University/Industry Relationships and Conflict of InterestJohn Jay Gargus, M.D., PH.D.Professor, Physiology & Biophysics/PediatricsChair, Conflict of Interest Oversight Committee
April 24, 2013
Agenda University/Industry Relationships Conflict of Interest Disclosure Requirements Conflict of Interest Oversight Committee Conflict of Interest and Graduate
Education Resources
Birch Evans Bayh IIDem SenatorIndiana ‘61-’81
The Bayh-Dole Act or University and Small Business Patent Procedures Act is United States legislation dealing with intellectual property arising from federal government-funded research. Adopted in 1980, it gave US universities, small businesses and non-profits intellectual property control of their inventions and other intellectual property that resulted from such funding.
Robert Joseph DoleRep SenatorKansas ‘69-’96
University vs. Industry University and Industry have fundamental
differences in their motives that can never be fully reconciled
University Industry (Pharmaceutical, Device &
Equipment Companies)
• Educate and generate knowledge
• Social obligation to public
• Sell products• Fiduciary duty to
their stakeholders to make money
University/Industry Relationships
University and Industry Overlap With new knowledge comes new technology
which leads to new products resulting in the Industry’s need to consult Academic Scientists for their expertise
Potential Conflict of Interest since University researchers have an obligation to put research integrity and the education of their trainees and peers first when faced with a choice between making money or doing their duty
University/Industry Relationships
“Drugs and Disclosure”Reported October 11, 2008 “Dr. Charles Nemeroff of Emory University—the principal
investigator on a government-financed study of antidepressant drugs made by GlaxoSmithKline—repeatedly promised to keep his consulting fees from Glaxo below $10,000 a year in compliance with federal and university conflict-of-interest rules…Dr. Nemeroff failed to report some half-a-million dollars in fees and expenses from Glaxo while he led the study.”
Dr. Nemeroff had to step down from university research projects funded by NIH and NIH “froze funds for a $9.3 million project on depression led by Nemeroff”
NIH also “instituted tighter rules on approving grants for Emory” Editorial by The New York Times
White, Gayle and Schneider, Craig. “Depression Expert at Emory Pulls out of Research Projects.” The Atlanta Journal Constitution, October 14, 2008.
University/Industry Relationships
“University Sues Researcher”Reported January 3, 2012 “Craig Thompson, current president of Memorial
Sloan-Kettering Cancer Center, is being sued by his former employer, the Leonard and Madlyn Abramson Family Cancer Research Institute at the University of Pennsylvania, which he headed for 12 years, for not disclosing industry activities” for $1 billion dollars
Failed to disclose that he “founded biotech company called Agios pharmaceuticals”
University claims “it has rights to intellectual property that the company was founded on”
http://the-scientist.com/2012/01/03/university-sues-researcher/
University/Industry Relationships
Summary Articles highlight some consequences of
failing to disclose financial interests Failure to disclose affects the perception
of the researcher’s integrity and work and the university’s reputation once the undisclosed financial interests are uncovered
University/Industry Relationships
Research FundingA non-trivial high stakes activity NSF spent $5.7 billion in research and
related activities in FY 2012 NIH awarded $30.9 billion in research
grants in 2012 America’s biopharmaceutical research
companies invested a record $49.5 billion in 2011 in research and development of new medicines and vaccines http://
www.nsf.gov/pubs/2013/nsf13002/pdf/06_chapter1_mannagement_discussion_and_analysis.pdf
http://www.nih.gov/about/budget.htm
http://www.phrma.org/sites/default/files/159/phrma_industry_profile.pdf
University/Industry Relationships
UCI Statistics(Year ending June 30, 2011) 178 invention disclosures 869 active inventions 315 active UC patents 3 startup companies formed $7,354,000 total licensing income
UC Technology Transfer Annual Report 2011 http://www.ucop.edu/ott/genresources/documents/IASRptFY11.pdf
University/Industry Relationships
Greater Scrutiny
Main changes Lower financial disclosure thresholds Disclosure requirements broadened to include
financial interests related to institutional responsibilities not just research project
New conflict of interest training requirement Disclosure for any reimbursed or sponsored
travel (no lower limit) Disclosed information available to publicImplementation began August 24, 2012
University/Industry Relationships
Revised PHS Regulations(Final rule published August 25, 2011)
http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc
Greater Scrutiny
Requires all US manufacturers of drug, device, biologics, and medical supplies covered under Medicare, Medicaid, or SCHIP to report payments to physicians and teaching hospitals annually to Department of Health and Human Services, which will post information on public website
Must also disclose physician ownership or investment interest
Law exempts payments less than $10 until the aggregate annual total per company, per covered recipient, reaches $100, then all retroactive payments must be disclosed
First report due on March 31, 2014 for payments made from August 1, 2013 to December 31, 2013.
University/Industry Relationships
Physician Payment Sunshine Act (Final Rule Issued February 8, 2013)
http://www.prescriptionproject.org/tools/sunshine_docs/files/Sunshine-fact-sheet-6.07.10.pdf
What is a conflict of interest? A situation where an investigator’s
outside financial interest(s) or obligation(s) bias or have the potential to bias a research project
Note: Considering the public’s perception is important when considering a conflict of interest
Conflict of Interest
What is a financial interest?Anything of economic value from an outside entity including: Income- salary, consulting fees,
honorarium, stipend Equity interests- stock, stock options Positions in an outside entity such as
director, officer, partner, consultant, etc. Travel payments/reimbursements Loans
Conflict of Interest
Important principles about Conflicts of Interests COIs rarely arise from a bad person doing
wrong (illegal, immoral, unethical, unprofessional) things. They usually arise from a good person who has two worthy objectives that conflict with one another
COIs are inevitable for faculty and institutions engaged in technology transfer
The faculty member or student/trainee is seldom consciously aware of having a COI until educated
Conflict of Interest
COI Disclosure Policies State of California Federal Government (PHS, NSF) Human Subjects (IRB)
Disclosure Requirements
State Required for non-governmental
sponsored research and research gifts (i.e. private companies and nonprofit organizations)
Principal investigators are required to disclose financial interests in the non-governmental sponsor
Disclosure Requirements
State Disclosure Thresholds If you, the Principal Investigator, have received one
or more of the following from the nongovernmental sponsor of your research: Ownership or management interests/position;
consulting/employment relationship Income ≥ $500 Equity ≥ $2,000 Personal gifts ≥ $50 Travel payment Loan…. then you would be required to submit a COI addendum for review
Disclosure Requirements
Federal (NSF) Required for NSF research
contract/grant including subaward where NSF is the prime sponsor and funding from organizations following these federal disclosure requirements
All persons involved in design, conduct, or reporting of research being funded by NSF are required to disclose their significant and related financial interests
Disclosure Requirements
NSF Disclosure ThresholdsIf you are responsible for design, conduct or reporting of the NSF funded research and received one or more of the following from an outside entity with interests related to the research: Income ≥ $10,000 Equity ≥ $10,000 or 5% Director, Officer, Employee, Partner, Trustee,
Consultant, or Management position Intellectual Property not owned by UC…then you would indicate “Yes” on the Federal Financial Disclosure Form and submit a COI addendum for review
Disclosure Requirements
Federal (PHS)- Revised in 2011 Required for PHS research contract/grant
including subaward where PHS is the prime sponsor and funding from organizations following these federal disclosure requirements
All persons involved in design, conduct, or reporting of research being funded by PHS are required to disclose their significant financial interests related to their institutional responsibilities
Disclosure Requirements
Federal Disclosure ThresholdsIf you are responsible for design, conduct or reporting of the PHS funded research and received one or more of the following from an outside entity with interests related to your institutional responsibilities: For publicly traded entities, total compensation and equity
interest >$5,000; For non-publicly traded entities, income >$5,000, or any equity
interest; Income received related to intellectual property (not owned by
UC Regents) >$5,000 Any reimbursed or sponsored travel related to the institutional
responsibilities…then you would indicate “Yes” for each type of financial interest on the Form 800
Disclosure Requirements
Human Subjects (IRB) Required for any study involving human
subjects All individuals listed in the protocol
application as research personnel must disclose their financial interests related to the research
Disclosure Requirements
IRB Disclosure ThresholdsIf you are listed as research personnel on the protocol application and received one or more of the following from an outside entity with interests related to the research: Income ≥ $10,000 Equity ≥ $10,000 or 5% in a publicly traded entity Any equity in a privately held company Director, Officer, Employee, Partner, Trustee, Consultant,
or Management position Intellectual Property not owned by UC…then you would indicate “Yes” on the IRB application and submit a COI addendum for review
Disclosure Requirements
Conflict of Interest Oversight Committee (COIOC) Faculty advisory committee appointed to
3 year terms by the Vice Chancellor for Research
Representatives from Office of Technology Alliances and Research Administration are non-voting
Committee meets once a month; recommendations are forwarded to Institutional Official for final determination
COIOC
Current Composition of UCI’s COIOCFaculty (3 year terms; appointed by VC-Research)School of Biological Sciences – 0School of Medicine – 4College of Health Sciences – 0School of Engineering – 1School of Physical Sciences – 2School of Information and Computer Sciences – 0School of Social Sciences – 1Merage School of Business – 0
Ex officioBruce Morgan – Assistant Vice Chancellor of ResearchKevin Kennan, J.D. – Office of Res-Tech AlliancesGrace Park, J.D. – COI AdministratorNadia Wong – COI Analyst
Our function is to protect…
1.Human research subjects.2.Student researchers.3.Reputation of the University.4.Public funds (NIH/NSF), California tax payers.
… by reviewing COI disclosures of research projects and making recommendation to the VC-Research for: (1) approval,(2) management(3) disapproval
COIOC Not a punitive body Protect integrity of research related to
university/industry partnerships, personal investments, or consulting NOT discourage those activities
COIOC
COIOC Procedures Investigator/Researcher discloses financial
interests….YOUR RESPONSIBILITY COIOC reviews disclosure
We review WHAT YOU DISCLOSE We are not responsible for DISCOVERING your
conflict Determines whether or not conflict is
manageable Send recommendation to Institutional Official Implement management plan
COIOC
COI Management Strategies Public disclosure in publications and
presentations Monitoring by independent reviewers Disqualification from project
participation Divestiture Severance of relationships that create
COI Notification of sponsor (NIH, NSF,
others)
COIOC
PNAS 2009 vol. 106 4906-4911
Example of a proper COI disclosure in a publication.
COI Management Strategies Public disclosure in publications and
presentations Monitoring by independent reviewers Disqualification from project
participation Divestiture Severance of relationships that create
COI Notification of sponsor (NIH, NSF,
others)
COIOC
What the COIOC considers… Professionalism Protection of human subjects Protection against exploitation of
students/trainees Integrity of data Trust Setting standards in education Reputations and credibility
COIOC
Potential Risks of a COI Compromise of scientific integrity Improper direction of student or
employee’s work Inappropriate delay or restriction on
publications Unbalanced allocation of faculty
member’s time or effort Appearance of impropriety
COIOC
Graduate EducationCOI policy addresses conflicts that might stem from any financial interest of the graduate student’s mentor/thesis/dissertation advisor that has the potential to harm the student’s academic interests and degree progress
COI and Graduate Education
When is the best time to raise a concern about a COI? > When thesis advisor and project are chosen or anytime student has a concern. School has a form that must be signed at the end of the first year when student transfers from the Gateway Program to a lab.
Who can identify and report a conflict of interest? > The student, advisor, dept. chair or grad. advisor, assoc. dean or director of grad program, the campus COIC.
What are the responsibilities of my academic unit? > Notify students of the nature of COI and UC policy. > Provide students with name of Designated Resource Person – typically the dept. grad advisor. > Ensure faculty are informed about COI policy and procedures (APM-028), and how these might affect their relationship with students.
What is the responsibility of the thesis advisor?> Disclose any pertinent COIs to student and the dept. grad. advisor in a timely manner. (more later!)
Is there COI-related documentation that I should be aware of ? > Departmental Transfer Agreement: end of 1st year. > Advancement to Candidacy.
Graduate Education
COI and Graduate Education
1st Year- Gateway Program2nd Year- Transfer AgreementIf COI, appoint Oversight Member to Thesis CommitteeAdvancement to CandidacyIf COI, Oversight Member on Advancement CommitteeThesis DefenseIf COI, Oversight Member on Thesis Committee
Managing COI when involves Graduate Students Process may be initiated by student, faculty
mentor, departmental representative, or COIOC1. Report potential COI to Designated Resource
Person (usually departmental graduate advisor) or Department Chair
2. If DRP determines COI issue may be harmful to student, DRP notifies Dean of Graduate Studies requesting an Oversight Member be appointed
3. Dean of Graduate Studies selects an Oversight Member from a list of 3 nominations agreed upon by the student, faculty research advisor, and DRP
COI and Graduate Education
Oversight Member Participates as a non-voting Ex Officio
Member in all student research advisory and/or thesis/dissertation committee meetings.
Is aware of COI issues and relevant campus policies
COI and Graduate Education
Oversight Member Determine whether any harmful results from COI
issues If no harmful results from COI issues, sign brief
statement to that effect after each committee meeting and sign advancement to candidacy and final exam forms
If problem arising from COI issues, does not sign advancement to candidacy or final exam forms and does inform Dean of Graduate Studies of problem Dean of Graduate Studies responsible for determining
solution
COI and Graduate Education
COI and Graduate EducationOne priority of the COIOC and COI Policies regarding financial interests is to protect the academic interests and degree progress of graduate students
COI and Graduate Education
Research conflicts NOT related to financial interests
Whistleblower Policy http://www.evc.uci.edu/whistleblower/ If you suspect that a UC employee is engaged in improper governmental activities (such as corruption,
bribery, theft or misuse of university property, fraudulent claims, fraud, coercion, willful omission to perform duty; or economic waste; or gross misconduct, gross incompetence or gross inefficiency; or any condition that may significantly threaten the health or safety of employees or the public). (An "improper governmental activity" has to directly involve the university as either the victim of the improper activity or the perpetrator of the improper activity via the action of an employee.) The report can be submitted anonymously by calling 800-403-4744 or submitting a report online at http://universityofcalifornia.edu/hotline.
Research Misconduct http://www.research.uci.edu/ora/misconduct_FAQ.html Research Misconduct is defined by federal law and University policy as fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or
results such that the research is not accurately represented in the research records. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving
appropriate credit. If you suspect that research misconduct has occurred, contact the Research Integrity Officer (RIO) at (949)
824-5796 to submit an oral or written complaint. If you are unsure whether a suspected incident falls within the definition of research misconduct, you may consult with the RIO to discuss the incident informally.
Office of the Ombudsman http://www.ombuds.uci.edu/homepage.shtml The Office of the Ombudsman provides a safe and comfortable environment to discuss complaints,
concerns or problems confidentially. The office is confidential, informal, and neutral. To make an in person or telephone appointment, or if you have any questions, please contact the office at (949) 824-7256 or (714) 456-5605.
Resources COI in Graduate Education FAQs http://
www.grad.uci.edu/forms/faculty-and-staff/faq_coi.pdf
Conflict of Interest Office http://www.research.uci.edu/ora/coi/index.htm Grace Park, COIOC Administrator [email protected] Nadia Wong, COI Analyst [email protected]
