Clinical research means every systematic approach to study interventional or non-interventional questions in healthy humans or patients with the aim to increase scientific knowledge.
"Interventional" means that a procedure is applied according to rules laid down in the study protocol. "Non-interventional" means that study participants are only observed.
The research nature of a project can always be assumed if publications in scientific journals or presentations at scientific meetings are planned.
Planning and conduct of clinical research has to be in line with the German Medical Association's professional code of conduct and the Declaration of Helsinki in their current versions for all types of research.
If applicable, the German Drug Law ("Arzneimittelgesetz"), the German Medical Device Law ("Medizinproduktegesetz"), and the Good Clinical Practice Guideline (GCP) must be considered for further regulations.
In general, ethical advice is mandatory for all interventional and non-interventional prospective studies.
"Prospective" means that data and/or biomaterial acquisition is planned for the future and study participants will be seen and examined in the future, no matter if already existing data will also be analyzed in the project.
For studies regulated by the German Drug or Medical Device Law, a second application has to be sent to the regulatory authorities ("Bundesinstitut für Arzneimittel und Medizinprodukte", BfArM, or "Paul-Ehrlich Institut") as well, and the study is only allowed to be conducted if both, ethics committee and regulatory authoritiy, have approved the study. These studies also need local registration with the regional government authority ("Niedersächsische Gewerbeaufsicht").
For all studies described, informed consent procedures are mandatory as described in "Protection of Participants".
Asking for ethical advice is not mandatory in the case of a strictly retrospective data analysis of anonymized data or biomaterials. Please seek advice from the Data Security Officer of Hannover Medical School to ensure proper anonymization. However, this type of study also requires informed consent of concerned individuals. Informed consent may have been provided via the contract governing medical treatment. There may be other options as well. Possible exemptions may be discussed with the Ethical Committee or the Data Security Officer.
For questions or in the case of doubt, do ask the Ethics Committee before starting a project. Providing an a posteriori advice is not possible.
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