Clinical ethics consultation among Italian ethics committee: A mixed method study
Autoři:
Ludovica De Panfilis aff001; Domenico Franco Merlo aff002; Roberto Satolli aff003; Marta Perin aff001; Luca Ghirotto aff004; Massimo Costantini aff005
Působiště autorů:
Unit of Bioethics, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
aff001; Infrastructure for Research and Statistics, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
aff002; Zadig, Agenzia di Editoria Scientifica, Milano, Italy
aff003; Unit of Qualitative Research, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
aff004; Scientific Directorate, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
aff005
Vyšlo v časopise:
PLoS ONE 14(12)
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pone.0226710
Souhrn
Objective
The general purpose for ethics consultations is to deliberate on issues on medical and scientific research and act towards the safeguard of the patient's rights and dignity. With the implementation of European Union (EU) Regulation 536/2014 on clinical trials and cost and time-optimization, the nature of consultations and the bodies they are carried out might be to some extent affected. Accordingly, we sought to gain an updated perspective on the current role and current practices of ethics consultations nationwide in both clinical and research settings.
Methods
The study was carried forth by a three-step mixed-method approach: i) review of policies/regulations for ethics committee (EC) nationwide; ii) a structured survey on ethics consultation activity completed by each EC during 2016; iii) incorporated into the third part, a qualitative assessment with a selected sample of 8 key-informants for a semi-structured interview, discussing EC history, the ethics consultation function, and the professional experience of consultants.
Results
Review of the policies/regulations promoted by ECs showed that 72,6% (n = 69) of all the ECs (N = 95) being actually capable of providing ethics consultation service by policy.
71 ECs (74.7%) responded to the survey on ethics consultation requests; among them, 48 (67.6%) provided ethics consultations of which 23 (23/48) actually received requests for this service in the year 2016. Many ECs did not have a structured database in place to provide precise figures of requests received in the last year nor of their contents.
Conclusion
To date, ethics consultation in clinical and research practice is largely underappreciated and not well understood by users. The consultants themselves lack a comprehensive vision of work carried out in their field, and bioethics training programs to keep them updated. Despite clinical ethics consultation services should not necessarily be mandatory, following the recent EU Regulation on clinical trials, institutional ethics consultation bodies should be re-evaluated.
Klíčová slova:
Clinical trials – Health care policy – European Union – Italian people – Geographic areas – Regulations – Medical ethics – Bioethics
Zdroje
1. Regolamento (UE) n. 536/2014 del Parlamento europeo e del Consiglio, del 16 aprile 2014, sulla sperimentazione clinica di medicinali per uso umano e che abroga la direttiva 2001/20/CE (Testo rilevante ai fini del SEE). In: Gazzetta Ufficiale dell’Unione Europea. 27 May 2014. Avaiable from: http://eurex.europa.eu/legalcontent/IT/TXT/?uri=CELEX%3A32014R0536
2. National Committee for Bioethics. I comitati per l'etica nella clinica. 31 Mar 2017. Avaiable from: http://bioetica.governo.it/media/172155/p127_2017_i-comitati-etici-per-la-clinica_it.pdf.
3. Istituto Superiore di Sanità Tesauro italiano di bioetica. Gruppo di Studio Istituto Superiore di Sanità “Tesauro italiano di bioetica” 2006, x, 132 p. (Strumenti di riferimento 06/S3), http://old.iss.it/binary/sibi/cont/thesa.1151313180.pdf
4. Furlan E., Comitati Etici in sanità: Storia, funzioni, questioni filosofiche. Milano: Franco Angeli; 2015.
5. UNESCO. Guide No 1: Establishing bioethics committees. 2005. Available from: http://unesdoc.unesco.org/images/0013/001393/139309e.pdf.
6. Rice T.W. The historical, ethical, and legal background of human subjects research. Respiratory Care, 2008, vol. 53 n. 10 1325–1329 18811995
7. Marra L, Clementi ML. Il dibattito bioetico in ambiente laico in Italia e l'esperienza dei Comitati. In: Geddes M, Berlinguer G, editors. La salute in Italia: Rapporto 1998. (Roma): Ediesse; 1998.
8. Ministerial Decree March, 18, 1998 “Reference guidelines for the establishment and functioning of Ethics committee, G.U. n.122, May, 28, 1998.
9. Ministerial Decree February, 8, 2013. “Parameters for the composition and functioning of Ethics committee”, GU, April, 24, 2013.
10. Petrini C. What is the role of ethics committees after Regulation (EU) 536/2014?2016. Journal of Medical Ethics, 2016; vol. 42, n.3.
11. Fox E, Myers S, Pearlman RA. Ethics consultation in United States hospitals: A national survey. Am J Bioet. 2007 Feb; 7(2): 13–25.
12. Hurst S, Theil S, Perrier A, Forde R, Slowther AM, Pegoraro R, et al. Physician's access to ethics support services in four European countries. Health care Anal. 2007 Dec; 15(4): 321–335. doi: 10.1007/s10728-007-0072-6 17943449
13. Caminiti C, Diodati F, Gatti A, Santachiara S, Spinsanti S. Current functions of Italian ethics committees: A cross-sectional study. Bioethics. 2011 May; 25(4): 220–227. doi: 10.1111/j.1467-8519.2009.01769.x 19860746
14. Cresswell JW, Plano-Clark VL. Designing and conducting mixed method research. (ed. n).Thousand Oaks (CA): Sage; 2010.
15. Creswell JW. Mixed methods research. (EDIZIONE). Thousand Oaks (CA): Sage; 2015.
16. Holloway I, Galvin K. Qualitative research in nursing and healthcare. 4th edition. Oxford (UK): Wiley Black
17. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Medical Research Methodology. 2013; 13:117. doi: 10.1186/1471-2288-13-117 24047204
18. Friuli Venezia Giulia Region. Deliberation of the regional council 22nd January 2016, n.73: Istituzione del Comitato etico regionale per la sperimentazione clinica. In: Bollettino ufficiale della regione Friuli Venezia Giulia. 10 Feb 2016. Avaiable from: http://bur.regione.fvg.it/newbur/visionaBUR?bnum=2016/02/10/6.
19. Veneto Region. Regional Resolution n. 4049 of 22nd December 2004: Interventi in materia di bioetica, Istituzionalizzazione del Comitato regionale per la bioetica: Linee guida per la costituzione e il funzionamento dei Comitati etici per la pratica clinica. In: Bollettino ufficiale della Regione Veneto. 25 Gen 2005. Available from: https://bur.regione.veneto.it/BurvServices/pubblica/DettaglioDgr.aspx?id=178000
20. Autonomous Provinces of Bolzano South Tyrol. Decree of the President of the Province n.30 of the 16th August 2017.Comitato Etico Provinciale. In: Bollettino Ufficiale. 22 Aug 2017. Avaiable from: http://lexbrowser.provinz.bz.it/doc/it/208599/decreto_del_presidente_della_provincia_16_agosto_2017_n_30.aspx?view=1.
21. HURST S., Clinical ethics, in R. CHADWICK, Encyclopedia of applied ethics, 2nd edition, Academic Press, San Diego (CA) 2012, vol. 1, pp. 476–487.)
22. De Panfilis L, Merlo DF, Satolli R, Coppola T, Ghirotto L, Costantini M. Clinical Ethics consultation and Research Ethics Consultation: a Call for Italy. The American Journal of Bioethics. 2018; 18:1, 63–64, doi: 10.1080/15265161.2017.1403665 29313784
23. Schildmann J, Nadolny S, Haltaufderheide J, Gysels M, Vollmann J, Bausewein C. Ethical case interventions for adult patients. Cochrane Database of Systematic Reviews 2019, Issue 7. Art. No.: CD012636. doi: 10.1002/14651858.CD012636.pub2 31424106
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