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 (TBI) 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.

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.

BACKGROUND: The 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. METHODS: We 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. RESULTS: From 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). CONCLUSION: We 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.

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. With this article, we aim to start a discussion of the practical ethical issues rising in research and development of epigenomic technologies and to offer guidance for researchers working in the field of epigenetic and epigenomic technology.

[Is medical scientific research allowed in emergency situations without prior consent from the patient?] / Medisch-wetenschappelijk onderzoek in spoedeisende situaties.

Is medical scientific research allowed in emergency situations without prior consent from the patient? Obtaining consent for conducting scientific research before carrying out an experimental medical treatment is not always possible in emergency situations. We discuss features that can be used to determine whether research can be conducted using the concept of deferred consent.

Will the Eu Data Protection Regulation 2016/679 Inhibit Critical Care Research?

There is an inherent tension between critical care research and data protection. Because of their condition it is not possible to ask for the patients' informed consent to be enrolled in observational research at the point of admission to the hospital. Often this is not possible at a later moment either. Yet informed consent is the baseline to be enrolled in research with personal data and exceptions must be allowed for by national legislation. This was the case under Directive 95/96/EC and will be the case under the General Data Protection Regulation (GDPR, Regulation 2016/679 EU) which will replace the Directive from 25 May 2018 onwards. Though being a Regulation and therefore directly applicable in the Member States, the long debate about the research exceptions in the GDPR left many aspects of observational research including the exception to the informed consent principle, mainly to the Member States. It may be assumed that most Member States will leave their present state of the law intact in this respect as that was part of the political compromise. We compared existing national privacy legislation from the perspective of critical care research and found great variation. Although this may not impede the collection of emergency and critical care research with data without prior informed consent in countries which are more responsive to such research, it might be a challenge to exchange such data from the national nodes in European wide research collaboration. We make a case that countries which are not responsive to such research should adapt their legislation in the interests of future critical care patients.