Romania - RECs and Medical Research

History

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 necessary.

The Ministry of Health also has a bioethical committee that acts in a national advisory role.

Summary of Romanian RECs

Type of REC	National Bioethics Committee	Institutional Bioethics Committee
Where situated?	-	Major hospitals & research institutions
Who applies to them?	Researchers	Researchers
Formal/Informal	Formal	Formal
National/Regional	National	Regional
Laws Involved	Ministry of Health orders: 858/19.10.1997 - introducing rules of good practice in clinical trials (defines and states activities of ethics committees) 579/28.08.2001 - setting up authorisation system to allow clinical institutions to host trials 215/29.03.2002 - aspects of medical research Ordinance No: 57/16.08.2002 - general research Laws: 2/1998 (organ transplants) 46/2003 (patient's rights)	Ministry of Health orders: 858/19.10.1997 - introducing rules of good practice in clinical trials (defines and states activities of ethics committees) 579/28.08.2001 - setting up authorisation system to allow clinical institutions to host trials 215/29.03.2002 - aspects of medical research Ordinance No: 57/16.08.2002 - general research Laws: 2/1998 (organ transplants) 46/2003 (patient's rights)
Guidance Involved	Declaration of Helsinki EU-GCP Oviedo Convention College of Physicians Ethical Code 1997	Declaration of Helsinki EU-GCP Oviedo Convention College of Physicians Ethical Code 1997
Membership requirements	15 members: 12 physicians 1 lawyer 1 priest 1 biologist	Between 5 & 17 members- 2 of whom must be medical doctors not working at site of trial, and including a pharmacist, medical assistant and a jurist. Members should be of different age groups & both genders must be represented.
Responsible/accountable to whom?	Ministry of Health	National Bioethics Committee
Approval or Advisory powers	Approval	Approval

Not submitting research or failing to follow review

For trials on medicinal products for human use, researchers can be fined or imprisoned. For any other medical trial, they can be reprimanded or have their licence revoked.

Which body, if not the REC itself takes this action, and how do they proceed?

In the first instance the courts will take action after being notified by the National Agency of Medicinal Products. For other trials the College of Physicians would take action after being informed by the relevant EC.

Legal action that can be taken against RECs

The decision of an Institutional Ethics committee can be contested to the National committee, or directly to the Ministry of Health through their Bioethical committee.

Links section

National Medicines Agency (in Romanian & English)
Romanian Government (in Romanian, French & English)
Ministry of Health (in Romanian)
Links page to Romanian Laws (in English)

See the REC bibliography section for more links and papers