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.