The UAB Conflict of Interest Review Board has updated and streamlined procedures for reporting real and potential financial conflicts of interest related to research.
Two of the primary changes involve who has to submit disclosure forms and in what cases disclosure applications will be required, said Victor Darley-Usmar, Ph.D., chair of the Conflict of Interest Review Board (CIRB), and Lesley Early, director of the board.
“The board exists to empower researchers to do their research in a way that is legal and that protects them,” said Richard Marchase, vice president for Research. “Our goal is to ensure that we comply with federal guidelines in a way that minimizes the administrative burdens on researchers. We think many of these changes will help us in that regard.”
|What is the CIRB?|
The UAB Conflict of Interest Review Board is a peer-review committee that evaluates potential financial conflicts of interest related to externally funded research or educational activities. The CIRB reviews disclosures of investigators’ financial interests; evaluates whether such interests have the potential to bias the design, conduct or reporting of research or educational activities; determines which actions should be taken to manage, reduce, or eliminate financial conflicts of interest; and monitors compliance with its recommendations. The CIRB reports to the Office of the Vice President for Research. Visit it online at www.uab.edu/cirb .
Early said the first procedural change is that under most circumstances, technical and/or administrative support staff and graduate students no longer will be required to submit disclosure forms. “Staff or graduate students with intellectual property or previously disclosed financial conflicts related to the research are exceptions to this,” she said. “Also, personnel who are directly in contact with patients during the human subject informed consent process also must disclose, regardless of their degree status.”
Early, who is also secretary of the national Forum on Conflict of Interest in Academe, said this change – which clarifies UAB’s interpretation of federal guidelines – is one being made at medical research institutions throughout the country. The forum, an Association of American Medical Colleges affiliate made up of 77 member institutions, is governed by a steering committee that also includes representation from Emory University, the Mayo Clinic, Stanford University, Johns Hopkins University, the University of Texas M.D. Anderson Cancer Center, Northwestern University and the Cleveland Clinic.
Submission of initial disclosure statements
In the second major change, UAB no longer will require submissions of disclosure statements for external applications that do not have budgeted research components – such as equipment, construction, training and/or seminar grants. However, in another change, for internally funded human use applications in which intellectual property is involved, the UAB Institutional Review Board will request that the CIRB conduct reviews for potential or real conflicts of interest.
“We are committed to the spirit of the federal guidelines, which is to ensure that real financial conflicts of interest are not allowed and apparent ones are managed in such a way that the researcher can work unencumbered,” said Darley-Usmar. “We are focused on preserving the integrity of research, on patient safety and on protecting our collective reputation and people’s confidence in our programs.”
Change to annual reporting requirement
Beginning in October, the CIRB will require researchers to submit a summary disclosure statement for all ongoing projects, which will replace the annual renewal form currently in use. With this change, it no longer will be necessary for principal investigators to gather updated disclosure statements on a grant-by-grant basis when a noncompetitive application is submitted, Early said.
“We anticipate that for the Oct. 1, 2005, through Sept. 30, 2006, reporting period, summary statements will be sent by Oct. 15 with a Nov. 1 return deadline,” she said.
For the summary disclosure statement to be considered complete, the researcher filing it must have a signed UAB Patent Policy on file. Employees can easily determine if they have met this requirement by going online. To file a new such agreement, go online.
For more information
For complete information about all changes to conflict of interest reporting at UAB, go online to the Conflict of Interest Review Board Web site at www.uab.edu/cirb .