PUBLIC CONSULTATION :: Position on Consent/Assent in Compassionate Use/Expanded Access – GE2P2 Global Foundation
About this Public Consultation
This draft position was developed over an 18-month period by an 11-member working group of the GE2P2 Global Foundation’s Center for Informed Consent Integrity. Members of the working group have been actively involved in analysis of and direct advisory work for a number of expanded access/ compassionate use/managed access programs for almost 10 years.
The Foundation has a strong record of responding to public comment and public consultation opportunities globally to strengthen and refine the development of laws, regulations, standards, policies, and guidance, and in support of other deliberative processes involving scientific rigor, bioethics/medical ethics, and research integrity. Reflecting this experience, we decided to utilize a public consultation process to further refine and strengthen this position.
The working group will consider all inputs, refine the position, and publish a final 1.0 version in early October. Given the pace of evolution in the CU/EA field, we expect to review and update this position at least annually.
Download MS WORD draft position via link below:
Center for Informed Consent Integrity 