Verbal consent in biomedical research: moving toward a future standard practice?

Area of Science:

• Medical Ethics
• Clinical Research Methodology
• Health Policy

Background:

• Informed consent is crucial for human subject research.
• Traditional written informed consent is standard but challenged in specific contexts.
• Verbal consent is increasingly prevalent in settings like COVID-19 and rare disease research, sparking debate.

Purpose of the Study:

• To review current medical settings where verbal consent is common.
• To analyze the advantages and disadvantages of verbal consent.
• To examine the legislative and policy landscape surrounding verbal consent.

Main Methods:

• Literature review of verbal consent practices.
• Analysis of existing legal and policy frameworks.
• Synthesis of arguments for and against verbal consent.

Main Results:

• Verbal consent is a growing norm in specific research areas.
• Identified benefits include flexibility and accessibility.
• Identified drawbacks include challenges in documentation and potential for coercion.

Conclusions:

• The debate on verbal consent should conclude.
• Legislators and policymakers must acknowledge and formalize verbal consent.
• Formalization will enable regulation and provide guidance for clinician-researchers.