Transcript Intellectual Property and Conflict of Interest

Conflict of Interests
Andrew Gelasco, Ph.D.
Vice-Chair, Research Conflict of Interests Committee
Press Titles
Surgeon's Royalties Bring Heat to a Medical School With a Strict
Ethics Policy
(U. Wisconsin SOM) – $19.4 Mil over 4 yrs)
Emory U. Psychiatrist Failed to Report Income From Drug Makers
($3.9 Mil Consulting on a 3 M NIH Trial of 5 Co. Products)
How a Cancer Trial Ended in Betrayal With Millions at Stake,
University Research became partners in Commerce – and Medicine
Pays a Price
(UAB Patient report on worthless drug and physicians ties)
Doctors Face Pressure to Disclose all Side Pay
(Medical industry pays $20 Bil/Yr in payments and gifts)
Harvard Medical School in Ethics Quandary
(Professor promoted cholesterol drug product in class)
Press Titles (Cont.)
U.S. Probes Emory Doctor’s Glaxo Ties
Grassley, Kohl seek information about money going from medical device
makers to doctors
Introduced S.2029, the Physician Payments Sunshine Act,
Require companies that make pharmaceuticals, medical device and biologics to disclose
payments they make to physicians. The information would be made publicly available
online by the U.S. Department of Health and Human Services.
Stanford medical school to provide online disclosure of faculty's
consulting activities.
Glaxo Expands List of Public Payments to Doctors
Cap of 150 K per yr
Doctors Urged End to Corporate Ties
Industry Support of Medical School Departments
28%
20%
14%
14%
Types of Funding (Survey Reponses)
Research Support
Technology Transfer Funds
Research Equipment
Support for students and postdocs
Declaration of Financial Interests
• PHS and NSF enacted regulations (1995).
• Investigators must disclose any significant financial interests to the
institution that would reasonably appear to be affected by the proposed
research.
• Significant financial interests are defined as anything of monetary value,
including but not limited to, salary or other payments of services (e.g.,
consulting fees, honoraria); equity interests (stocks, stock options or other ownership
interests); and intellectual property rights (e.g., patents, copyrights and royalties
from such rights) when aggregated for the investigator and the
investigator’s spouse and dependent children, are greater than, or equal
to, $10,000 in value and 5% ownership interest in any single entity.
• Institutions determine whether or not these interest could directly or
significantly affect the design, conduct or reporting of research … and
how to proceed (eliminate, reduce, or manage the conflict).
FASEB COI Toolkit
3 Guiding Principles*
• Conduct research activities objectively
• Operate with transparency
• Be accountable
* Based on FASEB Guiding Principles
Conduct Research Activities Objectively
• How to maintain objectivity?
– Intellectual honesty in proposing and
conducting research
– Report research results to public and scientific
community
– Lack of influence by competing interests,
primarily $
• Equity position, officer of company, family member
involvement, purchasing, etc.
Case Study 1
• Dr. Doe receives a consulting fee of
$8,000 in return for technical advice to
ABC Pharmaceuticals.
• Dr. Doe also receives a sponsored clinical
trial contract from ABC to test the efficacy
of their pharmaceutical XXX.
• What are the major issues?
Operate with Transparency
• What is Transparency?
– Openness and willingness to accept scrutiny
• Are you Transparent with your research?
• How can you be more transparent?
– Regular internal reporting
– External disclosure
– Perception is reality
Case Study 2
• Dr Doe receives an additional $8,000 from ABC
for speaking about pharmaceutical XXX. This
had not been disclosed by the investigator.
• Dr. Doe also received a second award for
fundamental bench research from ABC on
pharmaceutical YYY.
• What conflict issues are there now?
Be Accountable
• What is Accountability?
– Obligation to take responsibility for one’s actions
• Who are you accountable to?
– State or Federal sponsors
– All sponsors
– Human Subjects in Clinical Trials
• How do you handle accountability with different
roles?
– Mentee vs. Mentor (PI)
Case Study 3
• Being creative, Dr. Doe has a really novel, patentable
pharmaceutical, ZZZ, and his Chair and Dean have
formed a company, XYZ Pharmaceuticals, to
license/make/market this new product through RDF. All
three are officers in the company as is Dr. Doe’s wife.
• XYZ contracts Dr. Doe to conduct bench research.
• XYZ, being a virtual company with only employees, also
requests that XYZ employees assist in the research
conducted in university facilities.
• What are some of the new issues?
Other Conflict of Interests Issues
Others than research-related, individual COI issues
•
Institutional Conflict of Interests.
– University owns an equity position, so what?
– University officers own an equity position (i.e., shareholder)?
•
Clinical Activities and Conflict of Interests.
– Prescribing Pattern
– Implant and Equipment Selection
– Paid Speaker for Drug Companies
•
Acceptance of gifts.
– Meals including pharmaceutical lunches
– Entertainment, travel, etc.
•
Misuse of Confidential Information.
– HIPAA, Trade secrets
– Relationship to Vendors
•
New Programs e.g., CTSA, CoEE, provide more issues regarding COI
The Conflict of Interests (COI) Committee
• The COI Committee determines if a conflict exists, not the investigator.
• There is no real difference between a “real” and a “perceived” COI; they
are treated equally.
• Encourage investigators to submit a conflict of interests statement even
if there is uncertainty of whether or not a conflict exists.
– transfer of liability is the real issue; why you should disclose
• Significant financial interests are reviewed as per federal guidelines.
– monetary value, including salary or other payments of services, equity
interests, and intellectual property rights
– the investigator and family members have an interest of ≥ $10,000 and ≥ 5%
(significant) ownership interest.
• If a COI is determined, then it must have an acceptable “management
plan”.
Conflict of Interests (COI) Education
Module
The Institution recognizes that selected individuals are required to
have interactions with government agencies, business, and industry, as
important components in executing their assigned duties.
Unfortunately, many of these interactions with the private sector bring
an increased potential for personal financial opportunities that may
compromise or influence institutional duties.
It is the responsibility of our institution to acknowledge real and
potential conflicts of interest, and to provide administrative oversight to
managing these interactions such that the integrity of our public
institution is not questioned.
The disclosure process that follows should begin to lay the foundation
for transparency of potential conflicts of interest between employees of
the Institution (and our affiliates) and business organizations which
interact directly and indirectly with our institution.
Conflict of Interests (COI) Education Module
Conflicts of Interest (COI) have taken an increasingly prominent
role nationally in politics, businesses and clinical settings. High-profile
examples of undisclosed or incompletely reported financial conflicts of
interest have been well publicized with a strong sentiment for
transparency in acknowledging potential COI.
In responding to this concern, our Board of Trustees has adopted a
COI Policy which is the basis for this training module and the survey
questions that follow.
A COI may arise when an employee of the MUSC enterprise has a
job position that presents an opportunity for him or her to personally
gain financially from an outside professional and/or financial
relationship with a company in such a manner that the relationship
could potentially interfere with his or her obligations to our institution.
Conflict of Interests (COI) Education Module
Family member: The Board of Trustees’ COI Policy defines “family
member” to include the employee's parents, spouse, siblings, children,
stepchildren, and grandchildren. In responding to the survey questions,
“you” and “your family” include both you individually and your family as
defined above.
Financial Interest: A financial interest is defined as anything of
monetary value either directly to you as the employee or to a family
member from any company.
Do not report:
Any salary, royalties, stipends, honoraria, reimbursement for
expenses or any other remuneration from the MUSC enterprise.
Interest income, investment income, or other personal income that is
not related to your sanctioned activities.
Annual Conflict of Interests Disclosure Survey
Part A
Answer the following questions to the best of your knowledge.
If you or a family member has a material role, or a financial interest in a company that
does business with the MUSC enterprise:
A-1. Are you involved in purchasing or procurement decisions that involve
this company?
Yes No
A-2. Do you prescribe, use or implant products, e.g., drugs or devices,
made by this company?
Yes No
A-3. Have you received a 2008 IRS Form 1099, W-2 or K-1 from this
company? Yes No
A-4. Do you have a role in any regulatory activities of the MUSC enterprise
that involve this company?
Yes No
Continue
Annual Conflict of Interests Disclosure Survey
Part A
If you or a family member has a material role, or a financial interest in a company
that may or may not do business with the MUSC enterprise:
A-5. Do you have intellectual property rights, e.g., patents or trademarks, that are
held, licensed or optioned to this company? Yes No
A-6. Do you serve as a compensated consultant for this company or in any other
way advise investors with respect to research outcomes of clinical trials involving
drugs or medical devices? Yes No
A-7. Does this company sponsor or in any way support research activities in
which you are identified as an investigator? Yes No
View Response
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Questions?