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Overall the opt-out method was well received and participation in the study reached 85.5%.
The opt-out method of parental consent has been found to be ethically acceptable [ 39].
Two patients expressed concerns regarding the use of the opt-out method.
The opt-out method of parental consent has been found to be ethically acceptable.
Although the opt-out method improves recruitment, the ethical committee often does not approve this method because repeated contact is too burdensome for participants [ 37, 38].
Overall the opt-out method was well received by both general practitioner and patients and achieved a high level of participation in the study at 83.4%.
As the observation of working practices could involve interactions between individuals across the organisation, an opt-out method of general consent will be gained for these evaluation activities.
However, such response rates are expected in pediatric end of life studies utilizing the opt-in method of recruitment as opposed to the opt-out method [ 32].
The high level of participation of patients due to the opt-out method of recruitment ensures the reliability of the study results.
Ethical permission was obtained from the Local Ethics Committee at Lund University (Dnr 613/02), whereby informed consent was deemed not to be required other than by the opt-out method.
Approval was obtained from the Ethics committee at the Lund University (cohort I, ref no. 447 07), whereby informed consent was deemed not to be required other than by the opt-out method.
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