Are the Ethical Committees for Pharmacological Research Bureaucratic Bodies?

The question, reported in the title of this editorial, has the purpose of being intentionally a little provocative. It is obvious the Ethical Committees (CE), founded and established to approve clinical trials of new drugs that the pharmaceutical industry intends to market and, in general, biomedical research such as pharmaceutical no profit controlled clinical trials and observational studies, are Bureaucratic Bodies. Indeed, they are a group of people with various skills that work in compliance of well-defined rules and laws in order to realize the common good of health on the basis of criteria of impartiality, rationality, impersonality and, mostly relevant, independence; property, this latter, that it is not actually requested for a real Bureaucratic Body, but that is an essential requisite for an Ethical Committee. So, the answer can only be affirmative. It is however equally obvious that the above question refers rather to the negative connotations of the term bureaucracy, such as an inefficient, convoluted, too inflexible structure perched on privileged positions to consider with extreme fussiness irrelevant aspects and to formulate unnecessary requests for themselves to meet absolutely non-substantial needs. Indeed, the current question arises from an e-mail sent to me by a researcher working in a hospital afferent to the CE Milan Area 3 (CEMiA-3). The researcher’s complaints and outburst were due to the fact that the CEMiA-3 did not immediately approved a study of which she/he was the Principal Investigator. Indeed a suspension judgement was expressed, requesting the clarification of several aspects and the completion of some relevant documents, among which, in the information sheet for the patients to be enrolled into the controlled clinical trial, it had to be reported the time and the place of conservation of the biological samples (now suspended by you because there is no written as long as we keep the samples and where: at the XY or XZ hospital! and it goes next year! Was not a phone call enough?, just for reporting the exact text). Furthermore, she/he wrote This CE would not be able to approve the discovery of the wheel or the fire for a thousand pretexts on the experimental plane or on the danger ... in short, it lacks courage and confidence in the talented Researcher and gets entrenched in the bureaucracy. Obviously, the talented researcher with capital R, as she/he wrote, had only grasped the aspect of the conservation of the biopsy specimens which is, let me to say, a minor flaw compared to the shortcomings and mistakes that the CEs systematically find in the documentation of the studies submitted for their judgement. However, it must be recognized that what the researcher wrote is a widely held opinion of the physicians/researchers who have to interact with the CEs and the aim of this Editorial is precisely that of trying to start to build a bridge of understanding and collaboration; indeed, it is clear that if the ECs and the researchers remain seated on the opposite banks of a river, they may perhaps recognize who it belongs the body that passes first in the river stream, but certainly they will never actively communicate. I have to say that first of all I asked myself how it is possible to make clinical researcher understand that the EC do not make mere vexatious requests of a bureaucratic nature. I argued that, since the physicians member of the CEs, do not share this opinion but rather take it for granted that they are absolutely legitimate, a solution could be to impose a period of mandatory participation in the work of the ethics committees to all the clinicians and researchers. However, I must say, this solution could be impractical and even counterproductive. In addition, I also wondered if it is ever possible to establish an active relationship of mutual collaboration between the CEs and the clinical researchers, given that every time the CE tried to do it through several workshops that I have proposed and contributed to organize for this purpose, the participation of researchers was extremely scarce and practically null. I refer to the following three workshops held at the ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy. Workshop Il Comitato Etico di Niguarda e La Sperimentazione Clinica. 27th September 2006. [Niguarda’s Ethics Committee and Clinical Trial]. Workshop del Comitato Etico dell’Azienda Ospedaliera Ospedale Niguarda Ca’ Granda: Sperimentazioni Cliniche: Nuovo Decreto Ministeriale Clinical Trial Application (CTA). 29th September 2008. [Workshop of the Ethics Committee of the Hospital Agency Hospital Niguarda Ca’ Granda: New Ministerial Decree Clinical Trial Application (CTA). Workshop del Comitato Etico dell’Azienda Ospedaliera Ospedale Niguarda Ca’ Granda: Validità del consenso informato ed applicabilità nelle situazioni critiche. Lo stato dell’arte degli aspetti normativi e le sfide per il futuro. 27th September 2012. [Workshop of the Ethical Committee of the Hospital Agency Hospital Niguarda Ca’ Granda: Validity of informed consent and applicability in critical situations. The state of the art of regulatory aspects and challenges for the future.] Finally, I refer to the recent conference: Quale prospettive per i Comitati Etici in Italia?, 1 December 2017, Bergamo, Italy. [Conference: What prospects for the Ethics Committees in Italy?]