conflict of interest issues for the research administrator
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Conflict of Interest Issues for the Research Administrator. NCURA August 5, 2013 Policy/Compliance. Today’s Presenters. Lois Brako ( [email protected] ) – Assistant Vice President for Research, Regulatory and Compliance Oversight - PowerPoint PPT PresentationTRANSCRIPT
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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 ([email protected]) – Assistant Vice
President for Research, Regulatory and Compliance Oversight
Terri Maxwell ([email protected]) – Senior Project Representative, Office of Research and Sponsored Projects
Cathy Handyside ([email protected]) – Senior Product Manager, Information and Technology Services
Lori Deromedi ([email protected]) – 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/Guida
nces/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
InvestigatorResearch
Administrator
COI Office
Sponsored Projects OfficeContracts
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