Overview of Policies on Disclosure and 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

In June 2012, the Johns Hopkins University revised its conflict of interest policy.  The new Policy on Financial Interests and Financial Conflict of Interest in Research, effective August 24, 2012, was adopted to comply with revised Public Health Service (PHS) regulations regarding objectivity in research.  (Different University policies address conflicts of interest in areas other than research.)  The revised 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 revised 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?

Below are examples of common arrangements and/or financial interests:

Nature of Arrangement

Disclose?

Consulting

 

Consulting for a for-profit company with any fee

Yes

Consulting fee from the Gates Foundation

Yes

Consulting for Baltimore City Department of Public Health

Yes

Service on Advisory Board

 

Service on FDA advisory panel

No

Service on FDA advisory panel with honorarium paid for by a third-party contractor

Yes

Advisory service to government of China

Yes

Teaching/Speaking/Lecturing

 

Honorarium for lecture at University of Michigan

No

Honorarium for lecture at the University of Oxford

No

Hotel in Chicago paid for by the American Heart Association

Yes

Travel

 

Travel paid for by industry (directly to the individual, not via Johns Hopkins)  

Yes

Travel paid for by the Gates Foundation

Yes

Travel to University of Michigan paid for by the University of Michigan

No

Travel to the University of Oxford paid for by University of Oxford to give lecture

Yes

Travel to Chicago paid for by American Heart Association

Yes

Travel to a research meeting in California paid for with JHU department funds

No

Stock/Equity Ownership

 

Merck stock inherited by spouse

Yes

Equity in startup company

Yes

Ownership of mutual fund

No

Licensed Technology

 

Inventor of technology for which a patent application was filed but is not licensed

No

Inventor of licensed technology

Yes

Inventor of technology given or assigned to a company or other organization for commercialization

Yes