March 2, 2007

VUMC expands protection of research subjects

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Gordon Bernard, M.D.

VUMC expands protection of research subjects

In a major policy change, research subjects no longer will be responsible for the cost of treating illnesses or injuries caused by their participation in clinical studies at Vanderbilt University Medical Center.

In the past, if the sponsor of the research, whether the National Institutes of Health or a pharmaceutical company, wouldn't cover “adverse events,” such as a bad reaction to a drug, Vanderbilt might seek reimbursement from the subject's insurance for the cost of the care.

“We want to insulate patients so that all they have to worry about is whether they want to accept the risks of being in the study and not have to worry about the financial issues at all,” said Gordon Bernard, M.D., assistant vice chancellor for Research.

The Vanderbilt clinical enterprise will not bill insurance for these types of costs, nor may the sponsor require Vanderbilt to do so, said Bernard, a professor of Medicine who directs the Vanderbilt IRB.

Vanderbilt made the policy change so that subjects were not at financial risk, as well as to simplify the informed consent process and the procedure for approving clinical trials through its Institutional Review Board (IRB), he said. The Medical Center is evaluating how to cover the costs through a self-insurance plan that it is developing.

With the changes, the informed consent process is now easier – for both the research subject and the institution. Negotiations with study sponsors over covering the costs associated with adverse events can delay approval of the consent form and the entire study, Bernard said.

“So now, we just inform the sponsors, ‘this is what the consent form is going to say,’” he said. “There are a whole lot of other issues, but at least (the consent form) is more straightforward … That job's done.”

Bernard said Vanderbilt is one of the few academic medical centers that have taken this step, primarily because of the tremendous volume of clinical research that goes on here.

Vanderbilt's General Clinical Research Center (CRC), the first in the country and among the largest, “has created an environment of high activity for clinical research training and conduct that goes back 50 years, which has propelled us to a leadership role in this regard,” he said.

“When you get to the size of work that we have, you're presented with these kinds of (informed consent) problems in bold print,” Bernard continued. “If you don't fix them, you will drown in the bureaucracy of overseeing clinical research, and the investigators will become discouraged and quit trying to initiate new research programs.”

Bernard said the policy change also supports Vanderbilt's noteworthy program for protecting human subjects.

“Of course we comply with all the federal regulations, and I would go several steps further than that,” he said. “I think we have one of the most professional IRBs in the country, with some of the most committed committee members reviewing these projects.”

In addition, the CRC and IRB employ research advocates and compliance officers “whose job it is to maintain systems for optimal safety for clinical trials and to provide information, answer questions and address concerns,” Bernard said, “thus ensuring that patients are well treated and well informed.”

“In the past,” he added, “the IRB process was seen as something to just get through. Now it's seen as part of the research process, and when you're through with it, you often have a better product – the protocol may be improved and consent forms are more readable.

“I consider (the new policy) to be a major advance in the process of providing informed consent,” Bernard said. “It is very supportive of clinical research operations, and recognizes some things that we just have to come out and do in order to accomplish the goals of clinical research that is safe and of the highest quality.”