Office of Research and Sponsored Programs (ORSP) 843-792-3838

1. Conflict of Interest Regulation Changes & Research Proposal Submission Process Changes09/11/12updated 6/18/13 Office of Research and Sponsored Programs (ORSP) 843-792-3838

2. Topics Covered • Highlight Changes in PHS COI Regulations • ORSP’s Proposal Submission Changes • Time of Award COI Process • Other COI Related Information • Questions/Clarifications?

3. Changes in PHS COI Regulations August 24th, 2012 Deadline for Compliance • Lowered disclosure threshold of Significant Financial Interest (SFI) • From $10,000 to $5,000 • ALL SFI’s related to investigator’s INSTITUTIONAL RESPONSIBILITIES • NOT what an Investigator deems as related to the PHS-funded research • Much more broad now

4. Changes in PHS COI Regulations • New exclusions (mutual funds, etc.) • Provided the Investigator does not directly control investment decisions • Travel Reimbursement/ Sponsored Travel • Must disclose ANY reimbursed travel (not sponsored by a federal, state, or local government agency etc.)

5. Changes in PHS COI Regulations • Reporting of COI to NIH • ORSP responsibility • More (much) information required • Public Accessibility • Publicly accessible Web site OR • Must respond to a written request within 5 business days (MUSC’s choice)

6. Changes in PHS COI Regulations • FCOI Training • All investigators must have FCOI training prior to engaging in research involving any PHS-funding and at least every 4 years thereafter OR • Immediate Training Requirements • If MUSC’s FCOI policies change in manner that affects investigator requirements • Investigator is NEW to MUSC • Identified Non-compliance with MUSC’s FCOI policy or management plan

7. Changes in PHS COI Regulations • Retrospective Reviews for cases of Non-compliance • Not required to report UNLESS • A case where bias is identified AND THEN • Must report actions taken and plans to eliminate or mitigate effect of bias FOR MORE INFORMATION SEE: http://grants1.nih.gov/grants/policy/coi/summary_of_major_changes.doc

8. ORSP’s Proposal Submission Changes • ALL MUSC personnel must be listed in Personnel Section of ePDS (PAID or NOT) • Automated System to System CHECK • ALL disclosures on file and current (not older than 1 year) GOOD to submit! • No disclosure on file or out of date….CANNOT submit until issue rectified. NO EXCEPTIONS!

9. ORSP’s Proposal Submission Changes • For ALL NON-MUSC contributors, MUSC PI MUST complete and certify an External Contributor Listing Form • http://academicdepartments.musc.edu/research/orsp/external_contributor_listing_form.pdf • Documents which External Contributors, if any, meet PHS definition of “investigator” • (see PHS definition of “investigator” on the form link above)

10. ORSP’s Proposal Submission Changes • All Non-MUSC contributors identified as External “Investigators” MUST complete an External INVESTIGATOR Financial Conflict of Interest (FCOI) Certification Form • http://academicdepartments.musc.edu/research/orsp/external_inv_FCOI_cert.pdf • Applies only to NON-CORPORATE FUNDING • MUST BE COMPLETED & SUBMITTED TO ORSP PRIOR TO PROPOSAL SUBMISSION

11. ORSP’s Proposal Submission Changes • External INVESTIGATOR Financial Conflict of Interest (FCOI) Certification Form • External Investigators (entities, individuals, etc.) MUST indicate if they have a PHS compliant FCOI policy or follow MUSC’s • MUST BE SIGNED BY AN AUTHORIZED INSTITUTIONAL OFFICIAL • EXCEPTION: • When External Investigator’s Organization is listed on the FDP FCOI Clearinghouse NO FORM REQUIRED: http://sites.nationalacademies.org/PGA/fdp/PGA_070596 • Encourage your “investigators” to register in the Clearinghouse

12. ORSP’s Proposal Submission Changes • ePDS must be completed and routed BEFORE ORSP can submit the proposal • PLEASE keep in mind the 3 business day rule • NOTE: Regulations DO NOT allow for ANY flexibility in the requirements at proposal submission stage

13. Time of Award COI Process • Just-In-Time (JIT) and/or at Time of Award • ORSP re-checks or verifies COI status of ALL MUSC contributors (system to system check) • If necessary, refers to MUSC COI Officer for action • No COI related action needed, award is processed • NO award will be accepted/processed until all FCOI’s are managed or eliminated • ANY COI changes – MUST be reported within 30 days to MUSC’s COI Officer

14. Other COI Related Information • ORSP COI Web Page & Information: • http://academicdepartments.musc.edu/research/orsp/orsp_coi.html • MUSC’s Main COI Web Page & Information • http://academicdepartments.musc.edu/coi/ • MUSC’s External Contributor Financial Conflict of Interest (FCOI) Certification Form • http://academicdepartments.musc.edu/research/orsp/external_contributor_coi_form.docx • External Contributor Listing Form • http://academicdepartments.musc.edu/research/orsp/external_contributor_listing_form.pdf • MUSC’s COI Disclosure Form • http://academicdepartments.musc.edu/research/orsp/external_coi_disclosure_form.pdf

15. Other COI Related Information (Cont.) • NIH’s Financial Conflict of Interest Page • http://grants.nih.gov/grants/policy/coi/ • FDP Clearinghouse list of PHS FCOI compliant entities • http://sites.nationalacademies.org/PGA/fdp/PGA_070596 • FDP Main Web Page (to download official invitation to join FDP Clearinghouse) • http://sites.nationalacademies.org/PGA/fdp/index.htm

16. Questions/Clarifications? • PLEASE CALL ORSP IF YOU HAVE ANY QUESTIONS/CONCERNS (792-3838) • THANKS FOR YOUR TIME!