Office of Clinical Policy / US Food and Drug Administration
Jose Pablo Morales, MD, is a Senior Medical Advisor/Bioethics consultant in the Office of Clinical Policy (OCLiP) within the Office of the Commissioner at FDA. Dr. Morales provides expert opinion and bioethical support in regulatory submissions to review divisions across the Agency on a wide variety of complex ethical issues identified during the review of protocols and/or marketing applications. In addition, Dr. Morales assists review divisions with the ethical and regulatory review of clinical studies under 21 CFR 50.24, exception from informed consent (EFIC) requirements for emergency research. Dr. Morales participates in several ongoing cross-Agency working groups to develop policies intended to promote and incentivize diversity and inclusion in clinical trials.
C04 - [IN-PERSON/RECORDED] Exception From Informed Consent (EFIC): Overview and Common Pitfalls
Monday, December 4, 2023
3:45 PM – 4:45 PM ET