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Risk-Sensitive Populations

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:

  • The risk-sensitive population is the focus of the study. 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 study involves participants that are more likely to be risk-sensitive. 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.
  • The study inadvertently discovers participants in a risk-sensitive situation. 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.

This section includes information on how to include a risk-sensitive population in a study and then provides information that is specific to these groups. Please note that this list is not all-inclusive and risk will be assessed in each protocol.

Section Topics

How to include risk-sensitive populations in a research study
Child Abuse
>>Including Abused Children in a Study
>>Reporting Responsibilities
 Abuse of Adults with Diminished Capacity to Consent
>>Including Abused Adults with Diminished Capacity
>>Reporting Responsibilities
Domestic Abuse: Emotional, Physical, and Sexual Abuse of Adults
>>Including Victims of Domestic Abuse
>>Reporting Responsibilities
Suicide Threat
>>Including Suicidal and Previous Suicidal Participants in a Study
>>Reporting Responsibilities
Specific and Immediate Threats to Cause Bodily Injury or Death to a Third Party
>>Reporting Responsibilities
>>How Do I Report a Threat?
Participants with Stressful Health Conditions
Participants in Dire Economic, Political, and/of Social Situations
Considerations for minority and/or ethnic groups

Additional Topics

Understanding Risk in Research
Education: Reporting Child Abuse
Undesirable Research Events
Certificate of Confidentiality

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