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Conflict of Interest Issues for the Research

AdministratorNCURA

August 5, 2013Policy/Compliance

08/05/13

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Today’s Presenters

Lois Brako (lbrako@umich.edu) – Assistant Vice President for Research, Regulatory and Compliance Oversight

Terri Maxwell (tmax@umich.edu) – Senior Project Representative, Office of Research and Sponsored Projects

Cathy Handyside (chandys@umich.edu) – Senior Product Manager, Information and Technology Services

Lori Deromedi (lderomed@umich.edu) – Compliance Change Management, Office of the Vice President for Research

08/05/13

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U-M by the Numbers

3: Campuses - Ann Arbor, Dearborn, Flint

19: Schools and colleges (Ann Arbor campus)

7,141: Total regular faculty

36,710: Total staff and supplemental faculty

60,798: Total enrollment

$1,274,000,000: Research volume

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What’s at stake for U-M

2012 data

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COI Regulations

Public Health Service (PHS/NIH) 1995 Regulation – Responsibilities of the Investigator 2011 Revised Regulation – Responsibilities of the Institution

http://grants.nih.gov/grants/policy/coi/

National Science Foundation (NSF) 2005 Grant Policy Manual – Responsibilities of the

Institution and Investigator http://www.nsf.gov/pubs/manuals/gpm05_131/gpm5.jsp

Food and Drug Administration (FDA) 2013 Guidance documents (e.g., Financial Disclosure by

Clinical Investigators) http://www.fda.gov/downloads/RegulatoryInformation/Guid

ances/UCM341008.pdf08/05/13

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COI Regulations: Commonalities

Common regulatory points: Definitions:

Investigator Outside interest Conflict of interest Significant financial conflict of interest

Institutional policy requirements: Disclose outside interests to institution Report significant conflicts

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COI Compliance: Who’s Involved?

Regulatory

Compliance

Investigator

Research Administrat

or

COI Office

Sponsored Projects Office

Contracts Office

Information Technology

Performance Support

Discloses outside interests

Ensures compliance

Provides structure

Facilitates disclosure process

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Why Should We Care about COI?

Investigator Point of View Undue influence on professional

judgment Balance between primary obligations to

the university vs. outside interest

Research Administrator Point of View Research objectivity/integrity Open publication of research results Appropriate use of funds Projection of human subjects Proper transfer of intellectual property Maintain relationships with/fulfill

obligations to colleagues, students, andtrainees

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COI policies provide researchers and the institution a way to manage actual or perceived conflicts of interest; safeguarding objectivity in research……and avoiding negative news headlines.

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Institutional Responsibilities

What do research institutions look for to determine COI?

Commitment to the home institution Outside activities do not negatively impact institutional

responsibilities Outside activities do not exceed institutional policy limit for time and

effort Publication is credited to institution Use of institutional resources is approved by the institution

Impact on objectivity of their research (real or perceived)

Impact on human subject rights

Loss of trust in physician/patient relationships

Impact on students and trainees Student progress is not affected

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COI Office

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Common COI Situations

Investigator serves on a Board of Directors, Scientific Advisory Board, or consults for a company that is sponsoring research or is involved in human subject research

Investigator holds equity in a start-up company and is collaborating on a SBIR or STTR award with the company

Investigator wants to use institutional facilities or resources for work on behalf of an outside entity (e.g., equipment, lab space)

PI wants to have graduate students or other trainees work on projects for an outside entity with which the PI has an FCOI

Investigator want to buy research supplies/software from a company with which he/she has a relationship

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COI Office

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Managing COI for Research Activity

Policies and procedures:

Disclosure Annual Changes reported within 30 days (PHS)

Review Unit Central Office

Person Project

Management

Reporting

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COI Office

RA

Discloser’s Responsibilities

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Main outside interest considerations: Activity related to

institutional responsibilities Consulting/

Advising Leadership roles Board roles

Ownership/Equity Intellectual Property Travel (PHS)

Disclosers need to be aware of changes: Timing Thresholds Travel (PHS)

Research Administrators (RAs) assist faculty and staff in units: Disclosure Policies Disclosure System Resources for help

Investigator

RA

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Sponsored Projects Office Role

Sponsored Projects (pre-award office) ensures COI compliance through proposal and award management processes

At time of proposal submission, checks whether PHS FCOI regulations apply YES:

Verifies all Investigators at all sites must have disclosed Verifies who will manage COI for sub-award Investigators

(your institution or theirs) NO: follows applicable federal regulations and

institutional COI review procedures

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Sponsored

Projects Office

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COI Check at Award

For NIH awards, U-M Sponsored Projects uses the “Just-In-Time” (JIT) point to alert the COI Office that an award is likely COI Office: review and management

Reviews Investigators’ outside interests in context of the research activities to be conducted

If a conflict of interest is determined, establishes a management plan and creates the FCOI report for Sponsored Projects to submit to the sponsor

Sponsored Projects Office: reporting Reports to the sponsor BEFORE any funds are drawn down. Submits via Commons

Key elements are entered in text boxes or radio buttons Uploads actual FCOI Plan

Or, submits FCOI report directly to the sponsor per their instructions

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Sponsored

Projects Office

COI Office

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COI Check for Sub-Awards At time of application: management

Investigator/RA obtains sub-award institution’s PHS COI policy attestation Own policy or listed on the FDP Clearinghouse demonstrates compliance

(policy and disclosure “trust model”) No policy or not on FDP Clearinghouse? Subcontractor investigators

disclose to the awardee institution. Research Administrators obtain completed forms.

Sponsored Projects/Contracts Office records attestation

At time of award: management, review, reporting RA requests up-to-date disclosures, if needed Contracts Administration (post-award office) verifies sub-award

institution’s PHS COI policy attestation via the draft agreement If applicable, COI Office reviews disclosures If FCOI Report (from COI Office or sub-award institution)

included, Sponsored Projects reports to the sponsor08/05/13

Sponsored

Projects Office

Contracts Office

RA

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Subcontract COI Terms

By signature, Subcontractor certifies that they: Have an up-to-date, written and enforced administrative process

to identify and manage FCOI which complies with 42 CFR Part 50 for PHS research projects; or follow the awardee institution’s process

Promote and enforce Investigator compliance with requirements including disclosure of significant financial interests

Make information about Investigators’ disclosures and Subcontractor’s reviews (regardless of COI determination) available to the awardee institution

Report any FCOI to the awardee institution and PHS within 45 days of any identified FCOI and before expenditure of authorized funds

Fully comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors

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Contracts Office

Paraphrased from FDP forms

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Changes/Annual Review

Annual disclosure required by PHS and/or institution

COI Office reviews annually or when change reported

A new outside interest creating an FCOI in the course of a project requires notification to Sponsor within 60 days If change is not reported within 60 days, a retrospective

review of Investigator’s activities is required to determine if there was any bias to the research

A lengthy report of that review has to be submitted to the sponsor including the reason for the retrospective review

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Sponsored

Projects Office

COI Office

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Information Technology Role

Tools and Automation

Disclosure

Review

Management

Reporting

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Information

Technology

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Performance Support Role

Change Management Plan

Coordinate with campus One voice for compliance

Audience evaluation Methods

Targeted communications E-mail Web Job aids

Web pages design Simplify Resources Not all text

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Research Administrators assist with unit communication: Unit procedures Resources for help

Performance Support

RA