UPDATE FOR COI CONTACTS 2013 - PowerPoint Presentation

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UPDATE

FOR COI CONTACTS 2013

http://research.illinois.edu

University of Illinois at Urbana-Champaign

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Thank you for all you do to support disclosure and management of conflicts of interest at Illinois. We hope that this presentation is helpful. Your participation is very

importantEncouraging meetings of management oversight committees

Encouraging awareness of issuesVigilanceIdeas

Welcome!

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The University of Illinois Policy on Conflicts of Commitment and Interest was revised effective July 1, 2012 to accommodate new federal regulations in 42 CFR Part 50 Subpart F

Please see http://research.uillinois.edu/coci/coci-policyRevisions were reviewed by the University Senates Conference, and approved by the University of Illinois Board of Trustees.

Basic principles remain the same.

University of Illinois Policy

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A conflict of interest exists when an academic staff member is in a position to advance his/her own interest or that of others to the University’s detriment

A conflict of commitment arises when the external activities of an academic staff member are so demanding of time or attention that they interfere with the individual’s responsibilities to the University

Definitions

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Prior approval from supervisor for non-University activities

Unit heads should not approve an activity unless satisfied that it

benefits the institution and the employee and conflicts can be managed. Employee’s primary responsibility is to the University

Annual Full Disclosure of non-University Activities

Under University Policy, identification of conflicts is facilitated by our annual disclosure process in September, currently using the Report of

Non-University Activities.

The Unit Executive Officer and OVCR work with the academic staff member to identify and evaluate potential conflicts and to manage or eliminate them.

What Activities Are Required By University Policy?

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A Professor’s start-up company employs the Professor’s thesis studentsStudents are involved in faculty consulting

A spouse’s company sponsors faculty researchUniversity resources are used to support research for a company in which the employee has a financial interest

Immediate family members are paid by a faculty grant

Examples of Apparent COI

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DisclosureMonitoring

Oversight committees or review panelsDisclosure in publications and presentations

Recusal from decisionsDivesting financial interestsLeave of absence or reduction in appointment

Severing relationships

COI Management Strategies

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September 16, 2013: Notification to employees of form availabilitySeptember 30, 2013: Completed forms turned into departments

October 21, 2013: Reviewed forms and checklists forwarded from departments to colleges

November 11, 2013: Reviewed forms and checklists due from colleges to OVCR

Please see http://research.uillinois.edu/rnua

RNUA Process 2013-2014

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Changes in RNUA Form

1. Simplified Part I – Single Yes/No

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2. Part II – no retrospective reporting and more room for explanation

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3. Part III - Affirmation Includes

Links to PHS Disclosure Forms

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4. Part IV - Clearer Instructions

Please

see

http://research.uillinois.edu/rnua/forms-instructions

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5. Part II Form – More space for explanation – two activities per page

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Your Assistance is Needed

RNUA Forms – please make sure that forms are completed and that boxes are checked, signatures are in place, etc., before forwarding to the next level

CHECKLISTS – please make sure that the checklist is completed before it is forwarded to the next levelDid your expert in this area retire this year? Please call us if you have questions or need help with the process at 333-0034.

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The University’s Policy on Conflicts of Commitment and Interest focuses on disclosure of income-producing outside activities to identify conflicts of commitment or interest for all academic employees.

www.research.uillinois.edu/policy/

cociHHS Regulations focus on disclosure of significant financial interests and externally sponsored travel to identify conflicts of interest for PHS investigators.

www.grants.nih.gov

/grants/policy/coi/index.htm

Comparing UI Policy To HHS Regulations

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InvestigatorsA very broad definition

“Any person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by the PHS”

All academic employees, including students and residentsPI, co-PIs, postdocs

, RAs, fellows, emeritus faculty, research coordinators, others.

Who is Covered By The HHS Regulations?

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Office of Global Affairs Office of the Assistant Secretary for Health

Office of the Assistant Secretary for Preparedness and Response Agency for Health Care Research & Quality Agency for Toxic Substances and Disease Registry

Centers for Disease Control and Prevention Food and Drug Administration Health Resources and Services Administration

Indian Health Service

National Institutes of Health Substance Abuse and Mental Health Services Administration

HHS

– Public Health Service Agencies

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Administration for Children and Families

Alliance for Lupus Research American Cancer Society

American Heart Association American Lung Association Arthritis Foundation

Danforth Plant Science Center

Juvenile Diabetes Research Foundation Lupus Foundation of America

Susan

G. Komen for the

Cure

Non-PHS Agencies That Follow Regulations

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DisclosureFinancial interests

TravelTraining

What Activities Are Required By The HHS Regulations?

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Disclose all significant financial interests that appear to be related

to your institutional responsibilities. These include financial interests held by immediate family members – parents, spouse, siblings, children.

Payments from exempt sources do not require disclosure.Disclosure Requirements

Non Exempt

sources include

non-profits

international universities

corporations

Exempt

sources include:

U of I

other US universities

federal, state, or local government

agencies

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Fillable PDF available at:www.research.illinois.edu/coi

PHS Investigator Financial Interest Disclosure Form

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Disclose ANY externally reimbursed travel from a single source with an aggregate value ≥

$5000, unless exempt: 

The U of I, other U.S. academic institutions, federal, state or local government agencies are all exemptAll travel covered by corporations, non-profit organizations, international universities or organizations must be disclosed 

Family travel expenses

, including the travel of spouse and dependent children.

Travel Disclosure

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Travel Disclosure Website

Available at:

www.phstraveldisclosure.research.illinois.edu

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Each PHS investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years

For

UI traineesOVCR Training Portal

http://portal.research.illinois.edu

For

non-UI

trainees

OVCR Training Portal

http://portal.research.illinois.edu

Email

phsdisclosure@illinois.edu

for login information

Training

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Training And Disclosure Verification

Fillable PDF available at:

www.opsra.illinois.edu/forms.htmlList all project information on

the first page

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Training And Disclosure Verification

Fillable PDF available at:

www.ospra.illinois.edu/forms.htmlList all project investigators on

the second page

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The OVCR maintains records of training and disclosure.

Data on completion of training and disclosure for faculty, staff and students is available from the OVCR

through Box, uofi.box.com.  Please contact phsdisclosure@illinois.edu to request access.

Training And Disclosure Verification

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Award StageOSPRA

will confirm with OVCR that a signed verification form is on file prior to forwarding the award to Grants and Contracts. 

Funds cannot be expended until all PHS investigators on the project are trained and up to date with their disclosures.  No anticipation accounts will be granted

or award funds created

until OSPRA has received an approved certification form from the OVCR. 

Training And Disclosure Verification

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Office of the Vice Chancellor

for Research

Contacts: Melanie Loots, Ph.D.Linda K. Lee Drozt

phsdisclosure@illinois.edu217-333-0034

For More Information