ICH GCP E6 R3 is a draft no longer! How should it be announced? I imagine white smoke rising from the headquarters in Geneva, Switzerland, to announce its adoption.  Perhaps a twenty-one gun salute would be more appropriate, or carrier pigeons dispatched to all the European capital cities with microscopic manuscripts attached to their legs, or a masquerade ball with attendees dressed as their favorite informed consent element. 

In any case, the final version was adopted by the ICH Assembly on January 6, 2025, the part of the process known as "Step 4."  "Step 5," or adoption by various regions, is underway.  The guideline will come into effect in the EU on July 23, 2025. 

The final version includes some minor wording changes from the draft which, although subtle, provide a glimpse of the committee's thought process - what they thought should be emphasized, clarified, or pulled back.  We downloaded the draft version when it first came out (hey, we'll never again assume a government website will always be available) so we could compare it to the final. Below are changes from the Principles section:

• Principle 2.1, the first principle of informed consent, now includes this information about participants who cannot provide informed consent: "These potential participants should be informed about the trial in a manner that facilitates their understanding. In the event that a minor is a participant, assent should be collected from that minor, as appropriate, and in accordance with local regulatory requirements (see ICH E11(R1) Clinical Investigation of Medicinal Products in the Pediatric Population)."
• A new sub-principle has been added to this section regarding informed consent in emergency situations (2.4).
• Principle 3.1 now states that “A trial should be conducted in compliance with the protocol that received prior IRB/IEC approval,” whereas it previously said it should “always be conducted in compliance….”  
• Principle 4 now states that clinical trials should be based on “adequate and current scientific knowledge and approaches” whereas the previous version said “robust" rather than "adequate."
• Principle 6.1 now states that quality "is considered in this guidelines as fitness for purpose,” previously, it was described as “fit for purpose.” The statement, “The quality and amount of the information generated during a clinical trial should support good decision-making” has been deleted from this principle.
• Principle 6.2 now adds that factors critical to the quality of the trial should be identified "prospectively."
•  Principle 6.3 now states that strategies should be implemented to “avoid, detect, address and prevent recurrence of serious non-compliance”; previously, the word “prevent” was not included.
• Principle 7 now includes a statement that clinical trial processes should avoid unnecessary burdens on participants and investigators. A new sub-principle 7.4 reiterates this point and adds that trial processes should be operationally feasible and avoid unnecessary complexity, procedures, and data collection.  Principle 8 now adds a requirement that protocols should be “operationally feasible” in addition to clear, concise, and scientifically sound.
• Principle 9 now states that the quality and amount of information generated in a clinical trial should be “fit for purpose” in addition to “sufficient.”
• Principle 9.5 now stats that “essential records” (previously, “clinical trial-related records”) should be retained per regulatory requirements and that they should be available not just to regulatory authorities but also to “monitors, auditors, and IRBs/IECs.”
• Principle 9.6 now adds that “communicating trial results to participants should be considered.  Such communication should be objective and non-promotional,” perhaps addressing a concern that “communicating” results could be perceived as a marketing activity. 
• Principle 11 now states that IMP should be “managed” in accordance with the product specifications and trial protocol (previously, “stored, shipped, handled, and disposed of.”  However, processes for “handling, shipping, storage, dispensing, returning, and destroying or alternatively disposing of investigational product” are now specified in sub-principle 11.6.

Happy Revision 3, however you choose to celebrate, and stay tuned for more information about the differences between the draft and final versions.