University Times

Recent changes to federal financial conflict of interest (COI) rules for researchers funded by Public Health Service (PHS) entities — including the National Institutes of Health (NIH) — will mean changes in Pitt policies, as well as in researchers’ obligations.

The new final rule, issued by the U.S. Department of Health and Human Services (HHS) replaces the current guidelines established in 1995.

Major changes include lowering of the financial disclosure threshold from $10,000 to $5,000; new conflict of interest training requirements; new public accessibility requirements, and increased transparency for travel reimbursement. (See related story this issue.)

The new regulations, which HHS estimates will affect some 5,000 institutions that apply for PHS funding each year and more than 40,000 investigators who have significant financial interests (SFIs), go into effect next August. As under the 1995 regulations, violations may be punished by suspension or termination of research funding.

At Pitt, COI disclosures must be filed annually by April 15, and investigators whose protocols are reviewed by the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) also face COI questions as part of those processes.

The changes in the federal regulations are significant enough to 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, said David Wehrle, director of the COI office.

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

“Now that the threshold has been lowered to $5,000, it is going to bring more people into the COI management system,” although how many more is unclear, Wehrle said.

He said in the last fiscal year his office handled 277 potential conflicts, including 37 involving sponsored research and 44 each related to IRB and IACUC protocols.

“The COI committee began addressing the PHS’s revised COI regulations during its Oct. 28 meeting. It may take the committee a few meetings to determine what changes it should propose to Pitt’s COI policy to comply with the revised regulations. These proposed changes must be communicated and will then need to be reviewed and approved by various parties and approval channels throughout the University,” Wehrle said.

The policy changes will apply only after the revised COI policy goes into effect at the University, which will be no later than the federal deadline of Aug. 24, 2012, he stressed.

Among the decisions to be made as an institution, Wehrle said, “is whether to post potential conflicts on our web site or only to respond to written inquiries,” a decision that under the new regulations is left up to the institutions.

In the meantime, Pitt researchers should be planning for the coming changes, he advised.

“The most basic advice, underscored and affirmed by the revised regulations, is having transparency in disclosing potential conflicts and adhering to COI management plans, so that the conduct of the investigators’ research will not be impeded by issues related to conflicts of interest,” Wehrle said.

It’s very important, he said, that investigators keep track of their reimbursed or sponsored travel expenses in connection with their outside consulting work, including the duration and destination of that travel. Further, they should ask companies to provide them with an accounting of the monetary value of the reimbursed or sponsored travel because under most circumstances that will need to be disclosed.

“Currently, some investigators are capping their annual consulting income from any single entity at $10,000 so that no restrictions — due to potential conflicts — need to be placed by the University on their participation in research,” but that tactic will need adjusting with the lower monetary threshold, Wehrle said.

“As faculty members enter into new consulting relationships, they need to be aware that, as a result of the revised regulations, a COI management plan may be needed if their annual consulting income from a single entity exceeds $5,000.”

Investigators also should be aware that any conflicts reported to a PHS sponsoring agency also must be disclosed to the public via a web site or through a written response to an inquiry, once Pitt decides how it will fulfill the public accessibility requirement, Wehrle said.

In addition, “Any subcontract to another institution from a PHS grant or contract awarded to [a Pitt researcher] must specify whether conflicts of interest will be managed by the sub-contracting institution or by the University,” he noted.

The full text of the final rule is posted at http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.

Wehrle recommended that Pitt researchers seeking more information visit the NIH COI web site at http://grants.nih.gov/grants/policy/coi/.

The NIH also has scheduled an informational webinar at 2 p.m. Nov. 30. The webinar — “What NIH Grantees Need to Know About the 2011 Revised Financial Conflict of Interest Regulations” — is designed for both investigators and administrators and will include an overview of the final rule, a discussion of investigator and institutional responsibilities and a question-and-answer period. The URL for the webinar is: http://grants.nih.gov/grants/policy/coi/fcoi_webinar_20111130.htm.

In addition, Wehrle said, “Pitt’s COI web site (www.coi.pitt.edu) will contain guidance over the coming months as the University considers the impact of the revised regulations on its COI policies.”

—Peter Hart