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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 research

Line 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,......“.

2.    Protection of fundamental rights

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.

3.    4.8.15: Emergency Situations   

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).

4.    5.06: Risk Review

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".

Full text:
Comments based on the revised draft and the amendments of the First Reading of the European Parliament, formulated by the EUREC in June 2013

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.

Full text:
Comments formulated by EUREC in September 2012

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)


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