The reactions to research participation questionnaires for children and for parents (RRPQ-C and RRPQ-P).

Systematic assessment of the effect of clinical research studies on child and parent participants has been limited. Such assessment could provide an empirical basis for the ethical conduct of research, assisting investigators and institutional review boards in balancing the need for sound research with the need to protect study participants. The Reactions to Research Participation Questionnaire for Children (RRPQ-C) and the RRPQ for Parents (RRPQ-P) are brief measures designed to assess child or parent views of clinical research studies. Both measures were piloted and then administered as part of an interview-based study of traumatically injured children and their parents, to assess their psychometric properties and potential usefulness as addenda to future study protocols. The RRPQ-C and RRPQ-P each demonstrated acceptable internal consistency. Exploratory factor analyses provided general support for their conceptual basis. Both were easily administered and well-accepted by respondents. There is evidence that children and adults were willing to answer honestly, even about negative responses. Brief measures such as the RRPQ-C and RRPQ-P may provide a practical and empirically informed method for assessing children's and parents' responses to research participation. Investigators should consider including systematic standardized assessment of participant reactions in child clinical research studies.