A Modern History of Informed Consent and the Role of Key Information

Background: The concept of informed consent has evolved significantly with regard to both the practice of medicine and research conducted with human volunteers. Yet the process of informed consent used in clinical research and the lengthy consent documents that are difficult to comprehend have been criticized. Methods: We review the history of informed consent as a legal and regulatory concept and the intended impact of the new key information section, a requirement that was introduced in the 2017 revisions to the Common Rule. Results: The key information section is intended to be a concise and focused presentation at the beginning of the informed consent document that facilitates potential participants’ comprehension of the research. However, the lack of regulatory guidance regarding content and length has been problematic. To avoid the risk of noncompliance, many institutions have sought safe harbor by following the limited format guidelines included in the preamble to the revisions to the Common Rule. Conclusion: Research examining formats for the key information section and aids to increasing potential participants’ understanding of a research project should be conducted to ensure that the new regulations achieve the original intent rather than simply lengthening an already lengthy paper document. In addition, the human research protections community should evaluate whether the key information section increases research participants’ understanding of what they will be undertaking in a particular study.