Transcript Office of Institutional Compliance

Office of Institutional
Compliance
Presentation to the CRAD
October 16, 2008
Compliance Office – Four Components
•
•
•
•
The Core Compliance Program
University Administrative Policies
Delegations Management
Conflict of Interest Program
2
The University’s Core Compliance
Program
• Modeled in large part after the Federal
Sentencing Guidelines
• Approximately 30 different risk areas
• Partnership with OGC and the University’s
Office of Internal Audit
• Ensures a coordinated approach:
– Identification and management of risk
– Setting compliance-related priorities
3
The University Core Compliance
Program
• Compliance Partners are identified for each
compliance area.
• Reporting process occurs twice annually.
• Compliance Partners submit written summary of
identified risks, related risk management
approaches, and the identification of trends.
• In person meetings are held.
• Six Compliance Partner Education lunches are
convened per year.
4
The University’s Core Compliance
Program – Subject Matter Areas
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Athletics
Boynton Health Service
Community University Health Care Center
Conflict of Interest
Copyright
Dining Services
Disability Services
Environmental Health & Safety
Equal Opportunity and Affirmative Action
Facilities Management
Fiscal Operations
Grants Management
HIPAA Compliance
Housing and Residential Life
Human Resources & Payroll Operations
5
The University Core Compliance
Program – Subject Matter Areas
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Information Technology
Internal Audit
International Programs
Occupational Health & Safety
Privacy
Public Safety
Research – Animal Subjects
Research – Human Subjects
Research – BioSafety
Research- Controlled Substances
School of Dentistry (billing compliance)
Student Finance
Tax Management
Technology Commercialization
6
The University’s Core Compliance
Program – Current Emphasis
• Occupational Health & Safety
• AAALAC
• Conflict of Interest Program
7
The University Core Compliance
Program
• Occupational Health & Safety (OHS)
– A few years ago, President Bruininks asked VPs Carol
Carrier, Tim Mulcahy and Kathy O’Brien to form a
Working Group charged with evaluating the then
current status of the University’s OHS Programs.
– The working group:
• Interviewed the University’s key stakeholders
• Reviewed programs at other industry and academic
institutions
• Found that OHS programs across the University are many
and varied and are currently under the leadership of 8
different VPs
• Prepared a comprehensive interim report in June 06
8
The University’s Core Compliance
Program – Current Emphasis - OHS
• Steering Committee Formed
– Chaired by Sr. VP Frank Cerra
• Kathy O’Brien, Gail Klatt, Carol Carrier, Terry Bock, Ross
Janssen, Patricia Franklin, Tim Mulcahy, Lynn Zentner
– Goals:
• Develop an integrated and carefully coordinated
program
• Utilize the expertise that exists within the many
departments within the scope of OHS
• Close gaps that exist in services and training
• Reduce redundancies
9
The University’s Core Compliance
Program – Current Emphasis - OHS
• Efforts are currently underway to retain an
outside consultant to review current programs
and provide feedback re the most effective ways
to:
– Integrate the operations of our current programs;
– Identify, evaluate and manage all related risks
– Develop comprehensive standards, policies, and
procedures; and
– Establish a leadership model.
• A national search will be initiated to select a
Director
10
The University Core Compliance
Program –Emphasis – Animal Research
• The Association for Assessment &
Accreditation of Laboratory Animal Care
(AAALAC) conducted accreditation site visits in
early 2007 and again in February 2008.
• AAALAC identified problems the University is
committed to resolving:
– Strengthening the oversight, leadership and
expertise of the membership of the IACUC
11
The University’s Core Compliance Program
– Emphasis – Animal Research
– Developing greater consistency in the use of
Personal Protective Equipment; and
– Ensuring that certain biohazard containment
practices are sufficient to properly contain the
hazard and minimize risk to personnel.
12
The University’s Core Compliance
Program - UReport
• UReport is a web-based and call center
reporting service
– To report violations or suspected violations of
local, state, and federal laws and University
polices
– Provides for anonymous reporting
13
The University’s Core Compliance
Program - UReport
2008 metrics:
• 161 reports submitted
• 139 were submitted on-line; 19 were received
via the call center, 2 were received via the mail
and 1 was received “in person”
• 29% were anonymous
• 20% were deemed to be credible reports of a
violation of law or policy
14
The University Policy Office
• Merged with OIC in 2007
• Michele Gross manages the process of policy
development, revision, maintenance and
retirement.
• The Policy Advisory Committee (PAC) ensures
that policies are needed and aligned with
institutional mission, goals, and priorities.
• The President’s Policy Committee (PPC) provides
final institutional review and approval.
15
The University Delegations Management
Program
BOR policy:
• Reserved several authorities to itself.
• Delegated general executive management and
administrative authority to the President and
to further delegate that authority to other
executive officers and employees.
• Formerly managed by OGC.
• Currently reviewing the existing electronic
tracking system for possible modifications.
16
The Conflict of Interest Program
• Effective September 1, 2008, the Conflict of
Interest Program was transferred from OVPR
to OIC.
• The University evaluates both individual and
institutional COIs.
17
The Conflict of Interest Program
BOR Policies
• An individual business or financial COI:
– A situation that compromises a covered
individual’s professional judgment in carrying out
University teaching, research, outreach, or public
service activities because of an external
relationship that directly or indirectly affects a
business or significant financial interest of the
covered individual, an immediate family member,
or an associated entity as defined in related
administrative policy.
18
The Conflict of Interest Program
BOR Policies
• An institutional COI:
– A situation in which the research, teaching,
outreach, or other activities of the University may
be compromised because of an external financial
or business relationship held at the institutional
level that may bring financial gain to the
institution, any of its units, or the individuals
covered by this policy.
19
Conflict of Interest – the Enforcement
Landscape
Scrutiny by the Federal Government:
• The Pharmaceutical Industry
– Serono - $567 million in part for kickbacks paid to physicians
– TAP Pharmaceutical - $559 million in part for kickbacks paid to
physicians
– Bristol Myers Squib- $515 million in part for kickbacks to
physicians
– Smith Kline Beecham- $325 million in part for kickbacks to
physicians
– AstraZeneca Pharmaceuticals- $266 million in part for kickbacks
to physicians
20
Conflict of Interest – the Enforcement
Landscape
The Device Industry:
• Settlement of claims against 5 orthopedic
companies in September 2007 for $311 (Stryker,
DePuy, Zimmer, Smith & Nephew and Bionet)
– Scrutinized consulting agreements for legitimacy and
$$ paid
– Deferred prosecution agreements
– On-site monitors
• Fall 2005 Department of Justice subpoenas
served on Medtronic, St. Jude and Guidant (now
Boston Scientific).
21
Conflict of Interest – the Enforcement
Landscape
By Whistleblowers:
• September 2008 whistleblower suit reported
in the local media regarding alleged receipt of
kickbacks by local physicians for prescribing
the off-label use of a biologic marketed and
sold by Medtronic.
22
Conflict of Interest – the Enforcement
Landscape
By Congress:
Re Alleged Inadequate Disclosures in Higher Education:
• Harvard: Senator Charles Grassley (IA) alleged that two Harvard
faculty/physicians failed to report $1.6 million in consulting fees to their
institution.
• Stanford: Senator Grassley alleged that the Chair of the Department of
Psychiatry failed to report $6 million in ownership interest in stock in a
company involved in a government-funded study that the physician
oversees.
• Emory: One of the nation’s most influential psychiatrists is alleged to have
earned more than $2.8 million in consulting arrangements with drug
makers from 2000 to 2007, failed to report at least $1.2 million of that
income to his university and violated federal research rules
23
Conflict of Interest – the Enforcement
Landscape
• In early August the media reported
that Senator Grassley sent letters to
several institutions of high education
seeking information about the quality
of the reporting system by which
academic researchers report their
outside income to their institutions.
24
Conflict of Interest – the Enforcement
Landscape
Senator Grassley’s concerns:
– That colleges and universities often do not
monitor or audit the information the researchers
report so the only person who knows if the
reported income is accurate is the person who is
receiving the money.
– Although he is not saying that there is something
inherently wrong with accepting money from
industry, for the sake of transparency and
accountability, it is his view the American public
should know who the physician is taking money
from.
25
Conflict of Interest – the Enforcement
Landscape
Legislation
• Federal: September 2007, Senators Grassley and Herb Kohl
(WI) introduced legislation requiring manufacturers of
pharmaceutical drugs, devices and biologics to disclose the
amount of money they give to physicians through payments,
gifts, honoraria, travel and other means.
– Senator Amy Klobuchar is a co-sponsor.
26
Conflict of Interest – the Enforcement
Landscape
– Senator Amy Klobuchar’s comments on the proposed
legislation: “This is a common sense legislation that helps
ensure the integrity of our health care system. It is
important to shed light on the millions of dollars these
companies spend on marketing – money that could be put
into research or lowering the cost of prescriptions.”
– Letters of endorsement from the AMA, the Association of
American Medical Colleges, AdvaMed, Pharma, Medtronic,
and Merck.
27
Conflict of Interest – the Enforcement
Landscape
By States:
• Several states and the District of Columbia have “sunshine
laws” - some that provide public disclosure and others that
do not; some that require disclosure by only the
pharmaceutical industry and some that require disclosure
by both the pharmaceutical and device industries:
–
–
–
–
–
–
Minnesota (the first)
Vermont
Maine
District of Columbia
West Virginia
Massachusetts
28
Conflict of Interest – the University’s
Internal Disclosure & Review Process
Policies:
• Three administrative Policies – one to address
individual conflicts and two to address
institutional conflicts, and
• Several procedures to address conflicts of
interest arising out of gifts, licensing &
technology transfer, purchasing, investments
and conflicts that arise in the context of
human subjects research.
29
Conflict of Interest – the University’s
Internal Disclosure & Review Processes
Three Committees:
• An Institutional COI Review Committee
• Two Individual COI Committees:
– AHC
– Provost
30
Conflict of Interest – the University's
Internal Disclosure & Review Process
The Disclosure Process:
• Annual Financial Disclosure forms completed
by University “officials”
• Proposal Routing Forms
• REPAs
• ROCs
31
Conflict of Interest – the University’s
Internal Disclosure & Review Process
Other avenues for disclosure:
• When submitting new or continuing
applications to the IRB, the IACUC or the IBC;
• When receiving a contribution or gift which
has the appearance of creating a conflict; and
• When involved with technology transfer.
32
Conflict of Interest – the University’s
Internal Disclosure & Review Process
Review and resolution:
• First level staff review
• Executive Committee review
• Full Committee review
• Development of a Management Plan
33
Conflict of Interest – Recent and
Current Activities
• Met with representatives of the Dean’s
Council, CRAD and the FCC
• Efforts underway to conduct an external
evaluation
• May result in the revision of current policies
and procedures
• Efforts underway to create a COI database
• Will develop a more comprehensive approach
for management plan follow-up
34