We're recapping changes in ICH GCP E6 R3 that took place between the May 2023 draft and January 2025 final versions. Today, hot off the press (check out that hip Times New Roman font!), we look at changes to the Institutional Review Board/Independent Ethics Committee section. 

• Information about how submissions to the IRB/IEC and regulatory authorities may be combined, as in situations where the EU Clinical Trial Information System is used, has been moved from section 1.5 to the top of this section, emphasizing its importance.
• Step 1.2.1, “The purpose of an IRB/IEC is to safeguard the rights, safety and well-being of all trial participants” has been augmented with this statement: “Appropriate consideration should be given to trials that intend to recruit vulnerable participants,” a nod to the recently updated Declaration of Helsinki.
• In step 1.2.7, which previously said that if minors were to be included in the trial, the IRB/IEC should review the assent information “considering the age, maturity and psychological state of the minor,” the bolded words have been replaced by “the minor population intended to be enrolled,” thus making it clear that IRBs/IECs will not be considering each minor participant individually.
• Step 1.2.8 now specifies that payments to participants should be timely.  The IRB/IEC has latitude to approve “reasonable…expenses, such as for travel and lodging,” indicating that expenses are not restricted to travel and lodging. 
• Step 1.3.3 regarding requirements for IRB/IEC meetings (meetings must be announced and include a quorum of members) now adds that “alternative processes may be applicable for expedited review.”
• Step 1.4.7 regarding IRB/IEC procedures that require prior approval for protocol changes now excepts cases in which  “the change(s) involves only logistical or administrative aspects of the trial.”