Regulation of Medical Emergency Research legal policy and medical practice

This thesis focuses on the medical practice and legal regulation of medical scientific research with humans in medical emergency situations

Informatieproblemen oplossen: een digitale en leerzame toets

In dit verslag wordt een advies gegeven over de bruikbaarheid van een Amerikaanse toets informatievaardigheden voor het Nederlands Hoger onderwijs. Deze toets is geëvalueerd binnen het DU-project Instrumentatie van Onderwijs in Kenniscompetenties (IOK). In de eerste fase van het project is gebleken dat deze toets deels bruikbaar lijkt binnen de Nederlandse onderwijscontext. In de tweede fase van het project is een selectie van de items vertaald en aangepast aan de Nederlandse context. De op basis hiervan ontwikkelde toets is afgenomen bij tweehonderd studenten in het hoger beroepsonderwijs en wetenschappelijk onderwijs. Uit de resultaten blijkt dat de toets in te zetten is als een diagnostisch meetinstrument. Daarbij blijken studenten door het gebruik van het instrument bewuster te worden van hun eigen (on) bekwaamheid op het gebied van informatievaardigheden. De studenten zijn met name positief over de in het instrument geïntegreerde feedback. Op basis van de reacties van studenten en inhoudsdeskundigen blijkt wel dat de toets nog voor verbetering vatbaar is

Ethical Issues in Research and Development of Epigenome-wide Technologies

To date, few scholarly discussions on ethical implications of epigenetics and epigenomics technologies have focused on the current phase of research and development, in which researchers are confronted with real and practical ethical dilemmas. In this article, a responsible research and innovation approach, using interviews and an expert meeting, is applied to a case of epigenomic test development for cervical cancer screening. This article provides an overview of ethical issues presently facing epigenomics researchers and test developers, and discusses 3 sets of issues in depth: (1) informed consent; (2) communication with donors and/or research participants, and (3) privacy and publication of data and research results. Although these issues are familiar to research ethics, some aspects are new and most require reinterpretation in the context of epigenomics technologies

Microbial solar cells: applying photosynthetic and electrochemically active organisms

Microbial solar cells (MSCs) are recently developed technologies utilizing solar energy to produce electricity or chemicals. MSCs use photoautotrophic microorganisms or higher plants to harvest solar energy, and use electrochemically active microorganisms in the bioelectrochemical system to generate electrical current. Here, we review the principles and performance of various MSCs, in an effort to identify the most promising systems as well as the bottlenecks and potential solutions towards „real life. MSC application. We give an outlook on future applications based on the intrinsic advantages of MSCs, showcasing specifically how these living energy systems can facilitate the development of an electricity-producing green roof.This is a "Post-Print" accepted manuscript, which has been published in "Trends in Biotechnology". This version is distributed under the Creative Commons Attribution 3.0 Netherlands License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Please cite this publication as follows: 2011 Trends in Biotechnology Microbial solar cells: applying photosynthetic and electrochemically active organisms. David P.B.T.B. Strik, Ruud A. Timmers, Marjolein Helder, Kirsten J.J. Steinbusch, Hubertus V.M. Hamelers, , Cees J.N. Buisman. Trends in Biotechnology 29 (1), 41-49 You can download the published version at: http://dx.doi.org/10.1016/j.tibtech.2010.10.00

Informed consent procedures in patients with an acute inability to provide informed consent : Policy and practice in the CENTER-TBI study

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 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.Peer reviewe

How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

BackgroundThe European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency.MethodsWe reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe.ResultsFrom 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75–224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074).ConclusionWe found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.</p