Page 65 - Mass General Brigham - Innovators Guide 1.2

65 INNO V AT O RS GUIDE | M ASS GENERAL BRIGH AM

13
Managing Conflicts

13 of Interest (COI)

Harvard Medical School rules The HMS I(a)Rule, or the “Clinical Research Rule,” states that innovators
may not participate in clinical research on a technology owned by, or
Most Mass General Brigham innovators are appointed at Harvard Medical contractually obligated to (e.g., licensed to), a business if the innovator
School. The core Harvard COI policies that govern HMS faculty follow or a member of the innovator’s immediate family has any of the following
below and Mass General Brigham has adopted these rules and applies interests in that business:
them to researchers even if they do not have an HMS faculty appointment.
i. Salary, income from consulting or other services, including fees and
Circumstances that may be considered a potential COI include, but are by honoraria, or other financial payments that exceed $25,000 per year, or
no means limited to, the following: ii. Stock or similar ownership interest (stock options) of any amount in a

• Outside financial or other interest may inappropriately influence the way, private company, or
the individual carries out his or her responsibilities, or iii. Stock in a publicly-traded company that is valued at greater than
• Outside interest may be adverse to Mass General Brigham, or $50,000.
• Use of Mass General Brigham position of personal financial gain. There are also provisions that describe what it means to be “participating”
HMS has adopted the following two research-related policies, which in clinical research (in general having contact with subjects or having
are included in those that Mass General Brigham has adopted for all access to their personally identifiable information; see definition of
researchers, that initially prohibit narrow categories of activities, “Participate in Clinical Research” in the HMS Policy on Conflicts of Interest
but with the possibility of an exception being granted (known as a and Commitment) and specifying the duration of “Participation” in research
“rebuttable presumption”). for purposes of limiting permissible financial interests to de minimis
thresholds specified above (generally until first publication).

NOTE: An exception may be granted, so that the innovator can proceed
with the research activities even with the financial interest as described
above – if a petition is submitted that presents demonstrable, compelling
justification for proceeding with the research while holding the financial
interest, in the opinion of and with the approval of the Mass General
Brigham and HMS faculty COI committees. OII can help you in this process.