial costs, such as damage to a employability, as a consequence of participation in the research.
Legal risks exist when the research methods could make participants liable for a violation of the law, either by revealing that the participant has or will engage in conduct for which the subject or others may be criminally or civilly liable, or by requiring activities where that person may be criminally or civilly liable.
The loss of confidentiality is another type of risk that applies to all research involving human participants. Confidentiality of identifiable information must be maintained unless the investigator has permission of the participant to do otherwise. All participants have the right to be protected against injury or invasion of privacy. The more sensitive the research, the greater the care that must be exercised in obtaining, handling, and storing data. In order to minimize the risk for loss of confidentiality, investigators should only collect personal information that is absolutely essential to the research activity and should be coded and securely stored so that only the investigator and authorized staff may access it.
The IRB evaluates such risks to determine if they are reasonable in relation to anticipated benefits or desired outcomes from participating in a research study. The IRB will consider risks and benefits that may result from the research in its review a a protocol application.
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