Context and impetus for the policy
With the aim to promote research for the development of new medicines, a Joint Ministerial Decision was signed in October 2024 by the Minister of the Interior, the Deputy Minister of National Economy and Finance and the Deputy Minister of Health, providing for the establishment and operation of Independent Departments of Clinical Studies in public hospitals.
Content of the policy
The Joint Ministerial Decision sets out the responsibilities of Independent Departments of Clinical Studies in public hospitals as well as the regulations for their organization, operation and staffing with specialized and experienced personnel.
The Independent Department of Clinical Studies in each hospital will be autonomous and will be the point of reference for the Principal Investigators and their research teams, the staff and the departments of the hospital involved in the clinical studies and more generally biomedical research, sponsors or commissioned research organizations and Independent Research Partners.
Among the Department’s responsibilities, the main ones include:
- Keeping an annual record of research programs and protocols related to biomedical research, and monitoring their implementation.
- Working with the hospital’s Data Protection Officer (DPO) to check compliance with the General Data Protection Regulation.
- Estimating the costs related to the conduct of the study, such as the cost of laboratory and diagnostic tests, hospitalization, pharmaceutical expenses and other procedures that are expected to be carried out in the context of the biomedical research.
- Certifying the coverage of costs by the Sponsor.
Another important role that will be undertaken by Independent Departments of Clinical Studies is the provision of informational material to patients and patient organizations. Departments will take care of informing the public about the hospital's available clinical studies and patient selection criteria as well as providing information on clinical studies in general.
Implementation
Independent Departments of Clinical Studies will operate in every public hospital with a capacity of more than 200 beds. Independent Clinical Research Departments of hospitals can systematically cooperate with each other, communicate, exchange practices and experiences. Regarding their staffing, Departments will be staffed by a minimum of two employees and their number can be adjusted to each hospital, based on the number of clinical studies carried out in each of them.