IRB-Identifying and Assessing Risk


IRB rules and regulations require that researchers assess the level of risk or harm in human subject’s research. In any given study, risk of harm usually occurs from a breach in privacy, a breach of confidentiality, or from the study procedures themselves. A breach of privacy can occur if a subject’s participation in a study is revealed or if participant information is collected without consent. Similarly, a breach of confidentiality could arise if data or information on a participant is released without authorization leading to a negative impact for the subjects personal or professional life. A few examples of this include revealing participants’ medical information or information of illegal activities that could result in legal consequences. While there are safeguards that should be in place to protect privacy and confidentiality, sometimes just participating in a study can cause harm. An example of this could be if a researcher is using a vulnerable population, such as abuse victims. The study procedures may re-traumatize participants, thus causing psychological distress.

The level of risk of a research study can be determined by assessing the likelihood of experiencing harm along with the severity of that harm should it occur. A researcher should consider the situation and time frame of the research, as many sensitive topics can cause harm if asked in areas in which it is taboo or illegal. Additionally, the subject population itself should be accounted for as well, such as vulnerable or underserved populations who are at a higher risk. Therefore, the goal of a study should be to balance the potential risks with the expected benefits of the information learned. Meaning, if there are little benefits to using an abused population, the risk of re-traumatizing them in your study may be too high of a risk. However, if a researcher plans to deceive their participants to learn a new truth of human behavior, the level of that risk may be acceptable for the benefit of the new information.

The level of risk for each study is examined by an IRB committee and its members will determine if a study’s risk of harm is acceptable and will make suggestions on how to change the level of harm when necessary. Additionally, safeguards, such as removing participant identifiers from the data or obtaining consent and confidentiality forms, may be suggested.

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