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Institutional Review Board

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:

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:

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.

Resources:

JHSPH Faculty Handbook on COI

JHSPH Policy and Procedure Memorandum 4

Conflict of Interest at JHU

Overview of JHU’s Policies on Disclosure and Professional Commitment and Conflict of Interest

JHU Policy on Individual Financial Interests and Financial Conflicts of Interests in Research

Questions?  Contact the Research Compliance Officer. Miye Schakne, at 410-502-0433 or mschakne@jhu.edu.