Legal and ethical aspects in clinical research in mental health institutions for children and adults

The project wants to document the legal and ethical matters in which are applied clinical research on children and adults with mental health problems and proposed a set of ethical principals to be followed by the central authorities with responsibilities in the field;

Target group:
–    10 representatives from the central authorities with attributions in the field, NGOs representatives, the National Mental Health Centre, the Pharmaceutical company association and experts in the area of clinical research, legal and ethical issues;
–    children and adults with mental health problems involved or former involved in clinical research in mental health institutions, legal representatives and communities, psychiatrists and psychologists from at least 6 to 8 mental health institutions (approximately 1, 200 people);
–    authorities with responsibilities related to individuals deprived of their freedom as the Ministry of Justice, the Ministry of Health, the General Prosecutor’s Office.

The target groups will be actively involved in identifying the problems regarding the clinical studies in mental health institutions and the best solutions for implementing the legal and ethical studies in the area of clinical research and in implementing an independent mechanism to monitor mental health institutions with focus on clinical research in Romania, via meetings, working group, monitoring visits and a seminar.

Bucharest and mental health institutions from other administrative regions from Romania


  • Documenting and presenting the present situation of the respect for the rights of children and adults with mental health problems involved in clinical research and deprived of their fundamental freedoms.
  • Raise awareness about the manner in which clinical research is conducted on children and adults with mental health problems, publishing results and disseminated with decision makers, National Professional Medical Association and the pharmaceutical companies representatives
  • Proposing legal amendments at the Law no. 487 from 2002 and at the Norm of appliance, National strategy on Mental Health and the Actions Plan.

Period of implementation: December 2009 – September, 2010

Total cost of the project: 17 750 Euro (14,000: Matra – Kap Grant, 3,750: CRJ)

Project coordinator: Georgiana Pascu