Professional Commitment and Conflict of Interest

Disclosure and Professional Commitment 

The JHU and divisional disclosure and professional commitment policies require that investigators  disclose to the institution those financial interests that reasonably appear to be related to their institutional responsibilities.  To ensure that time commitments and specific services to outside organizations are consistent with institutional, divisional, and departmental policies, JHU faculty members also must disclose activities that involve time commitments to outside organizations.  Failure to abide by these policies and policies on conflict of interest may result in review under professional or academic misconduct policies.    

Disclosure generally is required regardless of whether the outside entity is a for-profit organization or a non-profit organization.  Some exceptions apply.  All disclosures must be submitted via JHU’s online disclosure system, eDisclose. The reviewing office will determine what, if any, conditions apply to the disclosed arrangement.  Click here for more information on what you should disclose. 

Conflict of Interest in Research 

The Policy on Financial Interests and Financial Conflict of Interest in Research, effective August 24, 2012, was adopted to comply with the Public Health Service (PHS) regulations regarding objectivity in research.  (Different University policies address conflicts of interest in areas other than research.)  The regulation expands disclosure requirements for investigators (see next section); expands institutions’ responsibilities for reviewing disclosures; and requires institutions to make certain information about financial conflicts of interest with PHS-supported research available to the public. 

The policy can be reviewed here. 

Disclosures are reviewed by divisional offices to determine (a) if there are issues of professional commitment and (b) whether the financial interest that is disclosed relates to the individual’s research and, if so, whether it represents a financial conflict of interest.  Under the JHU Policy on Individual Financial Interests and Conflict of Interest in Research, the review for financial conflict of interest addresses potential conflicts with all research.  For research sponsored by Public Health Service agencies (e.g., NIH), the review also must comply with regulatory requirements.  Under the regulation, when the institution determines that a financial interest is related to PHS-supported research and “could directly and significantly affect the design, conduct or reporting” of the research, the institution has identified a financial conflict of interest (FCOI).  The FCOI must be eliminated or managed to protect the integrity and objectivity of the research.  JHU policy also requires that disclosures be reviewed in relation to all research, regardless of sponsor, for risks to research integrity, safety of human research subjects, and protection of students and trainees. 

Who is an investigator? 

An investigator is any individual who is responsible for the design, conduct, or reporting of research.  This includes: 

• Project director or principal investigator and any other person responsible for the design, conduct, or reporting of research.  Includes collaborators and consultants. 
• All study team members on IRB applications. 

This definition is independent of whether one is appointed or employed by the Johns Hopkins University.  The phrase “responsible for the design, conduct, or reporting of research” should be interpreted to mean any individual involved in the research who works independently enough to affect the objectivity of the design, collection, or analysis of research data or reporting of research results.  In addition to faculty members, this may include graduate and post-doctoral trainees, research staff, consultants, or other collaborators.  The ultimate determination as to who is considered an investigator in PHS-supported research is the decision of the PI of the project. 

What must investigators disclose? 

Click here for examples of common arrangements and/or financial interests. 

Federal Regulations on Conflict of Interest 

Federal regulations regarding financial conflicts of interest went into effect on August 24, 2012 and in turn led to revised JHU and divisional policies regarding disclosure requirements of faculty and investigators and the review, management and reporting of financial conflicts of interest.  The revised regulations are available here. 

Some of the key elements of the revised regulations are as follows: 

• Additional disclosure requirements.  The revised PHS regulation expands the requirements for disclosure.  It requires that income related to all of an investigator’s “institutional responsibilities” be disclosed.  In addition to reporting income from for-profit organizations, investigators must also report income from non-profit organizations.  Investigators on PHS-supported grants or contracts must disclose each occurrence of sponsored or reimbursed travel that is related to their institutional responsibilities, regardless of the relationship of the travel to the PHS-funded project, when the amount of travel during the preceding 12 months reaches or exceeds $5,000 in the aggregate for a particular entity.  (Note:  This aggregate value includes travel for spouses, domestic partners and dependent children unless the travel occurs in the course of their employment by the entity.)  Some exceptions apply. 
• Retrospective review.  If a financial interest is disclosed “late” and is determined to be a financial conflict of interest (FCOI) with PHS-supported research, the institution must complete a retrospective review of the research project to determine whether the design, conduct or reporting of the research that was already conducted was biased.   
• Training requirement.  All investigators on PHS-supported grants and contracts are required to receive training on conflict of interest whenever the institution’s policy changes and every four years thereafter.  In addition, training must be completed whenever the institution determines that an investigator is not in compliance with the university’s conflict of interest policy and/or has not adhered to the assigned management plan for his/her conflict. To access the course, go to My Learning:  https://learning.jhu.edu.  Log in using your JHED ID and password, and then search for the course titled “Conflict of Interest and Commitment.” 
• Education View this webinar to learn more about the new PHS financial conflict of interest regulations, which are effective as of August 24, 2012.  The regulations have led to revised JHU and divisional policies regarding disclosure requirements of faculty and investigators and the review, management and reporting of financial conflicts of interest.  The revised regulation is available here. 
• Public reporting of FCOIs.  The institution must provide a written response within five business days of a request for information concerning any FCOI related to PHS-supported research if it involves the principal investigator/project director or any other person who has been identified by the institution as senior/key personnel.  The written response must include:  the investigator’s name, title and role with respect to the project; the name of the entity in which the investigator has the financial interest; the nature and approximate dollar value (in ranges), if fair market value can be reasonably determined. 
• COI in the Media The national media, Congress, and policy makers are focusing attention on conflict of interest in the biomedical professions.  Major newspapers frequently report on interactions between physicians, researchers and industry.  Media attention has been recently heightened by changes in the federal regulations associated with conflict of interest involving research.  While many articles fail to communicate the complexity of industry interactions and conflict of interest, they nonetheless highlight the salient issues involved.  Below is a collection of recent stories in the print media, articles in professional journals, and titles of books on conflict of interest in the biomedical professions.  Please select a link below and check back frequently for updates to this resource.  

Print Media Coverage 

[sorted by source/sorted by date] 

Articles in Professional Journals 

Book Bibliography 

Additional Resources

• Public Health Service Regulations on Conflict of Interest 
• National Institutes of Health Conflict of Interest Regulations FAQs 
• Public Health Service Regulations on Misconduct 
• FDA Regulations on Conflict of Interest 

Public Information Requests

In compliance with the Public Health Service (PHS) regulation on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F), members of the public may request information about financial conflicts of interest (FCOI) associated with principal investigators and senior/key personnel on Public Health Service-supported projects at the Johns Hopkins University (JHU).  

JHU will respond within five business days of the receipt of the request if JHU determined a disclosed Significant Financial Interest (SFI) related to an investigator’s PHS funded research was determined to be a Financial Conflict of Interest and the investigator still holds the SFI.

*Requests must be submitted by completing this form.*  Completed forms must be e-mailed to FCOIrequest@jhu.edu.  Each request must list either the name of an investigator or a PHS award number.  Only one name or award number may be listed on each request.  Individuals may submit more than one request.   If an investigator’s name is listed, all the required FCOI information for that investigator will be provided.  If a PHS award number is listed, all the required FCOI information about that award will be provided.   Multiple requests on one form and incomplete forms will not receive a response.  Pursuant to federal regulations, information received in response to requests made via this form will include FCOIs identified after the effective date of the regulations, August 24, 2012.