German RECs Seek to Simplify NIS Approval

Germany – Professional Advice under Section 15 BO Ärzte: Speeding up the Process for Non-Interventional Studies?

Author: Mark Heinemann, Principal Regulatory Advisor, CHCUK Consulting

German Ethics Committees (ECs) make an important step towards the simplification of the ethical evaluation of Non-Interventional Studies (NIS).

A number of University and State Medical Association Ethics Committees take part in a coordinated evaluation process for multi-centre research projects that require doctors to seek ethical advice under professional law (§15 BO).

A coordinated evaluation procedure, whose aim is to accelerate and simplify of the ethical evaluation, is now available for “research with data collections: that includes drug observation studies (AWB) and non-interventional PASS.

At present, non-interventional studies require individual endorsement decisions from ethics committees formed under Laender-law in Germany. Although the professional law concerns mainly the participating medical doctors, sponsors of commercial NIS will collaborate in practice with the ‘investigators’ and assemble the paperwork required for the prior ethical advice.

With a limited geographical scope of the ECs, the required submissions and approvals increase with the number of participating doctors in the different German regions.

This means for sponsors a costly and time-consuming start-up process following the initial approval from the German coordinating doctor’s EC.

As of this year, 24 German ECs participate in a test-phase for parallel submission and a coordinated evaluation of multi-centric research including non-interventional research. Five of these ECs are located in Germany’s most populated state, Nordrhein-Westfalen.

At the end of the assessment procedure, whose duration is a maximum of 75 days stands a statement from a Central EC based on feedback of locally applicable ECs, but also all individual votes of the local ECs.

To note here that individual EC votes may diverge from the coordinating EC’s vote and that the overall duration of the decision finding process is not legally binding.

The graphic below illustrates the procedure; it is to say that information is still scarce on the websites of the participating Ethics Committees.

Applicants are invited to clearly state their request for a “coordinated evaluation procedure” in their applications. Harmonized application forms or other submission documents do unfortunately not exist.

In the best-case-scenario, the outcome of a coordinated EC evaluation procedure for prospective non-interventional studies is indeed an accelerated study-start-up for sites in the scope of the participating ECs; nonetheless, doctors located in other German regions must continue to apply for ethical advice from their applicable state medical association or university ethics committees prior to participation as investigators in prospective non-interventional studies.

Further information is available on the website of the Association of German Medical Ethics Committees (Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e.V).

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