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Research

Ethics Committee

The scientific research activity of the Casa di Cura Igea is supported by the Ethics Committee Milan Area 2 (hereinafter referred to as CE) based at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico which has the task of providing public guarantees of the protection of the rights, safety and well-being of subjects participating in a clinical trial, through the expression of ethical and scientific opinions before the start of any study involving human beings.

The CE carries out an overall evaluation of the trial, with particular attention to the existence of the requirements regarding informed consent, privacy information, insurance coverage and innovative content of the trial.

The CE also provides support in current clinical practice and formulates opinions in relation to complex ethical issues connected with healthcare activities, with the aim of protecting and promoting the values ​​of the human person.

The CE is inspired by respect for physical integrity and human health, as indicated in the Charter of Human Rights, in the national (December 16, 2006 version) and international codes of medical ethics and in particular in the Helsinki Declaration of 1964 (and subsequent amendments) and in the Oviedo Convention of 04/04/1997, ratified by Law 28/03/2001, n. 145 (GU n. 95 of 24/04/2001). The recommendations of the National Committee for Bioethics (established by Decree of the Presidency of the Council of Ministers of 28/03/1990) also constitute a reference, where applicable.

The independence of the EC from the institution to which it belongs is guaranteed:

  • from the lack of hierarchical subordination of the CE towards the structure in which it operates
  • from the presence of members external to the healthcare facilities for which the CE operates, in a measure not less than one third of the total
  • from the non-involvement and lack of conflicts of interest of the EC members with respect to the proposed clinical studies
  • from the lack of economic co-interests between the members of the CE and the companies promoting the experimentation, declared according to the methods set out in the Ministerial Decree of 17/12/2004. To this end, the members of the CE must annually sign the declaration set out in the aforementioned Ministerial Decree of 08/02/2013 in art. 3, paragraph 2, letter c).
VIEW EC REGULATION