University/Industry Relationships and Conflict of InterestJohn Jay Gargus, M.D., PH.D.Professor, Physiology & Biophysics/PediatricsChair, Conflict of Interest Oversight Committee

May 28, 2014

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/Industry Relationships

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

Positive Interactions:Significant University Stake in Research Intellectual Property

Northwestern University professor develops IP

IP sold outright (not licensed) to Pfizer Product ultimately marketed as Lyrica

University royalties > $700 Million Professor endows $95 Million research

center Chicago Tribune…..3/10/08

Negative Interactions:“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-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

Tatsuya Suda, UCI professor of more than 25 years, pleaded guilty to failing to disclose his secret payments from Japanese companies funding his academic research.

Originally charged with six felony counts for allegedly receiving $325,000 to $700,000 illegally from a major Japanese firm from 2006 to 2009.

Owes more than $400,000 in restitution and costs to the university, and was sentenced to 3 years probation.

Suda is the first UC professor criminally charged and convicted for violating the state’s system for monitoring/preventing conflicts of interest on the 10 UC campuses.

University/Industry Relationships

Felony Charges for Failure to Disclose Financial Interests

Summary Appropriate disclosure can be very positive Articles highlight some serious

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 $5.5 billion in research and related activities in FY 2013

The NIH invests nearly $30.1 billion annually in medical research.

America’s biopharmaceutical research companies invested a record $48.5 billion in 2012 in research and development of new medicines and vaccines http://www.nsf.gov/pubs/2014/nsf14002/pdf/nsf14002.pdf

http://www.nih.gov/about/budget.htm http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf

University/Industry Relationships

UCI Statistics(Year ending June 30, 2012)

117 invention disclosures 901 active inventions 334 active UC patents 4 startup companies formed $7,514,000 total licensing income

UC Technology Transfer Annual Report 2012 http://www.ucop.edu/innovation-alliances-services/_

files/ott/genresources/documents/IASRptFY12.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 COIOC

Faculty (3 year terms; appointed by VC-Research)School of Biological Sciences – 0School of Medicine – 5College 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. – Principal Subcontract and Research Compliance OfficerNadia Wong – COI AdministratorAmy Green – COI Analyst

COIOC

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

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.

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

Scenario 1: A faculty member owns stock in an outside entity that may or may not be supporting research on which the faculty is working, but which stands to benefit from that research. The faculty member directs the student, who is also working on this project to delay publication of his/her dissertation and graduation until the faculty member can complete his research.

Scenario 2: A faculty member establishes a company that stands to benefit financially from a research or other project. The company is also supporting the Faculty member’s research in this area at the university laboratory. The faculty member pressures a student to work on the research project of interest to his/her company.

How does COI relate to graduate education?

COI and Graduate Education

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 COIOC.

COI and Graduate Education

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.

COI and Graduate Education

What is the responsibility of the thesis advisor?Disclose any pertinent COIs to student and the dept. grad. advisor in a timely manner.

Is there COI-related documentation that I should be aware of? • Departmental Transfer Agreement: end of

1st year. • Advancement to Candidacy.

COI and Graduate Education

Graduate Education

COI and Graduate Education

1st Year- Gateway Program

2nd Year- Transfer AgreementIf COI, appoint Oversight Member to Thesis Committee

Advancement to CandidacyIf COI, Oversight Member on Advancement Committee

Thesis 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

COI 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 Nadia Wong, COI Administrator nadiaw@uci.edu Amy Green, COI Analyst acgreen1@uci.edu

Resources for non-COI Concerns… Whistleblower Policy http

://www.evc.uci.edu/whistleblower/If suspect 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). The report can be submitted anonymously by calling 800-403-4744 or submitting a report online at http://universityofcalifornia.edu/hotline. 

Resources for non-COI Concerns Research Misconduct

http://www.research.uci.edu/ora/misconduct_FAQ.htmlResearch 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. Office of the Ombudsman http://

www.ombuds.uci.edu/homepage.shtmlThe 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.