Binnen de Nederlandse jeugdhulpverlening komt het voor dat ouders door hulpverleners onder druk worden gezet om ‘vrijwillig’ mee te werken aan hulpverlening, en soms zelfs aan een uithuisplaatsing... Show moreBinnen de Nederlandse jeugdhulpverlening komt het voor dat ouders door hulpverleners onder druk worden gezet om ‘vrijwillig’ mee te werken aan hulpverlening, en soms zelfs aan een uithuisplaatsing van hun kind. Dit wordt in de praktijk ‘drang’ genoemd. Waar het vrijwillige en gedwongen kader van jeugdhulpverlening duidelijk bij wet zijn geregeld, ontbreekt voor het drangkader een wettelijke grondslag. Vanuit verschillende hoeken wordthier kritiek op geuit, omdat dit leidt tot grote onduidelijkheden ten aanzien van de rechtsbescherming en verantwoordelijkheden van betrokkenen.In dit boek worden fundamentele uitgangspunten geformuleerd die gelet op de rechtshistorie en het internationale mensen- en kinderrechtenkader aan het jeugdhulpverleningsstelsel ten grondslag (behoren te) liggen. Vervolgens wordt diepgaand inzicht gegeven in het drangkader, de positie van dit kader binnen het jeugdhulpverleningsstelsel en wat dit betekent voor de rechtsbescherming en verantwoordelijkheden van betrokkenen in de praktijk. Tot slot bevat het boek aanbevelingen ter versterking van de rechten van jeugdigen en ouders die te maken krijgen met jeugdhulp op het snijvlak van het vrijwillige en gedwongen kader. Hiermee is dit boek waardevol voor beleidsmakers en professionals die werkzaam zijn in de praktijk van de jeugdhulpverlening, maar ook voor ouders, jeugdigen enoverige betrokkenen. Show less
Even after thousands of years of experience in treating patients with TBI, decisions regarding the optimal treatment strategy remain difficult for both healthcare workers as policy makers. The... Show moreEven after thousands of years of experience in treating patients with TBI, decisions regarding the optimal treatment strategy remain difficult for both healthcare workers as policy makers. The first part of this thesis investigated the challenges of the treatment decision-making process in patients with (severe) TBI by focussing on three factors considered to be important in this process: patient outcome, in-hospital healthcare consumption, and in-hospital costs. The second part investigated the procedural difficulties in TBI research efficiency by focussing on the process of institutional review board approval and the use of informed consent procedures in patients with TBI with an inability to provide informed consent. Finally, we elaborate on the role of patient outcome and in-hospital costs in the acute treatment decision-making process in patients with severe TBI and make suggestions to optimize future research initiatives. Show less
Wijk, R.P.J. van; Dijck, J.T.J.M. van; Timmers, M.; Veen, E. van; Citerio, G.; Lingsma, H.F.; ... ; CENTER-TB1 Investigators 2020
Purpose: Enrolling traumatic brain injury (731) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in... Show morePurpose: Enrolling traumatic brain injury (731) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and practice.Methods: Variation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries.Results: Variation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N 426;20%) and deferred consent (N 334;16%). Deferred consent was only actively used in 15 centres (26%), although it was considered valid in 47 centres (82%).Conclusions: Alternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of different informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers. (C) 2020 Published by Elsevier Inc. Show less
Objectives: European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International... Show moreObjectives: European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International Organizations of Medical Sciences (CIOMS) provisions are met (consent would be impractical or unfeasible, yet the trial would have high social value and pose no or minimal risk to participants). We aimed to identify whether any such trials of medicines were being conducted in Europe.Study Design and Setting: This is a survey of all phase 4 "ongoing" RCTs on the EU clinical trial register between July 1, 2016 and June 30, 2018, to identify those with potentially high levels of pragmatism. Trials that were excluded were as follows: those conducted on rare diseases; conducted on healthy volunteers (except those assessing vaccines); masked (single-, double-blind) trials; single-center trials; those where one could expect to lead patients to prefer one intervention over the other; and miscellaneous reasons. The degree of pragmatism of the RCTs was self-assessed by trials' investigators by means of the PRECIS-2 tool. Investigators of those trials considered to be highly pragmatic assessed the fulfillment of the three CIOMS provisions. Seven patients assessed the social value of the RCTs. Finally, 33 members of 11 research ethics committees (RECs) assessed the social value of the trials and whether they posed no more than minimal risk to participants. Investigators, patients, and REC members assessed the fulfillment of the CIOMS provisions as "yes," "not sure" or "no."Results: Of the 638 phase 4 trials, 420 were RCTs, and 21 of these (5%) were candidates to be pragmatic. Investigators of 15 of these 21 RCTs self-assessed their trial's degree of pragmatism: 14 were highly pragmatic. Of these 14, eight fulfilled the three CIOMS provisions. Assessments by patients and RECs were inconsistent for several trials.Conclusions: We found few low-risk participant-level pragmatic RCTs that could be suitable for modified or waived participants' informed consent. European regulators should consider amending the current regulation and encouraging the conduct of such trials. (C) 2019 Elsevier Inc. All rights reserved. Show less
Muller, P.C.E.H.; Yildiz, B.; Allaart, C.F.; Brinkman, D.M.C.; Rossum, M. van; Suijlekom-Smit, L.W.A. van; ... ; Vries, M.C. de 2018
