The Office of the Scientific Ethics Committee has collected links to international conventions, laws and regulations that concern the committee's activities.

Laws

The activities fall directly under the law no. 44/2014 on scientific research in the field of health.

Here are other laws related to the activity:

• Administrative Law no. 37/1993

• Information Act no. 140/2012

• Law no. 90/2018, on personal protection and processing of personal information. 

• Law no. 41/2007, on the national doctor and public health. 

• Law no. 110/2000, on biological collections and collections of health information.

• Law no. 55/1996, on artificial insemination and the use of human gametes and embryos for stem cell research.

• Law no. 55/2009, on medical records.

• Medicines Act no. 100/2020.

• Law no. 132/2020, on medical devices.

Rules and Regulations

• Regulation no. 155/2019, on the project of the Scientific Ethics Committee.

• Regulation no. 520/2018, on the organization of scientific research.

• Regulation no. 443/2004, on clinical drug trials on humans.

• Regulation no. 1311/2021, on clinical trials of human medicines.

• Rules no. 230/2018, on how people can be selected and approached to participate in scientific research in the health field and what education must be provided to them before their consent is sought.

• Procedures no. 578/2018, on processing applications for access to health data

• Rules no. 1117/2022, on minor changes and reporting obligations to the Scientific Ethics Committee or the Health Research Ethics Committee.