Ethics committee; application for registration

If you want to evaluate clinical trials of medicinal products as a public ethics committee, you must first register with the Federal Institute for Drugs and Medical Devices (BfArM).

Description

Clinical trials of medicinal products are designed to demonstrate the efficacy of new drugs 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 ethics committee of a federal state, you must register to participate in the process of 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 consultation with the Paul Ehrlich Institute (PEI).

Prerequisites

  • the necessary up-to-date scientific expertise of the members of the ethics committee and of the external experts
  • interdisciplinary composition of the ethics committee with participation of
    • at least one lawyer each
    • 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 physicians who have experience in clinical medicine,
      • one specialist in clinical pharmacology or pharmacology and toxicology
    • one lay person
  • the Ethics Committee shall include female and male members and, in the selection of members and external experts, equal consideration shall be given to women and men with the aim of equal participation
  • rules of procedure, which in particular lay down binding regulations on the working methods of the ethics committee; these include, in particular, regulations on the management, the chairmanship, the preparation of resolutions, the passing of resolutions, and the honorary status and duty of confidentiality of the members and external experts:
    • an office with the qualified personnel necessary for the organization of the tasks of the ethics committee
    • a material endowment that makes it possible to carry out voting procedures at short notice and to prepare statements and evaluation reports in a timely manner
  • the Ethics Committee obtains declarations of independence for each application from the members and external experts involved, which include that they have no financial or personal interests that could affect their impartiality
  • Registration application must contain information on whether the ethics committee is registered with the Federal Office for Radiation Protection in accordance with radiation protection law

Procedure

You can submit the application electronically. To do so, proceed as follows.

  • First write an e-mail to Registrierung-EK@bfarm.de.
  • You will receive a personalized link where you can access the application documents.
  • Fill out the form.
  • Upload all required documents.
  • Submit the application electronically.
  • You will receive a notification in text form via email 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 in text form by e-mail about the decision.
  • If the application is successful, your ethics committee will be included in the list of registered ethics committees participating in the procedure for evaluating an application for approval of a clinical trial in the Federal Gazette.

Deadlines

You must register before you participate in the process of evaluating a clinical trial application.

You must also immediately report any changes regarding your registration.

Processing time

Processing usually takes between 1 and 3 months.

Required documents

  • Required Documents

    • Geschäftsordnung der Ethik-Kommission

Online procedures

  • Ethik-Kommissionen - Registrierungsverfahren

    Sponsors of public ethics committees must register. To do so, they must submit a request for assignment of a link by e-mail. After receiving the personalized link, they can submit the registration request electronically.

Fees

  • You can submit the application free of charge.

Legal bases

Remedy

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

Links to more information

Related issues

Status:23.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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