Independent Ethics Committee

Contact

Prof. Schmalzing

Name

Günther Schmalzing

Head of the Department of Molecular Pharmacology

Phone

work
+49 241 80-89963

Email

E-Mail
 

the medical Ethics Committee is responsible for ethically and legally evaluating research projects on humans, that are to be conducted at the RWTH Aachen Faculty of Medicine or one its institutions, and advising the researchers responsible for these projects.

The Ethics Committee is also consulted when research is being planned that will be conducted on the deceased and body materials that have been obtained or epidemiological research projects with personal data.

It reviews whether the research project can be approved from an ethical and legal standpoint. Studies on humans with somatic cell therapy, gene transfer, and genetically modified organisms must also be submitted to the committee for review.

If you would like to submit an application for advising from the Ethics Committee, you can find the necessary information and application documents under the menu option Requests.

Additional Information

 

Responsibilities of the Ethics Committee

The Ethics Committee at the RWTH Aachen Faculty of Medicine was founded on February 19, 1981, in order to advise and accompany clinical research trials at our faculty.

Clinical research means acquiring new knowledge about human diseases; testing new treatment methods, new medications, new equipment, medical products, and new examination methods on people; and directing their actual purpose. Clinical research aims to apply new things to people and ensure their value for healing those who suffer. For this reason, the Ethics Committee is located at the cross-section of science, law, and practical medicine.

Before sick people are included in scientific research projects, they must be comprehensively informed and consent. The written patient information to prepare for the oral informing, conducted by the attending physician, is documents, in which all of the aspects of a clinical research trial are described – its nature, meaning, consequences, and risks. They are given to the patients or subjects and their advisors, thus reaching the limited public, more or less.

When advising such research projects, the Ethics Committee must, on the one hand, ensure that no patients or test subjects suffer any physical or emotional harm and on the other hand, that the legally determined boundaries do not impede the research and further development of medicine.

The Ethics Committee must make sure that clinical research is conducted for the good of those suffering and never forget the principle "nil nocere." To fulfill this function, it must supervise projects to ensure that subjects in clinical research do not become the objects of an idea of progress. It must demand the principles of medical actions in a Hippocratic sense and impart patients and subjects with the view of how necessary clinical research on and with people is to move forward in medicine.

Our country passed laws that promote and require medical-ethical principles and which help, to maintain these priniciples of medical behavior. In its 25-year existence the Ethics Committee has become an important component of clinical research and part of the scientific infrastructure in the Faculty of Medicine and our university.

 

Activities of the Ethics Committee

Advising on research projects on and with people

  • taking professional legal and ethical aspects into account
  • to protect patients, subjects, and principal investigators, as well as for quality assurance
  • for individual research projects and multicentric studies
  • for members of the University

The Ethics Committee was founded on February 19, 1981, according to the federal state law, and registered with the Federal Institute for Drugs and Medical Devices, BfArM; the German Institute of Medical Documentation and Information, DIMDI; at the Federal Office for Radiation Protection, BfS; and the Office for Human Research Protections, OHRP, under IORG0006299.

The Ethics Committee practices an administration action, because it handles individual regulations for matters governed by public law that have an external impact.

In NRW, ethics committees have been established in medical associations and at the faculties of medicine at universities (§ 7 Heilberufegesetz NRW).

As the Ethics Committee is located in an institution governed by public law and practiced administrative actions, its actions are not subject to taxation. A fee is charged to cover the committee's efforts.