Position on Consent/Assent in Compassionate Use/Expanded Access
GE2P2 Global Foundation CURRENT AT 02 April 2026
…the investigational/pre-approval status of CU/EA interventions means that patients receiving them may face risks and potential harms at least comparable to those faced by participants in clinical trials. Indeed, the risks and potential harms of a CU/EA intervention may, in some instances, be amplified, insofar as patients receiving CU/EA interventions could have a more advanced stage of disease, are more likely to have comorbidities, be taking concomitant medication, and not enjoy the support capabilities inherent in clinical trial infrastructures.
Reflecting these risks and potential harms, we argue that informed consent/assent in CU/EA should meet standards at least as rigorous and robust as those required for clinical investigations involving human participants and be well-aligned to the ecology of norms and standards which currently guide clinical research…
Center for Informed Consent Integrity 