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

Area of Science:

• Medical Ethics
• Clinical Research Governance
• Bioethics Policy

Background:

• Ethics consultations are crucial for deliberating medical and scientific research issues, safeguarding patient rights and dignity.
• The European Union (EU) Regulation 536/2014 on clinical trials may impact the nature and execution of ethics consultations.
• An updated perspective on the current role and practices of nationwide ethics consultations in clinical and research settings is needed.

Purpose of the Study:

• To gain an updated perspective on the current role and practices of ethics consultations nationwide.
• To assess the impact of EU Regulation 536/2014 on ethics consultation services.
• To understand the current landscape of ethics consultation in clinical and research settings.

Main Methods:

• A three-step mixed-method approach was employed.
• Included a review of nationwide ethics committee (EC) policies and regulations.
• Utilized a structured survey of ECs' 2016 consultation activity and semi-structured interviews with key informants.

Main Results:

• 72.6% of ECs were capable of providing ethics consultation services by policy.
• Only 23 out of 48 ECs that provided consultations actually received requests in 2016.
• Many ECs lacked structured databases for precise request figures and content.

Conclusions:

• Ethics consultation in clinical and research practice is currently underappreciated and not well understood.
• Consultants often lack a comprehensive vision of their work and updated bioethics training.
• Institutional ethics consultation bodies require re-evaluation in light of the recent EU Regulation on clinical trials.