When assessing the risks of a research protocol, review boards need to consider not only the possible harms but also the expected discomfort levels caused by the various study procedures. However, data on how children experience various study procedures are scarce. This study assessed perceived discomfort levels in 671 healthy children aged 0-2 years undergoing vaccinations, venipunctures, and nasopharyngeal swab taking. In half of the study participants, venipunctures caused a moderate or high level of discomfort (49%). Corresponding figures for nasopharyngeal swabbing and vaccinations were 28% and 12%, respectively. Within the reported age group, increasing age was related with higher discomfort levels. In a majority of cases for all study procedures, the perceived levels of discomfort met the parents' expectations.

Children, Ethics, Research subjects, Review board, Risk assessment, Vaccines
dx.doi.org/10.1525/jer.2013.8.3.66, hdl.handle.net/1765/64529
Journal of Empirical Research on Human Research Ethics
Department of Medical Ethics and Philosophy of Medicine

Westra, A.E, van Gils, E.J.M, Aarts, F, Rodenburg, G.D, Veenhoven, R.H, Hak, E, … Sanders, E.A. (2013). Perceived discomfort levels in healthy children participating in vaccine research. Journal of Empirical Research on Human Research Ethics, 8(3), 66–72. doi:10.1525/jer.2013.8.3.66