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, you will be reminded of your selection at the top of the Risk section. 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 have no risk to address in the study.
Risks & Benefits Questions
Is loss of confidentiality and/or privacy a risk to participants? What will be done to protect participants from loss of confidentiality and/or privacy?
If the first question is marked yes, the second question will appear as a text box. Describe your process for protecting participants from loss of confidentiality and/or privacy. For more information, please see Privacy and Confidentiality.
Describe any remaining potential risks to participants. For example, are any of your participants or participant groups "risk-sensitive"? Include information about the probability of harm (i.e. how likely it is that harm will occur). What will be done to reduce risk to participants? If something unexpected involving risk happens, how will you handle it?
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 if 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 unexpected 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 Unexpected Events for more information.
Are there direct benefits to the participants in this study?
For most studies the answer to this question is no and that’s not problematic. The Board doesn’t expect every study to provide direct benefit to participants but if the study does, it is good for the Board to understand the direct benefits as they weigh them against the risks to participants. If there are direct benefits, you will be prompted to describe them in the next textbox in addition to the overall benefits; if there are no direct benefits, you will only describe the overall benefits.
Describe the overall benefit of this study.
The Board is tasked with weighing the benefits of the study against the risks to participants; for many studies, the overall benefit may not be great. For example, a student researcher is not as likely to contribute findings that will significantly benefit science and/or the population in which they study. However, the opportunity to practice research methodology and train for future studies is beneficial. Even though the benefit to society is modest, it doesn’t mean the study can’t take place but at the same time, the board also expects the risk to be lower as well. For a researcher who has more experience working with a population, there is a greater potential benefit to be gained from the study and it may be more acceptable for the study to involve greater risk.
Pre-Reviewer Evaluation
- The benefits to society at large or to the field of study are articulated in the protocol.
- The risks are adequately described.
IRB-SBS Reviewer Evaluation
- Foreseeable risks are reasonable in relation to anticipated benefits.
- The researcher has the proper procedures or methodologies to deal with any potential risks that individual subjects may experience.
- The researcher will deal with any limits to confidentiality in an appropriate way (e.g. the requirement to report suspected child abuse).
- The researcher will provide appropriate protections to prevent risks associated with disclosures of personal data.
- The risks are reduced to the least possible level.