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Public Health Service
Subrecipient Financial Conflict of Interest Resource Repository |
Memorandum from Pamela Webb dated 8/2/12 distributed to all PHS Principal Investigators, Departmental Administrators, Certified Approvers, and Research Associate Deans
Department Research Administration Presentation RECORDING - Financial Conflict of Interest (FCOI)
Department Research Administrator PowerPoint PRESENTATION - Financial Conflict of Interest (FCOI) (8/1/12)
Email from Pamela Webb announcing streamlined process for subrecipients on FDP List of PHS FCOI Compliant Institutions (7/16/12)
Memorandum from Pamela Webb dated 6/26/12 announcing new business process for PHS subrecipients effective 8/24/12 (updated 7/16/12)
COMMONLY NEEDED FORMS AND INFORMATION
Form 1 – ALL PHS SUBRECIPIENTS - Documentation of PHS Subrecipient Financial Conflict of Interest (FCOI) Policy (7/31/12)
- Signed by the subrecipient institutionally-authorized representative
- Must be on file before SPA can submit a new/renewal proposal containing subawards to a PHS agency on or after 8/24/12
Form 2 – USE ONLY FOR PHS SUBRECIPIENTS WHO NEED TO USE UMN FCOI POLICY - Subrecipient Disclosure of Significant Financial Interests (11/1/12)
- This form is required ONLY for subrecipient investigators using the U of Minnesota FCOI policy because their entity does not have its own policy
- One form must be completed for each subrecipient investigator meeting the test of “investigator”
- Completed disclosure must be on file before SPA can submit our proposal to a PHS agency on or after 8/24/12
Link to On-Line FCOI Training - USE ONLY FOR PHS SUBRECIPIENT INVESTIGATORS WHO NEED TO USE UMN FCOI POLICY
- This training is required to be taken ONLY by each subrecipient investigator using the U of Minnesota FCOI policy because their entity does not have its own policy
- Course takes approximately 20 minutes to complete
- An automated notification to SPA and the Office of Institutional Compliance is sent when the investigator completes the training
- This training must be completed before UMN issues a subaward to the proposed subrecipient and again every four years
List of PHS Agencies
Definition of "Investigator"
- “Investigator” means an individual responsible for the
design, conduct, or reporting of research proposed to or funded
by a PHS agency. This always includes the prime
award's principal investigator and any subrecipient principal
investigator, and may include other personnel if they hold responsibility for the functions listed above. This is often true for others
called "key personnel." Collaborators, consultants, and service
providers (other than subrecipients) normally submit their results
to our principal investigators or other key personnel, who in turn
assume responsibility for the use of the
consultant/collaborator/service provider's contributions. In these
instances, collaborators, consultants, and service providers do not
meet the definition of "investigator." On a case-by-case basis, a
PI may decide that one of these contributors does meet the test for
an "investigator." In that case, the
collaborator/consultant/service provider must be treated similar to
a subrecipient entity for the purpose of FCOI disclosures and
training.
FDP Model Financial Conflict of Interest Policy (8/8/12) and Model Disclosure Form (for potential adoption by subrecipients not yet having their own
FCOI policy)
- The model policy and form listed above is intended to assist
subrecipients who wish to create their own Financial Conflict of
Interest policy. This model policy has been developed by members
of the FDP who are familiar with PHS Financial Conflict of Interest
requirements; however, subrecipients are independently responsible
for conducting their own review to ensure that this model or an
adapted version is compliant with PHS policy. Tools are available
on the NIH web site to assist institutions with this process,
including a Checklist for Policy Development at: http://grants.nih.gov/grants/policy/coi/checklist_policy_dev_20120412.pdf.
CONFLICT OF INTEREST REGULATIONS, POLICIES, AND PROCEDURES
University of Minnesota FCOI Policy and Verification
The University of Minnesota maintains an enforced, PHS-compliant
FCOI policy, and all University of Minnesota campuses are on the FDP
list of compliant institutions at: http://sites.nationalacademies.org/PGA/fdp/PGA_070596.
Our sponsors are expected to use the FDP list as verification that
the University of Minnesota has a compliant policy. Sponsors may
not dictate to the University of Minnesota the content,workflow, or
processes necessary to meet FCOI obligations. The University of
Minnesota will not agree to provide disclosures of significant
financial interests to other institutions or entities, as such
disclosures are handled internally via our own policy requirements.
However, the University will report to sponsors positive
determinations of financial conflict of interest, following
deliberations by our Conflict of Interest Committees and as
required under federal policy. Such disclosures will be at the
level of detail stipulated in federal policy or sponsor
requirements stipulated in award terms and conditions.
Pre-August 24, 2012 FCOI Policy: http://www.policy.umn.edu/Policies/Operations/Compliance/CONFLICTINTEREST.html
PHS Conflict of Interest Regulations: http://grants.nih.gov/grants/policy/coi/
University of Minnesota Conflict of Interest Policies and Procedures: http://www.compliance.umn.edu/conflictPolicies.htm
PHS CONFLICT OF INTEREST FAQS
PHS FAQS
UMN FAQs
RESOURCES AND CONTACTS
University of Minnesota Office of Institutional Compliance, Conflict of Interest web site: http://www.compliance.umn.edu/conflictHome.htm
Conflict of Interest Questions:
Jon Guden, Associate Director, Office of Institutional Compliance
612-626-4727, jguden@umn.edu
Subrecipient FCOI Process Questions:
Judy Krzyzek, Associate Director, Sponsored Projects Administration
612-624-2546, krzyzek@umn.edu
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