Stony Brook University Office of Research Services

New PHS Regulations on Investigator Financial Conflict of Interest, Effective 8/24/12

The U.S. Public Health Service (PHS), which includes the National Institutes of Heath (NIH), has revised their Financial Conflict of Interest (FCOI) Regulations.  

Since Stony Brook receives National Institutes of Health or other PHS funding, we must be in full compliance with all of the revised regulatory requirements beginning August 24, 2012. Consistent with SBU’s prior handling of this regulatory requirement, some of these changes will impact all investigators, and others will be specific to investigators submitting to, or awarded funds from, PHS (including NIH).

For details concerning significant changes required to our current policy as a result of the new PHS regulation, please visit our Investigator COI website at: http://www.stonybrook.edu/research/orc/coi-new-regulations.shtml#training-tab

One big change involves WHO has to comply with the new FCOI regulation:

Investigators must comply with the regulation, and an “investigator” is now defined as: The project director, principal Investigator, co-principal Investigators and all other person(s) who are responsible for the design, conduct, or reporting of:

  • externally supported activities, or

 

  • internally supported activities where support is granted following formal application to an SBU program in response to a request for proposals (for example, Targeted Research Opportunity ‘TRO’ Grants).

For PHS/NIH funded activities, this definition includes collaborators and consultants.

Important clarification concerning who must comply: Individuals who do not make independent decisions regarding the design, conduct, or reporting of the activity in question, and only work on or are engaged in the activity do not meet SBU’s definition of an investigator (for example, in most cases research assistants, undergraduates and secretaries will not be considered ‘investigators’).

Another big change is the need for investigators who are awarded funds beginning on August 24th to complete FCOI training at least once every 4 years.

WHEN should you, as an investigator, complete SBU’s FCOI training?

 

  • If you are currently supported by PHS/NIH funds, you should complete training as soon as possible, but no later than the issue date of your next annual Notice of Award for continuation or for your competitive renewal.  

 

  • If you have applied for PHS/NIH funds you should complete training by the issue date of your Notice of Award received on August 24th or thereafter.

 

  • All other investigators must complete the FCOI training prior to establishment of an account for a grant or contract awarded on August 24th or after.


HOW
 can you satisfy SBU’s FCOI training requirement?  

SBU is using the Collaborative Institutional Training Initiative (CITI) web-based program to meet our training needs. It is a short tutorial and shouldn’t take up too much of your time. It’s live and ready to go for SBU, so if you would like to get a jump start on the training requirement, please feel free to do so!

  • If you have already undergone training via the CITI program (e.g., for IRB, IACUC, RCR etc.), go to http://www.stonybrook.edu/research/orc/coi-new-regulations.shtml#training-tab and follow the “For existing CITI Users” instructions to access the FCOI training modules

 

  • If you have not already undergone training via the CITI program (e.g., for IRB, IACUC, RCR etc.), go to http://www.stonybrook.edu/research/orc/coi-new-regulations.shtml#training-tab and follow ‘For New CITI Users” instructions to access the FCOI training modules

Please stay tuned for further updates on ‘big changes’ and SBU’s progress toward implementation of this important regulation.

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