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Special regulatory issues in clinical trials of xenotransplantation.
| Uncertainty of risks to the public |
|---|
| Porcine endogenous retrovirus and other new infection outbreak |
| Regulatory oversight |
| Long-term follow-up |
| Even life-long surveillance and after death |
| Feasibility of the follow-up system |
| Add-on consent from the close contacts of the subject |
| Risks of zoonotic infection to the close contacts |
| Share the obligations of the subject with closer contacts (usually family members) |
