At this point in the protocol, the Board should have a good idea as to all of the components of the study— who is participating, what data will be collected, etc. This section is an opportunity to demonstrate your ability to distinguish what is a true risk for participants. While it’s important to identify any potential risks and how you will handle them if a problem should arise, it’s also important to not overstate risk as well, not only to the Board but to the participants as well.
If you have indicated that you have “vulnerable” participants in the “participant group” section or other situations that could increase risk in the study, at the top of the Risk section, you will be reminded of your selection. The Board has additional considerations for participants in these categories and it is important that you demonstrate your readiness to work with these participants (not only in the Risk section but in other sections as well). Please note that not all situations that could cause risk in a study will be indicated at the top of the Risk section; if nothing is displayed there, don’t assume that you automatically have no risk to address in the study.
In this text box, identify other potential risks to participants and how you will handle the situation if it should arise. Demonstrate your sensitivity to potential harm your study could cause and develop a reasonable plan to prevent harm and mitigate it should arise. The Board does not expect every study to be minimal risk otherwise there would be no purpose to conducting research. However, they do expect expertise, precision, and care to be taken with research participants. Part of the toolkit for mitigating risk is providing adequate information to participants in the consent process.
If an unexpected adverse event occurs during the study, you need to report the event to the IRB-SBS. You can make a copy of the protocol form, answer the questions regarding adverse events, and submit the protocol for review. It may be necessary to adjust the “risks” section so that it more accurately reflects any new information regarding risks. This process is not meant to be punitive; rather, the purpose is to help both researcher and IRB-SBS better understand how to protect participants and continue to adjust recommendations so that they are effective and accurate. See Unexepected Events for more information.