Idioma:

Clinical ethics consultation among Italian ethics committee: A mixed method study

De Panfilis, Ludovica ; Merlo, Domenico Franco ; Satolli, Roberto ; Perin, Marta ; Ghirotto, Luca ; Costantini, Massimo Holloway, Kelly

PloS one, 2019-12, Vol.14 (12), p.e0226710-e0226710 [Periódico revisado por pares]

United States: Public Library of Science

Texto completo disponível

Citações Citado por

Enviar para

Título:
Clinical ethics consultation among Italian ethics committee: A mixed method study
Autor: De Panfilis, Ludovica ; Merlo, Domenico Franco ; Satolli, Roberto ; Perin, Marta ; Ghirotto, Luca ; Costantini, Massimo
Holloway, Kelly
Assuntos: Bioethics ; Biology and Life Sciences ; Clinical medicine ; Clinical trials ; Clinical Trials as Topic - ethics ; Clinical Trials as Topic - legislation & jurisprudence ; Committees ; Consultants ; Consultation ; Earth Sciences ; Ethics ; Ethics Committees - organization & administration ; Ethics Consultation - legislation & jurisprudence ; Ethics Consultation - trends ; Ethics, Medical ; European Union ; Human subjects ; Humans ; Italy ; Medical research ; Medicine and Health Sciences ; Mixed methods research ; Optimization ; People and Places ; Policies ; Policy ; Polls & surveys ; Referral and Consultation - legislation & jurisprudence ; Referral and Consultation - standards ; Referral and Consultation - trends ; Regulation ; Regulations ; Research and Analysis Methods ; Science Policy ; Scientific research ; Social Control, Formal ; Social Sciences ; Studies ; Training
É parte de: PloS one, 2019-12, Vol.14 (12), p.e0226710-e0226710
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
Competing Interests: The authors have declared that no competing interests exist.
These authors also contributed equally to this work.
Descrição: 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. 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. 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. 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.
Editor: United States: Public Library of Science
Idioma: Inglês

Links

View this record in MEDLINE/PubMed

Voltar para lista de resultados

Realização: Logos de Redes Sociais:

Clinical ethics consultation among Italian ethics committee: A mixed method study

De Panfilis, Ludovica ; Merlo, Domenico Franco ; Satolli, Roberto ; Perin, Marta ; Ghirotto, Luca ; Costantini, Massimo Holloway, Kelly

United States: Public Library of Science

Buscando em bases de dados remotas. Favor aguardar.