Strong Interest in DZL Webinar on Ethics Consultation “One Study – One Vote”

The new ‘One Study – One Vote’ procedure aims to simplify and standardise the ethical review of medical research projects in Germany. One year after its introduction, a webinar organised as part of the DZL initiative ‘DZL Ethic@Lunch’ reviewed the progress: What experiences have been gained so far, and what can still be improved? More than 160 people from the biomedical research community were interested in these questions.

The event, organised by Dr. Gesine Richter (Christian Albrechts University of Kiel, ARCN) and PD Dr. Karoline I. Gaede (Research Center Borstel, ARCN) from the Biobanking & Data Management Platform of the German Center for Lung Research (DZL), began with presentations by two high-profile speakers: the chair of the Working Group of Medical Ethics Committees in Germany (AKEK), Prof. Dr. Georg Schmidt from the Technical University of Munich, and Dr. Inga Kaufhold from the Office of the Ethics Committee at the University of Lübeck, also a member of the AKEK.

Ethical approval is mandatory for studies involving human test subjects and patients

Based at universities and medical associations, ethics committees advise researchers on project design. This applies to studies involving humans or human biological samples, such as blood or urine. Research involving clinical data is also covered. Doctors are obliged to acquire this ethical and legal advice in accordance with their professional code of conduct; they must obtain an ethics vote. The landscape of ethics committees in Germany is fragmented and highly federal in nature. This poses major challenges, especially when several partners from different institutions with different ethics committees collaborate on a study.

Old procedure delayed start of clinical studies

Previously, the lead partner in the project would obtain an ethics vote from their responsible ethics committee. The other partners would then have to do the same with their local ethics committees. Although they could rely on the lead partner’s ethical vote, they often had to submit additional documents or documents in a different format due to local regulations. Given the possibility of further rounds of corrections, this process could take months. For a long time, this process was also carried out on paper and by post. ‘The bureaucratic effort was enormous and, in extreme cases, could lead to months of delays in conducting clinical trials in Germany,’ comments Karoline Gaede.

Introduction of a standardised procedure long overdue

Researchers and ethics committee members discussed ways to simplify the procedure at length. Georg Schmidt presented the outcome of this process in the webinar’s opening presentation: On June 15, 2024, the German Medical Association (BÄK) and AKEK decided to introduce the “One study – One vote” procedure, thereby standardizing professional legal advice on research projects nationwide. Under this procedure, only the lead partner needs to obtain a vote from their ethics committee. All other partners then submit this vote and other standardised documents to their ethics committees. There is no second, third or fourth vote. Additionally, documents agreed upon by the German ethics committees are transmitted electronically in the meantime.

How has the procedure worked in practice so far?

One year after its introduction, Inga Kaufhold of the Lübeck Ethics Commission reports that 81% of German ethics commissions have now established the legal framework for implementing the new regulations. She also explains how studies started under the previous regulations are being handled. The principle of ‘One Study – One Vote’ also applies to amendments to studies that received their initial approval before June 2024. Wherever legally possible at a local level, transition to the new procedure will take place immediately . The committee responsible for advising on the amendment will also check that the AKEK’s standardised documents have been followed and reprimand any deficiencies.

Webinar participants’ experiences contribute to the discussion

Following the presentations, a lively discussion ensued among the 160-plus participants. ‘We have clearly struck a chord with this topic,’ said Karoline Gaede. The webinar was joined by numerous individuals from various research networks, including the German Centers for Health Research (DZG), biobank networks, the Medical Informatics Initiative, and the Centers for Clinical Studies (ZKS).

‘In order to generate lasting benefits, the questions from the webinar will be collected and forwarded to the AKEK,’ Gesine Richter added. ‘Based on this, an FAQ collection could be set up to answer any questions applicants may have before submitting their own ethics application,’ Richter suggests. If ethics committees and applicants were better informed, ‘One study – One vote’ could realise its full potential and enable studies to be implemented with less bureaucracy.

Further questions related to ‘One Study – One Vote’ can be sent to the DZL initiative ‘DZL Ethic@Lunch’ via ethik@dzl.de.

 

/jbul/Gesine Richter/Karoline Gaede

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