Federal regulations regarding Conflict of Interest (COI) require each Federal awarding agency to establish conflict of interest policies for Federal awards. The non-Federal recipient entity must disclose in writing any potential conflict of interest to the Federal awarding agency or pass-through entity in accordance with applicable Federal awarding agency policy (see 2 CFR § 200.112). Additionally, CSU Policy and Colorado statute require disclosure of conflicts of interest or commitment (Faculty and Administrative Professional Manual, section D.7.6 and D.7.7) to preserve the public trust. This disclosure process includes an initial disclosure and an annual disclosure thereafter as well as updates at any time that a real or potential conflict emerges.
As an example, for federal agency COI requirements, the US Department of Energy’s (DOE) Conflict of Interest Policy specifies that “Investigators on a project funded by a DOE award are required to update the disclosures at least annually, in accordance with the specific time period prescribed by the non-Federal entity, during the period of the award and also within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.”
Please note that the COI disclosure is required for ALL CSU Employees, annually if there are no updates and contemporaneously with each new interest that must be disclosed. If there are no conflicts to disclose, the Kuali system automatically approves the disclosure. If there are new interests disclosed, the Conflict of Interest Office, currently supported by the Office of General Counsel and the CSU Research IT Services Unit, reviews the disclosure and either approves with a “no conflicts” designation or approves subject to a management plan being put in place.
Thus, to comply with federal requirement, at proposal stage OSP must confirm that all key personnel listed on a KR PD proposal have completed their annual (or initial) COI Disclosure within the last 12 months. Investigators must certify whether they have a real or potential conflict of interest with the proposal in the KR PD Person Certification. When you submit a proposal, all key personnel in the proposal must have completed a conflict disclosure within the past 12 months. The disclosure does not need to be approved at this point, just submitted.
At award and with subsequent amendments, OSP is required to check that the key personnel’s COI Disclosures have been completed and that if a conflict has been disclosed, obtain confirmation from CSU’s COI Officer that the conflict is either managed or the conflict itself does not have any bearing on the subject award. The Office of Sponsored Programs is unable to set up a new account or update/modify an existing account if the “Key Personnel”, as set up in Kuali Research Proposal Development (KR PD), COI Disclosures are not approved at the time of award set-up/modification. If someone’s status is not approved, OSP will contact the Conflict of Interest Office to determine if the award can be set up pending approval.
The Conflict of Interest Office is responsible for campus COI approval. OSP does not have access to COI Disclosures or Management Plans, only indicators of the date the Disclosure was filed and if it is approved with no conflicts or if there are potential conflicts and if a Management Plan is in place. Currently, there is a backlog of COI disclosures, and the COI Office is currently hiring a Conflict of Interest Director and opening a search for a conflicts specialist. Until then, OSP will do its best to alert the COI Office when a disclosure needs immediate attention for processing.
We recognize that this process is causing frustration however the need for robust internal controls surrounding potential and actual conflicts of interest remains of vital interest to our University for the continued health of our research and because it is expected of us by our sponsors. If you have questions concerning your COI disclosure, please contact Sam Halabi ([email protected]) or Rich Wright ([email protected]).
Below are some links to CSU policies and some federal grant regulations regarding conflict of interest.
CSU Conflict of Interest Policy
CSU Conflict of Commitment and Consulting Policy
CSU Financial Conflicts of Interest in Public Health Service Funded Programs
COI Requirements for Recipients of Federal Grants and Conflict of Interest in Procurements on Federal Grants
NSF Conflict of Interest Policy
NIH Financial Conflict of Interest Policy
DOE Conflict of Interest Policy
Blog post by Bill Moseley, OSP Pre-Award Manager; Sam Halabi, Senior Associate Vice President for Health Policy and Ethics; Ashley Stahle, OSP Associate Director; Shannon Irey, OSP Training & Information Coordinator