Organizational Conflict of Interest in Research
Conflict of Interest
FDP TRAINING FOR [YOUR ORGANIZATION]:
FDP TRAINING FOR [YOUR ORGANIZATION]:
Organizational Conflict of Interest
Organizational Conflict of Interest
May 21, 2019
From the Organizational Conflicts of Interest Working Group
Organizational Conflict of Interest
OCI WORKING GROUP
Mary Lee, Stanford University; Joy Bryde, Univ. North Carolina - Chapel Hill,
Kristy Hall, University of Virginia and Zack Byrnes, University of Pittsburgh.
Working Group participants: University of California, Northeastern University,
Vanderbilt University, University of Tennessee, Columbia University, State
University of New York, Colorado State University.
Disclaimer
Content provided in this presentation is
for general information and educational
purposes only. Please consult with your
legal and compliance offices to
determine the appropriate approach for
your university.
Requirements/information in these slides are
subject to change per federal regulations or sponsor
requirements.
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COI Types
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Individual
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Institutional
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Organizational
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Organizational COI (OCI)
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OCI Procurements and Subcontracts
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OCI Certification Processes
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Conclusions
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Resources
3 Types of Research Related COI
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Institutional COI Examples in Research
Institutional COI Examples in Research
Scenario #1
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University licensed IP is used in a human study at the University
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An entity in which the University owns equity or has a financial
interest is the sponsor, particularly for a human study
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The donor sponsoring a gift supporting the study has an interest in
the data outcomes
Scenario #2
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An institutional leader has a financial interest related to the
University research and is in the position to influence the research.
Is It Fair?
Bob
Bill
Jane
Is It Fair?
Bob
Bill
Jane
Is It Fair?
Bob
Bill
Jane
Sally
Is It Fair?
Bob
Bill
Jane
Sally
Is It Fair?
Sally
Poll Question
How did you feel when you found out that Sally had insider information
or an unfair advantage with respect to the funding opportunity?
(a) My proposal preparation was a waste of time
(b) Those things happen …
(c) Who do I complain to?
(d) All of the above
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When does an OCI come into play?
Two most common:
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FAR 9.5 for contracts if included by agency (some non-
federal entities also expressly incorporate FAR 9.5)
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Uniform Guidance 200.318(c)(2) (July 2018)
Others:
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Federal Agencies upon inclusion in grants and contracts RFP or
awards
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Private agencies or foundations requirements for proposals, grants,
contracts
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Management support or consulting services
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Supporting and furnishing systems
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Technical evaluation services
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Preparing specifications or requirements
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Systems engineering and technical advice
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Making product recommendations
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Systems integration
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Three categories
• Biased ground rules
• Impaired objectivity
• Unequal access to information
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“[A contractor], as part of its performance of a
government contract, has in some sense set the
ground rules for another government contract
by, for example, writing the statement of work
or the specifications.”
Aetna Gov’t Health Plans,
Inc.; Foundation Health Fed. Servs., Inc
., B-
254397,
et al
., July 27, 1995, 95-2 CPD ¶ 129
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• If a contractor is in the position of evaluating its own
performance or products, or the performance or products of a
competitor
• Making decisions based on contractor’s commercial or policy
interests, rather than best interests of government
• Contractor’s ability to “render impartial advice to the
government will be undermined, or impaired, by its relationship
to the product or services being evaluated . . . .”
Overlook Sys. Techs., Inc.,
B-
298099.4,
et al
., Nov. 28, 2006, 2006
CPD ¶ 185
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A firm gains access to nonpublic information through the
performance of one federal contract that is competitively useful in
obtaining a separate federal contract:
1.
Competitor’s proprietary information from Source Selection, or
2.
Government’s confidential information (possibly from
another contract)
(Must have a direct government connection to be an unequal access
to information; does not include getting access to information from a
non-government, third party source.)
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“Parent/subsidiary procurement COI”:
If the non-Federal
entity has a parent, affiliate, or subsidiary organization that
is not a state, local government, or Indian tribe, the non-
Federal entity must also maintain written standards of
conduct covering organizational conflicts of interest.
Organizational conflicts of interest means that because of
relationships with a parent company, affiliate, or subsidiary
organization, the non-Federal entity is unable or appears to
be unable to be impartial in conducting a procurement
action involving a related organization.
Poll Question
How often do you see OCI Requirements in funding announcements?
(a)
Very Often
(b)
Somewhat Often
(c)
Hardly Ever
(d)
I don’t know
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Research Project
PROPOSAL
Sponsor’s
Awarded
Contracts to
University
Named
Investigators’
funded projects or
submitted
proposals
Any University
Awards or
Submitted
Proposals using
Key Words from
RFP
Review proposal for (1) Unequal Access to Information,(2) Biased Ground Rules, or (3)
Impaired Objectivity.
Organizational Conflict of Interest
Sample Process Flow -
University of Pittsburgh
Research
Office
Research
Office
Research
Office
COI Office
COI Office
Project Staff
Poll Question
Does your institution have a process to review Organizational COI?
(a)
Yes
(b)
No
(c)
I don’t know
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FAR 9.5 and UG 2 CFR 200 are just two examples of
OCI Requirements.
•
OCI Requirements may also be found in RFPs and
Agreements from
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Foundations
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State Agencies
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Private Entities
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Federal Agencies – with DIFFERING requirements
Remember …
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Pre-Award Stage
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If we are submitting the proposal, check the Broad
Agency Announcement/RFP. Search by “conflict”.
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If we are a Sub, identify the Pass-through Entity and
search for “conflict” in that Pass-through Entity’s
subcontract/subaward terms.
•
If “organizational” or “institutional” COI reporting is
required at proposal, then alert the appropriate
University stakeholder for review assistance, per your
University’s policies and/or processes.
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Award Stage
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Check the Proposal record for previous OCI analysis.
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Check the BAA/RFP at
Just-in-Time
or when
Award is
RECEIVED
. Search by “conflict”.
•
If we are a sub, ensure that the search includes the
PRIME award documents.
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IF “organizational” or “institutional” COI is required to
accept the agreement, then alert your appropriate
University stakeholder.
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Under the old OMB Circular A-110, individual cannot
participate in selection, award, administration of a
contract if apparent or real conflict of interest.
•
Under the Uniform Guidance, this requirement is possibly
extended to
selection of subcontracts
. CHECK WITH
YOUR LEGAL COUNSEL.
•
State Statutes also may apply.
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Inside information
Federal sponsor
or Prime
Awardee
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Check with your own Sponsored
Research and COI Offices as to
what is applicable for your entity!
ARPA-E 340 Form –
Business Assurances &
Disclosures Form
SAMPLE OCI CERTIFICATION
Poll Question
Have you seen OCI Certification forms from any of the following (chose
all that apply):
(a)
DoD (including DARPA)
(b)
DOE (including ARPA-E)
(c)
NASA
(d)
NIH
(e)
NSF
(f)
Dept. of Education
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Who is covered by a University’s certification?
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Only University personnel. Not independent consultants,
subcontractors or subrecipients.
Who obtains certifications from Subs at time of PROPOSAL?
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Follow Practice at your University: Submitting Department
or Sponsored Research Office
Is FDP Clearinghouse Policy Sufficient for OCI?
•
No. FDP Clearinghouse is for policies on
Individual
COI,
not
Organizational COI.
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This presentation covers the various types of conflict of interest (COI) in research, including individual, institutional, and organizational COI. It discusses regulations related to COI and provides examples of institutional and organizational COI scenarios. The content emphasizes the importance of maintaining impartiality and avoiding unfair competitive advantages in research settings.
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Presentation Transcript
Conflict of Interest FDP TRAINING FOR [YOUR ORGANIZATION]: Organizational Conflict of Interest May 21, 2019 From the Organizational Conflicts of Interest Working Group
Organizational Conflict of Interest OCI WORKING GROUP Mary Lee, Stanford University; Joy Bryde, Univ. North Carolina - Chapel Hill, Kristy Hall, University of Virginia and Zack Byrnes, University of Pittsburgh. Working Group participants: University of California, Northeastern University, Vanderbilt University, University of Tennessee, Columbia University, State University of New York, Colorado State University.
Disclaimer Content provided in this presentation is for general information and educational purposes only. Please consult with your legal and compliance offices to determine the appropriate approach for your university. Requirements/information in these slides are subject to change per federal regulations or sponsor requirements.
Topics Covered in Overview Topics Covered in Overview COI Types Individual Institutional Organizational Organizational COI (OCI) OCI Procurements and Subcontracts OCI Certification Processes Conclusions Resources
3 Types of Research Related COI Type Description Regulations? Individual Research Bias: Individual s outside financial interests may bias research. Procurement COI: When individual spends university s funds on vendor related to individual. Numerous federal regulations. Institutional Institution is the person with a conflict 1. When Institutional Leader has outside financial interest related to University research and is in a position to influence the research or spend university funds for personal gain. 2. When Institution owns equity, intellectual property interests or could otherwise financially benefit (immediate or future) from influencing research. No federal definitions or regulations. See AAMC ICOI paper. State institutions subject to state laws. Organizational Avoid unfair competitive advantage 1. Uniform Guidance (UG): unable to be impartial in a procurement action involving a related organization. 2. Federal Acquisition Regulation: Where a related entity or current/prior work within the University has unfair competitive advantage from - Biased ground rules, - Impaired objectivity, or - Unequal access to information. 3. Others UG: 2 CFR 200.318(c)2 FAR 9.5, where included in federal contracts. Other requirements may not be found in regulations but in RFPs, BAAs or agreements.
Institutional COI (ICOI) Organizational COI (OCI) Institutional COI (ICOI) Organizational COI (OCI) Institutional COI Examples in Research Scenario #1 University licensed IP is used in a human study at the University An entity in which the University owns equity or has a financial interest is the sponsor, particularly for a human study The donor sponsoring a gift supporting the study has an interest in the data outcomes Scenario #2 An institutional leader has a financial interest related to the University research and is in the position to influence the research.
Is It Fair? Bob Bill Jane
Is It Fair? Bob Bill Jane
Is It Fair? Bob Bill Sally Jane
Is It Fair? Bob Bill Sally Jane
Is It Fair? Sally
Poll Question How did you feel when you found out that Sally had insider information or an unfair advantage with respect to the funding opportunity? (a) My proposal preparation was a waste of time (b) Those things happen (c) Who do I complain to? (d) All of the above
Organizational COI (OCI) Organizational COI (OCI) When does an OCI come into play? Two most common: FAR 9.5 for contracts if included by agency (some non- federal entities also expressly incorporate FAR 9.5) Uniform Guidance 200.318(c)(2) (July 2018) Others: Federal Agencies upon inclusion in grants and contracts RFP or awards Private agencies or foundations requirements for proposals, grants, contracts
FAR 9.5 FAR 9.5 Red Flag Contracts Red Flag Contracts Management support or consulting services Supporting and furnishing systems Technical evaluation services Preparing specifications or requirements Systems engineering and technical advice Making product recommendations Systems integration
OCI principles covered by FAR 9.5 OCI principles covered by FAR 9.5 Three categories Biased ground rules Impaired objectivity Unequal access to information
FAR Biased Ground Rules (FAR 9.505 (FAR 9.505- -2) 2) [A contractor], as part of its performance of a government contract, has in some sense set the ground rules for another government contract by, for example, writing the statement of work or the specifications. Aetna Gov t Health Plans, Inc.; Foundation Health Fed. Servs., Inc., B- 254397, et al., July 27, 1995, 95-2 CPD 129
Impaired objectivity (FAR 9.505 Impaired objectivity (FAR 9.505- -3) 3) If a contractor is in the position of evaluating its own performance or products, or the performance or products of a competitor Making decisions based on contractor s commercial or policy interests, rather than best interests of government Contractor s ability to render impartial advice to the government will be undermined, or impaired, by its relationship to the product or services being evaluated . . . . Overlook Sys. Techs., Inc., B-298099.4, et al., Nov. 28, 2006, 2006 CPD 185
Unequal access to information (FAR 9.505 Unequal access to information (FAR 9.505- -4) 4) A firm gains access to nonpublic information through the performance of one federal contract that is competitively useful in obtaining a separate federal contract: 1. Competitor s proprietary information from Source Selection, or 2. Government s confidential information (possibly from another contract) (Must have a direct government connection to be an unequal access to information; does not include getting access to information from a non-government, third party source.)
Uniform Guidance 200.318(c)(2) (July 2018) Uniform Guidance 200.318(c)(2) (July 2018) Parent/subsidiary procurement COI : If the non-Federal entity has a parent, affiliate, or subsidiary organization that is not a state, local government, or Indian tribe, the non- Federal entity must also maintain written standards of conduct covering organizational conflicts of interest. Organizational conflicts of interest means that because of relationships with a parent company, affiliate, or subsidiary organization, the non-Federal entity is unable or appears to be unable to be impartial in conducting a procurement action involving a related organization.
Poll Question How often do you see OCI Requirements in funding announcements? (a) Very Often (b) Somewhat Often (c) Hardly Ever (d) I don t know
How to Check for OCI at Your University How to Check for OCI at Your University Named Investigators funded projects or submitted proposals Any University Awards or Submitted Proposals using Key Words from RFP Sponsor s Awarded Contracts to University Research Project PROPOSAL Review proposal for (1) Unequal Access to Information,(2) Biased Ground Rules, or (3) Impaired Objectivity.
Organizational Conflict of Interest Sample Process Flow - University of Pittsburgh Research Office Research Office Research Office COI Office COI Office Identifies OCI Requirements (Proposal or Award) Submits proposal or negotiates award Notifies COI Office of Requirements Conducts Review Provides Response Project Staff
Poll Question Does your institution have a process to review Organizational COI? (a) Yes (b) No (c) I don t know
Remember FAR 9.5 and UG 2 CFR 200 are just two examples of OCI Requirements. OCI Requirements may also be found in RFPs and Agreements from Foundations State Agencies Private Entities Federal Agencies with DIFFERING requirements 24
OCI @ Pre OCI @ Pre- -Proposal Proposal Pre-Award Stage If we are submitting the proposal, check the Broad Agency Announcement/RFP. Search by conflict . If we are a Sub, identify the Pass-through Entity and search for conflict in that Pass-through Entity s subcontract/subaward terms. If organizational or institutional COI reporting is required at proposal, then alert the appropriate University stakeholder for review assistance, per your University s policies and/or processes. 25
OCI @ JIT Award OCI @ JIT Award Award Stage Check the Proposal record for previous OCI analysis. Check the BAA/RFP at Just-in-Time or when Award is RECEIVED. Search by conflict . If we are a sub, ensure that the search includes the PRIME award documents. IF organizational or institutional COI is required to accept the agreement, then alert your appropriate University stakeholder. 26
OCI OCI - - Procurements and Subcontracts Procurements and Subcontracts Under the old OMB Circular A-110, individual cannot participate in selection, award, administration of a contract if apparent or real conflict of interest. Under the Uniform Guidance, this requirement is possibly extended to selection of subcontracts. CHECK WITH YOUR LEGAL COUNSEL. State Statutes also may apply. Federal sponsor or Prime Awardee Inside information 27
SAMPLE Certification Process for OCI SAMPLE Certification Process for OCI Who Handles ? What Circumstance ? Check with your own Sponsored Research and COI Offices as to what is applicable for your entity! OSR/SPO If agreement is silent on topic COI Program If form or agreement has an OCI section or requires a OCI certification of any type, on behalf of the University Sub-Recipients or Consultants If flow down required and proposal has an OCI section or requires a OCI certification of any type. 28
SAMPLE OCI CERTIFICATION Business Assurances & ARPA-E 340 Form Disclosures Form
Poll Question Have you seen OCI Certification forms from any of the following (chose all that apply): (a) DoD (including DARPA) (b) DOE (including ARPA-E) (c) NASA (d) NIH (e) NSF (f) Dept. of Education
OCI Certification FAQs OCI Certification FAQs Who is covered by a University s certification? Only University personnel. Not independent consultants, subcontractors or subrecipients. Who obtains certifications from Subs at time of PROPOSAL? Follow Practice at your University: Submitting Department or Sponsored Research Office Is FDP Clearinghouse Policy Sufficient for OCI? No. FDP Clearinghouse is for policies on Individual COI, not Organizational COI. 31
Conclusions Conclusions Be familiar with the types of COI Stakeholder education & involvement is KEY Good Proposal Prep (including subs) = Successful OCI Review Easier with practice Welcome to the COI network! 32
