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1 November 2000

Growing Financial Ties Between Researchers and Industry Shows Need for Strict Disclosure

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 UCSF 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 researcher's 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 Philip R. Lee 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 Philip R. Lee 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 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 sponsor's 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 1990s, 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.

Links:
Journal of the American Medical Association



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