Attitudes in China, Japan, and the Netherlands toward the Use of Animals in Medical Research

Anthrozoös ◽  
2021 ◽  
pp. 1-14
Author(s):  
Bingtao Su ◽  
Chao Zhang ◽  
Pim Martens
Keyword(s):  
The Netherlands ◽  
Medical Research

scholarly journals Study protocol of the BLANKET trial: a cluster randomised controlled trial on the (cost-) effectiveness of a primary care intervention for fear of cancer recurrence in cancer survivors

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032616 ◽  
Author(s):  
Yvonne L Luigjes-Huizer ◽  
Marije L van der Lee ◽  
Niek J de Wit ◽  
Charles W Helsper
Keyword(s):  
Primary Care ◽  
The Netherlands ◽  
Medical Research ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cancer Recurrence ◽  
Fear Of Cancer Recurrence ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Fear Of Cancer

IntroductionMany successfully treated patients with cancer suffer from fear of cancer recurrence (FCR), affecting their quality of life and their physical, emotional, cognitive and social functioning. Effective psychological interventions for FCR exist but are not widely available, as they are typically offered by specialised psycho-oncology professionals and institutes. Concurrently, the role of primary care in cancer and survivorship care is increasing. Therefore, there could be a role for general practitioners (GPs) and mental health workers (MHWs) working in primary care in supporting patients with FCR. In the current study, the effectiveness of a primary care delivered FCR intervention will be evaluated.Methods and analysisA two-armed cluster randomised trial will be conducted. The primary outcome will be FCR severity; secondary outcomes will be FCR-related distress, healthcare uptake and healthcare costs. Primary care practices in the Netherlands will be invited to participate in the study. Participating practices will be stratified by size and socioeconomic status and randomised. In the control arm, practices will provide care as usual. In the intervention arm, practices will offer the cognitive–behavioural FCR intervention that is being studied, which consists of an intake with the GP and five sessions with the MHW. Patients who have finished successful curative treatment for cancer between 3 months and 10 years ago will be invited to participate in the study by invitation letter from their GPs. Participating patients will fill out questionnaires at baseline, after 3 months and after 12 months. Data on healthcare use will be collected from their electronic health records. Qualitative interviews are held at T1 with patients and practitioners in the intervention group.Ethics and disseminationThe Medical Research Ethics Committee (METC) Utrecht has reviewed the study in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO) and other applicable Dutch and European regulations. Based on the requirements of the WMO, the METC Utrecht has issued an approval of the above-mentioned study. Any protocol amendments will be communicated to all relevant parties. Written consent is obtained from study participants. Results will be dispersed through peer-reviewed publications and scientific presentations.Trial registration numberNL7573 in the Netherlands Trial Register on 25-02-2019.

scholarly journals Ethical review of COVID-19 research in the Netherlands; a mixed-method evaluation among medical research ethics committees and investigators

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0255040
Author(s):  
R. IJkema ◽  
M. J. P. A. Janssens ◽  
J. A. M. van der Post ◽  
C. M. Licht
Keyword(s):  
The Netherlands ◽  
Medical Research ◽  
Research Ethics ◽  
Mixed Method ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Registration System ◽  
Medical Research Ethics

Background During the beginning of the COVID-19 pandemic there was an urgent need for accelerated review of COVID-19 research by Medical Research Ethics Committees (MRECs). In the Netherlands this led to the implementation of so-called ‘fast-track-review-procedures’ (FTRPs) to enable a swift start of urgent and relevant research. The objective of this study is to evaluate FTRPs of MRECs in the Netherlands during the COVID-19 pandemic and to compare them with the regular review procedures (RRPs). Methods and findings An explanatory sequential mixed method study was conducted. Online questionnaires and four group interviews were conducted among MREC representatives and investigators of COVID-19 research. In addition, data from a national research registration system was requested. Main outcome measures are differences in timelines, quality of the review and satisfaction between FTRPs and RRPs. The total number of review days was shorter in FTRP (median 10.5) compared to RRPs (median 98.0). Review days attributable to the MRECs also declined in FTRPs (median 8.0 versus 50.0). This shortening can be explained by installing ad hoc (sub)committees, full priority given to COVID-19 research, regular research put on hold, online review meetings and administrative leniency. The shorter timelines did not affect the perceived quality of the review and ethical and legal aspects were not weighted differently. Both MREC representatives and investigators were generally satisfied with the review of COVID-19 research. Weaknesses identified were the lack of overview of COVID-19 research and central collaboration and coordination, the delay of review of regular research, and limited reachability of secretariats. Conclusions This study shows that accelerated review is feasible during emergency situations. We did not find evidence that review quality was compromised and both investigators and MRECs were content with the FTRP. To improve future medical ethical review during pandemic situations and beyond, distinguishing main and side issues, working digitally, and (inter)national collaboration and coordination are important.

scholarly journals Development of a casemix classification to predict costs of home care in the Netherlands: a study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e035683
Author(s):  
Arianne Mathilda Josephus Elissen ◽  
Gertjan Sebastiaan Verhoeven ◽  
Maud Hortense de Korte ◽  
Anne Odilia Emile van den Bulck ◽  
Silke Friederike Metzelthin ◽  
...  
Keyword(s):  
The Netherlands ◽  
Home Care ◽  
Medical Research ◽  
Study Protocol ◽  
Quantitative Methods ◽  
Short Form ◽  
Regression Tree ◽  
Classification Systems ◽  
Relative Wage ◽  
Care Providers

IntroductionCompared with fee-for-service systems, prospective payment based on casemix classification is thought to promote more efficient, needs-based care provision. We aim to develop a casemix classification to predict the costs of home care in the Netherlands.Methods and analysisThe research is designed as a multicentre, cross-sectional cohort study using quantitative methods to identify the relative cost predictors of home care and combine these into a casemix classification, based on individual episodes of care. The dependent variable in the analyses is the cost of home care utilisation, which is operationalised through various measures of formal and informal care, weighted by the relative wage rates of staff categories. As independent variables, we will use data from a recently developed Casemix Short-Form questionnaire, combined with client information from participating home care providers’ (nursing) classification systems and data on demographics and care category (ie, a classification mandated by health insurers). Cost predictors are identified using random forest variable importance measures, and then used to build regression tree models. The casemix classification will consist of the leaves of the (pruned) regression tree. Internal validation is addressed by using cross-validation at various stages of the modelling pathways. The Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis statement was used to prepare this study protocol.Ethics and disseminationThe study was classified by an accredited Medical Research Ethics Committee as not subject to the Dutch Medical Research Involving Human Subjects Act. Findings are expected in 2020 and will serve as input for the development of a new payment system for home care in the Netherlands, to be implemented at the discretion of the Dutch Ministry of Health, Welfare and Sports. The results will also be published in peer-reviewed publications and policy briefs, and presented at (inter)national conferences.

Legislation and Review of Medical Research with Minors in The Netherlands

2008 ◽  
Vol 15 (2) ◽  
pp. 145-151 ◽  
Author(s):  
Keyword(s):  
Clinical Trial ◽  
The Netherlands ◽  
Medical Research ◽  
Human Subjects ◽  
Clinical Trial Directive ◽  
Eu Directive ◽  
Therapeutic Research ◽  
The Eu

AbstractIn The Netherlands medical research with minors is regulated in the Medical Research Involving Human Subjects Act. During the legislation process in the Houses of Parliament in the 1990s the issue of non-therapeutic research with minors and incapacitated subjects was heavily debated. Stringent regulations were formulated for this type of research and the Act became operational in December 1999. In order to implement the Clinical Trial Directive 2001/20/EG, the Act was modified on several issues. However, the Act was not modified on the issue of non-therapeutic research with minors and incapacitated subjects. As a result at present the Dutch law is more restrictive on non-therapeutic research with minors than the EU Directive. Currently, discussion is ongoing to adapt the Dutch law in order to harmonize it with the EU Directive.

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