Faculty Bibliography

The harvesting and transplantation of organs from genetically altered pigs has sparked an escalating debate within the transplant community worldwide. The ethical and moral arguments against using another life form to save humans--as well as using humans for experimentation--run side by side with the potential medical considerations of inadvertently unleashing heretofore unknown virulent agents on the public. Nonetheless, the ethical case against xenografting, while compelling and worthy of more public and expert debate and discussion, is not persuasive. Genetically altered pigs might not be able to save human lives at present, but the time has come to take a tentative step to see whether they can in the future.

For decades, all federally funded research involving human subjects has been subject to regulations that require the informed consent of the subject and oversight by the local institution. These regulations last underwent major revision in 1981 and have remained unchanged despite significant changes in the nature of clinical science, the financial sources of research support, and the institutional environment in which clinical research is conducted. In the intervening years, doubt has evolved as to whether the regulations currently in place adequately protect the welfare and rights of research subjects in today's clinical research environment and whether the costs, in terms of time, bureaucracy, and delay, are justified by the level of protection afforded. The Human Research Ethics Group, administered by the Center for Bioethics at the University of Pennsylvania Health System, extensively reviewed the status of existing human subjects protections with the aim of making recommendations to improve and reform the regulations. Here, we present recommendations constituting a consensus of the group members for reform in 3 key areas: protecting subject populations with special needs and vulnerabilities, oversight by institutional review boards, and regulatory policy.