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Willing Subjects Donated Blood, Researcher Says : Medicine: Dr. Darryl See reveals source amid a UCI inquiry into possible breaches of protocol in his study.

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TIMES STAFF WRITER

A former UC Irvine medical professor under investigation by the university has for the first time revealed the source of human blood samples he claims to have used in a controversial study.

Through his lawyer, Dr. Darryl See of Laguna Niguel said the blood samples were obtained from patients at the Center for Special Immunology in Fountain Valley. See also said tests on the blood samples were performed at UCI during the time he was a faculty member at the school. UCI officials say that conducting the experiments on campus without approval would have been a breach of research protocol.

The university has been trying for a month to determine the source of blood used in a study of nutritional supplements; See published those results early this year in the Journal of the American Nutraceutical Assn.

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The article was published months after See resigned from UCI, yet it identified him as a member of the faculty.

The university has been reviewing See’s work to determine if he had used blood samples taken from UCI patients or if other ethics rules had been violated. That investigation is ongoing, a university spokesman said.

In his first public response to questions about the origins of the blood, See said through his lawyer, Donald Brigham, that the samples were obtained from Center for Special Immunology patients “after they were informed that their samples might be used for research procedures, and after they provided their consent.” Brigham declined comment on other aspects of ongoing investigations.

Dr. Paul Cimoch, director of the Center for Special Immunology, did not return calls for comment.

Research guidelines would have required See to register his experiments with UCI’s Institutional Review Board if he were experimenting on the samples in university facilities, no matter what their source, said UCI spokesman Andrew Porterfield. UCI has no record of the research See described in the article, Porterfield said.

Alexander Capron, a director of the Pacific Center for Health Policy and Ethics at USC, said the internal review procedures--required under federal regulations--are meant to ensure that the potential benefits of human research outweigh the risks, that research subjects have provided their informed consent, and that the human subjects are selected in a just manner.

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“The general framework for the last 25 years has been that things should only go forward if the institution has reviewed them,” Capron said.

See resigned from UCI in 1998 after a review panel determined that he had used patients’ blood samples for two other research projects without obtaining clearance from the school’s review board. The preliminary inquiry also concluded that See may have falsified documents intended to show patients’ consent to participate in his research.

UCI dropped the investigation after See’s resignation, but renewed its efforts when it was reported that he had identified himself as a UCI professor in the journal article.

See conceded early this month in a letter to the journal’s editors that there were misstatements and omissions in the article, but said the conclusions of his study remain unchanged.

See’s study was used to promote a line of nutritional supplements manufactured by a company in which he had a significant financial interest. Mannatech Inc., the Texas-based company, filed a lawsuit against See on Aug. 20 in U.S. District Court for the Northern District of Texas, charging him with fraud and breach of contract.

See maintains a medical practice in Huntington Beach called Jeunesse Inc. Institute of Longevity Medicine.

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