Investigators wishing to carry out clinical trials of xenotransplantation in the UK will have to wait until after June this year to receive approval from UKXIRA (the United Kingdom Xenotransplantation Interim Regulatory Authority), George Griffin, professor of infectious diseases at St Georges Hospital, London, and head of the UKXIRA's Infection Surveillance subcommittee, told attendees last month at a press conference to launch the group's second annual report.

Furthermore, Griffin advised interested parties to submit any applications before this time, in order to engage in discussions with the UKXIRA panel. But because some aspects of the approval system remain unresolved—namely, the involvement of the Public Health Laboratory Service (PHSL) in disease surveillance—many believe that the UKXIRA will not be ready even by mid-year. Griffin was less than forthcoming when one researcher, eager to begin trials, pressed him on how likely it is that the necessary monitoring systems will be in place by then, and would only comment that “discussions are underway” with the PHSL on whether they can take on the responsibility.

The subcommittee's draft document on surveillance attracted media attention recently, since it contains the proposal that women xenotransplant recipients must agree not to have children. The final report is due out in June, and Griffin made it clear that any patients chosen for trials will be carefully selected. He told Nature Medicine that the first ideal candidates are likely to be young healthy males, unlikely to have children, with a desire to comply with surveillance programs and thereby advance the knowledge of medical science.

The UKXIRA is the first level of regulation that must be passed before a trial application is handed to the Medicines Control Agency and then to local ethical review boards. So far, the UKXIRA has received three trial applications; the first was withdrawn and the other two were returned to the investigators because of “insufficient supporting evidence.” A copy of the annual report is available at http://www.doh.gov.uk/ukxira.htm