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Within the GINIplus framework, children were allocated to either an interventional study arm or an observational study arm, based on parental history of allergic diseases and consent for intervention.
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There is a separate consent for this intervention study, which is also approved by the Regional Committee for Medical Research Ethics.
Ninety seven (97) relatives responded with their consent for participation, intervention (n = 55) and control (n = 42).
Selected children and their parents were approached for a second time to provide written informed consent for the intervention part of the study.
Institutional ethics committee approval was obtained that included a provision for informed patient consent for the intervention (South Metropolitan Area Health Service HREC Reference 08/318 and Royal Perth Hospital HREC Reference 08/009).
The human subjects committee of the Kaiser Foundation Research Institute waived the requirement for individual informed consent for the intervention component, given the pragmatic, cluster randomized design [ 38, 39].
Consent for the intervention was provided at the community level with the option for individuals to opt-out either from receiving treatment or study assessments.
The information which was provided included reminding them about the microbicide study, the empirical study on understanding of procedures, and then requesting their consent for the intervention study.
In terms of the way that information about the study was communicated, parents preferred face-to-face meetings and phone calls when being asked for informed consent for this intervention.
Presence of physical or mental disability of sufficient severity to interfere with the ability to understand and consent for the intervention, as determined by program counselors in consultation with the treating physician, excludes enrollment.
Figure 1 shows that some patients could not be included in the study, for example, because they refused consent for the intervention or because the nurse practitioners advised not to approach him/her for the study because they considered the patient to have too much disease-related stress.
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