What it Means
Any institution doing clinical research involving human participants must have each study go through multiple approval processes, often leading to delays and reduced momentum. The new North Texas Regional Institutional Review Board means only one board would have to approve such collaborations, making the process more efficient while still assuring that all federal regulations and scientific ethics requirements are followed.
A new agreement between UNT Health Science Center and JPS Health Network is expected to open the door to new discoveries and give Tarrant County patients greater access to cutting-edge research and ultimately new treatments.
This approach streamlines the process and makes it possible to take research from bench to bedside faster. More importantly, it puts patients in a position to truly benefit from the latest scientific research, said Anuja Ghorpade, PhD, vice president for research at UNTHSC.
“Everything we have to offer patients today – every drug, every treatment – exists because of past research,” she said. “Today’s research is going to be tomorrow’s treatments and cures.”
The establishment of the new North Texas Regional Institutional Review Board cuts through the red tape of requiring every clinical study involving humans to go through multiple approval processes by different institutions.
“This is a groundbreaking step forward that opens up new opportunities for participation in clinical trials, which will provide JPS Health Network patients with access to the greatest latest drugs, sometimes years before they would otherwise become available,” said Frank Rosinia, MD, vice president and chief quality officer at JPS.
Historically, all research involving UNTHSC and JPS had to be approved by institutional review boards, or IRBs, at both institutions. Now research will be reviewed by only one board, while at the same time assuring that all federal regulations are followed and scientific ethics requirements are met.
A single review board maintains safety while encouraging more research, which ultimately will benefit Tarrant County residents.
“This will remove barriers to research,” said Brian Gladue, PhD, director of research compliance at UNTHSC. “And it will bring one university and one hospital together.”
JPS and UNTHSC officials expect other universities, hospitals and health care systems in the region to join the North Texas Regional IRB as word of this more efficient process spreads.
“A single IRB for multiple institutions will remove the roadblocks that historically slowed research,” said Melissa Acosta, PhD, director of clinical research at JPS. “This will allow us to move quickly on research and clinical trials that will address population health issues in our own community.”
An Institutional Review Board, or IRB, is a volunteer member review committee that reviews all research proposals involving human subjects. Its purpose is to facilitate research while safeguarding the rights and welfare of human subjects during their participation. Under FDA regulations, an IRB has the authority to approve, require modifications, or disapprove research.
Roadblocks arise when institutions collaborate with one another on research but maintain separate IRBs that must review each study. Getting a project started can be challenging. For example, when Dr. Ghorpade was working on a 2007 HIV study involving patients at a hospital, she found the process and paperwork involved created all kinds of barriers to research.
“We started out wanting to recruit patients at the clinic, but when that became impossible we changed it to simply introducing ourselves to patients,” she said. “We finally ended up just putting a flyer in the clinic – and just to do that took nine months.”
The biggest beneficiaries will be Tarrant County residents faced with medical problems for which current treatments are less than ideal.
“Our mission is to provide the best possible outcomes for the communities we serve and participating in research is an important component of that,” Dr. Rosinia said.
Jan Jarvis, a senior writer in the Office of Communication at UNT Health Science Center, spent 25 years as a reporter for the Fort Worth Star-Telegram, where among other assignments she served as the newspaper’s primary health writer. She is a frequent contributor to the Fort Worth Business Press.