ECGeneralEthicalReview object

Submission for Ethical review mandatory for

All research projects involving humans

Procedural interaction between CA and EC during approval process

Yes

Procedural interaction - Additional information

(1) Common Procedure: One single submission to NIPN/ OGYÉI (National Institute of Pharmacy and Nutrition). One copy of the documentation will be sent to the relevant Central Ethics Committee (CEC) - acting as co-authority- for ethical review and opinion. In case of favourable opinion, CA provides approval.
(2) Direct submission to EC: same formal requirements as for submission to CA apply

Additional Information

The three central ethics committees (CEC) in Hungary are officially appointed by law as public co-authorities (in the meaning of the general rules of public authority procedures) and are all part of the ETT (Egészségügyi Tudományos Tanács) Medical Research Council:

1. Committee for Clinical Pharmacology and Ethics of the Medical Research Council – KFEB

2. Committee for other biomedical research involving human subjects and non-interventional trials with IMP:
Scientific Research Ethics Committee of the Medical Research Council - ETT TUKEB

3. Committee for trials connected with human reproduction, human genetics and ATMP:
Human Reproduction Committee of the Medical Research Council (ETT HRB)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395