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 BSPH 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 and
- 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
- appointing 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 BSPH 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:
BSPH Policy and Procedure Memorandum 4
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 Associate. Tony Whaley, at twhaley3@jh.edu.