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Risk to confidentiality is another risk of research

All studies involve some level of risk. Sometimes, those risks are clear, such as in the case of investigational drug and device studies where the test article may have side effects. Other potential risks are much more subtle, however. One risk we see often overlooked in draft consent forms is the risk to confidentiality. Confidentiality is an issue in just about every study that collects identifiable information about subjects. Sharing of information collected as part of the research, whether that sharing is accidental or planned, increases the number of people who will have access to study participants’ information. Therefore, risks to confidentiality should be specifically mentioned in the risks section of consent documents. This risk tends to get overlooked, we’ve noticed, causing the IRB to have to send back a contingency requesting a correction. Making sure it’s included up front will help your study get through the IRB faster.