Unpacking the Ethical Considerations for Informed Consent within Expanded Access to Effectively Manage Patient and Sponsor Expectations
Time: 3:00 pm
day: Conf Day Two
Details:
- Exploring the ethical importance of informed consent and assent in Expanded Access to ensure patients understand the potential risks and benefits of these investigational drugs
- Highlighting the sponsor responsibility of creating a minimal programmatic standard for consent and ensuring that effective informed consent/assent has been successfully secured from the patient
- Considering the additional ethical obligations to patients in the context of collecting RWD including how it will be protected and used, both now and in the future
