The Internal Review Board for the assessment of non-interventional clinical studies, epidemiological and observational studies embracing a pluralistic ethical viewpoint, refers to national, EU and international regulations of legal and ethical nature. In particular, reference is made to the points expressed by Legislative decrees n. 200/2007 and n. 211/2003 and to Ministerial decree 12.5.2006 which regulate the institution of ethical committees for clinical drug testing, excluding from such legislation both observational drug trials and human testing that does not regard the use of drugs together with research regarding human biological material (tissues, cells etc.).
The Board is mainly inspired by the principles expressed in national, EU and international documents on appropriate clinical practice and human testing and focuses in particular on the current version of the Helsinki Declaration.
The Board's task is that of safeguarding the rights, dignity, integrity, as well as the physical, psychological and social well-being of all those involved in research.
To this end, the Board expresses its opinions on matters brought to its attention by researchers or teaching and scientific institutions. The Board also supports thought, understanding and public debate to promote the development of an ethical awareness.
In evaluating ethicality the Board verifies protocol accordance with the objectives of the research work being carried out and with sector rules and regulations. The Board acquires guidelines and specific procedures in line with related legislation and with the set of regulations at hand.