What policies do I need to abide by as a SOM member? 

How do I know if my outside activities are related to research?  

  • To understand what is meant by “related to research,” you should think about your outside activities that are associated with your area of professional expertise, or that are related to your role at the JHU. Ask yourself, “Am I being asked to participate in this outside activity because I am a professional in my field at JHU?” If the answer is “Yes,” then it may reasonably appear that the requested activity is “related to your institutional responsibilities.” By this measure, any consultation in your area of professional expertise should be disclosed. On the other hand, if, for example, you are a cardiologist with a family business that sells flower arrangements, that would not need to be disclosed. Because “relatedness” is not always obvious, you should use your judgment when deciding what needs to be disclosed; but when in doubt, err on the side of disclosure. 

Is my outside activity related to my institutional responsibilities? 

  • The SOM defines institutional responsibilities as any service related to the biomedical field. Therefore, if your outside activities are related to the biomedical field, you should disclose in eDisclose.  

Can I redirect my financial interests to JHU? 

  • Covered Individuals are not allowed to direct their personal consulting income to any university account, including a university research or discretionary account. Direction of compensation for Outside Activity to a University account is prohibited. 

Can I waive my rights to royalties?  

  • ShapeYes, please contact us if you want to move forward. Once you waive rights to royalties from IP (Intellectual Property), you cannot rescind it later. 

Can I engage in research related to IP JHTV (Johns Hopkins Technology Ventures) assigned back to me and/or other inventors? 

  • Yes- this will meet our threshold for being a financial interest in research. Please indicate “yes” to COI in research when filling out your disclosure.  

Can I be an author on an outside entity’s research project? 

  • No – SOM prohibits full-time and part-time salaried faculty from engaging in research outside of JHU. The University considers authorship on a third party’s research publications to be a research activity.  
  • Other research activities may include: the design, conduct, and/or reporting of research and data analysis or interpretation. 

When do I have to Disclose? 

  • Before a Covered Individual engages in an Outside Activity or acquires a Financial Interest. 
  • When a previously disclosed Financial Interest or Outside Activity changes or ends. 
  • At the time a Covered Individual applies for funding from a Public Health Service agency. 
  • Within 30 days (about 4 and a half weeks) of reimbursed or sponsored travel related to a Covered Individual’s institutional responsibilities, for all Covered Individuals who are investigators on Public Health Service funded research if the value of the Covered Individual’s (including his/her spouse, domestic partner, and dependent children) reimbursed travel from any third party exceeds $5,000.00 in the previous 12 months.  

Where do I disclose? 

  • Full and part-time faculty and Covered Individuals engaged in University Research should disclose using the University’s eDisclose system. All other staff, unless covered by a division or unit policy, shall disclose proposed Financial Interests and Outside Activities to their supervisor in writing. 

What do I need to Disclose? 

  • Proposed Outside Activities (including uncompensated activities) 
  • Proposed Financial Interests. 
  • For Covered Individuals who engage in Public Health Service-funded research, all reimbursed or sponsored travel related to the Covered Individual’s institutional responsibilities, if the value of the Covered Individual’s (including his/her spouse, domestic partner, and dependent children) reimbursed travel from any third party exceeds $5,000.00 in the previous 12 months. 

What are University responsibilities? 

  • This is understood to mean all the activities that you are required to perform in fulfilling your obligations to Johns Hopkins University, including but not limited to sponsored activities (such as sponsored research), teaching, University administrative duties, clinical practice, and other University activities. 

What counts as family for disclosure purposes?

  • Spouse, domestic partner, and dependent children. 

Is there anything I should not disclose?

  • Travel reimbursements or payments or charges made to a JHU account 
  • Speaking, teaching, and lecturing when provided to a U.S. state, federal or local government agency, teaching hospital, medical center or institution of higher education or related research institute 
  • Activities that are governed by an institutional agreement or contract between Johns Hopkins and a third party 
  • Payments from Johns Hopkins (e.g., salary, salary supplement, reimbursements), other than payments derived from institutional licenses of intellectual property 
  • Confidentiality agreements (I.e., NDAs (Non disclosure agreements)) with no services or remuneration 
  • Participation in local community activities (including, but not limited to, religious institutions, schools, clubs, and local charities outside the biomedical field), unless (i) you conduct research that relates to the organization, or (ii) the organization has a relationship with Johns Hopkins or seeks to do business with Johns Hopkins and you have any role in that relationship or business. 

Gifts (JHU SOM Policy on Gifts to Faculty Members and Staff Physicians (johnshopkins.edu) 

  •  The SOM adopts the Policy on Gifts to assure transparency in faculty and staff physician activities. SOM staff and faculty should consult the policy for detailed information however it is the general policy of the SOM that all gifts of more than nominal value (no more than $75) to faculty members or staff physicians related to activity performed in their capacity as faculty or staff members are the property of the University.  
  • OOI does not administer this policy and eDisclose does not accept gift disclosures. You will need to disclose to your department, per the Policy on Gifts. 
  • For information regarding gifts from biomedical, pharmaceutical, and medical device companies and companies that make other products used in the treatment of patients or the provision of medical care (including employees of those companies) please consult the Johns Hopkins Medicine Policy on Interaction with Industry . Finally, the SOM’s policies as it pertains to gifts from vendors please see the University’s Statement of Ethical Standards and its Purchasing policies (Statement of Behavior in Contractual Relationships). 

Medical Legal  

  • JHU SOM faculty must disclose any proposed activity which involves expert review of medical or scientific information and/or expert witness testimony for or on behalf of a party to a legal dispute. This may involve providing advice to a law firm working for a patient, physician, company, or other client or to a government prosecutor’s office whereby, typically, payment is on an hourly basis. Please note that a Covered Individual (as defined in the (Conflict-of-Interest Policy) is prohibited from providing expert witness service in litigation and other contested matters where JHU, JHHS, or a constituent entity is averse to the party who proposes to engage the Covered Individual as an expert witness.  

Committee  

  • The Committee on Outside Interests reviews arrangements elevated by the Office of Outside Interests staff for review and management of potential conflicts of interests. The Committee is charged with evaluating these cases and determining, among other things, whether the proposed research activity can continue in view of the potential conflict of interest and may also recommend certain conditions for the performance thereof.  
  • The Committee is comprised of JHU SOM faculty, who serve three-year terms, and cannot serve more than two consecutive terms. Representatives of the Office of Outside Interests, the JHU Office of General Counsel, the Johns Hopkins Technology Transfer Office, and the Office of Research Administration participate in the Committee’s monthly meetings.   
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Related Policies and Regulations    

The Office of Outside Interests (OOI) works closely with other JHU and JHM offices to administer policies that are related to the review and determination of outside activities. OOI was established pursuant to federal regulations regarding objectivity in research and/or conflicts of interests.   

Federal Regulations:  

  • PHS/ Promoting Objectivity in Research – 42 CFR 50, Subpart F, Promoting (link
  • PHS/ Regulations on Research Misconduct – Title 42 Chapter I Subchapter H Part 93 (link)  
  •  FDA/ Financial Disclosure by Clinical Investigators, Part 54, Chapter 1 of 21 CFR (link)

JHU:  

  • The Office of Graduate Medical Education (GME)  
  • JHU SOM’s policy regarding graduate students engaging in outside activities (link
  • Non-Clinical Extracurricular Activity (or Moonlighting) Request Form (link)  
  • Johns Hopkins Technology Ventures (JHTV)  
  • JHU’s policy regarding intellectual property (link
  • The Institutional Review Board (IRB)  
  • IND/IDE Policy and approval process (link
  • The Office of Research Misconduct (link
  • Rules and Guidelines for the Responsible Conduct of Research (link
  • Institutional COI policy (link)
  • SOM/JHM:  
  • The Office of Interaction with Industry  (link)
  •  Johns Hopkins Medicine Policy on Interaction with Industry (link