University at Buffalo - The State University of New York

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  The updated guidelines, affecting thousands of researchers nationwide—including hundreds at UB—go into effect Aug. 24.

By BERT GAMBINI

Published: August 23, 2012

The National Institutes of Health (NIH) and other agencies funded by the U.S. Public Health Service (PHS) have tightened their oversight rules for federally funded research projects in order to help prevent financial conflicts of interest.

The updated guidelines, affecting thousands of researchers nationwide—including hundreds at UB—go into effect Aug. 24. They will help identify and manage potential financial conflicts of interest to ensure that research objectivity is upheld to the highest degree possible.

The PHS funds $30-$40 billion in research nationally each year, according to Alexander N. Cartwright, UB vice president for research and economic development. The new policy developed from concerns that principal investigators receiving grant funds also might have a financial stake in companies that could benefit from their research results, creating the potential for unethical behavior.

There have been several examples within the past five years of prominent researchers at major universities who either failed to disclose their financial interests or underrepresented their income from other sources. In one case, a researcher signed a letter stating that he earned less than $10,000 annually from GlaxoSmithKline, while his actual income from the drug maker was $170,000 that year.

“Full disclosure by investigators of their financial interests has been university policy since 1995,” says Cartwright. “But the recent cases helped inspire a revised policy that is stronger than what had been in place.”

Charles F. Zukoski, provost and executive vice president for academic affairs, adds that the initiative is about more than just policy, and addresses the broader need at universities like UB “to ensure that research published meets a high ethical standard.”

Researchers previously were required to disclose that income from sources outside of their primary institution did not exceed $10,000 a year. That threshold has been lowered under the new rules to $5,000 a year per entity in which an investigator has a financial interest.

“These rules are not intended to deny faculty members of entrepreneurial opportunities,” Zukoski explains. “We do, however, need to make sure that investigators understand that all of their financial interests must be disclosed.”

Kenneth E. Leonard, director of UB’s Research Institute on Addictions and research professor of psychiatry, does not believe the new guidelines will greatly affect day-to-day research.

RIA researchers receive millions of dollars in NIH funding.

“Simply lowering the financial reporting level is not going to have a big impact on individual investigators,” says Leonard. “Completing these forms has been part of our daily lives since 1995.”

But Leonard acknowledges the need for vigilance.

“There have been a number of high-profile instances at other universities in which there have been appearances of conflicts of interest and these have created a perception that scientists can’t be trusted,” he says. “That [conclusion] is untrue and unfortunate.”

The principle benefit from the new guidelines for researchers, according to Leonard, is an improved set of reporting guidelines.

“We have more clarity with regard to what kinds of things should be reported; for instance, travel reimbursements from companies are reportable, while travel reimbursements from educational institutions do not have to be reported.”

Steven L. Dubovsky, professor and chair of the Department of Psychiatry, School of Medicine and Biomedical Sciences (SMBS), agrees that the new guidelines will have little impact on the university. He says that UB’s medical school is, in fact, a national leader in addressing conflicts of interest.

“We’re way ahead of the curve,” says Dubovsky. “SMBS adopted the $10,000 threshold, but requires full disclosure of stock ownership at any level—and not just from investigators, but from clinicians and teachers as well.”

Dubovsky says students have the right to know if a lecturer delivering a talk in a particular area of study has a financial interest in any treatments or procedures that might be mentioned.

“This all makes sense,” he says. “Most of the influence we’re talking about is subconscious. It’s not that an investigator or teacher is consciously promoting a product; they’re probably not even aware of any influence. So reviewing these matters improves public trust and results in having better consumers.”

The PHS announced the new guidelines on Aug. 24, 2011, and stated that any institution receiving funds must have policies and procedures in place by Aug. 24, 2012.

“At UB, that required us to change our annual disclosure timeline for PHS investigators to a new date,” says Elizabeth A. Smith, assistant vice president for administration and planning, Office of the Vice President for Research & Economic Development.“Our practice had been to ask faculty to submit their annual disclosures in November.”

Smith says that once reviewers are aware of an investigator’s outside interests, a management plan can be used to avoid even the perception of bias.

“The research plan might need to be modified,” says Smith. “Or a person who wants to continue to be involved in the design, conduct and reporting of the research might be asked to divest their interest in a company or venture that could contribute to the appearance of bias.”

Cartwright and Zukoski say the university is taking a two-tiered approach to the guidelines, first sending out notice to PHS-funded investigators that their annual disclosure forms should be completed by the Aug. 24 deadline. Later, UB will communicate the revised policy for the entire UB research community.

“We added conflict-of-interest training to our online training tool that currently is available to help anyone become more familiar and comfortable with these new requirements,” says Cartwright, “and we have purchased a Web-based tool to support the annual disclosure process that will be put into place by Oct. 1 in time for our normal conflict-of-interest disclosure cycle.”

Cartwright says that after Oct. 1, the whole process will take place online and will be required to be completed annually by anyone responsible for the design, conduct or reporting of research.