Endoscopy-based research in healthy volunteers.

Area of Science:

• Gastroenterology
• Clinical Research Ethics

Background:

• Healthy volunteers (HV) are frequently used as a control group in gastrointestinal research.
• Endoscopy-based investigations involving HVs are relatively uncommon in the field.
• The definition of 'healthy' is sometimes ambiguous, including individuals with conditions like Helicobacter pylori infection.

Purpose of the Study:

• To critically evaluate the multifaceted challenges and ethical considerations in the use of healthy volunteers in gastrointestinal research.
• To identify key issues impacting the quality and ethical conduct of research involving healthy volunteers.
• To propose improvements for enhanced 'good clinical practice' in this research domain.

Main Methods:

• Review and discussion of existing literature and common practices regarding healthy volunteer involvement in gastrointestinal studies.
• Analysis of problems related to safety, financial compensation, ethical approvals, documentation, and procedural limitations.
• Identification of areas for improvement in research conduct and ethical oversight.

Main Results:

• Identified significant challenges including safety concerns, financial compensation issues, incomplete ethical reviews, and inadequate documentation.
• Highlighted the overuse of invasive procedures in healthy volunteer studies.
• Questioned the strict definition of 'healthy' by noting the inclusion of individuals with infections like H. pylori.

Conclusions:

• The current practices in healthy volunteer research, particularly in gastroenterology, present several ethical and practical challenges.
• There is a need for stricter guidelines and improved 'good clinical practice' to ensure the safety and ethical treatment of healthy volunteers.
• Re-evaluation of the term 'healthy' and the necessity of invasive procedures is warranted for more responsible research conduct.