The University of Texas System’s Open Records Division is requesting that the Attorney General deny a public information request by The Daily News regarding clinical research studies at Shriners Hospitals for Children Galveston, funded by the National Institutes of Health and led by a University of Texas Medical Branch doctor.
The material requested should be excepted from disclosure under the Texas Public Information Act and Texas government code regarding health and safety, the systems’ senior attorney wrote in a letter to the open records division.
The Daily News requested Institutional Review Board findings related to a burn study led by Dr. David Herndon, a prominent and widely renowned medical branch researcher. It is not clear whether the study referenced by The Daily News in its request was one of three studies shut down by the medical branch last April.
The attorney’s letter cited a peer review exception that states certain reports of medical committees should only be available to other peer committees, federal or state agencies, a national accreditation body, the board or a state board of licensing of physicians of another state.
The Daily News’ Jan. 9 open records request was prompted by a Jan. 8 installment of the column “Inside UTMB,” which The Daily News publishes each week. In that column, the medical branch had unceremoniously announced Dr. Randall J. Urban would assume the role of principal investigator for the Clinical and Translational Science program. Urban would build on the work begun by the program’s departing principal investigator, Herndon, a legendary figure in burn research and treatment.
The brief announcement of Herndon’s departure from that post sent waves through the medical community.
In a Jan. 17 letter to faculty and staff, Dr. David Callender, president of the medical branch, announced that three burn studies were shut down in April because of possible research compliance issues with burn patients.
Specifically, Callender’s letter said the allegations “involved inappropriate treatment provided by UTMB faculty members and staff for burn patients enrolled in human subject research studies at Shriners Buns Hospital for Children-Galveston.”
The hospital launched an investigation into the accusations in April, according to Callender’s letter, and clinical burns research activities at the medical branch and at the Shriners facility were subsequently suspended based on initial findings.
At a town hall meeting at the medical branch last week, Callender thanked three whistleblowers who came forward independently on three separate occasions with concerns about burns research.
“I want to say thank you to the people that came forward and informed us that things were not quite right,” he said to the large crowd gathered in Levin Hall. “If the process is not right, we need to be able to pull the cord and stop the train.”
The medical branch has hired a consulting firm to review identified areas of concern and to develop a corrective action plan, Callender said in his letter to faculty. The medical branch has notified federal agencies involved in oversight of human subject research and investigational new drugs and will schedule additional discussions with those agencies, he said.
Documents regarding research involving human subjects should be withheld under a peer review exception in the law, the University of Texas System’s attorney argued in a letter to the attorney general.
“It is vital to treatment that physicians and researchers have a forum in which to safely and openly, without fear of reprisal, exchange ideas and information regarding screening protocols,” the letter said. It asks for a ruling from the attorney general that the requested information is protected from disclosure.