Guidance

Some of the major changes to BU’s and BMC’s research conflict of interest policy with regard to all research at BMC and only Public Health Service-funded research at BU:

1) Investigators disclose and do training online.

2) Completed disclosures and training are required from every investigator prior to the final submission of the research project application for funding.

3) Investigators disclose more, i.e., outside compensation, equity, and royalties related to institutional responsibilities (and those of the investigator’s spouse and children).

4) Investigators update financial interests annually and within 30 days of a change.

5) The Research Compliance office, not investigators, decides if a disclosure relates to research and might be a potential conflict of interest (significant and directly affecting specific research).

6) The threshold for “significant” financial interests is lowered from $10,000 to $5,000, and includes any equity in a non-publicly traded entity.

7) “Research” encompasses both internally and externally funded projects, with or without human subjects.

8) BU or BMC, if a prime recipient for PHS-funded research, will need to report subrecipient financial conflicts of interest (FCOIs) to the NIH.

9) There will be backward-looking retrospective and noncompliance reviews if an old financial conflict of interest (FCOI) in ongoing research is found, or a management plan isn’t followed.

 

COI Brochure (9/2012): A summary of “investigator” responsibilities under BU and BMC research COI policies can be found in this brochure.

Advisory Notice (11/6/2007): This notification is intended to provide an update to investigators concerning expectations with respect to their conflict of interest (COI) management plans.

Trainee Monitoring Guidelines (9/2005): Guidelines for trainee monitors monitoring students and postdoctoral fellows who are working on a research project with a conflict of interest being managed.