Outcomes research conducted soon after traumatic injury may raise concerns about potential risks and benefits to participants. Empirical examination of children's subjective experience of research participation can provide useful guidance to researchers and Institutional Review Boards (IRBs). This study examined children's and parents' assessment of potentially positive and negative effects of the research process, and their understanding of (and trust in) information imparted in the informed consent process.
In a prospective investigation of posttraumatic stress after injury, children (ages 5-17) and parents were enrolled during the child's acute hospital admission. After private interviews regarding the injury event and stress symptoms, each child and parent was asked about reactions to study participation utilizing the Response to Research Participation Questionnaire for Children (RRPQ-C) or the RRPQ-P for parents.
Children's (N=96) and parents' (N=104) assessment of the research process was overwhelmingly positive. Negative reactions to study participation were rare. However, the few children and parents who reported feeling "upset or sad" during participation had a higher mean severity of acute stress symptoms. Parents' answers indicated understanding and trust for most aspects of informed consent process; there was greater variability among children's responses. Older children were more likely to believe they had a choice regarding participation.
Without empirical evidence, investigators and IRBs may: 1) overestimate risks and fail to conduct studies beneficial to traumatized populations; or 2) underestimate risks and fail to adequately protect research participants. The development of the RRPQ-C and RRPQ-P allows for systematic assessment of reactions to research.
Learning Objectives: Following this presentation, participants will be able to: 1) Discuss ethical issues regarding child participation in traumatic injury research; 2) Describe research findings concerning children's and parents' views of participating in an injury research study.
Keywords: Public Health Research, Injury
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
Disclosure not received
Relationship: Not Received.