Conflict of Interest Regulation Changes &

Research Proposal Submission Process

Changes09/11/12

updated 6/18/13

Office of Research and Sponsored Programs (ORSP)

843-792-3838

Topics Covered

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

Changes in PHS COI RegulationsAugust 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

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.)

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)

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

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 biasFOR MORE INFORMATION SEE:http://grants1.nih.gov/grants/policy/coi/summary_of_major_changes.doc

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!

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/r

esearch/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)

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/r

esearch/orsp/external_inv_FCOI_cert.pdf– Applies only to NON-CORPORATE

FUNDING– MUST BE COMPLETED & SUBMITTED TO

ORSP PRIOR TO PROPOSAL SUBMISSION

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

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

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

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_c

ontributor_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_c

oi_disclosure_form.pdf

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

Questions/Clarifications?

• PLEASE CALL ORSP IF YOU HAVE ANY QUESTIONS/CONCERNS (792-3838)

• THANKS FOR YOUR TIME!