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Eurecnet - Archived News
Archived News
2024/06/04
Position of EUREC on compensation of research participants
EUREC acknowledges the ethical challenges associated with compensation for research participants and is pleased to announce its position paper on this topic. The document is intended to help RECs navigate these considerations.
2023/05/30
CIOMS draft report
The CIOMS Working Group (WG) GGPRI (Good Governance Practice for Research Institutions) welcomes public input to the report, or any parts of it. The report can be find here.https://cioms.ch/wp-content/uploads/2023/04/CIOMS_GGPRI_Guidelines_draft-for-comment_12042023.pdf
Only comments on this form will be considered: download here
2023/05/30
CIOMS draft report Good Governance Practice for Research Institutions now open for public consultation
The CIOMS Working Group (WG) GGPRI (Good Governance Practice for Research Institutions) welcomes public input to the report, or any parts of it. The report can be found here.https://cioms.ch/wp-content/uploads/2023/04/CIOMS_GGPRI_Guidelines_draft-for-comment_12042023.pdf
Only comments on this form will be considered: download here
2023/05/30
EUREC is now international member of CIOMS
In May 2023 CIOMS executive committee agreed to approve EUREC for full international membership.https://cioms.ch/
2021/03/22
Position of EUREC on ethics reviews outside biomedical research
EUREC would like to acknowledge the increasing importance of ethics reviews of research projects outside the field of biomedical research, and to encourage policy makers and research institutions to pay more attention to this issue. EUREC, as the representative body of research ethics committees in Europe, is ready to welcome more members from non-medical research ethics committees and to support them in carrying out their tasks.
2020/04/27
Position of EUREC on the Responsibility of Research Ethics Committees during the COVID-19 Pandemic
The COVID-19 pandemic is an enormous and extraordinary challenge for societies, economics, politics, healthcare systems, and in particular, for medical research. The diverse actions to contain the pandemic in Europe and worldwide must include the development and testing of effective drugs and vaccines. This is a particularly urgent matter. However, pharmaceuticals that are to be approved in the future to be used to cure COVID-19 must be as effective and safe as possible. Therefore, the European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published “Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic” (https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf) for sponsors on how to manage the conduct of clinical trials in this particular context and how to address questions of safety, risk assessment and informed consent.
This recent mode in medical research also leads to a tremendous challenge for European Research Ethics Committees (RECs). RECs are aware that they must contribute accordingly. This contribution is based, in particular, on the fact that the administrative processes for reviewing research protocols must be accelerated and simplified if these protocols are related to the treatment, prevention or diagnosis of infections caused by SARS-CoV-2. However, all this must be guided by the principle that RECs even under these specific circumstances will not compromise the quality of the review; an accelerated procedure cannot be at the expense of safety, notably that of the research participants. The recognised ethical principles of autonomy, beneficence, non-maleficence and justice must always be respected.
In particular, the following rules should be applied:
- RECs should give clear priority to the assessment of submitted studies that are linked to the prevention or treatment of COVID-19 and COVID-19 related illnesses. The assessment of trials on other serious diseases with no satisfactory treatment option should also be prioritised.
- The free and informed consent procedure must remain in accordance with European and national regulations. It is recognised that national regulations and their application may differ across Europe. The proposals in section 8 of the above mentioned European “Guidance” on how to deal adequately and in a simplified manner with informed consent under the conditions of COVID-19 should be taken into account by the European RECs.
- In the current pandemic situation, the traditional meetings of ethics committees cannot necessarily be organised in the usual, often face-to-face, manner. The RECs should therefore adopt new working methods, such as secure video conferencing, that are appropriate to the current situation, and respect the new rules of conduct concerning the pandemic. Where necessary, provision should be made accordingly for changes to the rules of procedure.
- It should be possible for RECs to hold extraordinary meetings outside the regular cycle to discuss research protocols relating to the treatment, prevention or diagnosis of infections caused by SARS-CoV-2.
- Responsible RECs must be composed of experts with the appropriate expertise. With regard to the assessment of trials concerning COVID-19, relevant experience and expertise must also be ensured within the REC.
- Digital communication technologies can speed up administrative procedures. However, the information and communication technology used must be designed in such a way that GDPR-compliant transmission of data is guaranteed.
- In the course of the study, the recording of undesired events and effects and their forwarding and evaluation must also be guaranteed by the investigator. The responsible REC must also be involved accordingly in pending decisions and modifications, e.g. of the protocol in the event of subsequent changes. It is advisable to document all deviations from the inspection plan that are attributable to the pandemic situation. All participants, including the RECs, should be informed, without delay, of any changes that are relevant to them during the course of the clinical trial. Where appropriate, a new informed consent may be required.
The overarching mission of all ethics committees is the protection of the dignity, rights, safety and well-being of research participants, namely patients and healthy volunteers, in medical trials. This also applies against the background of the current pandemic situation. Therefore, the pressure currently being exerted on medical research must not lead to research or testing of pharmaceuticals on humans without complying with the ethical standards applicable to medical research.
Adopted by the EUREC Board on 27 April 2020.
2019/02/04
Extension of involvement in ethical issues in paediatric research: EUREC supports the Pan-European Clinical Trial Network c4c (connect for children)
In addition to its engagement in Enpr-EMA, EUREC is now also involved as third party in the large collaborative European network c4c (connect for children) to extend the important focus on ethical issues in paediatric research. c4c aims to facilitate the development of new drugs and other therapies for the entire paediatric population.It brings together pharmaceutical companies, paediatric national networks as well as EU multinational sub-specialty networks, large patient advocacy groups, children’s hospitals and other public research organisations from across Europe. The project consortium is a novel collaboration between academic and private sectors that includes 33 academic and 10 industry partners from 20 European countries, as well as more than 50 third parties and around 500 affiliated partners. https://conect4children.org/2017/02/16
New collaboration to focus on ethical issues in paediatric research
Issues relevant to research and clinical trials in children are a very challenging field of research ethics. The balance between potential benefit and the protection of children as participants in clinical trials needs a sensitive approach. EUREC and the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will explore ways of collaboration to discuss those emerging issues. Enpr-EMA is a network of research networks, investigators and centres with recognised expertise in performing clinical trials in the paediatric population. EUREC, together with Enpr-EMA, wants to promote the dialogue between ethics committees and paediatric research, across Europe.
2016/01/29
European Network of Research Ethics Committees (EUREC) Inc. Comments on the INTEGRATED ADDENDUM TO ICH E6(R2): GUIDELINE FOR GOOD CLINICAL PRACTICE
The draft of the document touches some points that are fundamental in the view of EUREC.
1. Ethical principles of medical researchLine 8: „.......consistent with the principles that have their origin in the Declaration of Helsinki,...”
The origin of the ethical principles of medical research does not lie in the “Declaration of Helsinki,” which is already a composition of principles resulting from earlier philosophical considerations and experiences in jurisdiction of 19th century. In the view of EUREC here as in all other places of the document addressing the Declaration of Helsinki the more appropriate wording could be: “……consistent with the principles included in the Declaration of Helsinki,......“.
Lines 386 and 686 (and in other locations): The RECs are entrusted to inspect whether clinical trials are in compliance with the relevant protection provisions. Clinical trials affect fundamental rights of the human participants. Their protection is a first obligation of States. States of course are free to charge RECs with this protection. Thus, RECs should be entitled by national law to perform such inspections. This could be clarified in the text by adding in the appropriate place “in conformity with national law”. Alternatively, the approval of an authority could be required in conformity with national law.
An addition for clarification: Any waiver of consent by a REC needs a legal authorization by the State in which the REC is working.
The requirements for emergency research are only broadly formulated. An exact catalogue of the requirements and prescriptions for the procedure in emergency research – including approval by an authority, assessment by a REC – is given in Article 19 of the
„ADDITIONAL PROTOCOL TO THE CONVENTION ON HUMAN RIGHTS AND BIOMEDICINE CONCERNING BIOMEDICAL RESEARCH“, (Council of Europe Treaty Series - No. 195).
The sponsor shall prompt the review. It remains unclear, though, which institution conducts it. An independent institution would make sense, like, for example, a Data and Safety Monitoring Board (DSMB) with corresponding experts.
The E6(R2) Addendum is available for download on the Efficacy Guideline page.2014/11/13
Third EUREC Statement to comment on the functional specifications for the EU portal and EU database to ensure effective review of clinical trials by independent Research Ethics Committees
The newly adopted EU Clinical Trials Regulation (EU) No 536/2014 will come into force within two years. Among other novelties, this regulation imposes strict and tight deadlines to RECs to evaluate the ethical acceptability of a trial assuring that the dignity, rights and welfare of the participants are properly guaranteed. During the EUREC General Meeting in Paris in November 2014, the members jointly formulated a request to guarantee Ethics Committees full and direct access to the application and data-base through the EU portal, from the time an application for a clinical trial is submitted.
Full text:
EUREC Statement Paris - November 2014 (PDF)
2013/09/12
Second EUREC Statement on a Proposal for a Regulation on Clinical Trials
During the EUREC General Meeting in Lisbon in June 2013, the members reacted with a second statement to the revised draft and the amendments of the First Reading of the European Parliament (EP) to the "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC".
2013/02/25
Call for Abstracts
Research Ethics: Current Challenges in Preclinical, Clinical and Public Health Research
An international conference for young scholars
August 26-30, 2013 at Hannover Medical School, Germany
Deadline for Abstracts: April 15, 2013
The German Ministry of Education and Research (BMBF) sponsors a five-day interdisciplinary conference that takes up innovative and practice-oriented questions of all fields of research ethics from 15 young scholars (PhD-students and post-docs). The conference includes four meet-the-expert workshops (see below).
Participants are paid all travel and accommodation costs and an additional expense allowance of 300 € for preparing a manuscript until January 31, 2014 that shall be published in an anthology or supplement of a notable publisher or journal edited by the conference organizers.
All participants give an oral presentation (30 min) of their research findings, which will then be discussed in a plenary session (30 min). The conference language is English. The topics of the participants' contributions should be classifiable as (i) descriptive/empirical analyses of ethical challenges in current preclinical/clinical/public health research, or (ii) normative analyses of specific cases and problem areas in preclinical/clinical/public health research, or (iii) analyses of foundational concepts of research ethics.
The conference is open to scholars (i) from the fields of biomedicine, clinical research, nursing science, public health and other disciplines directly involved in these fields of research, and (ii) from the fields of biomedical ethics, philosophy, law, social sciences and other disciplines involved in research about ethical, legal and social issues concerning preclinical/clinical/public health research.
2013/01/29
EUREC Statement on a Proposal for a Regulation on Clinical Trials
During the EUREC General Meeting in Oslo in September 2012, the members formulated unanimously comments on the: "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC".
The Research Ethics Committees in Europe appreciate that the Commission acknowledges the importance of an ethical assessment of clinical trials, which proved to be both, important and effective regarding the protection of research participants in the past and which is today a standard accepted world-wide. Equally EUREC appreciates that, at the same time, the Commission has to respect the different cultural traditions, particularly in relation to ethics, within the Member States and therefore as a matter of subsidiarity has a limited possibility for harmonizing the whole governance of clinical trials at the EU level. However, EUREC misses in the proposal a framework of conditions and structural provisions for ethics in research which has been established not only by the current Directive but also in international conventions and guidelines. Since Research Ethics Committees are world-wide accepted bodies which should assess all biomedical research EUREC believes that the choice of the Commission to undo the positive steps established through the current Directive by omitting the clear position of Research Ethics Committees in the process is not acceptable.
2013/01/23
EGE Statement on a Proposal for a Regulation on Clinical Trials
The European Group on Ethics in Science and New Technologies (EGE) also drew up a statement on the Proposal. EGE is an independent, pluralist and multidisciplinary body advising the European Commission on ethics in science and new technologies in connection with Community legislation or policies. The EGE members serve in a personal capacity and are asked to offer independent advice to the Commission. They have been appointed on the basis of their expertise and a geographical distribution that reflects the diversity in the European Union. For every full Opinion to be issued by the Group, a roundtable is held before the Opinion is adopted, to which representatives of the Institutions of the European Union, experts of the fields, parties representing different interests, including NGOs, patients and consumer organisations and industrial stakeholders, are invited to participate in the debate.
http://ec.europa.eu/bepa/european-group-ethics/publications/opinions/index_en.htm
Full text: EGE Statement (PDF)
2008/12/03
EUREC meeting
On June 25th 2008, the latest EUREC meeting took place at the Conference Center Hotel Aquino in Berlin. The main objective of the meeting was to welcome the representatives of future member states and to introduce them to the EUREC project. Apart from the ten current EUREC partners in the meeting took part Kieran Ryan from Ireland, Gisela Dahlquist from Sweden, Antonio Faria Vaz from Portugal, Peter Rehak from Austria, Niklaus Tuller from Switzerland, Francesca Venturini from Italy and Elmar Doppelfeld from Germany. As representative of the EC Lino Paula was present at the meeting.
2008/05/15
Training events
During 2008 and 2009 training courses and workshops on research ethics will regularly be offered by the NRES (National Research Ethics Service) in Great Britain. Whereas some of the events are only for NRES members, others are open to the public. Please find places and dates of the events via the link to NRES and the list stated below.
NRES Training Schedule 2008-2009 (PDF)
NRES Events (External Link)
2008/03/06
New UNESCO Publication on Bioethics Has Been Just Published
The Social and Human Sciences Sector presents a new publication on bioethics – the book “Ethical Review of Biomedical Research in the CIS Countries (Social and Cultural Aspects)”.
2007/12/03
Eurec Newsletter
Beginning in spring 2008 the Eurec Newsletter appears half-yearly, providing current information about Eurec, upcoming events, and new literature.
Subscribe now2007/10/09
EMEA (European Medicines Agency)
Conference: Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future - A joint conference of the European Commission and the European Medicines Agency.
3rd of October 2007, London
The conference provided an overview of the experience to date with the operation of Directives 2001/20/EC and 2005/28/EC and their implementing texts, and to describe problems encountered and offer recommendations for the future.
- Program
- Post conference reporting
- EMEA - Conference - Report
- Contribution of EUREC:
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