Please
expect new OSPA procedures related to the revised PHS COI regulations in the
next few days for a short review period before we finalize and implement for
the August 24, 2012, effective date. Should you have questions in the meantime,
please don’t hesitate to call me.
June 13, 2012
Research Community,
The Public Health and Services (PHS), which includes the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), has revised the regulations that govern Conflict of Interest (COI). The regulation has new requirements for both MU as a PHS-funded Institution and the Investigators who work on those projects. Implementation of these new processes will begin on August 24, 2012. The COI Office is taking the lead on ensuring these regulations are met.
The Public Health and Services (PHS), which includes the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), has revised the regulations that govern Conflict of Interest (COI). The regulation has new requirements for both MU as a PHS-funded Institution and the Investigators who work on those projects. Implementation of these new processes will begin on August 24, 2012. The COI Office is taking the lead on ensuring these regulations are met.
We will be giving a detailed
presentation about these changes for all Investigators and Staff who are
interested on June 26, 2012 from 1-3pm in the Monsanto Auditorium in the Bond Life Sciences Center. We
encourage all to attend, especially those who currently have PHS funding.
Please feel free to forward this email as you deem
appropriate. If you have any immediate questions about how these changes
will impact your role in the research award process, or if you would like a
more detailed presentation of the changes for your department specifically,
please contact the COI Office at: 884-3317 or coi@missouri.edu.
Below is a summary of the changes that impact Investigators and the proposal/award process.
Below is a summary of the changes that impact Investigators and the proposal/award process.
At Proposal-
·
PIs must submit a form identifying all Investigators for each PHS
or NSF project.
o
This form will replace the previous COI form used on these projects
and will be distributed soon.
·
BEFORE the proposal can be
submitted, all Investigators listed on the form must have a current COI form
submitted within the previous 12 months. NO proposals
will be submitted until OSPA can verify that all Investigators have filed a
current COI form.
·
All Subcontracts on these proposals will require a certification
from the subcontractor that they have a COI policy that complies with PHS
regulations and will submit reports to MU as appropriate. OSPA is
drafting a Letter of Commitment that contains the appropriate language. MU is
not currently permitted to accept a subcontractor who will not make this
certification.
All Investigators, including the
PI, listed on a project at proposal will be contacted after the submission to
inform them about the requirements that need to be completed prior to the
expenditure of funds.
At Award-
PRIOR TO THE EXPENDITURE OF FUNDS (including
pre-award spending accounts and spending under expanded authorities) the
following must occur:
¡ The
Conflict of Interest Committee (COIC) must review and determine whether any
Outside Interests of the Investigators impact the project.
§ If yes:
A management plan must be created and approved by the COIC, Investigator,
Department Chair, and Dean. A Financial Conflict of Interest report must
then be submitted to PHS.
¡ All
Investigators must complete COI training through eCompliance electronically.
Please note that this training module is not yet available. Once
available, the Research Community will be notified.
¡ All
Investigators must report all Sponsored Travel within 30 days of the
trip. Sponsored Travel is any travel paid for by an entity other than MU.
¡ Any
new/changed Outside Interests must be reported within 30 days.
During an ongoing PHS-funded project-
·
NO new Investigators may be added
to a project until they have completed all the above requirements. Notify
the COI Office before adding personnel to these projects.
As mentioned above, please plan
to attend this
presentation to learn more about this process.
If your department would like a more detailed presentation about these changes,
please contact the COI Office to set up a time. Please call if you have
any other questions or concerns.