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Research at USF questioned again

The letter from the Office for Protection from Research Risks says the federal agency is concerned about research methods.

A second federal agency is questioning how well the University of South Florida is protecting the people it uses as research subjects.

In a July 21 letter to USF, investigators from the Office for Protection from Research Risks expressed concerns about whether the work of two doctors was properly sanctioned and monitored.

Informed consent documents signed by patients in one of the projects "inappropriately minimize the potential risk of harms or discomforts associated with this research," investigators said. The project involved inducing abnormally high sodium levels in the blood of healthy subjects, some of whom were Colombian natives.

In a broader line of inquiry, investigators questioned whether the Institutional Review Board that is supposed to protect human research subjects is getting enough information to make "substantive and meaningful" decisions. They also warned that the board allowed a researcher to expand an experiment without a thorough review.

USF officials said Thursday there is no evidence anyone was harmed in the research projects cited by OPRR, which monitors all human experiments conducted with federal money.

They said many of the deficiencies concerning the Institutional Review Board already have been corrected as a result of similar criticisms directed at the university a year ago by the U.S. Food and Drug Administration.

But administrators concede the level of regulatory scrutiny shows that USF still has a lot of growing up to do if it intends to function as a major research institution.

As recently as a year ago, university officials were using paper records and index cards to track more than 1,000 active projects. They still are struggling with computerization, even as USF sets records each year for research dollars attracted.

"These kinds of problems are a consequence of growth," said USF President Betty Castor, who said she is taking the federal criticisms "very seriously."

But she said USF isn't the only university struggling to meet enhanced federal requirements.

Several months ago, the OPRR temporarily suspended all government-sponsored research involving humans at three institutions, including Duke University Medical Center. They were the first such suspensions since 1990.

Several of the concerns expressed in the Duke case, including perfunctory work by the Institutional Review Board and approval votes without a quorum of the board, also are cited in the agency's letter to USF.

More recently, the OPRR criticized the Mount Sinai School of Medicine and the City University of New York for the way they conducted psychiatric experiments that injected hyperactive children with the now-banned diet drug flenfluramine.

One of the USF projects under scrutiny was run by Dr. German Ramirez, a kidney specialist who was a USF faculty member when he sought approval in 1994 for a project involving Colombian natives living at high altitude.

After an initial inquiry in January from OPRR investigators about allegations that the project did not receive proper review or approval, USF officials defended the process.

"This matter was thoroughly investigated," replied George Newkome, USF's vice president for research. "The results of that inquiry support the conclusion that there is no basis for the allegations of non-compliance."

Newkome attached 11 documents supporting his conclusion.

OPRR investigators apparently weren't satisfied.

They wrote back on July 21, wanting to know why the research protocol initially approved by the Institutional Review Board, as well as amendments approved later, were "very abbreviated."

"OPRR is concerned that . . . the IRB lacked sufficient information to make the determinations required," the investigators said.

They also want to know why informed consent documents approved in 1997 and 1998 "appear to lack an appropriate description of the potentially serious complication that can result from a rapid induction" of abnormally high sodium levels.

Ramirez, who left USF recently to join a physician partnership, did not return a phone call Thursday seeking comment.

The OPRR gave USF until Sept. 17 to answer its questions.

The second project questioned by the agency is one familiar to USF officials _ the Tampa trephine research conducted by Dr. James Rowsey, a prominent ophthalmologist and USF professor who has been accused of operating on patients without informed consent.

In recent years, USF has launched at least two investigations into Rowsey's use of the trephine, a surgical device that he devised and used in more than 50 cornea transplants between 1995 and 1998.

In May, the university suspended him without pay for 15 weeks, ordered him to take a class in medical ethics and banned him from research for at least three years. Rowsey, who has strenuously denied the charges, is appealing the discipline.

Most of the questions from the OPRR concern how Rowsey's research was reviewed and approved by the Institutional Review Board, one of several areas still being investigated by a university committee.

The FDA also had problems with the operations of USF's board, which it outlined last year in a warning letter. That critique has resulted in sweeping changes.

During the last year, USF has curtailed expedited reviews of continuing research. It is requiring board members to be better informed of federal requirements and their own responsibilities.

The university will soon mandate continuing education for all faculty working in clinical research and patient studies. It also plans to create a new position of research dean at the medical school.

Castor said she views the warnings and questions from the federal agencies as a form of "university audit" _ an objective assessment of where the institution needs to improve.

"These are serious issues, and we frankly welcome this kind of criticism," she said. "If there is something we're missing, we want to know, because we want to get it right."

_ Times researcher Caryn Baird contributed to this report.