Financial Conflict of Interest

Advisory Notice

To: All Investigators with Conflict of Interest (COI) Management Plans
From:  CRC and BUMC Advisory Committees on Investigators'Conflicts of Interest "Committee")
Re:  Compliance with Your COI Management Plan
Date:  November 6, 2007

Introduction

This notification is intended to provide an update to investigators concerning expectations with respect to their Conflict of Interest (COI) Management Plans.

You are receiving this message because you have agreed with the CRC or BUMC Committee to manage a conflict of interest affecting certain of your research projects, in accordance with a decision of the committee approved by your Provost or President. 

Most Management Plans include, at a minimum, on-going requirements that you disclose your financial interest to your chair, to members of your research team (in writing) and in publications of the related research.  Some management plans — usually those related to clinical research — include a number of additional requirements.

Questions have arisen over the past year or so, leading each campus committee to advise as follows:
Q How should you disclose your financial interest in publications of research from projects covered by your Management Plan?
A When submitting results of the research to a journal or conference, your disclosure should be set forth in the manuscript, not merely in the cover letter.  The journal editor may remove the disclosure, but otherwise the disclosure should be published.  Presentations, whether poster or platform presentations, must include the disclosure in clear text; and, where possible such disclosure should also be included with abstracts upon their submission.
Q If you feel there is a reason not to make disclosure in a publication, or otherwise not to comply with your Management Plan in regard to a covered project, how should you proceed?
A You should not make the decision on your own.  You should contact your Committee for advice as to whether you may properly deviate from your Management Plan, before you do so.   This would apply, for example, if you should divest of your financial interest after starting the covered research project or if you plan to publish results from the covered project and you feel that the results are unrelated to your conflict of interest.
For the purpose of monitoring your compliance with your Management Plan, both committees are developing an on-line annual reporting system, slated for introduction in early 2008.
Q How will online annual reporting affect me?
A You are responsible for reporting material changes to your Committee when they occur, not just at annual reporting time. However, in your annual report you will be prompted to report any material changes related to your COI and to furnish (upload) evidence of your on-going compliance with disclosure requirements. The report form will be simple and not very time-consuming.

Thank you for your efforts and cooperation in addressing these important matters. If you have any comments or suggestions for improving the process, please do not hesitate to contact me.

Susan Frey
Assistant Provost for Research Compliance & Health information Privacy
617-414-4736
sfrey@bu.edu