Abstract
Since 2005 the Emilia Romagna Region (Italy) adopted the policy of introducing traditional/non-conventional treatments the Regional Health Service after a strict evaluation of their safety and effectiveness. In order to introduce and evaluate those treatments in a western ethno-cultural context, a strategy including a plurality of research designs is required. Increasingly often, the local Ethical Committees (ECs) had to consider and evaluate research designs and protocols on complex procedures with long-standing practice but scarce biological foundations. Intense discussion and dialogue between researchers and the ECs was and is still needed in order to develop shared knowledge and reciprocal understanding. In particular, the central role of pragmatic trials and qualitative research in CAMs’ field has to be stressed and justified. In the framework of Non-Conventional Medicines Experimental Program of Emilia-Romagna Region a parallel, challenging, educational strategy is needed and is in course, addressed to CAM researchers (about clinical research general methodology), and to Ethical Committees’ members (about the specificities of clinical research in CAM).
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