Researchers wanted to study the effect of a time limited group therapy outpatient intervention for suicidal adults. Over the course of 2 weeks, patients would participate daily in intensive (8 hours/day) experiential-affective group work (focusing on issues precipitating the suicidal incident) and psycho-educational groups (covering stress management, impulse control, goal setting) with homework assignments. Groups would be run by masters' level psychologists. These group leaders would be supervised by the PI, a clinical psychologist with a specialization in suicide. Patients would return home each evening and on the weekends. Efforts would be made to limit the inpatient treatment to 3 days of those experimental treatment participants requiring acute hospitalization for stabilization purposes.
The experimental treatment would be compared to a treatment as usual (TAU) condition in which patients typically receive 7 days of inpatient care followed by a combination of outpatient group and individual treatment for time periods dependent upon the patient's needs. Control participants would receive a variety of treatments depending upon the practitioner's orientation and specific hospital from which he or she was referred.
Prospective participants, referred on the basis of suicidal risk factors, would be sent to the study by treatment staff of various city-run public emergency rooms and clinics. Treatment staff would be instructed to exclude individuals with substance abuse and psychotic or personality disorders. Those patients who agreed to be in the study would be randomly assigned to the treatment or control group and given a 1 day battery of standardized psychological tests on suicidal ideation and behaviors, life stress, depression,and family and individual psychiatric history. Follow-up assessments would be completed at 1, 6, and 12 months following completion of treatment. During the follow-up period participants would be asked to refrain from seeking psychological services from professionals unaffiliated with the research study.
Consider how each question would be viewed from the perspective of the Investigator, the Participant and his or her Family, Community Members, Treatment Staff, and the IRB.
- What type of information would the investigator have to provide his/her IRB to demonstrate that the treatment and the control conditions were ethically justified?
- What would be sufficient scientific or clinical background to support the potential efficacy of the new treatment?
- How can one determine whether the experimental treatment or Treatment as Usual (TAU) control group is being deprived of an effective treatment?
- What characteristics of the participant population need to be considered in evaluating clinical equipoise for this study?
- Is the investigator able to demonstrate that the scientific design can determine if the treatment is effective?
- What are the potential risks of not conducting this study?
- How would the IRB determine whether the design met other ethical standards?
- Does the investigator serve a dual role that may pose a conflict of interest?
- Are those selected to implement the interventions competent to do so?
- Is the selection of the subject population fair and equitable?
- How might recruitment and follow-up procedures effect the risk-benefit calculus for this study?
- How will the investigator determine whether the prospective participant is competent to give informed consent or if guardian consent should be sought?
- Does the protocol provide for adequate monitoring of and referral for subjects with adverse reactions to either the treatment or control condition?
- What are potential risks and what procedures are necessary to protect participant confidentiality and privacy?
- If a beneficial effect is demonstrated, does the control group have access to the experimental treatment?
- What forms of dissemination of research results could benefit or stigmatize the population?
M., Krohmal, B., Emanuel, E. Z., Grady, C., & Wendler, D. (2009). Benefits
and burdens of participation in a longitudinal clinical trial. Journal of
Empirical Research on Human Research Ethics, 4(3), 89-97.
R. (2008). Standard of care: An evolution in ethical thinking. The Lancet, 372,
S., & Belsky, L. (2004). The ancillary-care responsibilities of medical
researchers. An ethical framework for thinking about the clinical care that
researchers owe their subjects. Hastings Center Report, 34, 25-33.