Endoscopy-Based Research in Healthy Volunteers

Abstract

The role of healthy volunteers (HV) in research covers a wide spectrum. In gastrointestinal research HV are often considered a control population. Endoscopy-based investigations are rare in terms of all studies performed in this field. The term ‘healthy’ must be questioned in some cases, as Helicobacter pylori-positive individuals are included as well. Problems arise from several fields, e.g. safety, financial compensation, incomplete ethical votes, lack of documentation, lack of defining limitations, overuse of invasive procedures. This article will discuss these problems in detail and will finally give an overview of key issues for extended ‘good clinical practice’.

Recommendations of the ESGE Workshop on Ethics in Gastrointestinal Endoscopy-Based Research

“…Participants must be assured that withdrawal of consent does not imply any current or future disadvantages. The standards for an informed consent should be further tightened in the case of research on healthy volunteers [10].…”

“…The term ªhealthyº may sometimes be questioned, e. g. in a ªhealthy volunteerº infected by Helicobacter pylori. The use of healthy volunteers for nontherapeutic GEBR is probably ethical for important but limited indications, such as a study protocol that addresses a significant and valid scientific question [10].…”

“…In addition, currently we have no guidelines on how to use healthy volunteers, only general recommendations [10,14]. Thus, researchers should carefully balance the risk-benefit ratio to protect the lives, health, privacy, and intimacy of healthy volunteers.…”

“…Patients are scheduled for immediate interventions or limited investigations. The primary task is to treat the disease rather than to do no harm [10]. Patients included in nontherapeutic GEBR protocols should be treated following all the aforementioned ethical and legal rules.…”