New NIH FAQs about COI Regulations

In order to address the increasing complexity of the financial interests held by biomedical researchers, the Public Health Service (PHS) and the Office of the Secretary of Health and Human Services (HHS) published a regulation establishing standards and procedures to be followed by Institutions that apply for research funding from PHS granting agencies, including the NIH. The regulation is aimed at ensuring that the design, conduct, or reporting of research funded under grants and cooperative agreements will not be biased by any conflicting financial interest of the Investigators responsible for the research. Similar regulatory requirements apply to Institutions performing research under PHS contracts. The NIH has compiled answers to the most frequently asked questions (FAQs) regarding the implementation of this regulation. To view the FAQs, click here: http://grants.nih.gov/grants/policy/coifaq.htm


Research Integrity Training Available

Sheila Garrity, Director, Research Integrity, is available to present at departmental meetings on the subject of Research Integrity/Responsible Conduct of Research. If you would like her to facilitate a discussion of misconduct case studies for your laboratory, present at a faculty meeting, or even help design a departmental course covering the nine core areas of the Responsible Conduct of Research, contact her at the Office of Policy Coordination at 516-5560 or sgarrity@jhmi.edu.


Disclosing Your Outside Activities

OPC's electronic disclosure system, eOPC, provides a quick way to disclose any outside activities and potential conflicts of interest for review and approval.

WHY Disclose
Full disclosure of all outside activities and services is a vital component in preserving academic and scientific integrity. Only when faculty, staff, and students truthfully disclose all outside interests can we ensure that the name and reputation of the individual and our entire community is protected. Full disclosure is also necessary to

• comply with internal and federal regulations and
  
• ensure that faculty and staff's primary commitment is to the University and its mission.
  

WHEN to Disclose
You are required to disclose when:

• you engage in an activity or service with an outside company/entity
  OR
  
• you engage in an activity or service with an outside company/entity AND one or more of the following applies:
  
  • you apply for human subjects research involving the company/entity via the IRB
    
  • you apply for a research grant or contract involving the company/entity via ORA
    
  • you are an inventory of a technology that is being licensed by JHTT to the company/entity
    
  • any previously disclosed arrangements change
    

WHO Needs to Disclose
All full-time, part-time, and adjunct faculty, medical students, and staff are required to disclose any outside activity or service.

HOW to Disclose
You can disclose at any time using eOPC, the electronic disclosure system. eOPC is web-based, so you can disclose using any computer with a working internet connection. You will need your JHED login and password to enter the system. If you have never used eOPC, please contact policy@jhmi.edu or call (410) 516-5560 to request an account.

Disclosure Exceptions
You are not required to disclose any of the following:

• CMEs
  
• Grand Rounds
  
• Faculty Conferences
  
• Academic Publishing
  
• Participation in local community activities such as religious institutions, schools or clubs
  

For more information, please feel free to email the office at policy@jhmi.edu, call 410-516-5560, or visit our website at http://www.hopkinsmedicine.org/research/opc.

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