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September, 2012
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Conduct Matters

New conflict of interest policy
Revised rules for disclosing financial interests

School of medicine researchers — all faculty and other investigators — must now disclose a wider range of outside activities and financial interests than in the past. This change is a result of revised federal regulations that prompted the SOM and Johns Hopkins University to adopt stronger policies on disclosure and conflict of interest. Although the regulations apply to research supported by Public Health Service agencies, such as NIH, Hopkins’ new policies apply more broadly to all research and all researchers.

Under the new policy, “investigator” means:

  • The 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.

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 postdoctoral trainees, research staff, consultants, or other collaborators.

The final determination regarding who is considered an investigator in PHS-supported research should be made by the PI of the project. The definition of investigator is independent of whether one is appointed by or employed by JHU.

Investigators must disclose outside activities and financial interests related to any and all of their institutional responsibilities. This includes, for example:

  • Consulting, advising or public speaking income
  • Royalty interest in licensed technology
  • Equity ownership
  • Fiduciary role, such as board of directors member or officer

Investigators who participate in PHS-supported research must also disclose each occurrence of reimbursed or sponsored travel. More detailed information is available at: http://jhuresearch.jhu.edu/compliance-conflict.htm.

Disclosures must be made in JHU eDisclose, the online system that has replaced eOPC. eDisclose is similar to eOPC, and has been modified to reflect the new Hopkins policies and federal regulations. Users log in to eDisclose with their JHED ID and password: http://edisclose.jhu.edu.

By regulation, investigators must complete training on the new regulation and institutional policy. The conflict of interest training module at http://lms4.learnshare.com/l.aspx?CID=89&A=2&T=412863 is required for all investigators and must be completed by Oct. 31, 2012.

Information about the new policies, FAQs, and information about eDisclose are available on the Office of Policy Coordination’s website: http://www.hopkinsmedicine.org/research/OPC/

 
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