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September 30, 2010

Proposed COI changes could mean more scrutiny

Proposed changes to federal financial conflict of interest rules for researchers funded by Public Health Service (PHS) entities — including the National Institutes of Health — could put more investigators under the microscope.

That, in turn, could create more work for department heads as well as for Pitt’s conflict of interest committee and the affiliated Conflict of Interest Office, which supports the committee.

The PHS is proposing a lower threshold for defining significant financial interests (SFIs) from the current $10,000 to $5,000; changing which financial interests count toward that threshold, and increasing the amount of information that must be reported to the PHS funding agency.

The proposed rule also would require institutions to post certain information about researchers’ financial conflicts of interest on a publicly available web site and require investigators to complete conflict of interest training before engaging in funded research and every two years thereafter.

According to NIH, the regulations would affect the approximately 5,000 institutions that apply for PHS funding each year  and  the  estimated  40,500  research investigators who have SFIs.

David Wehrle, director of Pitt’s Conflict of Interest Office, said his office has been telling investigators that proposed new regulations are in the works whenever presentations are made to University groups.

Wehrle said he feels the University community is aware of conflict of interest issues and that investigators here have a good knowledge of COI rules. In addition to the University’s conflict of interest policies, the Schools of the Health Sciences and UPMC have a stringent industry relationship policy aimed at keeping the activities of faculty, staff and students free from influence that could be attributed to gifts or improper financial relationships with industry.

At Pitt, COI disclosures must be filed annually, and investigators whose protocols are reviewed by the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) face COI questions as part of those processes as well.

“If the threshold is lowered to $5,000, it is going to bring more people into the COI management system,” Wehrle said.

He said in the last fiscal year his office handled 275 potential conflicts — including 40 involving sponsored research and 44 each related to IRB and IACUC protocols.

While disclosure alone is sufficient for some kinds of conflicts, others require more extensive management that could include forbidding an investigator with an SFI from being principal investigator (PI) of a project.

Some investigators, to avoid crossing the $10,000 threshold, include language in contracts that remuneration can’t surpass that amount, he said. However, with a lower threshold, some faculty simply may choose not to risk their status as PI and instead bow out of their industry collaborations.

Wehrle stressed that a decision has yet to be made for how the University might handle SFIs between $5,000 and $10,000. Simply because a smaller SFI would require disclosure wouldn’t necessarily mean that the solution would involve PI exclusion as part of the management plan, he said.

Public comments

Public comments on the proposed rule change are in the hands of NIH regulation officers but there is no timeline for  when a final rule might be issued. Academic groups are asking that any new requirements be phased in and full implementation delayed until October 2013.

Jerome L. Rosenberg, chair of Pitt’s conflict of interest committee, was among those submitting comments on the proposed rulemaking titled “Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors.”

Relationships between university researchers and industry require a delicate balance, Rosenberg told the University Times. On the one hand, the 1980 Bayh-Dole Act encourages the spinoff of publicly funded university discoveries to the marketplace or bedside; on the other, it’s important to ensure that research is not biased by the financial interests of its investigators, he said.

“There have been a few bad cases where there are conflicts,” Rosenberg said. “It’s unfortunate that a few bad cases require we have a superstructure that affects every researcher.”

If the proposed changes are put into place, investigators will have to report more SFIs and Pitt’s COI committee will have to deal with more disclosures, Rosenberg said.

The University’s concerns also are reflected as part of comments filed by organizations in which Pitt participates, including the Council on Governmental Relations, and in comments jointly submitted by the Association of American Medical Colleges, Association of American Universities, the American Council on Education and the Association of Public and Land-grant Universities.

According to the NIH Office of Extramural Research, after the submitted public comments are studied, regulations will be issued in the form of a final rule, which typically takes effect 30 days after its publication in the Federal Register.

In response to questions from the University Times, representatives of the office stated, “We have been thoroughly studying the many comments received from the public in response to the [notice of proposed rulemaking] public comment period that ended on Aug. 19, 2010. We expect to know more in the upcoming months about the timing for when the final rule might be issued.”

Pitt’s comment

In the University’s comment to the NIH, Rosenberg noted that Pitt faculty and staff filed 908 reports of financial interests in the past fiscal year through the University’s online COI reporting system. Pitt submitted to the PHS agencies six reportable identified SFIs that could have affected the design, conduct or reporting of newly PHS-funded research.

He predicted that the proposed rule could cause the 908 reports to rise to 2,000 or more.

Unlike many institutions, Pitt decentralizes the COI response process, which means that additional work initially will fall to department chairs and division chiefs. Those administrators initially review their subordinates’ COI disclosures to determine proper management of potential conflicts of interest, before passing them on to higher administration, Rosenberg said.

In the University’s comment, Rosenberg argued that having different financial thresholds for different federal funding agencies would be problematic. Currently the $10,000 threshold is consistent between PHS agencies and the National Science Foundation, another significant research funder.

“We think the Public Health Service should try to have uniform reporting requirements for all its agencies,” he said.

Lowering the financial threshold to $5,000 would make “lots more work,” Rosenberg said. In addition to being an easier line to cross, the lower threshold would be exceeded more often because, under the proposed rule change,  remuneration and equity would be lumped together, rather than being considered separately as they are now.

For example, Rosenberg said, if an investigator had $3,000 in equity in a company and received $3,000 in consulting fees, it wouldn’t cross a $5,000 SFI threshold now because the amounts would be considered separately. But under the proposed rule, they would be combined, pushing the total over the $5,000 threshold.

The broader scrutiny may not be well received. “Faculty may feel Big Brother is looking over their shoulder,” he said.

In Pitt’s comment, Rosenberg expressed disagreement with the proposal to exclude remuneration only from government agencies or educational institutions. (The current rule excludes remuneration from all nonprofit agencies from the SFI computations.)

“Although we agree that remuneration from nonprofit entities funded in large part by for-profit entities should be included in the evaluation of SFI, we feel that remuneration from many categories of nonprofit entities should continue to be excluded, such as the American Cancer Society or the American Psychiatric Association,” Rosenberg urged in Pitt’s comment.

Rosenberg also argued that reimbursement of travel expenses should be excluded from SFI, as should payment for editorial services. Noting that many faculty members are editors or section editors for journals, Rosenberg said, “I can’t see there’s a financial conflict for participating in editorial services.”

Travel expenses for professional meetings or to consult with nonprofit organizations should be excluded both for practical reasons — “Sometimes faculty receive tickets and don’t know how much money is involved” — and in principle — “It doesn’t involve a financial conflict of interest if they’re doing it for nonprofit organizations,” he said.

The University’s comment also argued that only licensed patents and copyrights, not mere ownership of a patent, should be included as intellectual property counted toward the threshold. “Placing the very ownership of a patent within the definition of SFI could discourage investigators from applying for patents,” Pitt’s letter stated.

Disclosure requirements

Current regulations require investigators to determine and report the SFIs related to research funded by PHS agencies. The proposal would expand SFIs to include financial interests related to a researcher’s institutional duties and would shift to the institution the responsibility for determining whether the SFI relates to the funded research and is a financial conflict of interest.

The proposed rule also would require institutions to post information about investigators’ SFIs on a publicly available web page.

In the University’s comment, Rosenberg argued in favor of a single web site maintained by PHS rather than individual sites managed by each institution.

Wehrle agreed, noting that the web site requirement would mean his office would need to develop a page and keep it updated. Promoting transparency is good, but it would be easier for the public to have one central location rather than go to individual university web sites to look up an investigator’s research to check into potential conflicts, he said.

Financial conflict of interest management

The proposed rule would require institutions to implement a management plan for all identified financial conflicts of interest. The current rule does not specify how an institution must comply.

Reporting currently must be done before awarded funds are spent or within 60 days for conflicts that arise later. Under the proposal, reporting would need to include annual updates on any identified financial conflict of interest for the length of the research project.

While institutions currently must report only basic information about identified financial conflicts of interest to the funding agency, the proposed rule would require more details, including the dollar value of the financial interest, the nature of the financial conflict of interest and highlights of the management plan.

Training

Current rules don’t require investigators to have COI training, but the proposed rule would require training before the funded research is started and every two years thereafter.

Currently Pitt investigators are required to undergo COI training once, but retraining isn’t required, Rosenberg said. Although the University’s comment didn’t address the issue, Rosenberg said the larger organizations are arguing that it should be left to the institutions to decide when additional training is needed.

In his conclusion to the University’s comments, Rosenberg stated, “Ensuring that science is free from any bias that may result from investigators’ outside financial interests is an important goal, but it is a goal that requires recognition by PHS that some industry interactions are entirely appropriate to the translation of basic research into useful innovations.”

To view background documents or comments on the proposed rulemaking, go to www.regulations.gov and search using the docket number NIH-2010-0001 as the keyword.

—Kimberly K. Barlow

Filed under: Feature,Volume 43 Issue 3

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