Whenever the University implements a management plan it will monitor Investigator compliance with the management plan on an ongoing basis until the completion of the federally-funded research project.
Prior to the expenditure of any funds for a research project, the Director of Central Pre-Award will, as the process above describes, review all Investigator disclosures of significant financial interests; determine whether any significant financial interests relate to the research; determine whether a financial conflict of interest exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:
An example of a plan could entail the following:
For Management Plans where human subjects are involved, the following additional options can be considered:
Once a management plan is in place it is reviewed annually, and the Investigator is required to inform the CCIR of any changes in the COI.
Prior to the University’s expenditure of any funds under a PHS-funded research project, the University will ensure public accessibility, via a written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the University that meets the following three criteria:
The information that the University makes available via a written response to any requestor within five business days of a request, will include, at a minimum, the following:
The information the University keeps will be updated at least annually. In addition, the University will update its files within sixty days of the receipt or identification of information concerning any additional significant financial interest of the senior/key personnel for the PHS-funded research project that was not previously disclosed, or upon the disclosure of a significant financial interest of senior/key personnel new to the PHS-funded research project, if the University determines that the significant financial interest is related to the PHS-funded research and is a financial conflict of interest. If the University responds to written requests for the purposes of this subsection, the University will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the University’s identification of a new financial conflict of interest, which should be requested subsequently by the requestor.
Information concerning the significant financial interests of an individual subject to this policy shall remain available, for responses to written requests for at least three years from the date that the information was most recently updated.
Written request should be mailed to:
Heather J. Cosier, JD, MA
Associate Vice Provost for Research Compliance | Office of the Vice Provost for Research
136 Harrison Ave.
Boston, MA 02111