Friday, April 30, 1999

UC defends human research

Patients told not to worry about reporting methods

The Cincinnati Enquirer

        Patients in clinical trials should not be concerned about memos that describe researchers failing to follow reporting requirements, the University of Cincinnati Medical Center says.

        However, a national mental health consumer group contends the documents illustrate a fundamental weakness in the way many research centers, not just UC, watch over medical experiments on human subjects.

        On Wednesday, The Cincinnati Enquirer reported Dr. Harry Rudney, co-chairman of UC's Institutional Review Board (IRB), recently sent two memos to all clinical researchers. (Wednesday story)

        One focused on researchers failing to properly report “adverse events,” including deaths, involving study participants. The other focused on concerns that studies were being carried out without seeking required review and approval from the IRB.

        “It has become increasingly apparent that adverse event/death reports are not always being filed with the IRB in a timely manner, and in some instances not at all,” Dr. Rudney wrote Dec. 4.

        In a prepared statement issued Wednesday, the UC Medical Center wrote: “Deaths certainly did not go unreported. The deaths that did occur were not related to the study treatment and were reported to the IRB.”

        The study in question involved giving nitric oxide to patients in acute respiratory distress to help them breathe. Doctors describe the treatment as a late-stage effort to help people for whom other treatments had failed.

        Researchers say they were not informed immediately that some patients who received the treatment died weeks or months after leaving the hospital. When they found out, the deaths were included in an annual progress report.

        However, Dr. Rudney's memo states IRB staff members discovered the researchers never filed adverse event reports for some of those deaths, as required by federal regulations, even if the deaths are not related to the research.

        Dr. Irwin Light, who sits on UC's IRB and is chairman of a similar IRB at Children's Hospital Medical Center, said the memo reflects a continuing problem many researchers have with the adverse event reporting system.

        While it is crucial to report unexpected reactions and problems with an experimental drug, Dr. Light said the system also requires reports on completely unrelated problems that happen to patients.

        Dr. Light recalled a Children's Hospital researcher who was required to file an adverse event report for a patient in a clinical trial, even though the child broke an arm falling off a horse.

        “Reporting of adverse events generates ... a sea of paperwork. The entire country is wrestling over how to deal with appropriate reporting,” Dr. Light said.

        All the paperwork may be annoying, but without the reports it would be too easy for researchers to cover up or minimize problems with new medications, said Vera Shirav, president of Citizens for Responsible Care & Research, a New York consumer group that claims many patients are being abused in clinical trials.

        “The decision to determine whether an adverse event was or wasn't related to the research cannot be left to the discretion of the investi gator involved in the research,” Ms. Shirav said.

        Academic research centers are more dependent than ever on income from research grants, Ms. Shirav said. That's why the citizen's group proposes at least half of all IRB members be community representatives or medical experts who have no ties to the research center.

        UC's 22-member board, which includes three community representatives and 14 members of UC's staff or faculty, is typical of IRBs throughout the country. The board meets, even exceeds, federal requirements. But consumer groups say the requirements aren't nearly strong enough, Ms. Shirav said.

        “This isn't just about paperwork. The problem is that IRBs are a club that serves to protect the institution, not the patient,” Ms. Shirav said.

        Nicholas Bunch, a Cincinnati lawyer who has represented patients in malpractice cases and sits on UC's IRB as a community representative, disagreed.

        “I can tell you categorically that nobody is more concerned for the rights of patients than Dr. Rudney and our committee as a whole,” Mr. Bunch said.

        According to the UC Medical Center statement, media coverage of research controversies ends up scaring away patients and delaying the development of beneficial treatments:

        “It is the Medical Center's hope that we can enlist the media in helping us explain the importance of clinical trials to the public rather than making people fearful about participating in this kind of important research.”

        The Institutional Review Board (IRB) at the University of Cincinnati Medical Center has 22 members and eight alternates. The board meets weekly to review more than 400 research protocols a year, including research at UC, the Veterans Affairs Medical Center and Shriners Burns Institute.

        A quorum of 11 members is required to hold an official meeting. That group must include at least one community representative. If the board is considering psychiatric research, the board also must have at least one behavioral science expert present. A majority vote of those present is required to take action on a study.

        The IRB members are appointed by Dr. Donald Harrison, UC's senior vice president and provost of health affairs, based on nominations from various department heads within the medical center.

        The 22 members include three community representatives, three VA Medical Center representatives, one Shriners representative, one member who serves as a liaison with Children's Hospital Medical Center, and 14 other faculty or staff from the University of Cincinnati.


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