Child assent to clinical research participation : how to determine a child's ability to assent

Assent, currently defined as “a child’s affirmative agreement”, is a way in which some children are included in the decision-making process regarding their participation in clinical research. Current guidelines for paediatric research do not provide clear directions for how assent should be handled, resulting in confusion among researchers. The goal of this research project was two-fold: to examine the ethical arguments for assent with a view to developing concrete moral justification for its being required, and to develop a framework of significant issues for an investigator to consider when deciding whether to gain assent from an individual child. After an in-depth analysis, it was determined that the ethical justification for assent arises from the researcher’s dual obligations to the child and his parents. A child’s parents are responsible for determining when and how he will develop his decision-making ability. The researcher has an obligation to engage with the child in a manner that complements their pedagogical style, while also treating the child as a being of moral worth. As a child’s family context has an influence on his participation in medical decision-making, further research on children’s daily decision-making within their families is needed. To this end, a three-phase research agenda was designed: a qualitative focus group study, a quantitative questionnaire study, and a discussion panel with paediatric experts. The children in these studies clearly desired to make decisions but did not express an interest in having complete control. They expected their parents to provide them with decision-making guidance in most aspects of their lives. Data collected from parents illustrated that they often tried to involve their children in decisions by providing them with limited options from which to choose and encouraging family discussion. Participants in the discussion panel stated that they did not expect children to make an independent decision regarding medical care, but they might attempt to give children smaller decisions, such as the arm used to provide a blood sample. These results indicate that the definition of assent should be revised, emphasising the child’s involvement in the overall decision making process, without an expectation of an “affirmative agreement”, likely mimicking a familiar decision-making setting from his family context. This could then be documented in the child’s clinical notes through a brief description of all relevant interactions and/or discussions with the child, resulting in an accurate portrayal of the entire assent process.EThOS - Electronic Theses Online ServiceGBUnited Kingdo