How does the ethical review process work in Romania and which are the designated ethics committees?

There has been a regulated system of ethical review dedicated to medical research since 1997. Every medical institution has an Institutional Ethics Committee that is responsible for the ethical review of all research and clinical trials to be carried out in that institute.

Ministry of Health order 858/19.10.199 defines ethics committees and states their activities.

There is a National Ethics Committee that accredits Institutional Committees to review research involving medicinal products for human use. For clinical trials of medicinal products for human use, approval by the National Committee and the Committee for Medicinal Products is required.

National Ethical Commission
According to Art. 85 of Law 336/2002, a clinical study can be started only after it has been approved by the National Ethical Commission or the institutional ethics committee.

The National Ethical Commission functions under the authority of the Romanian Academy of Medical Sciences. The composition of this commission is as follows: 5 physicians, 2 pharmacists, 2 psychologists /sociologists, 1 jurist, 1 layperson, 1 nurse, 1 theologian. The President of this National Ethical Commission is Prof. Dr. George Litarczek.

Institutional ethical commissions
The institutional ethics committee functions as a local ethics committee during a clinical study.