From application to decision

Which studies must be submitted to an ethics committee?

How long does the review by an ethics committee take?

How high are the fees for the applying physicians or sponsors for the consultation by an ethics committee?


When physicians plan a clinical trial or other research project involving human subjects, they must first obtain the approval of an authority and the vote of an ethics committee. Only then may the study begin.

The exact requirements depend on the type of research.

  • If the research involves a drug resp. a medical product, the procedure with the authority and the ethics committee is governed by the German Medical Productss Act (AMG).
  • If research is to be conducted on a medical device (e.g. prostheses, apps, dressing materials), the procedure is based on the Medical Devices Act (MPG).
  • In addition, there are medical studies in which no medical products or medical devices are to be researched. These are, for example, surgical studies, or studies to improve diagnostics. In this case, the obligation to present an ethics committee results from the professional regulations of the physicians of the individual chamber of physicians.

As soon as the application is received at the office of the Ethics Committee, it is reviewed by the staff. If the documents are complete, they are discussed at the next meeting of the commission members. Meetings are usually held on a fortnightly or monthly basis. If there are no ethical or legal concerns, the applicants receive the positive vote of the ethics committee. However, there are usually conditions that the applicants must fulfill before they receive the final positive vote.


The duration from receipt of the study application by the Ethics Committee to the issuance of the vote varies greatly. It depends on the size of the study and the number of study sites involved, but also on the input of the physicians who wish to conduct the study.

  • In the case of clinical studies with mecical products or medical devices, there are legal time limits to which all participants must adhere.
  • The processing of a study without medical products or medical devices takes on average about 30 days per ethics committee.


The researchers or their clients must pay a fee for the review by the ethics committees. This is necessary because ethics committees work independently and therefore have to finance themselves for the most part. The fees are calculated in such a way that the ethics committee can cover its costs, but does not make a profit. The amount of the fee depends on the type of study, the number of study sites involved, and whether it is a publicly funded study or a commercial study.

  • Studies with medical products or medical devices and one study site cost on average 1,000 – 3,000 euros
  • Studies without medical products or medical devices cost on average 100 – 1,500 euros