Monitoring child and parent refusals to enrol in clinical research protocols

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Abstract
The aim of this paper is to report the rates and reasons for refusal given by 817 eligible participants from 10 completed and ongoing nursing and behavioural medicine studies in paediatric oncology from 1994 to 2004. Eligible participants have the right to accept or decline participation in research studies. Information about rates of refusal and reasons for refusal could be useful in determining participant-perceived burden related to study participation, in accurately estimating the time needed to accrue an adequate number of participants to achieve the study aims, and in interpreting study findings from certain groups of participants. A 13-item survey form about study characteristics was completed prospectively for each study included in this report; categories of reasons for refusal were inductively identified and defined using a semantic content analytic technique. The overall rate of refusal was 23.6% (range: 6.7-46.7%). The studies that involved blood sampling or end-of-life decision-making had the highest refusal rates and an instrumentation study had the lowest. Eligible male participants had consistently higher rates of refusal than did females across the 10 studies. Nine categories of refusal were inductively identified, with the most commonly reported reason being the burden of the research methods. A careful informed consent process will still result in some refusals. The refusal rates reported here can be used to help future researchers more accurately estimate accrual periods for studies involving blood sampling or investigating sensitive topics in paediatric oncology.