CONFLICT OF INTEREST & COMMITMENT Pam Rosse, M.S. Compliance Director, COIC

OVERLAP?

Consultant to FANTASTIC MICROSCOPES, Inc.

Equity in FANTASTIC MICROSCOPES, Inc. Equity in FANTASTIC MICROSCOPES, Inc.

Owner of FANTASTIC MICROSCOPES, Inc.

Inventor of FANTASTIC MICROSCOPES, Inc. Inventor of the FANTASTIC MICROSCOPE

CONFLICTS OF INTEREST FCOI The APS defines potential conflicts of interest as existing “when an employee’s financial or personal considerations may compromise, or have the appearance of compromising, an employee’s personal judgment” in one or more areas of academic responsibility.

APPEARANCES NIH Suspends Emory Grant Amid Questions Over Pharma Payments

Objectives: Transparency and Management Example of a Memorandum of Understanding (MOU)

AREAS POTENTIALLY AFFECTED BY COI Scientific and Scholarly Integrity Objectivity in Research Principles in Teaching Safeguarding Students from working on non-UCB projects Protection of Human Subjects Intellectual Property Procurement /Purchasing

NEW FOR 2013 Shared Space/Shared Lab Arrangements (action plan yet to be finalized) Self-Authored materials that are required for course instruction- Department approval will be required before disclosure (DEPA)is approved.

EXAMPLES OF PERMISSIBLE ACTIVITIES- no MOU required  Participation in scientific or professional association/society activities, editorial responsibilities, or service on scientific review boards and panels  Acceptance of honoraria for commissioned papers and occasional lectures  Service on boards and committees of organizations, public or private, which does not distract unduly from University obligations

A MOU does not imply improper behavior has occurred.

All Faculty ! Any Employee with responsibility for the: Any Student design, conduct, reporting of research design, conduct, reporting of research is considered vital to the research process and must disclose. WHO MUST REPORT?

1. 1.Tenure track faculty (assistant, associate, full profs.) 2 2. Instructors (assistant, instructor, senior) Adjunct faculty (assistant, associate, full profs.) 4.Visiting faculty (Adjoint faculty DO NOT report) 5. 5.Research faculty (professional research assistant, senior professional research assistant, research associate, senior research associate, faculty research associate, research professors-all levels) Museum faculty (Curator Adjoints DO NOT report) Librarians All KEY PERSONNEL listed on a research protocol or grant application, such as a PI, co-investigator, coordinator, graduate student/student. Note: Note: Lecturers and Teaching Assistants DO NOT need to report

No matter who looks over our shoulder, we’re ready with the right answers.

HOW TO REPORT COI STEP 1

HOW TO REPORT COI STEP 2 THE DEPA FORM D Disclosure (of) E External P Professional A Activities

WHAT IS REPORTED? SFI SIGNIFICANT FINANCIAL INTEREST Anything of monetary value received from an entity outside the university that meets or exceeds established thresholds appears related (or has the potential to be related) and that appears related (or has the potential to be related) to the discloser’s institutional responsibilities.

PRIMARY EXAMPLES OF SFI Salary /payments for services from a third party Equity interest (public and private entities) Company ownership Intellectual property rights

WHAT ARE THE SFI THRESHOLDS AT UCB? At UCB, Significant Financial Interest (SFI) thresholds are set in accordance with current funding agency regulations. Currently UCB uses a two-tiered threshold approach in evaluating SFI.

REPORTING VS. REVIEWING THRESHOLDS REPORTING THRESHOLD FOR ALL: $5,000 REVIEWING THRESHOLD: VARIES BY FUNDING AGENCY ie NON-PHS/NIH VS. PHS/NIH

THRESHOLD COMPARISONS NON-PHS/NIH- funded $10,000 for the AGGREGATED SUM of income and equity interest 5% ownership interest in any single entity. PHS/NIH- funded $5,000, alone, in income/payments for service $5,000 for the AGGREGATED SUM of income and equity interest received/ ownership of a publicly traded company ANY equity interest received/ownership of a non-publicly traded company. Sponsored Travel

NON-PHS/NIH- Funded (UNCHANGED) For Non-PHS/NIH- funded disclosers (who are NOT recipients of funding from Public Health Services [PHS] agencies) Threshold Values are: $10,000 for the AGGREGATED SUM of income and equity interest 5% ownership interest in any single entity.

PHS/NIH- Funded (CHANGED) For PHS/NIH- funded disclosers, (who are recipients of funding from Public Health Services [PHS] agencies including but not limited to NIH) Threshold Values are : $5,000, alone, in income/payments for service $5,000 for the AGGREGATED SUM of income/equity interest received/ ownership of a publicly traded company ANY equity interest received OR ownership of a non-publicly traded company

PHS/NIH- Funded TRAVEL For PHS/NIH- funded disclosers, travel reimbursement or sponsored travel related to institutional responsibilities in ANY amount must be report as SFI. Exclusions from this requirement include travel that is reimbursed or sponsored by the University of Colorado; a federal, state, or local government agency; another institution of higher education; an academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education.

University of Colorado Boulder Conflicts of Interest & Commitment Travel Report Form All travel reimbursement or sponsored travel related to institutional responsibilities must be reported as significant financial interest (SFI). Exclusions from this requirement include travel that is reimbursed or sponsored by the University of Colorado; a federal, state, or local government agency; another institution of higher education; or an academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education. LAST Name _____________________First Name ___________________ Job title (Faculty, PRA, RA, Student, etc) __________________________________________________________ Project title (PI, Co ‐ PI, Coordinator, etc) __________________________________________________________ Destination city ____________ Destination state ________ Destination country ________________________________________ Duration of the trip (in days) _____________ Estimated value of trip (in US dollars) ___________________ Trip Sponsor/organizer __________________________________________________________ _________________________ Purpose of the trip:

PHS/NIH- Funded Educational Training SkillSoft educational module: Conflict of Interest for NIH Must be taken once every 4 years. Due before 2013 disclosure is approved; sooner for new grants.

PHS/NIH REQUIREMENTS including training & travel

THE REPORTING PROCESS WHEN? Annually:1/15 – 3/31 (Reporting current status and anticipating events in the coming year) Within 30 days of a change in SFI (Includes travel for PHS/NIH funded)

ARE WE DONE YET???

REPORTING ISSUES: Access to CU Resources tab: Employee ID or POI ID is required 5-HELP Students and consultants often cannot access on first attempt. 5-HELP may direct them to Dept. PPL/Dept. Admin. for POI to be established.

Pam Rosse walking on water She cannot set a person up as a POI, provide an employee ID, establish an IdentiKey, or complete the DEPA for a discloser. (Note, electronic submission is needed).

EXPECTATIONS Allow adequate time for review, approval and the potential need for an MOU. Case review may involve: Entire COI Committee Additional CU input/expertise Gathering information from outside CU

ADDITIONAL DELAYS Discloser: Doesn’t provide all the facts upon initial disclosure Has multi-institutional /agency/company relationships Delays in agreeing with MOU language (may have to check with partners/company etc).

GETTING OUT THE WORD CAMPUSWIDE ANNOUNCEMENT PROPOSAL & AWARD -Annual collection -Throughout year

“ Only a hermit could avoid all conflicts of interest and apparent conflicts of interest.” (Shamoo & Resnick, 2009)