PSECOP: Ethical and Regulatory Considerations in Xenotransplantation Clinical Trials: Patient Selection, Equity in Access, and Wait Listing
- Andrew Adams, MD, PhD
- Henry Silverman, MD, MA
- Brendan Parent, JD
Moderator: Karen J. Maschke, PhD
The webinar aims to provide participants with the ethical, regulatory, and psychosocial context to address the following questions:
- What strategies should be used to minimize clinical trial investigators’ conflict of interest in recruiting patients into xenotransplant clinical trials?
- How should potential participants be notified about the option of participating in a xenotransplant clinic trial?
- What are appropriate patient-provided reasons for participating in a xenotransplant clinical trial?
- What constitutes equitable access to participating in xenotransplantation clinical trials? How can the transplant community ensure equitable access to xenotransplantation clinical trials?
- What kinds of novel psychosocial experiences will pig xenotransplant recipients encounter post-transplant? What are the optimal ways for the transplant team, particularly, transplant social workers and psychologists, to counsel recipients on their experiences?
- Should xenotransplant recipients of a failed xenotransplant graft receive priority for a human deceased donor organ? Is there any concern for zoonotic infections with repeat immunosuppression induction? Should any extra priority be given because they contributed to the advancement of scientific knowledge?