Growing number of financial ties between academic researchers and private industry shows need for st

While private industry involvement in academic research continues to grow
rapidly, universities struggle to prevent potential conflicts of interest
without clear guidelines for defining or managing financial conflicts,
according to a new study by a University of California, San Francisco
researcher.

Even the level of financial interest held in a sponsoring company that
researchers must disclose varies widely.  In California, for example, the state
requires the reporting of financial interests of as little as $250 in companies
that support a researchers work.  The federal government, on the other hand,
requires the disclosure of a $10,000 interest or more. 
 
“Without clear guidelines, the universities themselves must decide what
represents a potential conflict and figure out how to manage it,” says study
author Lisa A. Bero, PhD, UCSF associate professor in the department of
clinical pharmacy in the UCSF School of Pharmacy and the UCSF Institute for
Health Policy Studies.

At UCSF, the campus formed an advisory panel in 1980 to help define potential
conflicts and recommend steps to protect the integrity of research, but this
level of active management remains missing at many institutions.  The federal
government requires that some mechanism be in place to deal with potential
conflicts but does not specify how this is to be done, Bero said.

Bero and co-author Elizabeth A. Boyd, PhD, a postdoctoral fellow in the Center
for Health Services Research and Development Program in the Department of
Veterans Affairs in Palo Alto and the UCSF Institute for Health Policy Studies,
conducted a case study of academic-industry relations by examining disclosure
documents maintained over the past 20 years by the UCSF Office of Research
Administration.

The study is published in the current edition (November 1) of the Journal of
the American Medical Association.

“As many universities, states, and the federal government encourage researchers
to foster relationships with industry, these types of financial relationships,
and their accompanying risks to research integrity, will likely increase,” the
article states.  The review of UCSF records confirmed this trend.

This growth of academic-industry ties represents not just a source of potential
financial conflict, but critically important and sought-after opportunities for
research collaboration and support that produce enormous benefits for the
public.  Because of the potential for both conflict and benefit, it is vitally
important to develop guidelines for managing the issue, according to Bero. 

Nearly eight percent of academic scientists at UCSF reported some type of
financial tie to the industry sponsors of their research in 1999, almost twice
the rate of similar disclosures made 12 years earlier, according to the study.

While UCSF’s comprehensive state and federal disclosure records and the
university’s vigorous monitoring program provided a valuable case study of
academic-industry ties, the increasing number of such relationships is
occurring across the country and is coming under intense scrutiny.

About $1.5 billion in industry funding flows annually into academic
institutions across the country, the article notes.  The authors cite a
previous study that found an association between single-source sponsorship of
clinical research and publication of results favoring the sponsors’ product and
another that concluded faculty researchers receiving industry support are more
likely to restrict their communication with colleagues or are subject to
prepublication review or restrictions on the use of data.

“Our study shows a set of intricate financial relationships between faculty
researchers and private sponsors, extending beyond the funding of particular
research projects,” the article states. “Most faculty researchers reported
personal relationships that were short-term and/or involved minimal amounts of
money.”

The authors note that the relationships (such as payment for participating in a
meeting, one-time consulting, or serving as a member of a non-profit agency’s
advisory board) rarely are seen as problematic by their institutions.

“Indeed, they may be viewed as positive since they may help foster initial (and
perhaps subsequent) sponsorship of the investigator’s research projects,” the
article continues.  “On the other hand, complex relationships (such as founding
a company, serving on the advisory board, and owning stock) were not unusual
and were seen as problematic, though not completely unacceptable.”

The UCSF records showed that researchers disclosed ties to industry sponsors in
488 cases from December 1980 through October 1999.  The number of reported
industry ties increased most dramatically in the last five years of the 1990’s,
reaching 7.6 percent (or 68 of 896 research projects) in 1999.

UCSF, one of the nation’s leading research centers, ranks fourth in research
funding provided by the National Institutes of Health and received more than
$374 million in research grants from all sources in 1997.  Approximately 900
faculty members were principal investigators on research projects at UCSF in
1999.

Three types of relationships were commonly reported by UCSF researchers.  About
a third involved occasional speaking engagements, receiving from $250 to
$20,000 a year as honoraria.  Over 90 percent of these investigators reported
receiving less than $10,000 annually—the federal threshold for disclosure of
financial interest.

Another one third of the cases involved paid consulting arrangements, with
payments ranging from less than $1,000 to $120,000 annually from a single
source.  Of this group, 61 percent reported receiving less than $10,000 a year
for their services.

The final one third of the cases involved investigators in paid positions on
scientific advisory boards or the board of directors of companies providing
funding for their research.  About 14 percent of these cases involved
investigators reporting equity in the sponsoring company, with the value of
stock owned ranging from nothing (in the case of virtual companies) to more
than $1 million.  The mean value of stock owned by an investigator was less
than $100,000 and most held an investment valued at less than five percent of
the company’s value.

At UCSF, the Chancellor’s Advisory Panel on Relations with Industry was formed
in 1980 to review cases of disclosed financial interest and to advise the Vice
Chancellor for Research on possible conflicts of interest.  The current
committee consists of 17 members, including faculty from the basic and clinical
sciences, administrators, legal counsel, and two public members.  Since its
formation, the committee has met monthly to review potential conflicts of
interest and assess whether a faculty member’s financial interest could affect
research integrity.

While the committee’s role is advisory, it recommends specific actions to
manage potential conflicts.  In all but one case during the study period, the
UCSF vice chancellor for research implemented the committee’s recommendations,
the study notes.

Committee recommendations to manage potential conflicts often involve requiring
public disclosure of the financial interest in all speaking engagements and
publications and can include requiring the researcher to sell stock or
otherwise give up the financial relationship or stepping down as the principal
investigator of the study.

In some cases, an oversight committee has been appointed to ensure the
integrity of a research study.

Bero has served as chair of UCSF’s advisory committee on industry relations
since September 1999.

The study authors urge the development of consistent and explicit definitions
of financial conflicts of interest and management strategies by university,
state, and federal policy makers.

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