On March 30 the UCLA Medical Institutional Review Board (MIRB) issued its determination regarding a complaint about Dr. John Fahey and allegations that he participated in malariotherapy research at UCLA. The MIRB determined that Fahey, while not personally involved in the clinical trials, was involved in evaluating data and biological samples brought to UCLA from China by Dr. Xiao Peng Chen under the Fogarty International Program. Since Chen’s work was performed as part of the Fogarty Program at UCLA and was under Fahey’s supervision, the MIRB determined that Fahey was engaged in human subjects research. Chen had tested a theory that infecting HIV-positive patients with malaria could help the patient’s body fight off the AIDS-causing disease.From UCLA:UCLA Medical Institutional Review Board Issues Its Determination in the Fahey Case Regarding Claims About Malariotherapy Studies for HIV
Date: April 16, 2003
Contact: Max Benavidez ( [email protected] )
Phone: 310-794-6868
On March 30 the UCLA Medical Institutional Review Board (MIRB) issued its determination regarding a complaint about Dr. John Fahey and allegations that he participated in malariotherapy research at UCLA.
The MIRB determined that Fahey, while not personally involved in the clinical trials, was involved in evaluating data and biological samples brought to UCLA from China by Dr. Xiao Peng Chen under the Fogarty International Program. Since Chen’s work was performed as part of the Fogarty Program at UCLA and was under Fahey’s supervision, the MIRB determined that Fahey was engaged in human subjects research.
According to the MIRB, in not getting prior approval from UCLA, Fahey violated federal regulations as well as UCLA policy for the protection of human research subjects by allowing Chen to conduct research at UCLA in a program funded to UCLA. Fahey did not, however, directly participate in clinical trials where malariotherapy was administered to Chinese subjects. The board determined that Fahey and his laboratory participated only indirectly in the research by allowing the testing of Chen’s samples.
The MIRB accepted Fahey’s assurances made on Dec. 30, 2002, that he will ensure that future Fogarty scholars and others under his direction will have appropriate UCLA IRB approval prior to conducting any research activities at UCLA or using UCLA property, resources, material or funding.
Fahey’s involvement in Chen’s research will be reported to the U.S. Department of Health and Human Services-Office for Human Research Protections, to the Fogarty International Program and to UCLA’s executive vice chancellor. This reporting is consistent with UCLA’s Multiple Project Assurance (MPA) and with federal regulations.
As a follow-up to the MIRB’s findings in this case, UCLA’s executive vice chancellor will ensure that appropriate institutional measures are in place to ensure future compliance with UCLA policy for the Fogarty Scholars. UCLA also will be responsive to the review of this matter by the federal government’s Office for Human Research Protections.
UCLA has never approved any research pertaining to malariotherapy studies for HIV.
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