Revised PHS FCOI Regulations & Subrecipients In response to revised PHS regulations, UCI Sponsored Projects Administration (SPA) has: Revised Subrecipient Commitment Form Created Subrecipient FCOI Addendum Form Changed the procedures related to collection of disclosures from Subrecipients

Subrecipient Commitment Form Subrecipient Commitment Form was introduced to help: Expedite the process of setting up subawards. Designed to help subrecipients understand, at the proposal stage, what will be required of them by UCI should an award be made. Includes compliance with federal regulations such as those governing research with human or animal subjects, conflict of interest, and OMB Circular A-133. Subrecipient Commitment Form is required: for all proposals that include subawards and after-the-fact subaward proposal submissions. at the proposal stage as part of the proposal package submitted to the Sponsored Projects Officers for review. Purpose of the Subk commitment form was to streamline and help exepdite subk set up at the time of award and maintain compliance with regulations governing human subjects, animal subjects, COI and OMB A133 As a reminder: the subk commitment form is required for ALL proposals that list outgoing subks as part of the budget/SOW

Revised PHS FCOI Regulations Changes reflected in the revised PHS regulations include the following: Lower disclosure thresholds – $5,000 for publicly traded entities and $0 for equity interests in non-publicly traded entities; Investigator disclosure regarding their Significant Financial Interests (SFI) related to their institutional responsibilities – not just those related to the specific research project in question; Disclosure of all sponsored and reimbursed travel – reimbursements or travel sponsored by educational and governmental institutions are exempted; Investigators must disclose new SFIs (including sponsored or reimbursed travel) within thirty (30) days of discovering or acquiring a new SFI; and Mandatory Investigator training regarding the PHS regulations and UCI’s policy prior to engaging in the funded research. As Nadia just explained and as we have been communicating to the campus over the course of several months, PHS revised their regulations for FCOI. These are the updated items PIs must disclose and it is important to remind all investigators to complete the mandatory training. How does this relate to subks?? Well…

Revised PHS FCOI Regulations & Subrecipient Commitment Form Subrecipient Commitment Form has been revised. This new form is mandatory for use effective 09/06/2012. Revised form will allow Subrecipients under awards subject to these regulations declare whether they: a) already have a Conflict of Interest (COI) policy that complies with the new PHS regulations; or b) they will follow UCI’s Conflict of Interest policy. Subrecipients that have a policy that complies with the PHS FCOI regulations will not have any other requirements related to this section. However, those subrecipients that need to follow UCI’s COI Policy will need to complete form 800SR at the time of submitting their proposal package to UCI. The new PHS regulations also apply to awards received August 24th and thereafter. As a result, existing subrecipients under PHS funding or subrecipients that are subsequently added to funded PHS awards will be required to complete the Subrecipient FCOI Addendum. Please note that we will not be able to submit PHS (including agencies that follow PHS regs) and/or NSF proposals that include subrecipients from which we have not received the completed Subrecipient Commitment Form and other requirements of Section 8 of Subrecipient Commitment Form. Additionally, failure to provide a completed PHS FCOI addendum and any required form 800SR’s will delay processing of subawards. Questions? Please contact Soheil Jadali at jadalis@uci.edu or 949-824-9015. We updated the Subk commitment form to be used effective 9/6/12 It is important to use the updated forms and complete the required 800SR form if the subk site is going to follow UCI COI policy. If the subk site has their own COI policy that complies with the new regs then they just need to indicate that on the Subk commitment form. PHS and agencies that follow PHS regs.