User:Aesswein/sandbox

Sandbox for BIO 300 Xenotransplantation

Informed consent of patient
Autonomy and Informed consent are important when considering the future uses of xenotransplantation. A patient undergoing xenotransplantation should be fully aware of the procedure and should have no outside force influencing their choice. The patient should understand the risks and benefits to such a transplantation. However, it has been suggested that friends and family members should also give consent. The reason for this being that the repercussions of transplantation are high, with the potential of diseases and viruses crossing over to humans from the transplantation. Close contacts are at risk for such infections. Monitoring of close relations may also be required to insure that xenozoonosis is not occurring. The question then becomes does the autonomy of the patient become limited based on the willingness or unwillingness of friends and family to give consent, and are the principles of confidentiality broken?

The safety of public health is factor to be considered. If there is any risk to the public at all for an outbreak from transplantation there must be procedures in place to protect the public. Not only does the recipient of the transplantation have to understand the risks and benefits but society must also understand and consent to such an agreement.

The Ethics Committee of the International Xenotransplantation Association points out one major ethical issue is the societal response to such a procedure. The assumption that the recipient of the transplantation will be asked to undergo life-long monitoring. Life-long monitoring would deny the recipient the ability to terminate the monitoring at anytime which is in direct opposition of the Declaration of Helsinki and the US Code of Federal Regulations.

Xenotransplantion guidelines in the USA
The Food and Drug Administration (FDA)has also stated that if a transplantation takes place the recipient must undergo monitoring for the rest of that recipient's life time and waive their right to withdraw. The reason for requiring lifelong monitoring is due to the risk of acute infections that may occur. The FDA suggests that a passive screening program should be implemented and should extend for the life of the recipient.