Figure 1

Organization chart of the Safe Harbor’s primary component, an International Federation for Ethics Review (IFER). IFER would be constituted by a voluntary agreement among countries, granting agencies, philanthropies, institutions, and healthcare, patient advocacy, and research organizations. The dotted lines in the figure represent ad hoc or external parts of IFER. In particular, the IFER Ethics Committee can call upon a standing list of independent consultants who could provide special expertise to the Committee on proposed research projects, be it in methodology, disease, or legal domain. Applicants whose first appeal is rejected by the IFER Ethics Committee may further appeal to the External Ethics Appeal Board. Additionally, NCOs are a key feature of the Safe Harbor but are external to IFER; they work with the technical officers and the Compliance Branch, and coordinate with each other for each research project, but are situated in their own country and are subject to their country’s laws and regulations.