The purpose of the IRB review is not to create a "zero risk study" but instead to minimize risk where possible and confirm a justifiable balance between risk and benefit. Individuals whose life situations are more volatile may be inherently more susceptible to harm. It is important that "risk-sensitive" populations are studied because otherwise their risky situations will continue without the hope of change. However, if you are going to include risk-sensitive participants in a study, you need to be prepared to address the needs of your participants and you need to demonstrate your preparation in your protocol. The Board will not allow these populations to be studied unless the protocol demonstrates adequate preparation. Please consider the following when developing your protocol:
The Board needs to understand the scope of the study, what questions you will ask, in some cases what questions you won’t ask, that data you will collect, the instruments you will use, etc, and how they will impact the participant. The Board needs to understand what you will do if you obtain information that is outside the scope of the study but is a risk to the participant.
The Board will want to know who you are and how you have prepared to work with this population. They want to know that you will be able to make correct choices at crucial moments.
For some participants, even approaching them might put them at risk. The Board wants to know that you developed a procedure that is appropriate for the participants and doesn’t put them at additional risk. There may be additional issues to consider with a risk-sensitive population. For example, if you want to include an abused child, do you use a Parent Consent form or does contacting the child’s parent (who is possibly the abuser) put the child at further risk? (For more information, see Child Abuse: Consent.
Protecting the participant’s privacy and confidentiality is generally the most important step to protecting a participant. Some data might be a risk to the participant, such as recording information about illegal behaviors (see Certificate of Confidentiality). The Board needs to have a clear understand of how the data will be collected, processed, and stored, who will have access to it, how it will be reported, and how long it will remain until it is destroyed. Collecting data in a way that minimizes linking data to the participant’s identifiers (and ultimately collecting anonymous data) can significantly improve the ability to protect confidentiality.
The Board needs to know what you will do when things don’t go according to plan. For example, what will you do if you have a credible suicide threat? Part of your plan will include a requirement to file a report with our office. For more information, please see Unexpected Adverse Events.