Guidance
Date: November 13, 2025
The EC/IRB Guide for Understanding Post-Trial Continued Access aims to assist Ethics Committees (EC) and Institutional Review Boards (IRB) in interpreting their role under Paragraph 34 of the Declaration of Helsinki. Paragraph 34 requires sponsors and researchers to arrange post-trial provisions for “participants who still need an intervention identified as beneficial and reasonably safe.” Exceptions to this must be approved by an EC or IRB, necessitating an understanding of when post-trial, continued access is applicable.
This resource outlines principles and criteria for evaluating when continued access is appropriate. It provides tools and questions to guide equitable decisions, ensuring ethical and transparent approaches to post-trial, continued access decisions. Additional resources and frameworks are available through the MRCT Center’s Post-Trial Responsibilities: Continued Access project page to support ethics committees.