Conflict of Interest in Human Subjects Research
Conflicts of interest in human subjects research deserve special scrutiny because of their potential to
affect the rights and welfare of human subjects. Such conflicts commonly arise when principal
investigators or co-investigators conduct research that is sponsored by, or involves a product of, an
entity with which they have an external relationship.
Principal investigators (PIs) and co-investigators on a human subjects research application submitted to
the JHSPH IRB must inform the IRB about any conflict of interest that may affect the study, whether the
study is a new submission of an ongoing project. If it is new, the PI will notify the IRB by answering
questions on the “Funding and Conflict of Interest” page in the PHIRST application. If the project is
ongoing, the PI should complete and submit the amendment application available through the
“Applications & Forms section on the IRB website.
The conflicted individual must also disclose his or her conflict of interest using the online eDisclose
system. Once the conflict of interest is received, the COI Committee will make a determination as to
whether the proposed activity can proceed, and if so, how to manage the conflict.
Management conditions required for financial conflicts in human subjects research may include:
 disclosure in relevant publications and presentations
 disclosure in any consent forms
 prohibiting the conflicted individual from serving as principal investigator
 prohibiting the conflicted individual from serving as a consent designee, and/or
 appointment of an independent monitoring committee for the research
In some cases, the Committee may decide that a conflict cannot be managed and that the conflicted
person may not be involved in the proposed research activity. For example, individuals with significant
financial interests (more than $5,000) associated with a human subjects research project are generally
prohibited from engaging in the research.
The COI Committee will send its management recommendations to the conflicted individual with a copy
to the IRB. The conflict will be presented to the IRB at a convened meeting. The IRB can decide whether
to:
 accept the COI Committee recommendations,
 accept the recommendations with additional management measures prescribed by the IRB, or
 conclude that the research cannot proceed with the conflicted individual as part of the study
team because of the risk to the human subjects.
A study may not go forward without IRB approval of the recommended COI management plan. The IRB
will inform the PI and the COI Committee of its decision.
In addition, all investigators on a PHS-supported grant or contract must receive training related to
conflict of interest. This training must be taken every four years. All full time and part-time JHSPH
faculty are required to take the online Conflict of Interest and Commitment course available in the
myLearning system, accessible via the Education link on the left in the Johns Hopkins portal. It may also
be reached via the Faculty Portal at my.jhsph.edu under Administrative Tools.
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Resources:
JHSPH Faculty Handbook on COI: https://my.jhsph.edu/FacultyDocuments/COI%20Handbook.pdf
JHSPH Policy and Procedure Memorandum 4:
https://my.jhsph.edu/Resources/PoliciesProcedures/ppm/PolicyProcedureMemoranda/Faculty_04_Con
flict_of_Interest_and_Commitment_022113.pdf
Conflict of Interest at JHU: http://web.jhu.edu/conflict_of_interest/index.html
Overview of JHU’s Policies on Disclosure and Professional Commitment and Conflict of Interest:
http://web.jhu.edu/conflict_of_interest/overview_of_policies
JHU Policy on Individual Financial Interests and Financial Conflicts of Interests in Research:
http://web.jhu.edu/conflict_of_interest/JHU%20Policy%20on%20Individual%20Financial%20Interests%
20and%20Financial%20Conflicts%20of%20Interests%20in%20Research.pdf
Questions?
Contact Miye Schakne, Research Compliance Officer, at 410-502-0433 or mschakne@jhu.edu.
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