This week, Clinical Trials published Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel. This publication is the result of CTTI’s Informed Consent Project and is based on the expert interviews conducted with stakeholders who have long-standing experience with the informed consent process. The goal of these interviews was to identify limitations within the current informed consent process and actionable recommendations for change. Three major themes emerged from these interviews, namely reform of the informed consent document, enhancing participant understanding of the clinical research, and modification of IRB review.
“The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations.”
-B. H. Lorrell, et al.
Figure 1. Enhancing research participant understanding of a clinical trial. Derived from authors’ analysis of results from 25 interview transcripts.