Cooperation with Ethics Committees


Background: Trial registration is an ethical responsibility

The World Medical Association states in the Declaration of Helsinki, which is a set of ethical principles accepted as a guideline for clinical research worldwide, in paragraph 35:

"Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject."

The WHO states on its website:

"The registration of all interventional trials is a scientific, ethical and moral responsibility."

Why?

Clinical research has to meet the highest ethical principles.

People participate in clinical trials not only to profit of innovative therapies but also by the conviction to support medical progress with their participation and thus help future patients with the newly won knowledge.

Therefore, it is not just a scientific but also an ethical necessity to make the results of all clinical trials accessible immediately and in an undistorted way (usually as a scientific publication in a journal). However, according to observation in several countries only about 50 % of the once started trials are in the end published.

Trial registries which are publicly accessible aim to correct these deficiencies. With the help of the DRKS and other trials registers, a public birth certificate is created for every trial which makes future "disappearance" impossible and thus provides the possibility to search for results even if there was no journal publication. This is a first step to secure complete accessibility of all trial results.

Cooperation with Medical Ethics Committees in Germany

The necessity of a trial registry from the point of view of an ethics committee was pointed out in 2004 by Victor in "Deutsches Ärzteblatt". Ethics committees assess the risk-benefit ratio for individual participants and the significance of the research project for medical advancement. Furthermore, they assure that patients are adequately informed. The basis for this is knowledge on all finished and ongoing clinical trials as well as the available evidence related to the issue at hand. Because many clinical trials are not published immediately or are not published at all, comprehensive trial registries are necessary to facilitate a meta-analysis before the beginning of each trial. This is the only way to ensure that intended projects are put into perspective to the existing evidence, redundant studies are avoided, and findings are put into practice sooner.

Support through the Workgroup of Medical Ethics Committees

The workgroup of Medical Ethics Committees already stand up for the foundation of a clinical trial registry in 2003. In March 2013 the workgroup spoke in favour for the need of a registration obligation and for the implementation of this demand by statute. The president of the board of the German Medical Ethics Committee workgroup supports the German Clinical Trials Register through its membership in the scientific advisory board.

Last Modified: 10-17-2016