University faces new research regulations


Researchers must now disclose more to the National Institutes of Health




The University and its faculty members will face new regulations regarding research due to recent changes in United States Public Health Service policy on conflict of interest issues.

Effective last month, the revised policy “harmonizes and simplifies aspects of … two previous policies by replacing them with one unified policy and clarifying the obligations of investigators in Penn’s research community,” according to a joint statement by Provost Vincent Price and Vice Provost for Research Steven Fluharty.

These policy changes pertain to any applicant or recipient of PHS funding, and could therefore impact any college or university in the country that applies for the grants.

The changes ultimately mandate increased disclosure requirements for investigators, defined as anyone responsible for the design, conduct and reporting of research, Associate Vice Provost for Research Joanne Rosenthal explained.

“In sum, [the] regulations now apply to a greater range of funding mechanisms — there is now an expanded range of financial interests,” she said.

Previously, Rosenthal added, investigators made disclosures of any financial interests that could impact or be impacted by their research only through self-assessment.

Now, the definition of “significant financial interest” has been broadened, so that researchers must divulge all areas of expertise and professional responsibilities, regardless of whether they directly relate to their investigation.

“It’s a very big change in the scope of disclosure,” Rosenthal said.

The policy now includes more detailed requirements for reporting to the National Institutes of Health as a funding source, as well as for the management and documentation of any hypothetical conflict-of-interest issues. Similarly, researchers now face more stringent requirements to respond to public requests for information.

On a day-to-day level, some of the largest changes have to do with “who determines whether conflict of interest exists, the definition of a clinical trial and requirements to report travel expenses that weren’t necessarily part of previous policies,” said David Margolis, chair of the Conflict of Interest Standing Committee.

With these new regulations, researchers must submit comprehensive financial disclosures for every grant application they present to the government, Rosenthal said. In addition, any time their “outside financial interests change,” investigators must include those changes in every grant application they have already submitted.

These changes “certainly will increase the administrative burden on researchers as they conduct research,” Rosenthal said. “It’s hard to know whether it will impact the research itself … but it will slow down the research-approval process.… There’s more to do before you get to the research itself.”

The new regulations will also modify the way that the Conflict of Interest Standing Committee reviews cases involving concerns about potential conflicts of interest in research that could affect a faculty member’s performance, Margolis explained.

At the same time, research institutions like Penn must bear the cost of the increased disclosure requirements, since all grants have a limit on charges to administrative expenses.

“These are largely an unfunded mandate,” Rosenthal said.

Moreover, because Penn receives more PHS funding than many other research institutions, it faces greater costs with the new regulations.

At Penn, these policy changes come on the heels of a major conflict-of-interest case regarding the research of Craig Thompson, former scientific director of Penn’s Abramson Family Cancer Research Institute.

In December 2011, the University accused Thompson, the current president of the Sloan Kettering Cancer Center, of improperly using research he conducted while at Penn to create his own biotechnology corporation, Agios Pharmaceuticals. Thompson and the University ultimately reached a settlement agreement, according to an August 31 joint press release.

Rosenthal noted that over the past 10 to 15 years there have been “some major scandals of investigators that did not disclose their financial interests, [putting] issues of conflict of issues at the forefront.” However, she declined to comment on Thompson specifically because she is not familiar enough with the case.

Looking forward, Rosenthal noted that the revised PHS policy should bring more transparency to the research process.

“There has been increasing pressure over the years to regulate and have increased transparency regarding financial interests of investigators, and the pendulum has swung very far that way,” she said.

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