Informed Consent in IBD Trials: Where We Are and Where We Need to Go

• Published in: Inflammatory bowel diseases Vol. 25; no. 7; pp. 1115 - 1119
• Main Authors: Kurin, Michael, Katz, Jeffry, Kodish, Eric, Lashner, Bret
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 18.06.2019
• Subjects: Biomedical Research - standards; Clinical trials; Clinical Trials as Topic - methods; Clinical Trials as Topic - standards; Comprehension; Disclosure; Gastrointestinal diseases; Humans; Inflammatory bowel disease; Inflammatory Bowel Diseases - therapy; Informed consent; Informed consent (Medical law); Informed Consent - statistics & numerical data; Medical ethics; Medical research; Medicine, Experimental; Patients; Research Subjects; Maryland; Ohio; clinical trial; informed consent; ethics; capacity
• ISSN: 1078-0998; 1536-4844; 1536-4844
• DOI: 10.1093/ibd/izz067

Abstract Patient enrollment is increasingly recognized as a major limiting factor to inflammatory bowel disease (IBD) clinical trial completion. Many IBD trials will fail to enroll enough patients to adequately power their study. This has led to a renewed multifaceted effort to encourage more patients to enroll in clinical trials. Although this is of clear importance, it is also important to ensure that all efforts to enroll patients in clinical trials do not compromise the quality and validity of the patient’s/study participant’s informed consent. Informed consent has 4 components: disclosure, voluntariness, understanding, and capacity. The application of informed consent to IBD clinical trials for biologic agents has not been previously studied. Yet the nature of clinical trials for biologics in IBD creates certain challenges to properly fulfilling the requirements of informed consent in the recruitment process that should be examined. In the following commentary, the components of informed consent are reviewed, challenges to their fulfillment in IBD trials are reviewed, and practical advice is offered. This is a review of the components of informed consent and challenges encountered to fulfilling them in recruitment for clinical trials in IBD. We offer practical advice for suggested ethical practice in trial recruitment.