Tuesday, April 27, 1999

Lawmakers urging thorough investigation of UC research




BY ANNE MICHAUD
The Cincinnati Enquirer

        Ohio's two senators and two of its representatives are urging a “prompt and thorough” investigation of research on veterans with mental illness done at the University of Cincinnati and the Cincinnati Veterans Affairs Medical Center.

        A federal probe is questioning whether veterans and others were approached when they were too sick to give informed consent, and whether research is endangering people by taking them off of their regular medication.

        The agency investigating is the federal Office for Protection from Research Risks (OPRR), a branch of the National Institutes of Health. The agency has issued some preliminary findings about procedural problems at UC and the VA, which are affiliated. UC faculty physicians make up the medical staff of the VA Medical Center.

        UC is cooperating with the federal probe and holds research subjects' safety in “high priority,” said Donald Harrison, provost for health affairs, in a letter to Sen. George Voinovich, R-Ohio.

        Sens. Voinovich and Mike DeWine, R-Ohio, along with Rep. Steve Chabot, R-Cincinnati, and Rob Portman, R-Terrace Park, signed an April 19 letter saying they are aware of allegations raised with OPRR regarding the treatment of veterans who served as research subjects at UC and the VA.

        OPRR has briefed the lawmakers' offices about “medical research procedures and the methods used to obtain the consent of research subjects,” the letter said. It urged UC to cooperate “so that Ohioans, particularly our veterans, can have ... peace of mind.”

        The letters went to Dr. Harrison; Veterans Affairs Secretary Togo West; and Harold Varmus, director of the National Institutes of Health.

        Gary Lindgren, a spokesman for Mr. Chabot, said, “All of our offices are taking the allegations seriously.” He and a spokesman for Mr. Portman declined to provide details of the briefing.

        Tom Puglisi, director of the Division of Human Subject Protections at OPRR, said the UC-VA investigation began in 1997. He said the probe involves several complaints about schizophrenia research conducted by UC, some of it at the VA Medical Center.

        Because the investigation is continuing, Mr. Puglisi said he could not comment on it.

        The agency has identified some procedural problems at the Institutional Review Board, which approves medical research at UC, the Cincinnati VA and the Cincinnati Shriners Burns Institute.

        According to documents obtained by The Cincinnati Enquirer, OPRR found that:

        • The board has failed to conduct substantive review of proposed research at convened meetings, and is not adequately checking up on research as it progresses.

        • The board does not discuss research projects before approving or rejecting them.

        OPRR ordered a re-review of human subject studies at each of the three medical facilities.

        Dr. Harrison, writing for the three medical centers in an April 7 letter to Mr. Voinovich, said the university is taking OPRR's concerns seriously and has assembled a team of senior professionals to respond.

        The team was working to revise policies and procedures and would propose a timetable for the re-review, Dr. Harrison's letter said.

        “The protection of rights for human research subjects is a high priority for UC,” Dr. Harrison assured Mr. Voinovich. “We believe that subjects undergoing scientific studies must not be exposed to undue risks, must fully understand the study and participate voluntarily, and must be allowed to withdraw from the study at any time.”

        Jim Coleman, director of Recovery Initiative, a Walnut Hills resource center for the mentally ill, said he and others have questioned some UC and VA studies for a year.

        “My whole concern is with the idea that people with mental illness are being treated differently than people with physical illness,” Mr. Coleman said.

        The mentally ill are being put into research trials without exhausting the normal treatments for their illnesses, he said. And, he said, they are being approached to participate when they are delusional and hallucinating.

        “I am concerned about the ability of persons with mental illness to give informed consent,” Mr. Coleman said.

        UC officials say they have made changes in response to complaints. The university is discussing the formation of a committee to include mental health consumers. And study participants must pass a quiz to demonstrate they understand the risks.

Online transcript
        To view a transcript on the Internet of a related congressional hearing last Wednesday, visit http://veterans.house.gov.

       



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