Duke University School of Medicine
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Duke University
School of Medicine
Date
Policy Page
Updated
COI and Industry Relations -- 2
NB: The Institute on Medicine as a Profession has added the following
to this document:
1. The page numbers in red for ease of navigation
2. The yellow highlighting to indicate the referenced policy languageCOI and Industry Relations
Acceptance of Gifts, Favors or Hospitality to Individuals from Industry
Consulting and Research Relationships with Industry
Industry Funded Speaking Relationships
Disclosure of Industry Ties
Acceptance of Pharmaceutical Samples
Participation in Purchasing & Formulary Decisions
Site Access by Industry Sales Representatives
Industry Support for Continuing Medical Education
Attendance at Industry-Sponsored Lectures & Meetings Off-Campus
Industry Support for Scholarships & Funds for Trainees (See also Attendance at
Industry-Sponsored Lectures & Meetings Off-Campus)
Mechanism for Oversight and Compliance
Medical school curriculum or educational content related to drug development,
marketing and relationships with industry
Acceptance of Gifts, Favors or Hospitality to Individuals from Industry
DU/DUHS “Conflict of Interest Policy” states “covered persons should not accept any
material gifts, favors, or hospitality that might influence their decision-making or
compromise their judgment in actions affecting the University. A gift, favor, or hospitality is
„material‟ if it has a fair market value of twenty-five dollars or more.”
The DU/DUHS “Pharmaceutical & Nutritional Vendors Policy and Procedures”
notespromotional materials (e.g. all branded office supplies, personal items such as coffee
mugs, bags, calendars, note pads) and other devices will not be distributed within Duke
Hospital or Duke clinics. This policy also states “vendor representatives are prohibited from
displaying company advertisements, without prior permission from appropriate clinical staff
and approval from AVP Procurement & Supply Chain Management.” Clinic and hospital
managers may accept patient education or staff education materials imprinted with corporate
trade marks and brand names if the material is used to meeting legitimate teaching needs and
is complaint with Codes of Conduct authored by PhRMA. Examples where this is used
includes branded orthopedic implants for necessary use in the pre-op informed consent
process.
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Page 2 of 8The DUHS “Vendor Representatives Policy” states “food, drinks, and refreshments may
not be delivered to any hospital or clinic area unless it is directly related to a valid
educational session that has been approved by the area manager. Quantities should be limited
to staff who attend the educational session.”
Consulting and Research Relationships with Industry
Duke Medicine‟s primary mission is to serve our patients and the global community by
providing clinical integration of patient care, education and research. Consulting
relationships are important to the academic and health system mission and our patient‟s
welfare. These relationships promote continuing education, collaboration, and partnerships
toward the development and promotion of advances in health care.
Leadership recognizes that consulting is also an important part of the professional mission
for faculty. However, faculty and students need to be aware of the professional dangers often
associated with this activity. For example, consulting arrangements may occur in absence of
a written agreement of roles, responsibilities, and payment. Without a specification of the
work deliverable for a given payment, that payment may be considered to be a bribe by
outside agencies, like the Federal government. Medical students are discouraged to
participate in this activity.
The “Duke University School of Medicine Conflict of Interest Policy Related to Research”
states that “effective interactions between universities conducting research and industry is
essential to the translation of research findings. Ensuring the integrity of research funds and
prudent stewardship of public funds includes protecting sponsored research from being
compromised by the conflicting financial interests of any individual responsible for the
design, conduct, or reporting of sponsored research.”
This policy also states “collaborators/subrecipients/subcontractors of a research project must
provide a certification from their institutions to Duke that they are in compliance with
applicable Federal policies regarding individual Significant Financial Interest reporting and
that their portion of the project is in compliance with their institutions policies which must be
provided upon request.”
This policy is strictly enforced by the Office of Internal Audits.
Industry Funded Speaking Relationships
There can be no Duke policy explicitly limiting the participation in speaker‟s bureau, but it is
discouraged. Our parent Duke University Faculty bylaws (section 5.2.2.3 Consulting by
Duke Faculty http://www.provost.duke.edu/pdfs/fhb/FHB_Chap_5.pdf ) allows up to four
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Page 3 of 8days per month of outside consulting activity. According to these bylaws, faculty and senior
administrative staff members may spend up to four days per month in outside activities or
consulting work, averaged over an annual period of service (the academic year for faculty on
a nine-month basis.) Such activities are to be reported to: 1) the Provost, for those outside the
Schools of Medicine and Nursing; or 2) the Dean, School of Medicine/Vice Chancellor for
Medical Center Academic Affairs. A copy should be sent to the department chair. Lectures
or brief consulting activities to assist another educational institution need not be reported.”
These bylaws are not amendable by the Duke University Health System or Duke School of
Medicine.
All members of the Duke faculty and Duke Medicine are strongly discouraged from
participating in speaker bureaus or similar speaking arrangements. Exceptions could be
considered if 1) the activity promotes evidence-based clinical care and/or advances research;
2) financial support is appropriately disclosed; 3) faculty do not receive gifts or financial
compensation in the absence of a speaker‟s contract; 4) compensation and honoraria are
reasonable (i.e. fair market value); 5) lecture material represents a balanced assessment of
current clinical and/or scientific treatments; 6) the speaker discloses that the views and
material presented fairly represent his/her views and not solely standard, prepared material
provided by and/or approved by the bureau.
Faculty who participate in this activity must fully disclose this relationship as part of the
yearly conflict of interest attestation (see also Consulting and Research Relationships with
Industry.)
Medical students are strongly discouraged from attending such programs.
Disclosure of Industry Ties
The “Duke University School of Medicine Conflict of Interest Policy Related to Research”
states annual reporting is required by 1) all Duke University School of Medicine paid
faculty, 2) individuals with a conflict of interest identified in the previous year, 3)
investigators and other individuals identified on federal grants involve in the independent
design, conduct or reporting of research, 4) investigators and other individuals identified on
IRB applications involve in the independent design, conduct or reporting of research, and 5)
individual with intellectual property managed by Duke.
Individuals requested to provide an annual reporting form must include all financial interests
of >$600 for themselves and their immediate family. Financial Interest means receiving
anything of monetary value, including, but not limited to payment for services, equity
interests, intellectual property rights, gifts, gratuities or donations.
The Duke University Health System “Conflict of Interest Policy” states that employees
“shall report in writing on an annual basis, the existence of any actual or pending
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Page 4 of 8employment, activity relationships or other positions of divided interest with Duke
University that involve obligations or conduct or decisions of such person in conflict with the
interests of Duke University.”
This policy requests the disclosure of financial relationship of extended family members as
well, as these relationships might be perceived to influence the covered person‟s decision
making or compromise his judgment in actions affecting the University.
See also Consulting and Research Relationships with Industry
Acceptance of Pharmaceutical Samples
Our three hospitals, Duke University Hospital, Durham Regional Hospital, and Duke Health
Raleigh Hospital ban inpatient samples by policy, while Duke Home care and Hospice
has banned them by administrative action. Samples are permitted by policy in outlying
Duke Primary Care practices and the outpatient clinics associated with our hospitals.
Prescribing physicians are allowed to accept drug samples from pharmaceutical sales
representatives in the outpatient settings only, as approved by the clinic Medical Director per
clinic policy. (Students are not permitted to accept drug samples.) These samples must be
logged in through the designated secured sample storage process.
Logs include the name of the medication, lot number, expiration date, date of receipt,
quantity received, and the name of the individual in the practice receiving the samples on
behalf of the practice. These logs are maintained in the clinic for a specified time as
designated per policy.
All samples are labeled and dispensed in accordance with federal and state laws. A Sample
Medication Form (or similar form) is used to document dispensing information, patient
counseling, and auxiliary notes.
Per entity policy, drug samples are for patient use only. Hospital and clinic staff are not
allowed to acquire samples for personal use.
Participation in Purchasing & Formulary Decisions
Duke hospital adheres to its individual formulary policies through the hospital Pharmacy and
Therapeutics Committees. No outpatient equivalent exists for the PDC and Duke University
Affiliated Physicians, dba Duke Primary Care.
Duke hospital has developed a formulary based on the needs of its patient population,
provider preferences, and Medicare/Medicaid insurance reimbursements. These formularies
are created and maintained by a committee of institutional medical and pharmacy experts.
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Page 5 of 8Members of this committee must disclose any conflict of interest that may impact formulary
decisions. Members with a conflict of interest may participate in discussions but should
abstain from voting (see “Conflict of Interest” policy.)
Site Access by Industry Sales Representatives
Industry representatives may provide valuable information on new medical research findings
and therapies. However, patients and family members who observe these physician/industry
relationships may believe that these representative unduly bias physicians‟ treatment
decisions. Trainees are particularly vulnerable to the intended sales bias of these interactions.
The DU/DUHS “Vendor Representatives” policy states “vendor representatives are
prohibited from initiating discussions regarding products or therapies with residents or
medical students unless faculty or supervisors are present."
All Vendor Representatives are required to pre-schedule visits. At the facility, all Vendor
Representatives must register at a “Status Blue” on-site station and wear a Duke Medicine
issued nametag. Vendor Representatives may be present in common areas of the facilities.
However, initiating unsolicited contact with clinicians and facilities employees is prohibited,
and may result in suspension of visitation privileges.
All Vendors Representatives will adhere to Duke Health System Procedures, and will abide
by the laws and regulations of the State of North Carolina, federal government, The Joint
Commission, AORN, HIPAA Privacy Rule, and other regulatory standards of practice. Prior
coming to a Duke Medicine entity for business purposes, vendor representatives will register
with Status Blue for Duke Medicine, providing evidence of competency for desired/required
level.
Industry Support for Continuing Medical Education
The Office of Continuing Medical Education Policy for Regularly Scheduled
Conferences states that all regularly scheduled conferences are expected to be planned,
implemented, and evaluated in compliance with the ACCME Essentials, Policies, Standards
for Commercial Support.
Attendance at Industry-Sponsored Lectures & Meetings Off-Campus
The Office of Continuing Medical Education Policy for Regularly Scheduled
Conferences states that the ACCME requires the Duke Office of CME (DOCME) to monitor
internal regularly scheduled events to ensure that they comply with ACCME guidelines.
Therefore, internal events must comply with Accreditation Council for Continuing Medical
Education (ACCME) standards and guidelines.
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Page 6 of 8Individual health practitioners across the Duke University Health System and School of
Medicine may not accept direct industry reimbursement to attend educational meetings in the
absence of an independent contractor or consulting contract. Exceptions include travel
reimbursement for required off-site meetings for Duke University business where prior
approval has been obtained by Department Chair, Center Director, or Senior Leadership.
Industry may submit scholarship or fellowship funds and opportunity information directly to
CME and/or Department, Center, Institute, or Administrative Offices to be used per the CME
Office, Center, Institute, or Department‟s discretion for ACCME approved programs.
Eligible meetings should be open on equal terms for all interested practitioners. Industry may
not participate in the selection of attendees (unless the Duke attendee is under a speaker
contract for that specific meeting; see also Consulting, Speaker‟s Bureau).
Industry Support for Scholarships & Funds for Trainees (See also Attendance at
Industry-Sponsored Lectures & Meetings Off-Campus)
The “Duke University School of Medicine Commercially-Sponsored Educational Grants and
Gifts Policy” states “the Duke University School of Medicine policy is not to accept
educational grants or gifts that are given as remuneration for the past or current purchase of
any equipment, drugs, or other materials or services, by Duke from the funding company, or
an inducement to Duke to make any specific purchase from the funding company in the
future.”
Initial contact regarding commercially-sponsored educational grants and gifts often occurs at
the faculty or department level. If the grant or gift includes CME credits, the contract of or
letter of agreement can be negotiated by the Duke University School of Medicine Continuing
Education Office. Non-CME projects will be addressed by the Office of Corporate Research
Collaborations. All resulting agreements, regardless the path, must be submitted for approval
to the Office of Grants & Contracts.
Mechanism for Oversight and Compliance
The Conflict of Interest Committee, described in the “Duke University School of
Medicine Conflict of Interest Policy Related to Research” is charged with the protection of
the integrity of Duke‟s research and educational missions, as well as the integrity of the
organization and individual. This Committee advises the Chancellor of Health Affairs and
the Duke of the School of Medicine. Committee members, consisting of faculty members
and at least one community member, are appointed by the Chancellor of Health Affairs.
Medical school curriculum or educational content related to drug development,
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Page 7 of 8marketing and relationships with industry
Since 2001, the Duke School of Medicine Graduate Medical Office has required residents
and fellows to complete three comprehensive modules on the ethics of the relationships
between Pharma and residents and resident education. These educational modules includes
evidence-based literature review, analysis of what‟s known about this influence on residents
and fellows as well as training on Duke-specific Pharma and vendor policies. Residents and
fellows must answer 100% of the test questions correct to pass this training.
Additional information on these modules is available upon request.
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