Child and parent reactions to participation in clinical research

Background: Psychological and psychiatric research studies in medical settings often enroll children who are ill, injured, coping with pain or undergoing stressful medical procedures. Yet empirical evidence to date regarding the effects of research on these participants is scarce. This study assessed reactions of injured children and their parents to research participation and examined associations with demographic, injury and acute stress variables. Methods: Administered standard research reactions questionnaires to 203 injured children (5-17) and 200 parents participating in a study of acute posttraumatic stress. Results: Fifty-two percent of children and 74% of parents were glad they had participated; 77% of children and 90% of parents felt good about helping others. Self-reported distress from study participation was uncommon (5% of children and parents). Child age was associated with more positive appraisals of the research process and with greater trust in and information about elements of informed consent. Conclusions: Participation in a research interview following traumatic injury had little risk of generating distress for children or parents. The most commonly reported positive aspect of research participation was feeling good about helping others. This study supports the feasibility of incorporating standardized assessment of participant reactions in clinical research protocols. (C) 2005 Elsevier Inc. All rights reserved.