Risk - Part I

Risk, one of the central issues in research ethics, is one of the most misunderstood and misapplied terms in the entire field of human research protections. This will be a two-part discussion of risk. This first part will deal with the misunderstanding with regard to the evaluation of risk in research. The second part will misunderstandings about the role of risk in human research protections.

Most researchers and most IRB members confuse risk and harm. Risk is not harm, risk is the possibility of harm. The evaluation of risk requires evaluation of both the magnitude and the likelihood of possible harm. To quote the Belmont Report, “The term "risk" refers to a possibility that harm may occur. However, when expressions such as "small risk" or "high risk" are used, they usually refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned harm.” The federal regulations do not define risk; however, in defining “minimal risk” the regulations state, “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.”

Most protocols merely list the possible harms that might occur in the research. For example, a research protocol might list hair loss as a risk. This tells us nothing about the risks of this research. In order to evaluate the risk of hair loss, we need to know the severity of the hair loss and the likelihood of the hair loss occurring. A remote chance of slight hair loss is very different from the likely loss of all of one’s hair. IRBs must determine whether the risks are reasonable in relation to the benefits of the research. Most people would consider a high likelihood of total hair loss a reasonable risk in an oncology study but not in an acne study.

In addition to IRBs needing this information, subjects need this information to decide whether to participate in the research. A remote chance of slight hair loss may be a minor risk to most people, but to a teenage girl, the research would probably have to have significant benefit to justify that risk. The subjects must be provided information on both the magnitude and the likelihood of the possible harms in order to give true informed consent. This information must be provided to the subjects in language that they can understand and evaluate in terms of their own lives and values. As with the protocols, most consent forms merely list possible harms without provide real information about the risks of research.

This concern is not limited to biomedical research. The same requirement applies to social/behavioral research. Much social/behavioral research is “minimal risk,” but to make that determination, the IRB must examine both the magnitude of the possible harm and the likelihood that the harm will occur. Consider, for example, a survey on AIDS and substance abuse. While the magnitude of the possible harm if the information was inappropriately divulged is great, in order to evaluate the risk the IRB must also evaluate the likelihood of that occurring. If the confidentiality procedures were sufficient to ensure that there is an extremely small likelihood of the information being divulged, then the research might be considered a minimal risk study.

So, IRBs need to have information about both the magnitude of the possible harm and the likelihood of the harm occurring in order to determine if the risks are reasonable in relation to the benefits. If the IRB does not have enough information on both of these, it cannot approve the research.