48 - Ethics in Human Subject Research in Brazil

Summary

This chapter focuses on the relationship between ethics committees and researchers, which is not always characterized by a spirit of collaboration. Research groups that consider sensitive topics, such as sexual violence against children and adolescents (which is the focus of our research group), often encounter critical issues that ethics committees lack the appropriate training to evaluate. Sexual violence against children and adolescents is a severe public health problem.

In 2006, the World Health Organization (WHO) and the International Society for Prevention of Child Abuse and Neglect (ISPCAN) published guidelines for the psychological assistance of victims: (1) the interventions should be structured; (2) the results should be replicable and liable to measurement and assessment; (3) the cost-efficacy results should improve over time; and (4) the interventions should apply to different contexts. In addition, the guidelines recommend that the psychotherapy approach exhibit evidence of effectiveness, such as with the use of empirical studies. The interventions should relate to the technical skills of the assisting professionals and consider the patients’ individual and cultural characteristics and preferences (American Psychological Association Presidential Task Force on Evidence-Based Practice, 2006). Based on these guidelines and recommendations, we submitted to an ethics committee a proposal to assess the effectiveness (pre- and post-test design) of a cognitive behavioral intervention for girls who have been subjected to sexual violence. The study design included the application of a structured interview, based on the DSM-IV (American Psychiatric Association, 2000), to assess the symptoms of posttraumatic stress disorder (PTSD), which are common among victimized children. The ethics committee returned the proposal for revisions several times over six months. With each revision, the committee questioned a different item of the interview script. The committee eventually suggested that the entire interview be excluded, as there was concern that the process would “revictimize” the girls by provoking memories of the violence. That opinion dismissed the theoretical grounds of the project and revealed a lack of familiarity with the DSM-IV diagnostic criteria for PTSD. The opinion also displayed ignorance of the fact that diagnosis is crucial for planning appropriate interventions, which, in the proposed project, would be performed by the same team of investigators.