Office of the Vice Chancellor for Research 1 Update on PHS New Rule on Financial Conflicts of Interest (FCOI) Presentation to Business Managers January 2013 Jacquelyn Jancius, Director, COI

Conflict of Interest – PHS New Rule 2 Public Health Services (PHS) Regulation, Department of Health and Human Services 42 CFR Part 50 and 45 CFR Part 94, on Financial Conflicts of Interest (FCOI) Issued on August 25, 2011 Deadline for University to comply is August 24, 2012

Purpose of Regulation: 3 Promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest (FCOI).

Regulations require… 4 Investigators and senior/key research personnel to: Complete mandatory University training on Financial Conflicts of Interest (FCOI)  Reminder: Training is good for 4 years Disclose significant financial interests (SFIs) to the University  Reminder: Must be submitted annually Disclose sponsored or reimbursed travel to the University ($5,000 threshold) Manage Financial Conflicts of Interest (FCOI) prior to execution of an award or continuing review.

Regulations require… 5 The University may not expend funds from the Department of Health and Human Services (HHS), the Public Health Services (PHS), or the National Institutes of Health (NIH) until the requirements prescribed in the regulations have been met by all Investigators and senior/key research personnel. This applies to non-federal sponsors that have adopted the PHS FCOI regulations. List is available at on the COI website under the Business Manager’s Resources

Pre-Award (proposal stage) COI Certification & Proposal Approval Certification 6

Pre-Award (proposal stage) Conflict of Interest Certification, Section XIII, must be completed by:  All Investigators regardless of the funding source  Senior/Key Research Personnel on HHS/PHS/NIH sponsored research (Don’t list if listed as Investigator) 7

Pre-Award (proposal stage) Proposal Approval, Section XIII, Investigators will certify that:  He/She is current in his/her FCOI training, disclosures of sponsored or reimbursed travel and disclosures of known significant financial interests (and those of spouse or domestic partner, parents, siblings, and children) reasonably related to his/her University responsibilities.  When required under sponsor regulation, the PI will further ensure that all personnel including sub recipient(s) proposed under this submission are current in disclosures of known significant financial interests. 8

Pre-Award (proposal stage) Upon receipt of the PAF, ORS staff will notify the COI Office when a significant financial interest (SFI) has been disclosed on the PAF (COI Certification, Section XII). We will follow the standard existing process: ORS will place a “COI Hold” on the PAF. The COI Office will follow standard procedures to request disclosure and management plan, in accordance with our existing practices. This will not delay the processing of the proposal for submission. 9

Pre-Award (notice of award stage) New & Continuing Awards… When ORS receives Notice of Award (NOA) from the funding agency, ORS staff will verify if the funding agency applies the 2011 PHS FCOI Regulations.  If Yes, the ORS staff will add a hold for the “FCOI Training and Certification” in UIeRA for the related PAF.  If No, the ORS staff will not add an approval hold for the FCOI training and certification If there is a Significant Financial Interest related to the study disclosed in the PAF COI Certification, the “COI Hold” will continue to be in place until there an approved management plan. 10

Pre-Award (notice of award stage) Within 24 hours of receipt of the NOA, standard procedure, ORS Staff will send out an to the PI informing him/her of the additional requirements including the financial conflict of interest training and disclosure. Prior to expenditure of funds, PI must complete the Checklist of Investigator Financial Disclosure and FCOI Training and submit the completed checklist to Failure to complete the checklist will place the grant out of compliance with the federal regulations and could jeopardize the grant funding! 11

Pre-Award (notice of award stage) When the COI Office receives the checklist from the PI, the COI Office will: Review the checklist for completion and conduct a quality assurance assessment. If there are NO SFIs related to the grant and all of the investigators have completed their training and disclosure, then the COI Office will release the hold for FCOI Training and Certification in UIeRA, indicating the approval date and the approval period. If an investigator or key research personnel’s training or disclosure is incomplete, then the COI Office will continue to follow-up on completing the requirements to comply with the FCOI regulations.  This will continue to delay the processing of the award! 12

Pre-Award (notice of award stage) When the COI Office receives the checklist from the PI (continued): If a SFI is identified that is related to the research, the COI Office will work with the PI to complete the management plan (SFI- DMP: Part II). Once the SFI-DMP is completed and signed with the required signatures, the COI Office will release the COI hold and the hold for FCOI Training and Certification in UIeRA, COI Office will indicate:  the approval date  the approval period The SFI-DMP will remain on file with the COI Office. The PI should retain a copy of the SFI-DMP for the grant file. 13

COI Resources for Business Managers 14 s

COI Resources for Business Managers 15  FCOI Investigator Training and Disclosure Weekly Tracking Report (login required)  Memo from VCR to Investigators explaining the federal regulations and University requirements for Financial Conflict of Interest.  Checklist for Investigator Financial Disclosure and FCOI Training  List of sponsors and organizations that require compliance with PHS 2011 FCOI regulations  Link to Federal Demonstration Partnership Clearinghouse for COI.

FCOI Training and Disclosure Report 16

FCOI Training and Disclosure Report 17 Weekly report, updated on Mondays, updated report should be posted by end of day. You must login to access the report  COI Office obtained a list of business managers and college administrators (e.g., deans).  If you do not have access and would like to request access, send the request to The COI database uses the person’s address to track the disclosure and training, we recommend investigators use their UIC when taking the training or submitting their SFI disclosure.

FCOI Training and Disclosure Report 18 Report is organized by Last Name. Report includes: Last Name First Name Department Dates Training and Disclosure was completed If Date field is blank that means the item is not complete.

Checklist for Disclosure & Training 19

Checklist for Disclosure & Training 20 Must be completed for HHS, PHS, NIH sponsored research as well as sponsored research funded by agencies that have adopted the 2011 PHS FCOI regulations. Complete contact information for PI and business manager; and study information. Checklist must include all Investigators and Senior/Key Research Personnel (including sub-recipients that will follow the University Policy on Conflict of Interest) identified on the funding proposal. Instructions at the bottom link to definitions.

Checklist for Disclosure & Training 21 Must include: Last Name, First Name, UIC (preferred), and indicate the following:  FCOI Training Completed? (yes or no)  Disclosure (SFI-DMP: Part I) completed? (yes or no)  SFI related to the research project? (yes or no) By submitting the checklist to the COI office, the PI attest that the checklist is complete and accurate according to the grant application, progress report, or any other report submitted to the funding agency such that all investigators and senior/key research personnel (including sub-recipients that follow UIC’s policy) have been identified on the checklist and each has completed the disclosure and training requirements.

Checklist for Disclosure & Training 22 Submit the Checklist to the COI Office at ( submission is preferred). Save a copy for your department records. If you need additional space, you may complete a second checklist or if you need to provide explanation, you can send an to provide explanation. Update Checklist when…  New or change in Investigators or Key Research Personnel  If supplemental funds = new investigators or key research personnel  Annually – approval period will correspond to the budget approval period.

NIH Online Resources: 23 Department of Health and Human Services 42 CFR Part 50 and 45 CFR Part 94: Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Services Funding is Sought and Responsible Prospective Contractors (August 2011) 2011 FCOI Regulation: NIH FAQs:

Contacts: 24 Jacquelyn Jancius, COI Director (312) Scott MacEwen, COI Coordinator (312)