Ethical procedures and patient consent differ in Europe

Area of Science:

• Medical Research Ethics
• Clinical Trial Administration
• European Healthcare Systems

Background:

• Research ethics committee (REC) approvals, procedures, and requirements differ significantly across countries and organizational types.
• Variations in ethical review processes can impact the conduct and harmonization of multicenter clinical trials.

Purpose of the Study:

• To evaluate the diverse requirements and procedures of research ethics committees across European institutions.
• To assess variations in patient information dissemination and informed consent processes within a multicenter European trial context.

Main Methods:

• A survey was conducted using electronic questionnaires among European hospitals participating in the euCPSP (chronic postsurgical pain) study.
• Data were collected from 23 hospitals across 11 European countries, focusing on REC procedures, patient information, and consent.
• Analysis involved comparing REC requirements, institutional procedures for patient information and consent, approval durations, and associated costs.

Main Results:

• Approval process timelines varied widely, from under two weeks to over two months, with associated fees ranging from 0 to €575.
• Patient information sheets were provided in 20 hospitals, with lengths varying from half a page to two pages.
• Informed consent procedures differed significantly: written consent was mandatory in 12 hospitals, oral in 10, and no consent form was required in one hospital. Key details on consideration time, withdrawal rights, and risk/benefit communication were provided by only 25-30% of institutions.

Conclusions:

• Substantial variability exists in the administrative requirements for research ethics committee approval processes throughout Europe.
• These administrative variations directly contribute to inconsistencies in the quality and extent of patient information and informed consent procedures.