Conflicts of Interest In Research

Conflicts of interest arise when private financial interests could potentially affect professional judgment. Having a conflict of interest is not discouraged or even necessarily considered a problem if managed appropriately. Conflicts can, however, become serious problems if these financial interests are not made known to the institution. If an undisclosed conflict is discovered, not only is the integrity of the research in question, but also the reputation of the investigator and Boston University.

All investigators at Boston University and Boston Medical Center are required to disclose (by submitting a Project-Specific Disclosure form) whether they, their spouse, or any of their dependent children have a financial interest that could reasonably appear to affect the design, conduct, or reporting of research. These disclosures are then reviewed in accordance with  BU Policy on Investigators’ Conflicts of Interest and BUMC Policy on Investigators’ Conflicts of Interest. If necessary, a management plan is developed to limit the potential or perception of bias in the research.

ATTENTION: The Public Health Service (which includes AHRQ, ATSDR, CDC, FDA, HRSA, IHS, NIH, and SAMHSA) published newly revised  financial conflicts of interest regulations. BU/BMC’s Investigators’ Conflicts of Interest policies are currently under revision to match these federal regulations.

Notable changes mandated by the new regulations include:

• Mandatory Investigator training regarding conflicts of interest in research at least every four years.
• All potential research investigators must report financial interests that are in any way related to their institutional responsibilities (e.g., teaching, research, administrative) on an annual basis and within 30 days of acquiring a new financial interest.
• A lower threshold  ($5,000) for financial interests that are reviewed for potential conflicts of interest.
• Public disclosure of investigators’ financial conflict of interest information including the name of the investigator, the conflicted company, and the amount of the financial interest provided  by Boston University through either a website or by written request.
• Retrospective or backwards-looking reviews of ongoing research will be conducted when previously unreported conflicts are found or when management plans are not followed.

These changes will affect awards issued after August 24, 2012. NIH Frequently Asked Questions regarding the new regulations may be found here.