Recommendations of the ESGE workshop on ethics in gastrointestinal endoscopy-based research

When gastrointestinal endoscopy-based research (GEBR) is carried out the following principles should be followed. - Always bear in mind the medical priorities of the country in question. - Consider the risk vs. benefit for the individual and the society. - Design the study adequately. - Obtain approval from the ethics committee. - Healthy volunteers may be used in study protocols that address an important and valid scientific question. - Do not use paid healthy volunteers, if possible. If payment is inevitable, the inducement should not be excessive. - Obtain valid informed consent that is structured to the procedure. - The personal data of participants should be handled confidentially. - Maintain high safety standards, especially for healthy volunteers and therapeutic GEBR. - Allow experimental techniques to be performed only by experts. - Prolong monitoring for early detection of adverse events. - Obtain research material during procedures performed for diagnostic or therapeutic purposes. - Define the primary use of biopsies. - Obtain additional informed consents for "opportunistic" biopsies, commercial use, or use beyond the initial purpose. - Ask patients if they want feedback of biopsy results. - Anonymize biopsy samples after completion of the study. - Avoid reporting short-term results as end points. - Avoid release of results to the media before they have been evaluated by peer-reviewed medical journals. - Preserve research records for as long as necessary, if this is not otherwise regulated by national law.