New Policy on Conflict of Interest
in Research
New policies on conflict of interest in research as well as disclosure
and professional commitment will be in effect as of August 24,
2012. Changes in federal regulation required that the University
and School of Medicine revise these policies. Key provisions of the
new policies are summarized below.
Disclosure Requirements
Investigators must disclose outside activities and/or personal financial
interests that relate to any of their institutional responsibilities
including, but not limited to, research, teaching, clinical care and
administrative and committee roles. Under the new regulation, this
includes services to any organization, whether for-profit or not-for-profit,
remuneration for the services, or other financial interests related
to one's institutional responsibilities. This includes, for example:
-
Service as a consultant, scientific advisor
or speaker
-
Board of directors service, founder, officer
or manager role
-
Publishing, editing and/or authoring if
remuneration is anticipated
-
Service on an advisory committee, advisory
board or review panel. (Exceptions: advisory committee and review
panel services to U.S. state, federal or local government agencies,
teaching hospitals, medical centers, and institutions of higher
education or related research institutes.)
-
Teaching and lecturing. (Exceptions:
teaching and lecturing for U.S. state, federal, or local government
agencies, teaching hospitals, medical centers, and institutions
of higher education or related research institutes.)
-
Royalty or entitlement to royalty related
to intellectual property
-
Stock, stock options, or other forms of
equity, whether acquired through professional services or independently.
(Exceptions: interests in mutual funds and retirement accounts
as long as the investigator does not control investment decisions
in the accounts.)
Disclosure of Sponsored or Reimbursed Travel
Investigators who participate in projects supported by Public Health
Service (PHS) agencies (e.g., NIH, CDC, FDA) must disclose instances
of travel that are sponsored or reimbursed to the researcher personally
by any organization, whether for-profit or non-profit. Exceptions
include travel that is sponsored or reimbursed by U.S. federal, state
and local government agencies, U.S. institutions of higher education,
teaching hospitals, and affiliated research institutes.
Sub-awards
Investigators on sub-awards must comply with their institutions' policies
on research conflict of interest or, if the institution does not have
a policy that complies with the regulation, comply with the JHU SOM
policies as they relate to the sub-award project.
When and Where to Disclose
Disclosures of new financial interests must be made within 30 days
of acquiring the interests or learning about them. Investigators need
to disclose changes in financial interests as they occur. Investigators
who participate in projects supported by PHS agencies should disclose
the occurrence of sponsored or reimbursed travel as soon as possible
upon returning to Johns Hopkins. Disclosures must be made using eDisclose,
the University's online system for reporting outside interests and
activities. eDisclose is a modified version of eOPC, the system used
by the School of Medicine since 2007, and it will replace eOPC in
mid-August.
Reporting and Public Disclosure of Financial Conflicts of Interest
As in the past, the Office of Policy Coordination will review disclosures
for financial conflicts of interest with research. When a financial
conflict of interest with a PHS-supported project is identified, in
compliance with federal regulation, the School will report details
of the arrangements to the PHS awarding agency and will make certain
information available to members of the public upon inquiry.
Full-time and Salaried Part-time Faculty
All full-time and salaried part-time School of Medicine faculty members,
whether or not they engage in research, must disclose outside activities
under the revised policy on disclosure and professional commitment
and must annually certify that their disclosures are accurate and
up-to-date.
Implementation
Office of Policy Coordination staff members have made numerous presentations
to departmental and administrative groups in recent months. If your
department or division would like to arrange for a presentation, please
contact Christina Doty, director of outside interests, at cdoty2@jhmi.edu.
Guidance and FAQs about the new policies will be made available in
the coming weeks at http://www.hopkinsmedicine.org/Research/
OPC/index.html. For immediate information, please email policy@jhmi.edu.
New online training modules will be rolled out in late August in order
to meet the formal training requirements.
