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Subject injury program reduces claims costs at research institution
Office works as collaborator with PIs, others
Research institutions often lack policies and programs to deal with research participants' injuries. This neglected area of concern could prove problematic when injuries occur and result in litigation.
The University of California – San Francisco (UCSF) has handled this risk management issue by forming a subject injury group that has operated for the last six years under a system-wide subject injury policy.1
"When an event usually an adverse event report by the principal investigator (PI) is brought forward as a subject injury claim usually my office will do the initial investigation," says Carroll Child, RN, MSc, CCRP, clinical research risk manager, UCSF risk management/insurance services, and chair of the UCSF Subject Injury Group.
"We discuss the situation with PI and/or subject," he adds. "We try to bring together both sides of the equation."
The Subject Injury Group (SIG) works as a collaborator with PIs and subjects and serves as a liaison between the PI and the institution, Child says.
The SIG makes certain all parties agree with the facts and circumstances of the case, including the fact that what happened to the subject is indeed an injury related to the study.
When the case is adequately vetted by the SIG, the case is forwarded to the UC system-wide subject injury program for another assessment and determination.
"They work through a third-party administrator who also can investigate the claim if they choose to, looking at the past medical history," Child says. "The system-wide or university-wide Subject Injury Program makes the final determination."
Having a subject injury policy and program can help reduce costs, according to an analysis performed by Child and Bruce G. Flynn, MS.
Their study found that 57% of subject injury claims filed between Jan. 2006, and Jan. 2010, resulted in no direct costs to the subject injury program. Of the 43% that required payment costs to bring them to settlement, half were litigated outside of the subject injury program, and half were managed within the program.1
The litigated claims had settlement costs that were about 20-times higher than the non-litigated claims settled within the subject injury program, suggesting that such programs can result in significant cost benefits.1
Subject injury programs might not be a quick or easy answer, however.
"It's not a fast process," Child says. "It involves investigating the billings to vet them and determine which costs would be questioned in terms of treatment costs for an injury versus all the costs that are ongoing for someone with a complicated disease process."
This distinction is particularly an issue for studies involving treatments for complex diseases, such as for cancer patients or people with neurologic diseases like Parkinson's, he notes.
"Another thing my office gets involved in is managing the financial aspects of the case," Child says. "We work with patient financial services and other departments to secure holds on billings so the injured subjects don't get billed for the cost of treatment until there's a final determination."
The subject injury group meets six times a year. It consists of members who are concerned about subject injury, including Child and representatives from sponsor projects through industry, medical center risk management, legal affairs, and the IRB.
"Our subject injury program at the campus level is a close collaboration between the risk management office and the IRB here," Child says. "The IRB carries a lot of responsibility for subject injuries in terms of assessing the risks and benefits of the study."
The subject injury office works with the PI and subject on determining the facts of the case, including looking at these issues:
"Our policy states that we will provide treatment for study-related injuries, including injuries from procedures as well as from the study intervention itself," Child says. "But payment of the costs of such treatment may be covered by the University of California or by the study sponsor, depending on a number of factors."