MU
Grants Community,
In
light of the policy and procedure changes resulting from the 2011
Revised Federal Regulation on Financial Conflict of Interest, OSPA and the
COI Office have taken a closer look at the National Science
Foundation (NSF) Conflict of Interest Policies in relation to UM
CCR 420.030. As a result, the following requirement, currently applicable
to PHS proposals, will be in effect for NSF proposals as of Monday, November
12, 2012:
·
Proposals will not be submitted until it is confirmed
that all MU Investigators have a current Outside Interest Disclosure Form
(OIDF) on file and that required certifications are received for non-MU
Investigators.
An Investigator Form is required for all NSF
submissions. As a reminder, the Investigator Form initiates the Departmental
and OSPA review for required OIDFs and so should be completed and submitted to
OSPA well in advance of the submission deadline. Please watch for a separate
email this afternoon announcing a revised Investigator Form.
Requirements
at award, as described in the attached email, remain the same:
·
The
OSPA SGCA will work with the COI Office to ensure the required reviews, which
include confirmation that all NSF Investigators on the project have completed
mandatory Conflict of Interest Training. Upon notification from the COI Office
that the reviews are complete (and with all other approvals and certifications
in place), the SGCA will set up the award and distribute the Grant Award
Summary.
The
PHS and NSF policies differ in subtle ways, primarily with regard to COIC
review and reporting FCOIs to the sponsor. From the PI and Departmental
perspective, however, the procedures are essentially the same as of
11-12-2012. We will continue to communicate clarifications as we receive
additional guidance from sponsor agencies implementing COI regulations and
policies.
The
OSPA Sponsored Programs Procedure Guide (SPPG) will be updated to reflect these
changes. Should you have any questions or concerns, please don’t hesitate to
contact me.
The
COI Office and OSPA have clarified requirements and processes for National
Science Foundation (NSF) proposals and awards related to conflict of interest
(COI).
At
Proposal
Because
the NSF policy differs from the PHS regulation*, procedures as proposal will
accordingly differ:
·
Following
an NSF proposal submission, the COI Office will contact the PI directly (with a
copy to Department and OSPA pre-award staff) to identify Investigators (as
defined by NSF), confirm all required Outside Interest Disclosure Forms are
current, and guide the process of completing Conflict of Interest Training. Note:
Per University of Missouri policy, Conflict of Interest Training is mandatory
prior to expenditure of funds, should the proposal be awarded.
For NSF proposals currently in process: Investigator Forms and/or NIH-NSF Financial
Disclosure Forms currently received or in process for upcoming NSF proposal
submissions are now not required but are certainly not wasted effort. Please
submit to your SGCA who will, in turn, include the information when alerting
the COI Office to the proposal submission. The PI should still expect an email
from the COI Office.
At
Award
·
The
OSPA SGCA will work with the COI Office to ensure the required reviews, which
include confirmation that all NSF Investigators on the project have completed
mandatory Conflict of Interest Training. Upon notification from the COI Office
that the reviews are complete (and with all other approvals and certifications
in place), the SGCA will set up the award and distribute the Grant Award
Summary.
*The
NSF Conflict
of Interest Policies are less exacting in their timing requirement for
financial disclosures. For the purposes of MU’s COI policy and procedures, “at
the time the proposal is submitted” includes the post-submission period prior
to award. Recall that, in the past, OSPA would not stop a submission if an
NIH-NSF Financial Disclosure Form was outstanding but would follow up
thereafter to ensure all required forms were on file within a reasonable period
of time. With the COI Office now overseeing all disclosures through
eCompliance, the same line of reasoning applies.
This
is not the case for PHS per the 2011
Revised Federal Regulation on Financial Conflict of Interest, where
disclosure is unequivocally mandatory prior to proposal submission:
Please
take note of the COI Office presentations scheduled for Tuesday, September
18, and Monday, September 24 (see attached). I will be in attendance
should you have questions about related OSPA procedures.
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 began 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 the
new Investigator responsibilities for all Investigators and Staff who are
interested. This is especially important if you currently have PHS
funded research or anticipate receiving PHS funding. If you did not
attend the session offered over the summer, please plan to attend one of the
following times in the Monsanto Auditorium, Bond Life Sciences Center:
- Tuesday, September 18, 2012 from 9-11am
- Monday, September 24, 2012 from 1-3pm
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.
- This form will replace the previous COI form used on these projects and is available through OSPA or your Departmental Grants Administrator.
- 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 PHS proposals will be submitted until OSPA can verify that all Investigators have filed a current COI form.
- All Subcontractors on PHS-funded proposals must certify by way of the Subrecipient Commitment Form that the institution/organization has a publicly accessible COI policy that complies with the PHS regulation and will timely submit required reports to MU as appropriate. 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
report all Sponsored Travel
related to their institutional responsibilities within 30 days of the trip
through eCompliance. Sponsored Travel is any travel paid for by an entity
other than MU. https://ecompliance.missouri.edu/forms/10145-sponsored-travel-report/documents/new
During an ongoing PHS-funded project-
- BEFORE a new Investigator may be added to a project, he/she MUST complete all the above requirements. Notify the COI Office before adding personnel to PHS-funded 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.