Developing Language to Communicate Privacy and Confidentiality Protections to Potential Clinical Trial Subjects: Meshing Requirements under Six Applicable Regulations, Laws, Guidelines and Funding Policies

Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food and Drug Administration regulations, Health Insurance Portability and Accountability Act regulations, International Council for Harmonisation guidelines, the Confidentiality of Substance Use Disorder Patient Records statute, and Certificates of Confidentiality provisions under the 21st Century Cures Act. A consent form template is presented as one example of language that incorporates all of these requirements in an integrated manner that addresses some of the tensions among the various requirements.