Adverse Events Protocol
Timely, accurate, and complete reporting of safety information from this study is crucial for the protection of subjects and our interviewers. Given the sensitive nature of the population to be studied, and the items in the surveys, a few respondents may become anxious or upset. Some respondents may also imply that they are a victim of abuse, or that they may be suicidal. Any unintended event experienced by a subject participating in a survey, any symptoms reported by the subject, or any danger signs detected by the staff will be considered adverse events. This chapter reviews the procedures for handling adverse events, especially those concerning issues of domestic violence and child abuse that may arise during the data collection activities.
The PSY Evaluation project team takes the issue of adverse events very seriously. This protocol both proactively takes steps to minimize the likelihood of such events occurring and puts in place procedures to deal with a situation where a study participant’s responses or actions suggest the presence of high risk or active distress. At the same time, it is important to note that such events are extremely rare. While study participants can become emotional, e.g., sad or angry, our experts have indicated that there have only been a few instances where there was a concern of imminent danger or high levels of active distress on the part of study participants which required activating procedures for handling adverse events.
For this study, we employ a rather broad definition of an adverse event, which is any unintended event experienced by a subject in any setting, any symptom reported by the subject or program. Examples of adverse events that might occur include:
A study participant is crying for an extended period of time, becomes emotionally upset by a question or by a series of questions, or becomes unable to continue due to an emotional reaction to the questions;
A study participant is angered by a question, a series of questions, or the content of the interview in general, and reacts in a negative or violent way which is physically or emotionally harmful to him or herself and/or others;
A study participant indicates that he or she is a victim of abuse; and,
A study participant indicates that he or she is suicidal.
Procedures to Monitor the Safety and Well-Being of Study Participants
At the start of the survey, study participants will be informed that they can refuse to answer any question that they are uncomfortable with, that they may take a break or, if conducting the survey by phone, stop the interactions at any time if they feel uncomfortable or fatigued. In doing so, study participants will be given the opportunity to determine their own thresholds for when the situation or interaction has become too burdensome, uncomfortable or distressful for them. In addition, all study participants will be given a list of local resources or organizations that specialize in dealing with emotionally charged situations, violence, abuse, or suicide.
While conducting phone interviews, the interviewer should listen for cues or “red flags” that may require proactively ending the discussions in order to minimize the likelihood that the interaction escalates or spirals out of control. These will only be necessary for telephone surveys, and it will be particularly challenging to observe “red flags” during telephone interactions since you will be unable to view the participants and therefore will not have any visible cues. In these situations, it will be important to carefully listen to verbal cues.
In instances where you have heightened concerns about the tone and direction of the interaction, you should proactively end the interaction.
It is important to understand that some of our survey questions can be sensitive, and might cause the participants to become emotional. However, not all emotions mean something is wrong. It is important to listen for cues that imply something is wrong or not.
Procedures for Handling Adverse Events
Below are some specific examples of adverse events that may arise during administration of the survey, and guidance as to how to handle these situations. As every situation is unique, we ask you to always take your safety into consideration first, and then assist the respondent appropriately by reporting the situation to the appropriate individuals.
If you have concerns prior to conducting the survey, you should not conduct the interview and should schedule an alternative time. Upon ending the interview, you should follow the protocol for reporting an adverse event (found below).
In the event that you have concerns that the study participants’ responses suggest high risk or distress, or the study participant reveals that s/he is in a dangerous situation, you should ask the study participant whether there is someone (e.g., family members, friends, other relatives, clergy members) that s/he can speak with when he or she is upset like this. Give the study participant the list of local resources and encourage him/her to use this list of numbers as a resource to find help. Ask the study participant if he/she feels comfortable calling one of these resources, or if they would rather have someone call them. If the study participant wants someone to call them, have the program staff obtain the telephone number and a couple different times when it would be most convenient for someone to call. Then complete an Adverse Events Form and submit it immediately to your IRB. In the event of an immediate emergency, you should call “911.”
If a study participant reveals instances of a history of family violence, suicidal behavior, child abuse, etc., you should first remind the study participant that you are not a clinically trained professional, and then ask the study participant whether there is someone who is a mandated reporter (e.g., teachers, health care professionals, clergy members) that s/he can speak with. Also provide the study participant the list of resources and encourage them to use the list of numbers to get help. Then ask the study participant whether they have a family member or relative whom they trust and can speak with. Encourage the study participant or child to talk with someone about the issue. You should then follow the protocol for reporting an adverse event (found below). In the event of an immediate emergency, regardless of the age of the study participant or child, call “911.”
In the event that a participant’s confidentiality may have been inadvertently breached. In extremely rare occasions a respondent could be identified as a study participant if a laptop is stolen, or paper forms with identifying information are misplaced.
The severity of these situations can vary greatly from a small suspicion to witnessing an adverse event first hand. Calling “911” should only be used in true emergencies, or when you, or one of the study participants is in immediate danger. You should also be aware that if you are using a cell phone, you may not be able to connect to “911.” As a result, it would be a good idea to program in the local police number into your cell phone for quick reference.
In all instances when an adverse event occurs, you will be required to complete an Adverse Events Form and immediately report the information to your IRB.
In dealing with adverse events remember:
1. Remain calm.
2. Document the details of the incident and the conversations that transpired.
3. Don’t act as a counselor!
Interviewer Reporting of Adverse Events
If you have any sense that something you experienced with a study participant might be an adverse event, then you should fill out an adverse event form whether or not that situation was covered by the examples given in this chapter. The project team is committed to carefully addressing and documenting even potential adverse event. The directions for completing the Adverse Events Form include the following:
Describe the adverse event (date, location, individuals involved).
Write a factual account of your call or visit with the study participant. Give every relevant detail of the interaction. Quote the study participant verbatim. Provide information about what you said to the study participant during this interaction.
Note the interaction or the question(s) where the adverse event occurred.
Print your name and then sign and date the form.
Immediately turn the form into USC and the IRB.
Reporting of Adverse Events to the Institutional Review Board (IRBs)
As required by the University of Southern California Institutional Review Board (IRB) overseeing the PSY Evaluation project, research staff and administrators are required to have written procedures for ensuring prompt reporting of unanticipated problems involving risk to participants. The PSY evaluation team is required to promptly notify the IRBs of any unanticipated problems or adverse events that occur during fielding of the research activities. The notification process is as follows:
The interviewer will complete an Adverse Events Form whenever appropriate and notify his/her Field Supervisor about the event immediately (within 24 hours). Robin Petering, (858) 335-2172, needs to know immediately if such incidents occur.
The Project Director (Petering) is legally required to report, in writing, all such events to the USC IRB.