Fall/Winter 2004-5 Newsletter Section 7

Research on behavioral emergencies and crises often involves participants who have suicidal tendencies, the potential for violence, or a history of victimization or exposure to interpersonal violence. Researchers who intentionally study participants with issues such as these frequently confront ethical questions such as: (1) will the research procedures or assessments (related to suicidality, violence, or trauma) worsen the individual’s condition and increase risk to self or others; (2) if a participant becomes suicidal or potentially violent during his or her involvement in the research protocol, will there be a need to break confidentiality to protect the participant or others; and (3) if there are such risks, how can the ethical obligations to the participant, others, and the institution supporting the research can be met.

As Monahan, Appelbaum, Mulvey, Robbins, and Lidz (1993) have pointed out, the APA Ethical Principles of Psychologists and Code of Conduct (American Psychological Association, 2002), as well as other professional codes of ethics, offer general guidance on ethical research practice, but few practical guidelines for dealing with such specific research issues. There has also been surprisingly little empirical study of the questions involved.

Several years ago, for example, two of the authors (PK & JK) were required to address an Institutional Review Board (IRB) question as to whether inquiring about the participant’s suicidal ideation, and other variables associated with suicide risk, with a self-report assessment instrument might stimulate or exacerbate self-destructive impulses. The IRB’s concern about the possibility of negative outcomes from participation was not assuaged by the reassurance that clinical wisdom has long regarded as myth the thinking that asking about suicidal ideation (as is routinely done in mental status exams) will cause a patient to become more suicidal. As a result, an extensive literature search was conducted with a focus on the impact of participation in suicide–related research on suicidality, and only one relevant study was found. Clum and Curtin (1993) had investigated the reactivity of participants with chronic suicidal ideation to self-monitoring of suicidal ideation. Participants were required to rate the presence of suicidal ideation, its duration, and the level of self-control they felt on a daily basis for 7 weeks. During the course of this study, no subjects were lost to suicide attempts or completions. Moreover, there was no (Contevidence that increased attention to suicidal ideation resulted in an increase in suicidality. To the contrary, there was some evidence of decreases on measures of suicidal ideation following the period of self-monitoring, something that could be interpreted as a positive effect of disclosure.

More recently, Oquendo, Stanley, Ellis, and Mann (2004) described a randomized, controlled trial of pharmacotherapy for suicidal behavior that attempted to minimize the risk of morbidity and mortality. Lithium was compared to valproate for potential antisuicidal effects in bipolar disorder patients. Several types of protective interventions were included because the study participants had made past suicide attempts and were considered at high risk of further suicidal behavior. Thus, for example, so-called rescue medications could be added to the treatment regimen if a participant became depressed or manic. In addition, if a participant reported plans for a suicide attempt, hospitalization, a change in medication, or increased monitoring could be introduced. Moreover, the family of the participant was involved in monitoring behaviors related to suicide risk and family members were trained in interventions in the event of a relapse. While these procedures should reduce the risk of harm to the participants, the question is (as the authors have noted) whether they will also decrease the incidence of suicidal behavior “in a way that is inconsistent with ‘real world’ conditions” (p 1559) and, therefore, reduce the ecological validity of the study. The outcome of this study will be closely watched.

Trauma researchers have given somewhat more attention to the question of the impact of trauma research on participants. Newman, Kaloupek, Keane, and Folstein (1997) expressed the opinion that the trauma research community has failed to be self-reflective and to examine the impact of trauma research on participants. Clearly, inquiries about past traumatic events have been known to trigger intense recollections, flashbacks, physiological reactivity, and psychological distress, sometimes with concomitant suicidal or homicidal impulses. Newman and her colleagues (Newman, Willard, Sinclair, and Kaloupek, 2001) have therefore developed a questionnaire, the Reactions to Research Participation Questionnaire (RRPQ), to address this apparent shortcoming and to help promote ethical decision making about research practice. In the initial testing of this instrument, they found that participants’ appraisals appeared to fall into five categories on factor analysis: personal satisfaction, personal benefits, emotional reactions, perceived drawbacks, and a global evaluation. Their plan is to continue to validate the RRPQ as a means of empirically examining research participants’ distress (as well as their perceived benefits and satisfaction) and as a way of promoting the ethical treatment of those who participate in research.

Investigators who have studied the risk of violence have also struggled with ethical questions about risk for participants and others. In a large, prospective, multisite study (the MacArthur Study of Mental Disorder and Violence), the research team worked with a population of patients who had a relatively high potential for becoming violent (Monahan, et al, 1993). They had ethical concerns about the risk of violence for participants, the risk that others in the community might be victimized by research participants, and the risk that research staff themselves could be injured. Given what they saw as a “paucity of knowledge about the researcher’s duty to protect others from harm” (p. 392), they allowed their different research sites to develop their own methods for addressing these issues. Two of the three sites interpreted their ethical obligations broadly. Whenever routine data collection indicated the presence of suicidal or homicidal ideation, they required the interviewers to explore the degree of risk. Interviewers were provided with an outline of areas into which they were to inquire, and they were instructed to depart from the research protocol to do so. This information was then brought to the senior staff and was reviewed by the principal investigator and a clinical consultant. If the situation suggested an imminent threat of serious harm to self or others, the senior staff followed a set of guidelines and considered a range of preventive interventions.

The third site took a narrower view of their ethical obligations. Interviewers were instructed to notify their supervisors if participants behaved or were likely to behave in a manner that endangered their own lives, or if they showed indications that they posed a substantial threat to others. They were not, however, encouraged to deviate from the research protocol to explore the potential for suicide or violence. This group believed that it was beyond the abilities of non-clinically trained research personnel to carry out such difficult and complicated evaluations. This site saw their responsibility as reacting to manifest threats of imminent harm, but not as obligating them to evaluate more subtle risks to participants or others. If there appeared to be imminent risk, the supervisory staff followed the same guidelines as the other sites in considering preventive intervention.

Reports such as these, from very responsible investigators, indicate that there is concern about the ethical obligations of the researcher to protect high risk participants and third parties from harm. There is little empirical data, however, on reactions to research participation. Moreover, there is no consensus about the extent of the obligation to detect potential for harm or exactly how the duty to protect can best be discharged with research protocols that vary widely in form and across contexts. Our hope in reviewing the efforts of those noted above is to stimulate dialogue and further the investigation of these issues, the resolution of which we believe to be of great importance to the conduct of research on behavioral emergencies and crises. If others have thoughts, comments, or information relevant to this topic, we invite them to share it with us by contacting the first author at: Phillip.Kleespies@med.va.gov

References

American Psychological Association. (2002). Ethical principles of psychologists and code of conduct. American Psychologist, 57, 1060-1073.

Clum, G., and Curtin, L. (1993). Validity and reactivity of a system of self-monitoring suicide ideation. Journal of Psychopathology and Behavioral Assessment, 15, 375-385.

Monahan, J., Appelbaum, P., Mulvey, E., Robbins, P., and Lidz, C. (1993). Ethical and legal duties in conducting research on violence: Lessons from the MacArthur Risk Assessment Study. Violence and Victims, 8, 387-396.

Newman, E., Kaloupek, D., Keane, T., and Folstein, S. (1997). Ethical issues in trauma research: The evolution of an empirical model for decision making. In G. Kantor and J. Jasinski (Eds.): Out of the darkness: Contemporary perspectives on family violence (pp. 271-281). Newbury Park, CA: Sage.

Newman, E., Willard, T., Sinclair, R., and Kaloupek, D. (2001). Empirically supported ethical research practice: The costs and benefits of research from the participants’ view. Accountability in Research, 8, 309-329.

Oquendo, M., Stanley, B., Ellis, S., and Mann, J. J. (2004). Protection of human subjects in intervention research for suicidal behavior. American Journal of Psychiatry, 161, 1558-1563.