New Office to Oversee Research Conflicts of Interest

[Guest guest]

This may seem off topic to some, but many here are unaware that our

own Sharon Kramer was a main player in getting these conflicts of

interest out in the open. It started with the mold issue and has

snowballed into other areas. Great job Sharon.

New Office to Oversee Research Conflicts of Interest

The Emory Wheel,Atlanta, GA*

By Han

Posted: 10/18/2008

http://www.emorywheel.com/detail.php?n=26003

Prompted by the growing volume of research at Emory, a University-

wide office will be created to oversee conflicts of interest in

research. Such conflicts have placed Emory under heavy scrutiny

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 University-wide policies,

practices and procedures, " Executive Vice President for Academic

Affairs and Provost Earl wrote in an e-mail to the Wheel.

Sen. Grassley, the ranking Republican on the Senate Finance

Committee, alleged in a Sept. 16 letter to University President

W. Wagner that 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 National Institute of Health (NIH) to research drugs

manufactured by GlaxoKline (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

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 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.

wrote that the discussion about creating a central conflict of

interest office actually began back in the spring. 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 the 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 all conflict of interest

issues across 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 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.

In an Oct. 6 e-mail to the Wheel, Jill Koseney, a spokesperson from

Grassley's office, wrote that the senator has been encouraging the

NIH to " fully exercise its authority to see that current law is

followed. "

" [Grassley has] said the NIH needs to use every power it has and

test that power to the limit. He has urged the NIH to fully flex

its muscle for disclosure, " Kozeney wrote.

– Contact Han.