title: [Research ethics committees: one size fits all?].
abstract: Till now Poland did not create an effective system which should protect rights of the research subjects. A research involving human subjects includes the observational and interventional studies. In Poland the interventional studies conducted by physicians or dentists must be submitted for an approval to bioethical committees only. There is no legal obligation to obtain an approval of the independent research ethics committee for all observational studies or the interventional studies conducted by investigators others than physicians. Moreover, the existing system does not demand a further monitoring of the ongoing studies with an exception of the clinical trials. The system of bioethics committees for the assessment of interventional studies conducted by physicians or dentists should be complemented by two types of research ethics committees: committees which would evaluate projects of medical studies conducted by the other medical specialists (for example: nurses) and committees which would evaluate projects of biomedical studies conducted by the non-medical specialists (psychologists, sociologists). The new regulations should not restrain a progress of the science. Thus legislators should take into the consideration that the projects may differ in the degree of the complexity of ethical issues and the scientific validity. The different methods of the assessment of the biomedical research projects should be available.
authors.affiliation: Medical University of Warsaw, Poland, Department of Internal Medicine and Endocrinology. mczark@gmail.com
authors.forename: Marek
authors.initials: M
authors.lastname: Czarkowski
mesh_terms: D028744:Ethics Committees, Research / Q000458:organization & administration*; D032984:Ethics, Research; D005069:Evaluation Studies as Topic; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D011044:Poland; D015203:Reproducibility of Results