Revised Common Rule Changes to the Consent Process and Consent Form

Abstract

Background: The Federal Policy for the Protection of Human Subjects-the Common Rule-was revised in 2017 to reduce administrative burdens for low-risk research while enhancing protections for human subjects enrolled in greater-than-minimal-risk trials. These enhanced protections involve changes to the consent process. Methods: We review the general requirements applicable to the consent process, as well as the additional elements of consent mandated by the revisions to the Common Rule. The regulations apply to federally funded studies and are optional for non-federally funded studies. Results: Two new general requirements for the consent process, one basic required element for the consent form, and three optional additional elements for the consent form were added in an effort to improve potential subjects' understanding of research studies and to facilitate the exchange of information between the research staff and potential subjects. Important information about the study should be extracted into a concise key information section to help potential subjects make informed decisions regarding participation. Conclusion: The revisions to the Common Rule are intended to enhance human subject protection by providing more information in an understandable form during the consent process. The new consent elements aim to increase transparency and help improve clarity.

Keywords: Consent forms; ethics committees–research; informed consent.