EFGCP Acts to Reduce Ethics Problems

April 1, 2012

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-04-01-2012, Volume 21, Issue 4

The EFGCP has organized a meeting next month in Trondheim, Norway, that will focus specifically on complex cases.

Widespread differences still exist in Europe between research ethics committees and investigators/sponsors of research projects, and among research ethical reviews, the European Forum for GCP (EFGCP) has acknowledged. To rectify this situation, the EFGCP has organized a meeting next month in Trondheim, Norway, that will focus specifically on complex cases.

"The workshop will give an opportunity for these difficulties to be freely discussed by the participants who might represent research ethics committees, sponsors, and investigators and will hopefully lead to some conclusions as to how best these difficulties should be addressed or even avoided," noted the organizers.

Trondheim, Norway will host an EFGCP meeting in May. (Source: Medioimages/Photodisc/Getty Images)

Case-based discussions will focus on the use of a placebo group when standard therapy is available, academic clinical trials that have no independent scientific review, and the review of a study testing treatments for infantile spasms.

Also, Hugh Davies, from the National Research Ethics Service (NRES), UK, will present the results of a survey conducted among 24 European research ethics committees that reviewed the same study. On March 16, 2012, the NRES released an updated version of its guidance on the requirements for ethics committee review under the Governance Arrangements for Research Ethics Committees (GAfREC), together with a revised version of the standard operating procedures for ethics committees.

Version 5.1 of the NRES' SOPs for ethics committees came into effect in the United Kingdom on April 1, 2012. The new version takes account of the winding up of the Appointing Authority for Phase I Ethics Committees from January 31, 2012 and the re-constitution of the remaining committees within the NRES. It includes a series of minor changes and clarifications to the SOPs. These SOPs are kept under continuous review in the light of feedback and suggestions from stakeholders, according to the NRES.

For the Trondheim meeting, the importance of developing a better understanding of ethics committees' roles is the central theme of the keynote lecture by Petra Knupfer, from the Landesärztekammer Baden-Württemberg, Germany. The development of ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) GCP will also be addressed.

The organizers hope that research ethics committee members, researchers, and sponsors will all be equally represented.

The University of Norwegian Science and Technology in Trondheim has a proven track record in clinical research, especially in cancer research and molecular medicine, neuroscience, medical imaging, and children's and women's health. It houses the European Palliative Care Research Centre, Fuge Molecular Imaging Centre, Kavli Institute for Neuroscience/Centre for the Biology of Memory, Medical Imaging Laboratory (MI Lab), Nord-Trøndelag Health Study, and the Research Centre for Health Promotion and Resources.

Trondheim is known as the historical capital of Norway, and is situated in the county of Sør-Trøndelag, where the river Nidelven flows into the Trondheim fjord. In spite of its northerly location, the warm Gulf Stream means it enjoys a fairly mild climate in the spring. It is a popular destination for pilgrimages, and the St. Olav Ways to Nidaros (the old name of Trondheim) was awarded certification as a Cultural Route of the Council of Europe in May 2010.

The city was founded by Viking King Olav Tryggvason in 997 BC. It was the nation's first capital, and continues to be the coronation city where many of Norway's Kings have been crowned or blessed. The main features are the Nidaros cathedral, the wide streets, colorful wooden houses, the tall column with the statue of Olav Tryggvason in the middle of the town square, and the old town bridge (Gamle Bybro) with its carved gates.

For further details on the meeting, visit www.efgcp.eu, or contact +322 7328783 or conferences@efgcp.eu

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