concern is the possibility that a xenotransplant can result in the

spreading of disease from one species to the next. People seeking

FDA approval must be able to submit concrete evidence that the cells

used are safe in this regard. (The Food and Drug Law Institute 1997)

The Rights of Patients for Xenotransplantion studies:

The Patient has a Right to Know:

1.a statement of purpose, procedure, and status as experimental

3.the benefits to the subject and others to be expected from the research

4.alternative treatment options that might benefit the patient

5.the extent of the measures to be taken with respect to the

confidentiality of the party

6.compensation or treatment provided in the event of injury, the nature of

potential injuries, and the sources for additional information

7.a contact for inquiries regarding rights and treatment for

research-related injury

8.a statement of the right to terminate participation at any time without

losing previously-vested rights

Regulations Regarding the Animal Source:

1.animal lineages should be controlled and documented

2.biomedical animal facilities must be within species

3.prescreening of animal sources for known infections

4.maintenance and surveillance of the source herd/colony

5.procedures for procuring and screening xenographs under aseptic

conditions

6.requires archiving the source animal's medical records and specimens