The Investigator discloses any Significant Financial Interests to the institution's internal COI Committee. Before a Subaward is issued, ORA will utilize the FDP FCOI Institutional Clearinghouse. If an entity is not included in the Clearinghouse, ORA will require Subrecipients to certify whether a) they have a policy, and b) if there are any FCOI's to report.
If an FCOI is reported, or if a new FCOI arises after the Subaward is initiated, that FCOI has to be reported by the Subrecipient to UMD to allow UMD to report it to the government within 60 days.
• Do I need to submit?
• Subcontractor Certification
In the NIH FAQ's, the following Question/Answer is provided regarding FCOI's that are resolved prior to initially accepting NIH funds [or the start date of the Subaward]:
Q: Is an Institution [or Subrecipient] required to submit an FCOI report if the Institution eliminates the conflicting financial interest prior to the submission of the initial FCOI report?
A: No. In cases in which the institution identifies a FCOI and eliminates it prior to the expenditure of NIH-awarded funds, the Institution shall not submit an FCOI report to the NIH.
After the initiation of the Subaward, an Annual FCOI Report is required to be sent to UMD by those entities with their own FCOI policy to certify whether there have been any changes in status since the initial certification. If the Lead PI at the Subrecipient organization is registered in IRBNet, then that person would get a reminder to submit this report.
This is an excerpt from the NIH-FCOI website explaining what is to be included in any Subaward UMD issues under the new Policy:
Incorporate as part of a written agreement terms that establish whether the FCOI policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure [this is for those Subrecipients who have no policy of their own] and/or FCOI reporting requirements.
This excerpt explains the responsibilities of those Subrecipients with their own FCOI Policy:
Subrecipient Institutions who rely on their FCOI policy must report identified FCOIs to the awardee Institution in sufficient time to allow the awardee Institution to report the FCOI to the PHS Awarding Component (e.g., NIH through the eRA Commons FCOI Module) to meet reporting obligations.
For Subrecipients not participating in the FDP FCOI Clearinghouse, ORA will obtain from the Subrecipient a certification declaring that the Subrecipient does or does not have a PHS-FCOI Policy in place. ORA will send a copy to the UMD Compliance Administrator to upload into IRBNet Project as an attachment.
If the Subrecipient has an FCOI Policy and no FCOI’s to report, UMD will issue the Subaward. If there is no FCOI Policy in place, the certification will show that when it is returned by the Subrecipient. The Subrecipient must then submit a disclosure under UMD’s policy prior to the receipt of award funds.
A: PROPOSAL STAGE:
The University of Maryland College Park does not require Subrecipient organizations to submit any PHS-FCOI certifications with their PHS related Subaward proposals, but we do encourage them to send an FCOI Subrecipient Letter of Intent acknowledging that, in the event of an award, the UM PHS-FCOI policy will apply to their proposal should they not have an internal policy in place. Subrecipients with no internal PHS-FCOI Policy are encouraged to develop a policy using the model found at http://sites.nationalacademies.org/PGA/fdp/PGA_061001.
B: AWARD STAGE:
1. For Subrecipients included in the FDP FCOI Institutional Clearinghouse, the Subaward issued by UM will incorporate terms requiring the entity to report any financial conflicts of interest as required by the Federal Agency. If the Subrecipient indicates that new FCOI’s have emerged, these must be reported by the Subrecipient immediately to email@example.com. The Subaward document will specify that the Subrecipient’s FCOI policy shall govern the Subaward agreement.
2. For Subrecpients governed by UMD’s FCOI policies and procedures, the following steps must be completed by the party indicated:
STEP 1: [SUBRECIPIENT] All Investigators named by the Subrecipient on their FCOI certification must individually register in IRBNet.
STEP 2: [UM- PI] The designer of the Project Record (typically the UM Lead PI on the Prime Award) must then log in to irbnet.org and share the related Project Record with each of the Subrecipient Investigators.
STEP 3: [SUBRECIPIENT] Subrecipient Investigators must individually complete a Financial Disclosure in IRB-Net so that the UM COI Committee can review for any Financial Conflicts of Interest (FCOI’s).
STEP 4: [SUBRECIPIENT] Each of the Subrecipient Investigators must also successfully complete the online Conflict of Interest CITI Training Module provided by the University of Maryland.
STEP 5: [UM RESEARCH COMPLIANCE OFFICE] Upon completion of all the above, the UM-RCO will notify the UM Subaward Administrator that all Subrecipient investigators have been cleared by the RCO office.
STEP 6: [UM SUBAWARD UNIT] Subaward is issued to the Subrecipient organization.
Links to the appropriate electronic resources needed to complete these actions are provided below:
*FCOI Training can be completed on-line using the UM CITI Training module under “Required Training”.
**Registration and Disclosures can be completed on-line via www.irbnet.org by going to https://research.umd.edu/fcoi.
Any questions from subrecipient personnel concerning the use of the CITI Training Program or www.irbnet.org should be directed to Joe Smith, Manager, UM Research Compliance Office.
C. POST AWARD STAGE:
Due dates for submitting any required Interim and Annual FCOI Reports to the University of Maryland Research Compliance Office will be incorporated into the terms of the Subaward.