Conflict of Interest Regulation Changes & Research Proposal Submission Process Changes 09/11/12 updated 6/18/13 Office of Research and Sponsored Programs (ORSP)

Topics Covered Highlight Changes in PHS COI Regulations Highlight Changes in PHS COI Regulations ORSPs Proposal Submission Changes ORSPs Proposal Submission Changes Time of Award COI Process Time of Award COI Process Other COI Related Information Other COI Related Information Questions/Clarifications? Questions/Clarifications?

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

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

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

Changes in PHS COI Regulations FCOI Training 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 MUSCs FCOI policies change in manner that affects investigator requirements If MUSCs FCOI policies change in manner that affects investigator requirements Investigator is NEW to MUSC Investigator is NEW to MUSC Identified Non-compliance with MUSCs FCOI policy or management plan Identified Non-compliance with MUSCs FCOI policy or management plan

Changes in PHS COI Regulations Retrospective Reviews for cases of Non- compliance 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:

ORSPs Proposal Submission Changes ALL MUSC personnel must be listed in Personnel Section of ePDS (PAID or NOT) 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!

ORSPs Proposal Submission Changes For ALL NON-MUSC contributors, MUSC PI MUST complete and certify an External Contributor Listing Form For ALL NON-MUSC contributors, MUSC PI MUST complete and certify an External Contributor Listing Form – ch/orsp/external_contributor_listing_form.pdf ch/orsp/external_contributor_listing_form.pdfhttp://academicdepartments.musc.edu/resear ch/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) (see PHS definition of investigator on the form link above)

ORSPs Proposal Submission Changes All Non-MUSC contributors identified as External Investigators MUST complete an External INVESTIGATOR Financial Conflict of Interest (FCOI) Certification Form All Non-MUSC contributors identified as External Investigators MUST complete an External INVESTIGATOR Financial Conflict of Interest (FCOI) Certification Form – ch/orsp/external_inv_FCOI_cert.pdf ch/orsp/external_inv_FCOI_cert.pdfhttp://academicdepartments.musc.edu/resear ch/orsp/external_inv_FCOI_cert.pdf –Applies only to NON-CORPORATE FUNDING –MUST BE COMPLETED & SUBMITTED TO ORSP PRIOR TO PROPOSAL SUBMISSION

ORSPs Proposal Submission Changes External INVESTIGATOR Financial Conflict of Interest (FCOI) Certification Form 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 MUSCs –MUST BE SIGNED BY AN AUTHORIZED INSTITUTIONAL OFFICIAL –EXCEPTION: When External Investigators Organization is listed on the FDP FCOI Clearinghouse NO FORM REQUIRED: When External Investigators Organization is listed on the FDP FCOI Clearinghouse NO FORM REQUIRED: Encourage your investigators to register in the Clearinghouse Encourage your investigators to register in the Clearinghouse

ORSPs Proposal Submission Changes ePDS must be completed and routed BEFORE ORSP can submit the proposal 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

Time of Award COI Process Just-In-Time (JIT) and/or at Time of Award 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 FCOIs are managed or eliminated –ANY COI changes – MUST be reported within 30 days to MUSCs COI Officer

Other COI Related Information ORSP COI Web Page & Information: ORSP COI Web Page & Information: MUSCs Main COI Web Page & Information MUSCs Main COI Web Page & Information MUSCs External Contributor Financial Conflict of Interest (FCOI) Certification Form MUSCs External Contributor Financial Conflict of Interest (FCOI) Certification Form r_coi_form.docx r_coi_form.docx r_coi_form.docx r_coi_form.docx External Contributor Listing Form External Contributor Listing Form – r_listing_form.pdf r_listing_form.pdfhttp://academicdepartments.musc.edu/research/orsp/external_contributo r_listing_form.pdf MUSCs COI Disclosure Form MUSCs COI Disclosure Form sure_form.pdf sure_form.pdf sure_form.pdf sure_form.pdf

Other COI Related Information (Cont.) NIHs Financial Conflict of Interest Page NIHs Financial Conflict of Interest Page FDP Clearinghouse list of PHS FCOI compliant entities FDP Clearinghouse list of PHS FCOI compliant entities FDP Main Web Page (to download official invitation to join FDP Clearinghouse) FDP Main Web Page (to download official invitation to join FDP Clearinghouse)

Questions/Clarifications? PLEASE CALL ORSP IF YOU HAVE ANY QUESTIONS/CONCERNS ( ) PLEASE CALL ORSP IF YOU HAVE ANY QUESTIONS/CONCERNS ( ) THANKS FOR YOUR TIME! THANKS FOR YOUR TIME!