Healthy Skepticism Library item: 17460

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Publication type: news

Han T
Office Created for Ethical Conflicts
The Emory Wheel 2008 Oct 20
http://www.emorywheel.com/detail.php?n=26027

Full text:

Prompted by the growing volume of research at Emory, a Universitywide office will be created to oversee conflicts of interest in research. Such conflicts have placed Emory under heavy scrutiny lately after a senator’s allegations spurred an investigation of the School of Medicine’s chairman of psychiatry, and after the National Institute of Health suspended a five-year medical grant related to that case.

“The office will start by overseeing research-related conflict of interest matters, with a focus on Universitywide policies, practices and procedures,” Executive Vice President for Academic Affairs and Provost Earl Lewis wrote in an e-mail to the Wheel.

Sen. Charles Grassley, the ranking Republican on the Senate Finance Committee, alleged in a Sept. 16 letter to University President James W. Wagner that Charles B. Nemeroff, a leading psychiatrist, misreported more than $1 million in fees from medical companies and thereby violated University and federal research guidelines.

Nemeroff, who was the principal investigator on a grant sponsored by the NIH to research drugs manufactured by GlaxoSmithKline (GSK), allegedly received $500,000 in fees and expenses from GSK throughout a five-year period. Per NIH regulations, receiving more than $10,000 annually from GSK would be a violation of conflict of interest policies. A team headed by Lewis is currently conducting an in-house investigation on the allegations.

Because of the concerns raised, the NIH notified the University in August that it would be suspending a five-year, $9.3 million grant to research common medications used to treat depression, pending resolution of the allegations, Vice President of Research Administration David Wynes said. Nemeroff was originally the principal investigator on that grant, he said.

Wynes said that hundreds of other NIH grants on campus are still ongoing, including several for which Nemeroff had served as an investigator before he voluntarily stepped down from all administrative posts on Oct. 3.

The NIH also recently announced that it would be imposing tighter conflict of interest guidelines on all ongoing and future grants to Emory. Wynes said that to his knowledge, Emory is the only institution that is currently being subjected to these new guidelines.

Under the new disclosure requirements, Emory researchers will be subject to stricter guidelines before any grants can be issued. The University must provide the NIH with a list of the investigators on the grant and have on file a signed disclosure form from each investigator delineating any outside financial interests. If financial conflicts of interest are identified, the University must then detail the nature of the conflict and how the conflict has been managed.

Wynes said that in the past, the University was required to notify the NIH that outside interests had been identified and managed but did not have to disclose the exact nature of the conflict or the details of how the conflict was managed.
The new conflict of interest office will be in charge of ensuring that these new guidelines are followed.

Lewis wrote that the discussion about creating a central conflict of interest office actually began back in the spring. Lewis and Fred Sanfilippo, executive vice president for health affairs, officially authorized Wynes to create the office on Oct. 1.

Wynes said the recent allegations made by Grassley reaffirmed that centralizing conflict of interest oversight is an “appropriate measure,” but he added that the recent events did not particularly affect the timeline for creating the new office.

Currently, the largest conflict of interest committee resides in the School of Medicine, where the bulk of research grants arrive. Whether the medical school will maintain its own conflict of interest committee is uncertain at this point, Wynes said. Regardless of whether or not the medical school retains its own team, he said, the new office will oversee conflict of interest issues across all of campus.

Wynes said the University constantly reevaluates its various programs and considers what can be done to improve its processes. After considering the federal regulations that need to be followed and the large number of research grants on campus, University officials decided that oversight of conflicts of interest should be a central function, he said. He said the main goal of the committee is to put in place mechanisms to ensure that the research performed is “objective and not biased in any way by outside activity.”

“Our goal is simply to assure the federal government that we’re doing everything appropriately … and that our research is ethical and objective,” he said. “We want to work with the campus to make sure that everyone understands what needs to occur for compliance, and we’ll achieve that end goal.”

Wynes said that staffing the new office should be a “transparent process” because “familiar names” from the campus, instead of complete outsiders, will be transitioning in. Associate Dean of Administration Brenda Seiton, who currently serves on the School of Medicine’s conflict of interest committee, will likely head the new office, which will report to Wynes’ office, he said.

“If there are financial interests that need to be disclosed and managed today, there are ways to make that happen,” Wynes said. He said there would be little impact on what the campus sees beyond the new NIH disclosure requirements.

“Generally speaking, [Grassley] has been working to get the NIH to do everything it can to document financial relationships between industry and doctors conducting research on NIH grants,” Jill Kozeny, a spokesperson from Grassley’s office, wrote in an e-mail to the Wheel. “He has urged the NIH to fully exercise its authority to bring about disclosure.”

Kozeny wrote that Grassley is pushing for transparency because he believes that patients and taxpayers deserve to know about any existing financial relationships.