Once you have identified where there are risks in your study, the next step is to develop procedures that will minimize those risks. When the Board reviews a study, they aren’t looking for a study to be risk-free because that would defeat the point of doing research. However, it is crucial that your protocol communicates a well thought-out project that demonstrates an awareness of potential issues and a preparedness to deal with those issues. It is also important that you demonstrate your ability to handle situations that may arise through a description of your experience and also an adverse event plan. Putting what you write into practice when you conduct the study will accomplish the ultimate goal of the IRB review process: protecting participants in your study. The following list highlights the more crucial elements that need to be included in your protocol and study to protect participants and reduce risk in the study.
The participant is often the best judge as to what is an acceptable amount of risk (though there are participants where this is not the case; please see Vulnerable Participants and Risk-Sensitive Populations). Providing the participant with an accurate consent process that effectively communicates what the study entails will help the participant to make the decision that is best for them. The consent process involves more than just handing the participant a form to sign. Although with most studies, the participant will be required to sign a consent form to participate, it is important to make sure the participant actually understands what is written on the form. It is important to develop a process that is appropriate for the needs of your participants and still falls within the requirements set forth in the federal regulations. For more guidance on putting together a consent process, please see Consent.
For social and behavioral sciences, loss of confidentiality often proves to be the greatest risk to participants. Thus it is important that your data collection and storage methods use the best practice recommendations for your field and they are compliant with UVa's data storage protocol. You should not collect more identifying information than is necessary; a study that is collects information anonymously where the data cannot be linked to the participant can be considered minimal risk even if the data collected involve sensitive material. If you need to collect identifying information about a participant and link that information to the participant, you should provide justification as to why it is necessary to do so. Likewise, once the data are collected, it is important that the information is properly stored and eventually destroyed so that the participants’ confidentiality is protected. Please see Data for more information about data collection and storage practices.
As the researcher, you will be on the front lines working with participants and collecting data. Thus the IRB-SBS depends on you to make good decisions while you are conducting your research. In general, the Board requires that the level of risk in a study be equal or less than the expertise and ability of the researcher to handle. For that reason, the Board often requires students to do more moderate projects where they can gain good research experience but not put participants at risk (for more information on student research please see Student Research). In your protocol, you will be asked to describe your experience and qualifications for doing your study; providing this information will help the Board to better understand your ability to handle any adverse or unexpected events. In addition we require that all researchers listed on a protocol complete CITI training as a baseline measure for ensuring that everyone involved understands the regulations for conducting human subjects research. For more information, please see Researcher Responsibilities.
As you consider the risks in the study, you need to have a plan in place for how to handle an undesirable event, whether expected or not. For some incidents, there may be a required reporting procedure to our office and to OHRP. For more information, please see Unexpected Adverse Events.