For some participants, the probability of harm can be significant because of the participant’s life situation. Victims of abuse, individuals with debilitating health conditions, etc, put these participants in categories of heightened concern. Ultimately a study of this population may result in steps towards solutions, but when participants are involved in a study, simply interacting with researchers can cause problems. In order for the Board to approve studies where participants are considered “risk sensitive,” you need to provide a carefully constructed protocol that describes the risks to participants and the safeguards put in place.
Depending on the study, some of the vulnerable participants (participants who are unable to or have limited capacity to consent) in the previous section could also be considered “risk sensitive” participants, though the inability to consent does not always equate to a study where the probability of harm is high for a participant. As stated previously, the definition for “risk sensitive” can change depending on the participants and the nature of the study, so recommendations are made on a protocol-by-protocol basis.
In general, studies that encounter participants that are risk-sensitive can be divided into three categories:
Participants are already identified in the risk category and they are being studied because of that identification (i.e. the study is researching issues related to abused children and the participants are abused children).
The focus of the study is not inherently risky but the participants are more likely to be in risky situations. For example, a study is focused on the relationship of high school drop outs and their parents. It is possible to conceive that abusive relationships, illegal behaviors such as drug use, and other risky behaviors may be discovered as a result of this study even though they are not the focus of the study.
This situation is less likely to occur and doesn’t necessarily need to be dealt with in the protocol. However, even working among “normal” participants, it is possible to discover that a participant is in a risk-sensitive situation. For example, in working with a student in a normal educational practice study, a researcher learns of an abusive situation. It is important to become familiar with the signs of a harmful situation, your responsibilities for reporting a situation, and how to report. These situations are often complicated and delicate; if you are concerned about a situation and need further guidance, please consider contacting other individuals experienced in handling these kinds of situations. In some situations, you may not have the expertise to best help an individual in crisis and it would be appropriate to refer the participant to someone who can help them.
How Do I Include a Risk-Sensitive Population in a Study
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 Undesirable Research Events.