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Registration for ethics committees on the procedure for evaluating an application for approval of a clinical trial

Service Description

Clinical trials of medicinal products are intended to prove the efficacy of new medicinal products and to determine their safety and tolerability. An important part of the approval process for such clinical trials is an ethical review by ethics committees.

As a public-law ethics committee of a federal state, you must register in order to participate in the procedure for evaluating an application for approval of a clinical trial.

As the responsible body of the ethics committee, you must submit the registration application to the Federal Institute for Drugs and Medical Devices (BfArM). The BfArM decides on the application in agreement with the Paul-Ehrlich-Institut (PEI).

Process flow

You can submit the application electronically. Proceed as follows.

  • First send an e-mail to Registrierung-EK@bfarm.de
  • You will receive a personalized link that you can use to access the application documents.
  • Fill out the form.
  • Upload all the required documents.
  • Send the application electronically.
  • You will receive a notification in text form by e-mail that your registration application has been received.
  • The BfArM will review your application and make a decision in consultation with the PEI.
  • You will receive a notification of the decision in text form by e-mail.
  • If the application is successful, your ethics committee will be included in the list of registered ethics committees participating in the procedure for assessing an application for approval of a clinical trial in the Federal Gazette.

Requirements

  • the necessary up-to-date scientific expertise of the members of the ethics committee and the external experts
  • Interdisciplinary composition of the Ethics Committee with the participation of
    • at least one lawyer in each case
    • one person with scientific or professional experience in the field of ethics in medicine
    • one person with experience in the field of experimental design and statistics
    • 3 doctors with experience in clinical medicine,
      • one of whom must be a specialist in clinical pharmacology or pharmacology and toxicology
    • one layperson
  • the Ethics Committee has both female and male members and equal consideration is given to women and men in the selection of members and external experts with the aim of equal participation
  • rules of procedure which, in particular, lay down binding rules on the working methods of the Ethics Committee; these include, in particular, rules on management, chairmanship, the preparation of resolutions, the passing of resolutions and the honorary nature and duty of confidentiality of members and external experts:
    • an office with the qualified staff required to organize the tasks of the Ethics Committee
    • equipment that enables voting procedures to be carried out at short notice and opinions and assessment reports to be prepared on time
  • the Ethics Committee obtains declarations of independence for each application from the members and external experts involved, stating that they have no financial or personal interests that could affect their impartiality
  • Application for registration must contain information on whether the Ethics Committee is registered with the Federal Office for Radiation Protection in accordance with radiation protection legislation

Which documents are required?

  • Rules of procedure of the Ethics Committee

What are the fees?

You can submit the application free of charge.

What deadlines do I have to pay attention to?

You must register before participating in the process of evaluating an application for approval of a clinical trial.

You must also notify us immediately of any changes to your registration.

Processing duration

Processing usually takes between 1 and 3 months.

Legal basis

Applications / forms

  • Objection.
  • Objection.
    Detailed information on how to lodge an objection can be found in the notification of your application.
  • Administrative court action

Appeal

Forms: yes

Online procedure possible: yes

Written form required: no

Personal appearance required: no

Further Information

Author

Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry of Health

Professionally released on

26.07.2021

Source: Zuständigkeitsfinder Thüringen (Linie6PLus)

Start your request directly online:

Competent Authority

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) - Registrierung von Ethik-Kommissionen

Address
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, Stadt
Remark: Bonn office Administration, Legal Department

Address
Waisenhausgasse 36-38a
50676 Köln, Stadt
Remark: Cologne office
Telephone
+49 228 993070
Fax
+49 228 993075207
E-Mail
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