The following table includes those elements of informed consent that must be in all Informed Consent Forms (ICFs) globally. Those required by 21 CFR part 50 and 45 CFR i.e., Health Insurance Portability and Accountability Act (HIPAA) need to be in US country-specific ICFs only; the EU Data Privacy/EU Directive elements must be in ICFs for all EU member states or the equivalent wording for other countries as required by local laws or regulations.