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Oregon Health and Science University
School of Medicine
Date
Updated
Page
3/13/2013
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Conflicts of Interest
8/21/2012
11
OHSU School of Medicine: UME
Program Policy Manual Conflict of
Interest Policy
3/2013
17
Authorship Attribution
2/12/2008
19
CME Activity Planning Guide
06/2011
22
Pharmacy and Therapeutics
Committee Formulary Drug
Request Form
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42
Policy
Conflicts of Interest in Research
Gifts and Vendor Relationships
Individual Acceptance of Gifts,
Food, Beverages, Travel and
Entertainment
Institutional Conflicts of Interest;
Executive and Board Member
Conflict of Interest Disclosure
Outside Activity/Outside
Compensation
3/13/2013
44
2/3/2013
47
8/21/2012
51
3/13/2013
55
Requirements for Solicitation and
Acceptance of Gifts to OHSU
3/13/2013
63
Sample Medications
6/10/2011
67
Vendor Representative Policy
7/6/2010
69
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 language
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Conflicts of Interest in Research
Policy No. 10-01-035
Effective Date: March 13, 2013
1. GENERAL
Collaboration between OHSU and others is critical to OHSU's research, healthcare,
education, and community service missions including its Technology Transfer program.
This policy seeks to foster collaboration by (a) providing guidelines and mechanisms for
resolving potential or actual conflicts of interest in research, and (b) safeguarding OHSU
and OHSU Investigators' reputation for academic integrity. OHSU intends, by this policy,
to comply with applicable federal and state requirements.
2. RULE
For purposes of this policy, a conflict of interest in research exists when an investigator
has a significant financial interest that could directly and significantly affect the design,
conduct, or reporting of research, or may otherwise require management because of the
appearance of conflict of interest in research.
3. OBJECTIVES
The Office of Research Development and Administration (RDA) shall seek to:
A. Safeguard the integrity of OHSU research and educational programs.
B. Ensure that the academic or professional progress of graduate students, postdoctoral
researchers and other OHSU personnel are assigned only research duties consistent with
their status or position.
C. Ensure any significant financial interest of an Investigator which could affect the
design, conduct, or reporting of research or educational activities be disclosed and
eliminated or managed as appropriate.
D. Ensure that research sponsors' access to and use of university resources is consistent
with OHSU's legal, policy, financial and reputational interests.
4. DEFINITIONS
As used in this policy, the following terms mean:
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A. Designated Official: The Vice President for Research or individual(s) appointed by
the Vice President for Research.
B. Conflict of Interest in Research (CoIR): A determination by the designated official
that a significant financial interest (SFI) might affect, or reasonably appear to affect, the
design, conduct, or reporting of research. Such situations may require management, but
may not be found to constitute a FCoI as defined below.
C. Financial Conflict of Interest (FCoI): A determination by the designated official that
a significant financial interest (SFI) could directly and significantly affect the design,
conduct or reporting of the PHS-funded research. A FCoI is a specific type of CoIR.
D. Institutional Responsibilities: Investigator's professional responsibilities on behalf of
OHSU, which include, but are not limited to, activities such as research, teaching,
professional practice, committee memberships, and service on panels such as Institutional
Review Boards or Data And Safety Monitoring Boards.
E. Investigator: The principal investigator, co-investigator and other OHSU employees or
volunteers, or any OHSU research collaborator, including visiting scientists or
consultants, responsible for the design, conduct or reporting of research or educational
activities or responsible for preparing a proposal for research funding.
F. Significant Financial Interest (SFI) includes the following interests of the
investigator (and those of the investigator's spouse or registered domestic partner and
dependent children), or of any business controlled or directed by the individual or his or
her spouse, that reasonably appears to be related to the investigator's institutional
responsibilities:
1) Compensation: i.e., anything of monetary value including, but not limited to, salary,
gifts, consulting fees, honoraria or other payments for services that is more than five
thousand US dollars ($5,000) in the aggregate over the last twelve (12) months;
2) Equity interests: e.g. stocks, stock options, warrants, contractual rights to acquire or
receive ownership interests, or other ownership interests in a publicly-traded company
that is more than five thousand US dollars ($5,000) or any amount in a non-publiclytraded company;
3) With respect to a publicly-traded company, the aggregated value of compensation, as
defined above, over the last twelve (12) months and equity interest that is more than five
thousand US dollars ($5,000);
(4) Intellectual property rights: e.g. patents, copyrights and royalty income or the right to
receive future royalties under a patent license or copyright;
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(5) Non-royalty payments or entitlements to payments in connection with the research
that are not directly related to the reasonable costs of the research (e.g. bonus or
milestone payments to the investigators in excess of reasonable costs incurred);
(6) Service as an officer, director, or in any other executive position in an outside
business, whether or not remuneration is received for such service; and
(7) Reimbursed or sponsored travel (only applies to investigators involved in Public
Health Service funded research and their spouse, registered domestic partner or
dependent children) that exceeds $5,000 when aggregated per entity over the last twelve
(12) months. Disclosures shall include the purpose of the travel, the identity of the
sponsor/organizer, the destination and the duration of the travel, and any other
information as requested by the disclosure form or designated official. See exemptions in
(6) below.
Significant financial interest does not include:
(1) Interests of any amount in, or income from, investment vehicles, such as mutual funds
or retirement accounts so long as the investigator does not directly control the investment
decisions made in these vehicles.
(2) Payments to OHSU, or via OHSU to the individual, that are directly related to
reasonable costs incurred in the conduct of research as specified in the research
agreement(s) between the sponsor and OHSU.
(3) Salary and other remuneration from OHSU, including approved faculty practice plan
earnings and the distribution of those earnings that may be established by departmental or
other similar agreements provided that those agreements and departmental/divisional
group plans are approved by the President.
(4) Income from seminars, lectures or teaching engagements sponsored by a federal,
state, or local government agency, an Institution of higher education as defined at 20
U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute
that is affiliated with an Institution of higher education; or
(5) Income from service on advisory committees or review panels for a federal, state, or
local government agency, an Institution of higher education as defined at 20 U.S.C
1001(a), an academic teaching hospital, a medical center, or a research institute that is
affiliated with an Institution of higher education.
(6) Reimbursed or sponsored travel that is reimbursed or sponsored by a federal, state or
local government agency, an Institution of higher education, an academic teaching
hospital, or a research institute that is affiliated with an Institution of higher education.
G. Research: A systematic investigation, including research development, testing, and
evaluation, designed to develop or contribute to generalizable knowledge. As used in
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OHSU policies, the term "research" encompasses basic and applied research and product
development.
H. Retrospective Review: A review conducted of an investigator's activities, SFIs and
PHS-funded research to determine whether any such research, or portion thereof,
conducted during the period of non-compliance was biased in the design, conduct, or
reporting of such research.
5. INVESTIGATOR SERVICE
Service by an investigator on the governing board or as an officer of any sponsor of the
investigator's research shall require the prior approval as described in the Outside
Activity/Outside Compensation policy (10-01-015).
6. INVESTIGATOR RESPONSIBILITIES
OHSU investigators applying to conduct research:
A. Are required to familiarize themselves with this policy and identify all SFIs as
described herein during all annual or updated Conflict of Interest in Research disclosure
submissions;
B. Are required to complete required training at least every four years, and as otherwise
required by OHSU;
C. Must file, on at least an annual basis, a Conflict of Interest in Research Disclosure in
the form approved by Research Development and Administration (RDA). This disclosure
is to the investigator's department chair (or other official if delegated by the Unit Leader
or department chair). If circumstances change, the investigator must also revise and add
new disclosures. This annual disclosure is in addition to the annual disclosure statement
covering outside activities required under Policy 10-01-015;
D. Must fulfill all requests from RDA, designated official, or the Conflict of Interest in
Research Committee for more information relative to the investigator's annual or updated
Conflict of Interest in Research Disclosure in a timely manner; and
E. For investigators conducting research funded by PHS only, investigators must:
a. Submit an updated Conflict of Interest in Research Disclosure within thirty (30) days
of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.
b. Submit a Conflict of Interest in Research Disclosure as described in 6(A) no later than
the time of application for PHS-funded research.
7. FOR RESEARCH FUNDED BY PUBLIC HEALTH SERVICE (PHS)
ONLY
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A. It is the expectation that investigators will work with the designated official(s) in a
timely manner to create a complete and correct disclosure submission of conflict of
interest in research disclosures for institutional review. Unless otherwise specified by
law or regulation, any review required by the institution shall not have deemed to have
started until a complete and correct submission of the Conflict of Interest in Research
Disclosure has been proved to a designated official.
B. Reviewing SFIs for Financial Conflict of Interest (FCoI): Only a designated
official may determine if a SFI requires additional review to determine if a FCoI
exists. Prior to funds being spent on a new award, or within sixty (60) days of
determining a new SFI requiring a review, the designated official reviewing the SFI shall
determine whether a FCoI exists and implement a conflict management plan, at least on
an interim basis, in accordance with Section 10 below. The FCoI determination is risk
based and is made according to internal guidance developed in consultation with the
Conflict of Interest in Research Committee.
C. Determination of need for retrospective review: Only a designated official may
make a determination that a retrospective review is required. When required, the
institution shall complete a retrospective review. A retrospective review must occur in
the following circumstances: failure by the investigator to disclose a SFI in accordance
with Section 6(E) that is determined by the designated official to constitute a FCoI;
failure by the institution to review or mange such a FCoI; or failure by the investigator or
institution to comply with a FCoI management plan.
D. Retrospective reviews: Retrospective reviews shall only be completed for PHS
research. SBIR or STTR Phase I applications are exempt from retrospective reviews.
E. Determining bias: Only a designated official may determine whether any PHS-funded
research, or portion thereof, conducted during a period of non-compliance was biased in
the design, conduct, or reporting of such research. If a designated official determines
bias was found, a designated official shall promptly notify and submit a mitigation report
to the PHS Awarding Component.
8. RESEARCH CONFLICT OF INTEREST COMMITTEE
The Provost, upon recommendation of the Vice President for Research, shall appoint the
Conflict of Interest in Research Committee (Committee) composed of not more than ten
persons from the faculty. A majority of members of the Committee shall constitute a
quorum. In making appointments, the Provost shall seek to maintain a committee diverse
among disciplines and departments doing research at the University. Appointments shall
be for a term of three years.
Once a committee member completes his or her term, or resigns from the committee, a
replacement will be recommended to the Vice President for Research from the departing
member's department or discipline. The Committee shall select its chair and establish
procedures for its operation.
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9. APPROVAL OF CONFLICTS OF INTEREST IN RESEARCH;
APPEAL
A. Upon receipt of a proposal to conduct research, the department chair (or other official
if delegated by the Unit Leader or department chair) shall review the proposal to
acknowledge if all investigators have certified on the Conflict of Interest in Research
Disclosure that there is or is not a potential or actual conflict of interest in research, as
indicated by an affirmative response on the Conflict of Interest in Research Disclosure
form, with any of the requirements or objectives of this policy. Where a potential conflict
of interest in research is disclosed, the reviewer may suggest a preferred method of
managing the conflict to the investigator and to the designated official and/or the
Committee.
B. The Committee or designated official shall review in a timely manner proposals for
which a potential conflict has been disclosed to determine whether the interest may
reasonably be thought to directly and significantly affect the design, conduct, or reporting
of the sponsored research or educational activities.
C. If a CoIR is found, the Committee shall determine how to manage, reduce, or
eliminate the conflict and shall inform the investigator and the Unit Leader in charge of
the investigator's unit of the decision.
D. An investigator who disagrees with the decision of the Committee may appeal to the
Vice President for Research. Such an appeal shall be in writing only and must be made
within ten (10) days of the decision of the Committee. An appeal to the Vice President
may only be made upon grounds of procedural irregularity that resulted in prejudice to
the investigator, new material information that could not have been presented to the
Committee or that the decision is in conflict with applicable laws, rules or OHSU
policies.
The Vice President shall make a decision within ten (10) days of the date of the
investigator's appeal to the Vice President and the Vice President's decision shall be final.
10. CONDITIONS TO MANAGE CONFLICTS
A. The Conflict of Interest in Research Committee may impose conditions to manage a
CoIR involving sponsored research including, but not limited to:
(1) Public disclosure of an investigator's financial interest in any research sponsor or the
commercial success of any therapeutic strategy or product that is the subject of any
research results being reported;
(2) Monitoring of any research project by independent reviewers;
(3) Modification of any research proposal or plan;
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(4) Disqualification of any Investigator from participating in all or a portion of any
sponsored research;
(5) Divestiture by an Investigator of any financial interest in any research sponsor; or
(6) Severance of any relationship between an Investigator and a research sponsor which
may create actual or potential CoIR.
B. The investigator must agree to the conditions imposed by the Conflict of Interest in
Research Committee or appeal such conditions as described in Section 9(D) above.
11. MAINTENANCE OF RECORDS; CERTIFICATION AND
ENFORCEMENT
A. RDA shall inform those sponsors that require notification of the FCoI and action.
RDA shall keep and maintain records of all disclosures and all actions taken to manage
any actual or potential CoIR for at least three (3) years beyond the termination or
completion of the award or until resolution of any action by any federal agency involving
the records, whichever is longer.
B. The Vice President for Research shall certify to applicable federal agencies OHSU's
enforcement and management of FCoIs under this policy.
C. The Unit Leader in charge of the Investigator's unit and the Vice President for
Research shall investigate and resolve any alleged violations of this policy. They shall
take appropriate action to enforce this policy, including, not but limited to, imposing
sanctions including termination from employment upon Investigators found to be in
violation of this policy. The designated official shall promptly notify the federal sponsor
of unresolved FCoI.
12. VICE PRESIDENT FOR RESEARCH
The OHSU Research Integrity Office, under the direction of the Vice President for
Research, may provide guidelines, protocols and other procedures where necessary or
convenient to implement or administer this policy.
13. IMPLEMENTATION
FCoI determinations, Sections 6(E) and 7 will apply to each grant or cooperative
agreement with an issue date of the Notice of Award after August 24, 2012 or when the
investigator's next annual conflict of interest in research disclosure submission is due,
whichever is earlier.
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Background:
21 CFR 54.1-6
42 CFR 50.601-607
45 CFR 94.1-6
Related policies, procedures and forms:
Policy No. 10-01-015, Outside Activity/Outside Compensation
Policy No. 10-01-020, Conflicts of Interest
Conflict of Interest in Research website
Conflict of Interest in Research Form
Implementation date:
August 27, 2001
Revision dates:
June 5, 2002; December 23, 2002; July 16, 2003; April 16, 2010; November
19, 2010; August 21, 2012; March 13, 2013
Responsible office:
Integrity Office
Page 10 of 73
Conflicts of Interest
Policy No. 10-01-020
Effective Date: August 21, 2012
1. CONFLICT OF INTEREST
A conflict of interest (CoI) exists when an OHSU employee's financial interests or other
obligations interfere, or appear to interfere, with the employee's obligations to act in the
best interest of OHSU and its missions, and without improper bias. The appearance of a
conflict may be as serious and potentially damaging to the public trust as an actual
conflict. Therefore, potential conflicts must be disclosed, evaluated, and managed with
the same thoroughness as actual conflicts.
2. TO WHOM THIS POLICY APPLIES
This policy applies to all persons employed by OHSU whether full or part time. Some
OHSU employees have specific disclosure requirements under this policy. Additionally,
potential conflict of interest situations may arise involving OHSU students, other
trainees, or volunteers. For those situations, OHSU managers and other administrators
overseeing the students or volunteers may choose to apply the review mechanisms
discussed in 5.A. of this policy, as applicable.
3. DEFINITIONS
A. Relative: A spouse, registered domestic partner, domestic partner (as those terms are
defined in the current year's OHSU Program Selection Guide, whether or not proof of the
relationship is provided to OHSU pursuant to that Guide), or dependant child of an
OHSU employee.
B. Significant Financial Interest:
(1) Equity interest or entitlement to equity (e.g. stocks, stock options, warrants, or
contractual rights to acquire or receive ownership interests other than interests in a
diversified mutual fund) of any amount in a non-publicly traded company.
(2) Equity interest or entitlement to equity (other than interests in a diversified mutual
fund) greater than five thousand US dollars ($5,000) in aggregate over the last twelve
(12) months in a publicly traded company.
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(3) Compensation (anything of monetary value) including, but not limited to, salary, gifts,
consulting fees, honoraria or other payments for services that is more than five thousand
US dollars ($5,000) in aggregate over the last twelve (12) months.
(4) The aggregated value of equity interest and compensation, as defined above, that
exceed $5,000 over the last twelve (12) months in a publicly-traded company.
(5) Royalty income or the right to receive future royalties under a patent license, or
copyright agreement with an entity.
(6) Serving in an executive position (any position that includes responsibilities for a
material segment of the operation or management of a business, including a position on a
Board of Directors).
(7) Significant Financial Interests do not include the following:
(a) Salary and other payments for services from the institution, including approved
faculty practice plan earnings and the distribution of those earnings that may be
established by departmental or other similar agreements provided that those agreements
and departmental/divisional group plans are approved by the President.
(b) Income from seminars, lectures, or teaching engagements sponsored by a federal,
state, or local government agency, an Institution of higher education as defined at 20
U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute
that is affiliated with and Institution of higher education; or
(c) Income from service on advisory committees or review panels for a federal, state, or
local government agency, an Institution of higher education as defined at 20 U.S.C.
1001(a), an academic teaching hospital, a medical center, or a research institute that is
affiliated with an Institution of higher education.
4. EXAMPLES OF CONFLICTS OF INTEREST
Examples of OHSU employee CoI as defined in this policy include but are not limited to:
A. OHSU employees who are involved in decision-making concerning the approval or
purchase of medications, devices, or equipment, or the negotiation of other contractual
relationships with industry and who have or whose relative has a significant financial
interest in a company that might benefit from the institutional decision. Any such
interests must be disclosed as described in 5.B. below.
B. Receiving royalties on a product used or prescribed for use in patients.
C. Teaching, conducting research or providing patient care at another educational or
health care institution by any disclosing employee as defined in Policy No. 10-01-015
without prior written approval from an authorized OHSU official.
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D. Diverting clinical research trials, research grant applications or patient care (where not
medically indicated) away from OHSU to other persons or organizations.
E. Accepting or arranging a charitable gift or contribution to OHSU or OHSU Foundation
or Doernbecher Foundation in return for a business relationship with OHSU.
F. Privately pursuing patents, licensing agreements, copyrights, or trademarks for
intellectual property in which OHSU might have a legitimate interest (see Policy No. 0450-001).
G. Service on a board of directors or scientific advisory board or acting in any
management capacity for a private enterprise from which the employee, employee's
relative, or an entity associated with the employee, or employee's relative, receives
support for any OHSU activity without prior approval from an authorized OHSU official
and review by the Conflict of Interest in Research Committee if related to research
support.
The examples provided above are only illustrative and are not all inclusive. OHSU
employees are expected to always disclose and resolve any CoI before taking action that
may be improper or detrimental to OHSU.
5. COI DISCLOSURE STATEMENTS AND APPROVAL OR
MANAGEMENT PROCESS
A. GENERAL DISCLOSURE REQUIREMENTS
If any OHSU employee is subject to a CoI as defined in this policy or believes a CoI
exists or may appear to exist, the employee must disclose the circumstances and request
his or her direct supervisor to give directions on how the issue giving rise to the conflict
is to be resolved. The person to whom an employee must disclose shall specify what, if
anything needs to be done to avoid or dispose of a disclosed conflict. For example, a
department chair may require the employee to not be involved in or influence a decision
in which OHSU has an interest or may require the employee to take specific action
relative to his or her conflicting interest.
Where required by the faculty member's Dean or Director, the department chair or
supervisor shall forward the employee's disclosure statement and its resolution to the
Dean or Director who may, at his or her discretion, affirm or modify the resolution. A
copy of a faculty member's disclosure statement and its resolution shall be sent to the
Provost if the issue giving rise to the disclosure is one of those listed as requiring review
and management by the Provost on the OHSU Integrity CoI website. In which case, no
resolution of the conflict may be made without the approval of the Provost, whose
decision shall be final.
For other OHSU employees (classified and unclassified), a copy of the disclosure
statement and its resolution shall be sent to the Chief Administrative Officer if the issue
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giving rise to the disclosure is one of those listed as requiring review and management by
the Chief Administrative Officer on the OHSU Integrity CoI website. In which case, no
resolution of the conflict may be made without the approval of the Chief Administrative
Officer, whose decision shall be final.
If an OHSU employee is a Unit Leader, that employee must disclose to the Executive
Leadership Team member to whom he or she is accountable and comply with that
person's directive on how to dispose of the conflict. The President must disclose to the
Chair of the Board of Directors and comply with the Board's directive on how to dispose
of the conflict.
B. DISCLOSURE REQUIREMENTS FOR COI RELATED TO PURCHASING
DECISIONS
OHSU employees who participate on standing purchasing committees or other
committees involved in the selection of products and services (such as the Value Analysis
Committee and Pharmacy and Therapeutics Committee) must complete annual
disclosures during their service on these committees. The disclosure form or process will
be developed and administered by the department or unit supporting each committee in
consultation with the Integrity Office.
The disclosure process will include requirements to disclose any significant financial
interests, as defined in section 3.B. above, in entities that may benefit from the
institutional decision to purchase a product or service from that entity, as described in
4.A. above.
The committee or appropriate OHSU Logistics or Pharmacy official will determine
appropriate management, such as:
(1) Assuring that the person with the financial interest does not have sole decisionmaking authority in the purchase or contract;
(2) Public disclosure of the conflicting interest to the other committee members if serving
on a purchasing committee; and/or
(3) Recusing the member from the specific purchasing decision.
6. APPEAL PROCESS
A. An employee (other than a Unit Leader) who disagrees with his or her designated
approver on how to resolve a CoI issue may appeal in writing that decision within twenty
(20) calendar days of the decision to the Dean or Director in charge of his/her unit. This
person shall, within thirty (30) calendar days, reverse, affirm, or modify the decision. The
Dean or Director may elect to appoint a panel of three persons to review the issue and
information and advise him or her as to what decision to make.
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B. In circumstances where a Dean or Director was involved in making a decision on how
to respond to a conflict disclosure, an OHSU employee may appeal in writing that
decision to the Provost if the employee is a faculty member or to the Chief
Administrative Officer if the employee is not a faculty member. Such an appeal may only
be made upon grounds of:
(1) Procedural irregularity that resulted in prejudice to the employee;
(2) New material information that could not have been presented to the Dean or Director;
or
(3) Conflict with applicable laws, rules, or OHSU policies.
The Provost's or Chief Administrative Officer's decision shall be final.
C. A Unit Leader who disagrees with a decision of the officer to whom he or she is
accountable may appeal in writing that decision to the President, if the President is not
the officer whose decision the Unit Leader is appealing. The President's decision shall be
final. However, if it is the President's decision with which the Unit Leader is dissatisfied,
then the Unit Leader may appeal in writing to the Chair of the OHSU Board of Directors.
Any appeal to the Board may only be made upon grounds of:
(1) Procedural irregularity that resulted in prejudice to the Unit Leader;
(2) New material information that could not have been presented to the President; or
(3) Conflict with applicable laws, rules, or OHSU policies.
7. RELATIONSHIP TO STATE LAW
In addition to this policy, OHSU employees are subject to the State of Oregon
Government Standards and Practices Law of ORS Chapter 244 (including the Code of
Ethics of ORS 244.040).
Background:
ORS 244.010 through 244.135
Related policies, procedures and forms:
Policy No. 03-05-040, Employment of Family Members
Policy No. 03-60-005, Personnel Records of Unclassified Employees
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Policy No. 04-50-001, Intellectual Property and Royalty Distribution
Policy No. 10-01-015, Outside Activity/Outside Compensation
Policy No. 10-01-021, Institutional Conflicts of
Interest; Executive and Board Member Conflict of Interest Disclosure
Policy No. 10-01-025, Individual Acceptance of Gifts, Food, Beverages,
Travel, and Entertainment
Policy No. 10-01-030, Requirements for Solicitation and Acceptance of Gifts
to OHSU
Policy No. 10-01-035, Conflicts of Interest in Research
OHSU Integrity CoI Website
Implementation date:
August 27, 2001
Revision dates:
October 11, 2001; February 20, 2002; December 23, 2002;May 12, 2004; July
11, 2006; August 5, 2009; April 16, 2010; November 19, 2010; August 21,
2012
Responsible office:
Integrity Office
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OHSU School of Medicine: UME Program Policy Manual
2012-2013
SOM Policy
Effective Day: Nov 2009 / Revised: March 2012
Issued by: Office of Education & Student Affairs
Approved by: SOM Curriculum Committee
SOM Conflict of Interest Policy
______________________________________________________________________________
All OHSU School of Medicine Faculty and Staff are required to adhere to OHSU’s Conflict of Interest
policies: 1. Conflict of interest in research: http://ozone.ohsu.edu/policy/pac/chapt_10/10-01-035.htm;
2. Conflict of private interests of faculty/staff with academic responsibilities
http://ozone.ohsu.edu/policy/pac/chapt_10/10-01-020.htm; 3. Conflict of interest in commercial
support of continuing medical education: http://ozone.ohsu.edu/policy/pac/chapt_10/10-01-015.htm
All policies related to conflict of interest are contained in the OHSU Policy Manual. Research Roles
& Responsibilities are just one part of the total Integrity Program of OHSU, which also includes
Institutional Roles & Responsibilities, the Code of Conduct, and the Clinical Compliance Plan. The
documents that describe the Integrity Program are adopted by the OHSU Board of Directors and
represent the highest level of policy (OHSU Board of Directors Resolution 2004-12-20). The policy can
be viewed at: http://www.ohsu.edu/xd/about/services/integrity/policies/upload/Research-RR-8-272010.pdf
The OHSU Integrity Office requires Responsible Conduct of Research education prior to an OHSU
employee starting any human, animal, or basic science research. Completion of the appropriate modules
is tracked in the Big Brain, OHSU's web-based training delivery and reporting tool, and electronic
systems, such as the Electronic Institutional Review Board System (eIRB) and Electronic Institutional
Animal Care & Use Committee (eIACUC) connect with Big Brain so that an individual listed on a research
protocol cannot be approved until the online education is completed. In addition, “refresher” education
is provided approximately every 18 months. The OHSU Integrity Office requires annual disclosures via
Big Brain, which sends automated notices. Completion is tracked and failure to complete the disclosure
results in various sanctions.
In addition to OHSU Conflict of Interest policies, all faculty and outside agents addressing students
within School of Medicine programs are required to follow the following procedures:
1. Instructors within the School of Medicine are required to disclose any Conflict of Interest regarding
the content of their presentations, either in person or within the course syllabus.
2. If a presenter is using PowerPoint lecture slides, one slide clearly stating either a lack of a Conflict
of Interest or a disclosure of a potential Conflict of Interest will be inserted into the slide set at the
beginning of the presentation. If slides or other electronic media are not used, the presenter will clearly
state similar Conflict of Interest information verbally at the beginning of the presentation.
3. Course and clerkship directors will promulgate this policy with the instructors for their respective
courses. Additionally, course managers will distribute a Conflict of Interest slide template for presenters
to insert into their slide set prior to the date of presentation.
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OHSU School of Medicine: UME Program Policy Manual
Approved Curriculum Committee Nov. 12, 2009
Approved FSYC-SC (formerly BSSC) Oct. 25, 2010
Revised Curriculum Committee March 8, 2012
Page 18 of 73
2012-2013
(12-70-010) Authorship Attribution
1. Administration
http://ozone.ohsu.edu/policy/pac/chapt_12/12-70-010.htm
CHAPTER 12 - MISCELLANEOUS
2. Student Affairs
3. Human
Resources
4. Research
Services and
Intellectual
Property
5. Contracting and
Purchasing
6. Fiscal
7. Facilities
Management and
Support Services
8. Communications
9. Fees and Fee
Schedules
10. Conflicts of
Interest
11. Information
Technology
12. Miscellaneous
13. What's Proposed
AUTHORSHIP ATTRIBUTION
No. 12-70-010
Effective Date: February 12, 2008
1. General
The purpose of this policy is to ensure proper assignment of credit and responsibility for
published work and presentations. It applies to all types of scholarly writing including but
not limited to authorship of theoretical papers, review papers, case histories, book
chapters and books. It also applies to presentations of research or other scholarly work.
Authorship identifies those individuals who deserve primary credit and hold primary
responsibility for a published or presented work. Because scholarly activity as evidenced
by publication or presentation of original work is a major area in which faculty are evaluated
for appointment, promotion, tenure and research funding, the criteria used to determine
authorship are of critical concern.
2. Assignment of Credit
All individuals contributing intellectually to a publication should be acknowledged. While
technical contributions may not necessarily require acknowledgment, a substantial
intellectual contribution must be recognized by inclusion of the individual's name as an
author. In the case of publications or presentations describing original research findings,
such substantial intellectual contributions include those persons who:
A. Formulate the problem or hypothesis;
B. Conceive of or design the experiment, proposed analysis, or interpretation
of data;
C. Organize and analyze data;
D. Interpret the results; or
E. Write a major portion of the paper or presentation, and/or review or revise
it for intellectual content.
A substantial contribution to one or more of these activities is generally considered
sufficient for authorship. An individual whose contribution consists solely of developing
unique materials or techniques might also be listed as an author if those materials or
techniques were developed specifically for the project and represent a major contribution to
the overall project. If the manuscript is based upon a funded project (a federal or regional
peer reviewed grant), the principal investigator will have the responsibility of assigning the
order of authorship. In situations where several individuals make major contributions to a
publication or presentation, the individual who made the principal contribution is the senior
author and should be listed either as the last author or the first. Instances in which
authorship order does not reflect relative contributions (e.g., alphabetical listing of author
names) should be explained in a footnote.
Minor contributions may or may not warrant authorship. When the decision is that they do
not warrant authorship, they should be gratefully acknowledged in the text or in a footnote.
Although a minor contribution might be considered sufficient for authorship, authorship might
be justified if the completion several minor tasks by an individual constituted a major
contribution to the overall project.
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(12-70-010) Authorship Attribution
http://ozone.ohsu.edu/policy/pac/chapt_12/12-70-010.htm
In order to avoid potential conflicts regarding authorship, members of the research group
should discuss authorship and authorship order before beginning any specific research
project. Primary responsibility for initiating such discussions rests with the individual who
will, guided by the principles elucidated above, make the principal contribution to the
published or presented work.
3. Acceptance of Responsibility
By accepting credit for a publication or presentation, authors also accept responsibility for
the content of the work. All authors must share responsibility for ensuring:
A. The accuracy of the content of the publication or presentation;
B. That proper acknowledgment is given (via specific citations) for published
or unpublished materials that directly influenced the writing or research;
C. That no component of the publication or presentation has been plagiarized;
D. That all institutional and other requirements were met for protecting human
or animal subjects used in completing the work; and
E. That possible conflicts of interest (e.g., industry relationships) are
acknowledged in the text or in a footnote.
The senior author has primary responsibility for addressing these issues.
4. Student Authorship
Students who participate in scholarly activity under the supervision of a faculty member
should be listed as an author if they make a substantial contribution to the published or
presented work as defined by the criteria outlined above. In instances where a major
portion of the publication comprises a student's thesis work, the student should be listed as
first author.
5. Assigning Authorship Credit And Responsibility
In assigning authorship credit and responsibility, the following points must be considered.
The senior author bears primary responsibility for addressing each of these items.
A. Consent must be received from all individuals named as authors;
B. The senior author is generally responsible for determining order of
authorship and must ensure that major and minor contributions are
appropriately acknowledged;
C. All those listed as authors must examine the content of the manuscript and
give their approval before it is submitted for publication or presentation. In
addition, all authors must be notified about editorial decisions and, if revisions
are required, must give their approval before the revised manuscript is
submitted for publication. A copy of the manuscript and all editorial
correspondence must be given to all authors;
D. All authors must be notified about editorial decisions and, if revisions are
required, must give their approval before the revised manuscript or
presentation is submitted; and
E. A copy of the manuscript or presentation and relevant editorial
correspondence must be given to all authors.
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(12-70-010) Authorship Attribution
http://ozone.ohsu.edu/policy/pac/chapt_12/12-70-010.htm
When authorship concerns arise, authors are strongly encouraged to seek
the advice of colleagues who have not participated in the scholarly activity
being reported in the manuscript. Generally, this would involve the
department chair, institute director, research dean, or an individual in a similar
leadership position.
6. Relationship to Other OHSU Policies
Alleged violations of the Authorship Attribution Policy that appear to represent scientific
misconduct (i.e., fabrication, falsification, plagiarism) shall be referred to the Scientific
Integrity Committee. All other alleged violations (e.g., failure to assign proper authorship
credit) shall be referred to the Provost.
7. Investigation and Resolution of Disputes
A. When disagreements arise regarding proper assignment of authorship
credit, the Provost will designate an appropriate person to review the matter.
When the publication or presentation relates to research, the Provost will
coordinate selection of the reviewer with the Vice President for Research.
This reviewer will collect information from the parties in dispute, seek internal
consultation from other experts as needed, and make a recommendation to
the Provost (or Provost and Vice President for Research) for OHSU's
decision regarding the matter. Internal experts from whom consultation may
be sought will have expertise in the area of the scientific work and will have a
demonstrated record of senior authorship him/herself. The review process
will proceed in a timely manner so as not to unnecessarily delay publication or
presentation of the work.
B. The Provost (or Provost and Vice President for Research) will accept,
reverse, or remand for further deliberations the recommendation of the
reviewer.
C. The Provost shall advise the parties in dispute of OHSU's determination in
the matter.
D. The senior author of the publication or presentation will make the final
decision as to authorship. If the senior author disagrees with OHSU's
determination, the journal or presentation venue must be advised of OHSU's
determination.
Background:
Formerly Policy No. 04-35-005 (renumbered 3/9/05)
Implementation date: January 26, 1998
Revision dates: July 8, 1999; March 9, 2005
Related policies, procedures and forms:
Responsible office: Provost
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OHSU Continuing Medical Education OHSU CME Activity Planning Guide Division of Continuing Medical Education
School of Medicine, Oregon Health & Science University
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OHSU CME Activity Planning Guide Version: June‐2011 TABLE OF CONTENTS Mission Statement ................................................................................................................................................. 2 Section I Planning Your CME Activity ....................................................................................................................... 3 Section II Application/Planning Worksheet Instructions ............................................................................... 5 Activity Information .......................................................................................................................... 5 Leadership and Administrative Support .................................................................................. 5 Planning Process ................................................................................................................................ 5 Target Audience .................................................................................................................................. 5 Goals of OHSU’s CME Division ....................................................................................................... 5 Desirable Physician Attributes/Core Competencies ........................................................... 6 Identification of Professional Practice Gaps and Learning Objectives ......................... 7 Writing Learning Objectives ................................................................................................. 8 Verb table ...................................................................................................................................... 8 Educational Formats ......................................................................................................................... 9 Commercial Support and Exhibits ............................................................................................. 9 Barriers to Optimal Performance or Patient Outcomes .................................................. 10 Supplemental Educational Strategies ..................................................................................... 11 Collaboration with Other Stakeholders ................................................................................. 12 Evaluation and Outcomes ............................................................................................................ 12 Section III Preparing CME Content, Handouts, Syllabus and Slides .......................................................... 13 Section IV Publicizing your CME Activity Required Elements for Publicity ............................................................................................... 14 Section V OHSU CME Policies and Guidelines ...................................................................................................... 14 Conflict of Interest and Disclosure ........................................................................................... 14 Faculty Honoraria and Travel Reimbursement .................................................................. 15 Social Events/CME at Resort Locations ................................................................................. 16 Section VI Frequently Asked Questions ................................................................................................................... 17 Useful Links ............................................................................................................................................................ 19 Division of Continuing Medical Education Oregon Health & Science University 3181 SW Sam Jackson Park Road, L‐602 Portland, OR 97239 Phone: 503‐494‐8700 Fax: 503‐494‐0392 E‐mail: [email protected] www.ohsu.edu/som/cme 1 Page 23 of 73
MISSION STATEMENT
Oregon Health & Science University Division of Continuing Medical Education Purpose The mission of the Division of Continuing Medical Education is to promote high quality health care through effective educational activities. The goals of the division are to:  Improve healthcare provider competency and performance in order to enhance the health status of the population  Disseminate new medical knowledge  Improve patient safety and facilitate patient centered care  Translate research into effective healthcare delivery (knowledge translation)  Promote the practice of evidence based medicine  Optimize appropriate prescribing behaviors  Improve access to care Content The content of activities focuses on the body of knowledge and skills generally recognized and accepted by the health profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public. Information provided is scientifically balanced, evidence‐based and free of bias. Target audience Physicians, physician’s assistants, nurse practitioners, registered nurses and pharmacists practicing at OHSU and in Oregon and the western United States Activities A range of educational formats is used in CME activities. Examples of these formats include:  Live seminars and conferences  Department‐sponsored regularly‐scheduled conference series  Conjoint conferences with community hospitals and other physician groups  Activities including “hands‐on” skills training and simulation‐based learning  One on one supervised clinical experience for physicians who seek to re‐enter practice  Computer‐based enduring materials Expected Results The OHSU continuing medical education program assesses the impact of its activities on learners’ change in competence and performance. Methods of assessment include:  Self‐report of the learner’s anticipated change in strategy (competence)  Pre‐ and post‐activity skills assessment (competence)  Self‐report of changes in practice assessed by post‐activity questionnaire (performance)  One on one observation of change in clinical and communications skills and professionalism in a clinical practice setting (performance) 2 Page 24 of 73
Section I Planning Your CME Activity Step 1: Contact the Division of CME prior to planning  The activity program chair or activity coordinator contacts CME and is provided with an updated Application/Activity Planning Worksheet and instruction guide. Step 2: Activity Planning Meeting  The program chair (person with a faculty appointment at OHSU) and the activity coordinator meet with the Assistant Dean for Continuing Medical Education and the Administrative Director. Step 3: The activity program chair submits a completed CME Application/Activity Planning Worksheet and attachments. Applications cannot be accepted less than 45 days before the activity. Please keep a copy for your records.  Forms should be sent to CME 30 days in advance of the scheduled release date for activity registration materials. No publicity can be issued stating that credit has been applied for or is pending.  CME reviews application to ensure completion and provides feedback.  The application is submitted to the CME Committee for review. This process can take up to 30 days, please plan accordingly. Step 4: Activity receives approval from the CME Committee  An approval email is sent to the program chair and the program coordinator. This includes instructions and templates for materials due both before the activity and afterwards.  CME uploads the approved activity to the School of Medicine activity calendar. Step 5: Program coordinator submits draft of brochure/flyer/web page or email invitation  The publicity must contain: a description of the target audience, the course learning objectives, and the credit statement exactly as supplied by the CME office. No publicity may be distributed or circulated without prior written approval from CME. Step 6: Program coordinator submits to CME materials due two weeks before the activity. 
These are: 1. Signed disclosure forms from all presenters/moderators. If any faculty member has a potential conflict of interest, the program chair must complete and sign the Conflict of Interest Resolution portion of the disclosure form. See CONFLICT OF INTEREST POLICY for details. 2. Copy of the disclosure list to be distributed to the participants prior to the beginning of the activity. 3 Page 25 of 73
3. Copy of the acknowledgements list to be distributed to the participants prior to the beginning of the activity. AS OF JULY 1, 2012 NO LOGOS OTHER THAN OHSU’S MAY BE USED ON ACKNOWLEDGEMENTS LISTS 4. Copies of all letters of agreement signed by both parties, previously approved by CME. 5. One final copy of the printed brochure. Step 7: Program administrator submits post­activity materials to CME within 30 days of the activity 
The post‐course materials are due in the CME office within thirty days of the last day of the activity. Materials received after that date may be subject to financial penalty. 1.
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A completed copy of the activity report form An excel attendance list emailed to CME in the format provided Copies of the sign in sheets from each day of the conference A clean copy of the evaluation form A summary of the evaluation responses including all comments and suggestions A copy of the printed acknowledgements list distributed to the attendees A copy of the printed disclosure list distributed to the attendees A completed copy of the CME excel income and expense report One copy of the syllabus or any handouts distributed to the attendees Step 8: CME sends out Credit Memos to the participants 
Once the post‐course audit has been completed by CME and the material is found to be in compliance, the CME office will issue and mail the credit memos. The Division of CME maintains electronic and physical attendance records for a minimum of seven years. 
A billing statement is sent to the activity coordinator for the credit memos issued. 4 Page 26 of 73
Section II Application/Worksheet Instructions Activity Information Provide us with the name, sponsoring department, dates and location of the activity. Type of Activity Use the check boxes to indicate what type of activity this will be and how frequently it will be held (if applicable). Program Chair, Jointly Sponsored Activity, Program Coordinator, Planning Committee In these sections, list the individuals with overall responsibility for the planning, developing, implementing and evaluating the content of an accredited activity. This includes the Activity Program Chair, Co‐Chair (Joint Sponsor only, for definition of a joint sponsorship see page 17), Program Coordinator and members of the Planning Committee. The activity program chair must be a full time OHSU physician (MD or DO). All persons with input into the planning or design of the educational activity must complete an attestation (disclosure form) stating that the curriculum was designed based on valid professional practice gaps and was planned solely by committee members, free of the influence of commercial interests. Planning Process Use the check boxes to identify who has developed the program; how the presenters were chosen and ensure that the activity was developed independent of commercial interests. Target Audience CME activities must be related to what the learners actually do (or may one day do), in their professional practice. Meeting the CME Mission How does this activity align with the goals of OHSU CME? The mission of the Division of Continuing Medical Education is to promote high quality health care through effective educational activities. The goals of the division are to:  Improve healthcare provider competency and performance in order to enhance the health status of the population  Disseminate new medical knowledge  Improve patient safety and facilitate patient centered care 5 Page 27 of 73
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Translate research into effective healthcare delivery (knowledge translation) Promote the practice of evidence based medicine Optimize appropriate prescribing behaviors Improve access to care All CME Activities should be developed in the context of at least one of these goals. Desirable Physician Attributes/Core Competencies Which of the Desirable Physician Attributes/Core Competencies will be specifically addressed in the curriculum of this activity? CME activities should be developed in the context of desirable physician attributes. The American Board of Medical Specialties (ABMS)/Accreditation Council for Graduate Medical Education (ACGME) have designated competencies based on Maintenance of Certification. In addition the Institute of Medicine (IOM) has similar core competencies. 
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Patient care: Provide care that is compassionate, appropriate and effective treatment for health problems and to promote health. Medical knowledge: Demonstrate knowledge about established and evolving biomedical, clinical and cognate sciences and their application in patient care. Professionalism: Demonstrate a commitment to carrying out professional responsibilities, adherence to ethical principles and sensitivity to diverse patient populations. Communication/interpersonal skills: Demonstrate skills that result in effective information exchange and teaming with patients, their families and professional associates (e.g. fostering a therapeutic relationship that is ethically sounds, uses effective listening skills with non‐verbal and verbal communication; working as both a team member and at times as a leader). Practice­based learning and improvement: Able to investigate and evaluate their patient care practices, appraise and assimilate scientific evidence and improve their practice of medicine. Systems­based Practice: Demonstrate awareness of and responsibility to larger context and systems of healthcare. Be able to call on system resources to provide optimal care (e.g. coordinating care across sites or serving as the primary case manager when care involves multiple specialties, professions or sites). Interdisciplinary teams: cooperate, collaborate, communicate and integrate care teams to ensure that care is continuous and reliable. Information systems: Communicate, manage knowledge, mitigate error, and support decision making using information technology Evidence­based practice: Integrate best research with clinical expertise and patient values for optimum care, and participate in learning and research activities to the extent feasible. 6 Page 28 of 73
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Quality improvement: Identify errors and hazards in care; understand and implement basic safety design principles, such as standardization and simplification; continually understand and measure quality of care in terms of structure, process, and outcomes in relation to patient and community needs; and design and test interventions to change processes and systems of care, with the objective of improving quality. (Methods and Media) Professional Practice Gaps and Learning Objectives Step 1: Identify the practice gap. A professional practice gap is the difference between the current state of knowledge, skills, practice or patient outcomes and the ideal or desirable state. PPG’s are identified by comparing actual performance or patient outcomes of learners with optimal performance standards and/or patient outcomes. The following list is meant to be a guide and is by no means complete. Methods to identify the actual performance or patient outcomes of learners: 
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Institution data on provider practice or patient outcomes State health data Referrals requested from community health care providers Requests or surveys of the target audience Discussion in department or planning committee meetings National registry data National health/disease trend data Peer‐reviewed journals, government sources, consensus reports Methods to identify optimal performance standards or patient outcomes:  New practice guidelines  Review of board exam or recertification requirements  Evidence‐based literature  Legislative or regulatory changes affecting patient care  Advice from authorities in the field or relevant medical society  Joint Commission/Patient Safety regulations/recommendations Step 3: Identify the action needed to address the gaps: i.e. what do learners need to move from current to ideal practice or patient outcomes. Step 4: Prepare learning objectives: Learning objectives should reflect the content of the educational activity. Learning objectives should not be what you intend to teach but what you expect the learners know and/or do after participating in a CME Activity. 7 Page 29 of 73
Writing Learning Objectives: CME activities should be designed with the goal of changing physician’s competence, performance or patient outcomes not merely increasing knowledge. Learning objectives should be focused on outcomes such as those outlined below Learning Objective Outcome Table Comprehension assess contrast distinguish translate classify associate demonstrate estimate interpret discuss compare describe estimate interpret review differentiate express
Predict compute report Application apply examine order review use employ operate restate treat develop match report translate demonstrate locate relate solve complete interpret prescribe indentify choose interpolate predict select calculate illustrate practice schedule utilize Synthesis arrange create integrate prescribe construct generalize prepare validate formulate plan specify compose organize propose combine document produce collect detect assemble design manage Evaluation appraise decide judge critique grade recommend evaluate rate test select compare measure
choose estimate assess determine Skills demonstrate write visualize project diagnose empathize
integrate
palpate
measure
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operate listen Identifying Professional Practice Use the check boxes to indicate how the professional practice gaps were brought to your attention. Select all that apply and include back‐up documentation with your completed application packet. Educational Formats (Methods and Media) CME Activities which make use of multiple types of media, multiple instructional techniques and multiple exposures are more effective in improving physician knowledge, competence and practice 8 Page 30 of 73
behavior. Therefore we encourage program planners to use multiple media and multiple education techniques whenever possible. The educational format must be appropriate to the setting, objectives and desired results of that activity. For example, an activity designed to improve performance of a particular procedural skill would require a simulation or other "hands on" lab‐based session. A purely didactic approach would not be appropriate. Commercial Support and Exhibits Commercial support is provided by a *commercial interest. It includes financial contributions which course directors use to pay all or part of the costs of a CME activity, or the donation or loan of equipment or other goods for use during it. All commercial support funds must be in the form of a grant to the accredited sponsor or joint sponsor; a commercial interest may not make direct payments to faculty, facility or other vendor on behalf of the program. The terms and conditions of the support must be described in a written agreement between the accredited provider (OHSU) and the commercial supporter. OHSU will provide a standard letter of agreement; any other agreement form must first be approved by CME and the OHSU Contracts Office. Any form of agreement used must be signed by the Contracts Office, commercial supporter and educational partner (if any) and submitted to the CME office for final signature two weeks in advance of the activity. *Note: A “commercial interest” is an entity that produces, markets, re‐sells or distributes health care goods or services consumed by, or used on patients. Insurance companies and health care institutions such as nursing homes or hospitals are not included in this category. “In­kind support” includes the gift or loan of equipment, or other non‐cash benefit. An “exhibitor” has used resources dedicated for marketing/promotion to purchase space in an exhibit hall location. You may offer to sell exhibit space to a company that has provided a grant; however this must be a separate business transaction and is not part of the grant agreement. Placement of an exhibit cannot be a condition for the provision of a grant or in‐kind support. Advertisements and promotional materials cannot be displayed or distributed in the meeting room while an accredited educational activity takes place, nor immediately before or after such an activity. This provision includes the distribution of imprinted pens, pads of paper, etc. Requesting Grants If you apply for grants in support of the activity, you must provide a copy of the proposed grant request letter with your CME application and the letter must be reviewed by the CME office for compliance with the Standards for Commercial Support of the Accreditation Council for Continuing Medical Education. Your application must also include a list of the potential supporters, along with the dollar amount or description of in‐kind contribution requested/expected from each. If you apply for grants online, OHSU CME will require screenshots of the application request, a copy of the approval email, a copy of the agreement (electronic signature is fine) and a copy/screenshot of the fund transmission. The agreement must be reviewed and approved by CME and the OHSU Contracts office before it is accepted. 9 Page 31 of 73
Inviting Exhibitors Please submit a draft of your invitation to exhibit with your CME application. This document must also be reviewed by the CME office before use. ACCME Standards for Commercial Support A copy of the Standards was included with your application packet. It is also available on the ACCME’s website www.accme.org Barriers to Optimal Performance or Patient Outcomes Barriers are factors outside your control that may have an impact on patient outcomes. What potential barriers do you anticipate attendees may encounter in incorporating new knowledge, competency or performance objectives into practice? Some commonly encountered barriers are listed below. Factors outside of the Division of CME’s control which may have an impact on patient outcomes: Resources Regulation
Human Factors
Other Legislation
Geography/location
Lack of administrative Patient resources compliance Regulations
State of the science
Cost/lack of financial Patient health resources literacy Lack of time Insurance/reimbursement Cultural factors
Lack of consensus on professional guidelines Insurance/reimbursement Healthcare system Provider issues restrictions communication skills Healthcare system Physician restrictions resistance to change Poor team dynamics/ communication Examples of identified factors outside of organizer’s control with an impact on patient outcomes: Childhood Food Insecurity: This activity identified the limited or uncertain availability of nutritionally adequate or safe foods as a risk for behavioral, cognitive and other health‐related problems that can affect the well‐being and long‐term development of children. It also identified low income and lack of awareness of eligibility for food assistance programs as factors that increase food insecurity and increase the risk for adverse health impacts. Care Management Plus: This activity identified the increasing complexity of the healthcare system and consequent difficulty in navigating the system as factors that make it more difficult for patients with chronic illness and their care providers to manage their conditions and coordinate resources for appropriate care. 10 Page 32 of 73
Supplemental Educational Stratagies OHSU CME has used a variety of non‐educational strategies to enhance change and improve patient care (see table below). Supplemental How the strategy enhances Example(s) of implemented non­
educational change educational strategies strategy Information Provides an electronic system to A care management tracking system technology tools gather and track key measures and (ICCIS) was provided to all other needed information for on‐
participants in Care Management Plus, going patient care a course in chronic disease management. Validated tools provided to learners Visual pain scale assessment tool Assessment tools for use in their practice, can provided at multiple activities remind/prompt learners and addressing chronic pain. improve diagnostic skills Screening tools Validated tools provided to learners PHQ‐9 depression screening tool has for use in their practice, can been provided at multiple activities remind/prompt learners and addressing mental health issues. increase screening rates Geriatric screening tools have been provided at multiple activities. Mini‐
COG and CAM were provided as part of Delirium in the Hospitalized Patient. On­line or other Provide a repeated exposure to 41st Annual Primary Care Review and resources for learned material for review or more 17th Annual IM Review participants patient care were provided with a link to the AHRQ in‐depth investigation after the related website. A selection of AHRQ’s printed activity is over information Clinician’s Guides relevant to covered topics was also made available. EMR order sets Serve as a reminder and provide a A delirium order set was built into the menu of appropriate options from EMR as part of the Delirium in the which to choose Hospitalized Patient activity. Changes the system to promote A new screening protocol was adopted Change in organizational improvement in patient care. May by the hospital as part of the Delirium policy eliminate barriers to physician in the Hospitalized Patient activity. behavior change Email, phone, or Contact with learners after an Phone calls were made 6 months after other reminders activity to reinforce completing the Childhood Food or follow up learning/remind them to change Insecurity on‐line course to f/u on post­activity practice behavior changes in hunger screening, use of patient education materials, and other practice changes. Given to learners to provide to their Childhood Food Insecurity provided Patient handouts, patients to improve patient downloadable brochures on patient understanding of health conditions community resources for patients. information 11 Page 33 of 73
Collaboration with Other Stakeholders Collaboration with other interested parties can increase the reach and impact of educational activities. Forming partnerships with other groups (internal or external to OHSU) allows for the sharing of resources, expertise and experience. Are there other stakeholders, either at OHSU or externally that could be included in the planning or execution of this activity? If so, in what ways could these stakeholders be involved? Evaluation and Outcomes The following two questions are required by OHSU CME: 1) Were you aware of any commercial bias in the material presented? ____Yes____ No If yes, please describe: 2) Did you learn new information and strategies that you can apply to your work or practice? ____Yes____ No If yes, please describe: The ACCME requires that all accredited activities be evaluated. The evaluation is an important part of feedback loop, since the data gathered from the current activity is used to improve future curricula. Evaluating determines how successful the activity was in achieving its goals. While previous goals have typically been achievement of a change in knowledge, the ACCME now requires that accredited CME activities be designed to change competence at a minimum. The goal(s) of a CME activity one or more of the following: Increase the learners’ level of knowledge Increase learners‘competence (ability to put knowledge to use) Improve learners’ performance in patient care Improve patient outcomes The level of evaluation used depends on the goal of the activity. Examples: Change in… 1. Knowledge: Learner’s perception of knowledge gained Pre‐ and post‐test of knowledge 2. Competence: Pre and post test including “how would you……” questions on clinical case studies presented Use of audience response system Learners’ statement of specific expected changes in practice 3. Performance: Observation of performance Skills lab (suturing, etc.) Use of models (breast exam, etc.) Simulations 4. Practice: Survey at defined post‐course interval to determine whether actual change is reported such as an audit of prescribing practices 5. Patient outcomes: Audit of medical charts pre and post educational intervention Longitudinal review of outcomes in overall patient population 12 Page 34 of 73
Section III Preparing CME Content: Handouts, Syllabus and Slides Continuing medical education consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. The content of CME is that body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public. Content Validation OHSU expects that all of its CME programs will adhere to the ACCME’s content validation value statements. Specifically:  All the recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their use in the care of patients.  All scientific research referred to, reported or used in CME in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection and analysis. HIPAA Remove all patient identifiers from laboratory studies, x‐rays, imaging studies, slides, etc. OR obtain written permission from the patient to use his/her information as part of your presentation. Do not use identifiable photographs of patients unless written patient permission has been granted. Questions: http://www.hhs.gov/ocr/privacy/ Trade Names Presentations must give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. If the CME educational material or content includes trade names, where available trade names from several companies should be used, not just trade names from a single company. Product Logos No product logos should be included in the educational materials (slides, abstracts, acknowledgements, handouts, etc.). Product Promotion: Product promotion material or product‐specific advertisement of any type is prohibited in or during CME activities. The juxtaposition of editorial and advertising material on the same products or subjects must be avoided. Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME.  For print: advertisements and promotional materials cannot be included within the pages of the CME content. Advertisements and promotional materials may face the first or last pages of printed CME content as long as these materials are not related to the CME content they face and are not paid for by the commercial supporters of the CME activity. 13 Page 35 of 73
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For computer based CME: Advertisements and promotional materials cannot be visible on the screen at the same time as the CME content and cannot appear between computer ‘windows’ or screens of the CME content. For audio and video recording, advertisements and promotional materials cannot be included within the CME. “Commercial breaks” are not allowed. 
For live, face­to­face CME: Advertisements and promotional materials cannot be displayed or distributed in the educational space immediately before, during or after a CME activity. Providers cannot allow representatives of commercial interests to engage in sales or promotional activities. Section IV Publicizing Your CME Activity Required Elements for Advertising Any and all publicity (brochure, flyer, website, email invitations etc.) for the activity must have the following three elements present: 1. A description of the target audience 2. The learning objectives of the activity 3. The credit statement printed exactly as supplied by the Division of CME No publicity may be distributed, circulated or posted without prior written approval of the CME office. Section V OHSU CME Policies and Guidelines Conflict of Interest and Disclosure In accordance with the requirements of the Standards for Commercial Support of the Accreditation Council for Continuing Medical Education, each instructor, moderator and planning committee member is required to disclose relevant financial relationships they or their spouses/partners have or have had over the past 12 months with commercial interests that provide goods or services used for patients. Any conflicts identified must be resolved in advance of the activity; if that process is not completed satisfactorily the planner, speaker or moderator is not permitted to participate. This information is provided to the learners in writing before the activity begins: the name of the individual, the name of the commercial interest(s) and the nature of the relationship the individual has with each commercial interest. When no relevant financial relationships exist for an individual, learners are also informed of that fact. Instructors: When a conflict of interest exists, the course chair or other reviewer makes one of the following determinations based on information about the activity content and the financial relationships of the individual: 14 Page 36 of 73
1. The financial interests disclosed are not related to the content of the activity 2. The financial interests are related to content but patient treatment options are not addressed in the specific presentation/instructional materials 3. The financial interests are related to content and patient treatment options are discussed. In the first two instances, no further action is needed; in the third, the program chair then reviews the presentation/instructional materials to be certain they are evidence‐based and free of bias or advertising messages. Only those instructors and moderators who have completed a disclosure form and, if needed, had resolution of potential conflict of interest are permitted to participate in the educational activity. Planners: Those with responsibility for planning the activity are required to sign a statement that the curriculum for the activity was based on valid needs assessment and was planned solely by committee members free of the influence of commercial interests. These individuals also agree to abide by the ACCME Standards. In addition, planners and instructors must agree that all recommendations involving clinical medicine will be based on evidence that is generally accepted within the profession as adequate justification for their indications and contraindications in the care of patients; that all scientific research used in support or justification of a patient care recommendation will conform to the generally accepted standards of experimental design, data collection and analysis; and that material to be presented will be made available for advance peer review if requested. Faculty Honoraria and Travel Reimbursement 1. Funding received from commercial companies in support of a CME activity must be in the form of an educational grant to OHSU School of Medicine. OHSU or its joint sponsor partner will make all payments to faculty for honoraria and expenses. No payments may be made by a commercial supporter directly to course planners, teachers, authors or participants or to any vendor on behalf of the activity. 2. Honoraria and travel reimbursement practices must comply with the ACCME Standards for Commercial Support of Continuing Medical Education and the Oregon Health & Science University travel and business policies and procedures. 3. The OHSU School of Medicine CME honoraria payment scale is as follows: a. OHSU faculty physicians or equivalent: $ 0.00 ‐ $ 1,500.00 b. Course Directors: Up to $ 3,000.00 c. Non‐OHSU instructors who are nationally and/or internationally recognized leaders in the field: $ 750.00 ‐ $ 2,500.00 and above, depending on factors outlined below. 4. Factors influencing honoraria amounts include the total number and length of presentations, speaker qualifications and specialty, and preparation and travel time required. The decision regarding honoraria amounts is the responsibility of the OHSU activity chair and the CME committee and may not be influenced by commercial supporters. 15 Page 37 of 73
5. Instructors may be reimbursed for direct expenses associated with a presentation, such as media production or travel expenses, based on submission of original receipts. Payment is subject to CME review and OHSU reimbursement policies. 6. Recent developments at the Internal Revenue Service have led to changes in OHSU policy about submitting reimbursement requests for travel, entertainment and non‐travel business expenses. Departments will have 60 days from the date an expense was incurred to submit reimbursement requests. After 60 days, an expense will be treated as income to the employee unless extenuating circumstances exist. After 90 days, no exceptions will be possible, even with extenuating circumstances. After six months, expenses will not be reimbursed, granted an exception, or paid as additional pay. Note: In some instances, teachers or authors are listed on the agenda as facilitating or conducting a presentation or session but participate in the remainder of an activity as learners. In this event, honoraria can be paid and expenses reimbursed appropriate to the time dedicated to the teacher/author role only. Social Events/Resort Locations 1. Social events or meals at CME activities cannot compete with educational events (e.g., happen at the same time or become the main events of an activity). They may not dominate the activity publicity or costs. Details of expenses for social events and meals must be included in the CME application budget and the final activity income and expense report. 2. CME activities held at resort/recreational locations must offer a minimum of four hours instruction per day, with the exception of the first or last day of a course that is two or more days in length. 3. Funds received from a commercial interest in support of a CME activity may not be used to pay for travel, lodging, honoraria, or personal expenses for non‐teacher or non‐author participants at the activity. An exception may be made for scholarships for housestaff and fellows. Commercial support may be used to pay for travel, lodging, honoraria or personal expenses for bona fide employees and volunteers of OHSU or the joint sponsor, if any. Such payments must be made by OHSU or the joint sponsor; no payment may be paid directly by the commercial supporter. 16 Page 38 of 73
Section VI Frequently Asked Questions Who is the CME Provider? The official CME Provider is Oregon Health & Science University School of Medicine Division of CME. Who is the ACCME? The Accreditation Council for Continuing Medical Education. The ACCME's mission is the identification, development, and promotion of standards for quality continuing medical education (CME) utilized by physicians in their maintenance of competence and incorporation of new knowledge to improve quality medical care for patients and their communities. What is a Joint Sponsorship? When OHSU works with an organization that is not affiliated with OHSU, then the outside organization must be listed as Joint Sponsor. The activity is considered Directly Sponsored if there is no outside involvement in the planning process. What is a professional practice gap? A professional practice gap is best defined as the difference between the current state of knowledge, skills, practice or patient outcomes and the ideal or desirable state. Does OHSU CME offer credit for (nurses/pharmacists/other)? The School of Medicine, Oregon Health & Science University (OHSU), is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The division of CME designates AMA PRA Category 1 CreditTM (American Medical Association Physician Recognition Award) for approved educational activities. The AMA PRA Category 1 Credit™ system has become the CME standard for licensing boards and specialty organizations nationwide and is recognized by all U.S. jurisdictions. As of May 2011 thirty‐
nine states/territories accept the AMA PRA certificate or the AMA approved AMA PRA application as proof of having met the CME requirements for licensure, simplifying the medical re‐licensure process. Nurses: For the purpose of recertification, the American Nurses Credentialing Center accepts AMA PRA Category 1 Credits™ issued by organizations accredited by the ACCME (Accreditation Council for Continuing Medical Education). For the purposes of relicensure the Oregon State Board of Nursing accepts AMA PRA Category 1 Credits™ for attendance at structured learning activities offered by organizations (in this case: OHSU, Division of CME) accredited by the ACCME. (OAR 851‐050‐0142) Physician Assistant: The National Commission on Certification of Physician Assistants (NCCPA) states that the AMA PRA Category 1 CreditsTM are acceptable for continuing medical education requirements for recertification 17 Page 39 of 73
Certified Nurse Midwife: The American College of Nurse Midwives has granted reciprocity status for AMA PRA Category 1 CreditsTM issued by providers accredited by the ACCME and relevant to midwifery. It is the responsibility of the non‐physician individual to determine whether they will be able to use their participation at any AMA PRA Category 1 CreditTM approved course for relicensure. If you have doubts whether an activity will qualify for CE, contact the Board prior to registering for the course. Can a speaker get credit for giving a presentation? A physician may claim credit for preparing and presenting an original talk at a live activity that offers AMA PRA Category 1 CreditTM. They must however claim this directly through the AMA. The AMA states that a physician may claim two AMA PRA Category 1 CreditsTM per one hour of presentation time. Two things to bear in mind are: 1. It must be an “original presentation”. This credit is for preparing and presenting a unique and original presentation and may only be claimed once for a repeated presentation. 2. Credit may only be claimed for teaching at a live activity that is already designated for AMA PRA Category 1 Credit™. Do I have to include the credit statement on a "save­the­date" card? No. Typically these cards contain only initial, preliminary information like the activity date and location. If more specific information is included, such as faculty and objectives, the accreditation statement must be included What are “Core Competencies?” The American Board of Medical Specialties (ABMS) and the Accreditation Council for Graduate Medical Education (ACGME) have designated competencies based on Maintenance of Certification. In addition the Institute of Medicine (IOM) has a similar list of core competencies (see list page 6). What is a commercial interest? The ACCME defines a “commercial interest” as any entity producing, marketing, re‐selling or distributing health care goods or services consumed by, or used on patients. What would be an example of a non­commercial supporter? The American Red Cross, NIH, Department of Human Services or any entity which does not produce market or distribute health care goods or services consumed by or used on patients. Can I offer commercial interests different levels of designation for different amounts of commercial support? Yes. It is within compliance to designate different categories (e.g., gold, silver, bronze) of commercial (and non‐commercial) supporters for different amounts of support received. What if a company is providing an educational grant AND an exhibit fee? These are two separate transactions. Exhibits are considered promotional and therefore exhibit funds cannot be included as part of the educational grant. Please refer to the grants and exhibits section for more information. 18 Page 40 of 73
Which letter of agreement should be signed...the company’s or OHSU’s? OHSU may sign the company’s agreement if it meets the OHSU CME grants and contracts standards. If the grant amount changes or the date of the activity is moved, either a new agreement must be signed or the amount or date changed on the original agreement. Agreements must be signed & dated by all parties. Only one signed letter of agreement per company per activity can exist. Who is authorized to sign grant letters of agreement for OHSU CME activities? Letters of agreement must be signed by the activity chair. In addition all letters of agreement (other than OHSU’s standardized letter of agreement) must be reviewed and signed by the Grants and Contracts Office. What should I do if the commercial supporter asks me to accept the terms of their agreement online? Terms and conditions should not be accepted without prior approval by CME office. Once you receive a notice that a grant is approved pending acceptance of the terms, please provide the CME office with your login information or a copy of the original grant request and the electronic agreement terms. OHSU CME will review the terms and let you know if they can be accepted. When should I acknowledge commercial support? Commercial support must be acknowledged to the participants prior to the beginning of the learning activity. Failure to do so is a violation of the ACCME’s Standards for Commercial Support. Useful Links Accreditation Council for Continuing Medical Education (ACCME) Accreditation Council for Pharmacy Education (ACPE) Agency for Healthcare Research and Quality (AHRQ) Alliance for Continuing Medical Education (ACME) American Academy of Family Medicine (AAFP) American Board of Internal Medicine (ABIM) American College of Obstetricians and Gynecologists (ACOG) American College of Physicians (ACP) American Medical Association (AMA) American Osteopathic Association (AOA) American Psychiatric Association (APA) Association of American Medical Colleges (AAMC) Centers for Disease Control and Prevention CDC)Centers for Medicare and Medicaid Services (CMS) Food and Drug Administration Guidance for Industry Healthy People 2010 Institute for Healthcare Improvement (IHI) Institute of Medicine (IOM) Office of Inspector General (OIG) Office for Civil Rights ­ HIPAA OHSU Division of Continuing Medical Education Oregon Medical Board (OMB) Pharmaceutical Researchers and Manufacturers of America (PhRMA) US Department of Health and Human Services World Health Organization 19 Page 41 of 73
OREGON HEALTH SCIENCES UNIVERSITY
UNIVERSITY HOSPITALS & CLINICS
PHARMACY AND THERAPEUTICS COMMITTEE
FORMULARY DRUG REQUEST
INSTRUCTIONS AND INFORMATION
1. Formulary drug requests can be submitted only by staff physicians, with the approval of their department chairman or division head.
Members of the Committee are discouraged from submitting requests.
2. Complete (type or print) all parts of this form (both front and back).
3. Have the request reviewed and approved by the head of your department or division.
4. Send the completed form to: Director of Pharmacy Services, HRC 9D40, Mail Code CR 9-4.
5. A representative of the Department of Pharmacy Services will contact you to review and discuss cost effectiveness implications of the
request.
6. You will be supplied with a copy of the agenda, including your formulary drug request as submitted, supporting documentation, and
recommendations prior to the meeting at which it will be reviewed.
7. Committee policy requires that you attend the P & T Committee meeting at which your request is reviewed. If your request is on the
agenda for three months without being reviewed, it will be dropped. Committee meetings are normally held the last Monday of every
month, from 4:00-5:00 pm. You can obtain specific information about the date, time, and place of the meeting by calling x48007.
Brand Name:
Generic Name of Requested Drug:
Dosage Form(s):
Manufacturer:
NOTE: Drugs requested for the management of chronic outpatient conditions are not reviewed by the P&T Committee,
and are available for inpatient use, if necessary, through the nonformulary process (pager 1-1982). Please contact the
pharmacist carrying the nonformulary pager (1-1982) with questions concerning this policy.
1. What are the therapeutic indications for which the drug will be used and at what doses? (Attach references)
Indication
Dosage Range
2. What could be considered appropriate use criteria for this drug? (This information will be used to develop appropriate drug
usage evaluation studies.)
3. Is the drug being requested for :
full formulary status;
limited clinical trial.
4. List other drugs currently on the Formulary which are now being used for the indications listed in #1.
Drug
Indication
5. What are the advantages of the requested drug over drugs currently on Formulary? (Circle appropriate responses)
A. More efficacious
B. Better side effect profile
C. Better drug interaction profile
D. More cost effective
E. Other (Specify)
6. List those drugs currently on the Formulary which can be deleted if this drug is approved.
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7. Should the prescribing of this drug be restricted to specific physicians/divisions/departments/services? If so, specify who
and why.
8. Complete the adverse drug reactions table comparing the requested drug with comparable Formulary drugs listed in #4.
ADVERSE REACTIONS AND INCIDENCES
Reaction
Reaction
Reaction
Reaction
REQUESTED DRUG:
LIST OTHER DRUGS FROM #3
9.
What is the anticipated annual usage of this drug by your division/department/service?
Number of inpatients
Usual course of each patient's therapy _________
Number of outpatients
Usual course of each patient's therapy _________
10. Which other divisions/departments/services are likely to use this drug?
11. Does this drug pose a potential occupational safety risk to healthcare workers who may handle and administer it?
No
Yes
Unknown
(Pharmacy Service follow-up
).
12. Any physician requesting the addition of a drug to the OHSU Formulary is expected to disclose any real or apparent
conflict(s) of interest that may have a direct bearing on the formulary status of this product. This pertains to relationships with
pharmaceutical companies, biomedical device manufacturers, or other corporations whose products or services are directly or
indirectly related to this product. The intent of this policy is not to prevent a physician with a potential conflict of interest from
requesting the drug product, but to insure that any potential conflicts are identified openly so the Committee members may
form their own judgements regarding potential bias. Please initial:
No potential conflict(s) of interest exist ___________
Potential conflict(s) of interest exist ____________
Please describe potential conflicts:
Ext:
Name of requesting physician:
Mail Code:
Clinical department or division:
Date:
Signature of requesting physician:
Date:
Signature of department chairman or division head:
4-98
formulary-drg
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Gifts & Vendor Relationships | Conflict of Interest | OHSU
http://www.ohsu.edu/xd/about/services/integrity/coi/gifts/index.cfm
Gifts Policy Summary
Physician Payment
"Sunshine Provisions"
SPEAKERS BUREAU POLICY UPDATE
National Guidance & Articles
May I serve on a speakers bureau for a company?
No. Effective March 13, 2013, OHSU policy 10-01-015 now states:
REQUIREMENTS FOR PARTICIPATION IN INDUSTRY SPONSORED
LECTURES AND MEETINGS
The following section applies to all OHSU Members (including
non-employee or affiliates with an appointment at OHSU while serving in
their OHSU role):
A. For all lectures and meetings (on-and off-campus) sponsored directly
by industry or by intermediate educational companies subsidized by
industry, OHSU members should evaluate carefully their attendance
because of the potential for perceived or real conflict of interest. They
should be especially cognizant of this potential when considering
whether to play a leadership role in such meetings and conferences by
giving a lecture, organizing the meeting and the like. Except as noted,
these activities are allowed if the following criteria are met:
RESOURCES:
(1) Financial support by industry is fully disclosed at the meeting by
either the event organizer or the OHSU Member giving a presentation;
Gifts One Page Summary
(2) OHSU Members participating as lecturers:
Oregon State Ethics Law
a. May not participate in industry sponsored "speakers bureaus" (i.e.,
contractual relationships to give one or more talks in which the topic(s)
and/or content are provided by the company) or other dedicated
marketing, educational or training programs designed solely or
predominately for sales or marketing purposes for a product of an
outside commercial entity;
OHSU Policy Links
b. Must determine the content of the presentation, including preparation
of slides and written materials, which reflect a balanced assessment of
the current science, treatment options, or other content area; and
c. Must make clear to the audience that the content of the lecture
reflects the views of the lecturer and not OHSU or any sponsor.
FAQs-tracked with
new changes-April 2013
FAQs-clean
copy-April 2013
The Integrity Office is
happy to meet with schools,
departments, and units to
assist in education on the
final policies. If you have
any questions, please
contact Dr.Kara Manning
Drolet, Associate Director,
ORIO/OIO, or call
503-494-8849 (option 3).
(3) To the knowledge of the lecturer, attendees are not compensated
solely for attendance (e.g., through payment of travel expenses or other
compensation);
(4) Compensation for services of the lecturer are reasonable, travel and
lodging provided by industry is limited to that required for the event, and
food and beverages provided are modest; and
(5) The outside activity is appropriately disclosed and approved as
required in section 7 of this policy.
Gift Policy Summary:
The policy on Gifts to Individuals includes the prohibition on
individual gifts without regard to dollar value as recommended by
national standards. However, this prohibition is limited to those in a
"Position of Authority" with respect to the vendor offering the gift.
Position of Authority is defined as: A position in which one does or is
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Gifts & Vendor Relationships | Conflict of Interest | OHSU
http://www.ohsu.edu/xd/about/services/integrity/coi/gifts/index.cfm
expected or anticipated to influence the selection, retention,
evaluation, direction, or supervision of a vendor. Any position that
could influence the decision to place business, increase or decrease
business, or continue, modify, or terminate a relationship with a
vendor. This includes but is not limited to:
o Health care providers with prescription privileges;
o OHSU Members with grants who purchase supplies related to
the grant activities;
o OHSU Members with fiscal authority related to a specific
business decision;
o A person who is a voting member of a RFP (request for
proposals) committee;
o Each OHSU employee as to all vendor relationships:
- Within the employee's oversight authority;
- Where the vendor relationship is a part of a vendor selection
process in which the employee participates; and/or
- Where the employee exerts or attempt to exert influence over
the awarding of business to the vendor; and
o Employees with authority over specific financial decisions related
to a vendor.
OHSU policy requires that promotional gifts such as mugs, pens,
notepads, clocks, t-shirts, and similar items displaying vendor logos
or symbols not be accepted by any OHSU Member (defined as all
OHSU officers, employees, faculty, students, trainees, and
volunteers). These items must not be present on OHSU campuses.
The Gifts to OHSU policy includes the requirement that food
provided at OHSU educational events must be paid for with funds
provided to OHSU (as an unrestricted gift) and may not be directly
provided by vendors.
OHSU policies meet the requirements of the revised Oregon Ethics law.
The Oregon law also limits gifts from OHSU Vendors that may be
accepted or solicited by your relatives, including spouse or domestic
partner, child, sibling, spouse of sibling, parent, and spouse's parent.
OHSU policy advises you to instruct your relatives about the limitations
on their accepting gifts.
Physician Payment "Sunshine Provisions"
OHSU Members should be aware that the Patient Protection and
Affordable Health Care Act includes new "Sunshine Provisions,"
requiring pharmaceutical, medical device, biological, and medical supply
manufacturers to begin reporting to the federal government the
payments they make to physicians and teaching hospitals.
Additionally, the law requires the Secretary of Health and Human
Services to make this payment and ownership interest information
available on a publicly accessible, searchable, and downloadable
website. As a result, manufacturers' payments to consultants,
researchers, and others; physician ownership interests held in a
manufacturer or Group Purchasing Organization; and important
information related to such payments and disclosures, will now be a
matter of public record.
The scope of reportable payments is broad and includes consulting
fees, compensation for non-consulting services, honoraria, gifts,
entertainment, food, travel, education, research, charitable contributions,
royalties or licenses, current or prospective ownership or investment
interests, direct compensation for serving as faculty or as a speaker for
a medical education program, and grants.
Manufacturers will begin collecting and tracking information about
payments to physicians on August 1, 2013. The Integrity Office will be
monitoring this public database to ensure that all payments received by
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Gifts & Vendor Relationships | Conflict of Interest | OHSU
http://www.ohsu.edu/xd/about/services/integrity/coi/gifts/index.cfm
physicians have been disclosed on the Conflict of Interest disclosure
form(s) as appropriate, and that gifts in violation of the OHSU Gifts
Policies have not been received.
Additional resources on the Physician Payment "Sunshine Provisions":
AMA brochure
*CMS resource
*In the future, physicians will be able to register here to access their data
for review prior to public posting
National Guidance and Articles on Gifts, Conflicts of Interest
and Vendor Relationships
AAMC / AAU Joint Report
AAMC Report on Industry Gifts
AAMC Science of Influence
Advanced Medical Technology Association (AdvaMed) 2009 revised
Code of Ethics on Interactions with Health Care Professionals
AMC Policy Briefs
Examples of Model Policies (AAMC)
Examples of Model Policies (AMSA)
Examples of Model Policies
Financial Support of Continuing Medical Education
HCCA Gifts Survey
Health Industry Practices That Create Conflicts of Interest
Pharmaceutical Research and Manufacturers of America
(PhRMA)—2008 revised Code on Interactions with Healthcare
Professionals
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INDIVIDUAL ACCEPTANCE OF GIFTS, FOOD,
BEVERAGES, TRAVEL, AND ENTERTAINMENT
No. 10-01-025
Effective Date: February 3, 2010
1. BACKGROUND
Acceptance of Gifts by OHSU Members from OHSU Vendors and others seeking a business relationship
with OHSU can compromise or appear to compromise the obligation to act in the best interests of OHSU,
OHSU patients, or OHSU research subjects. In addition, Oregon law restricts the ability of OHSU
Members to accept Gifts in certain circumstances.
Even if acceptance of a Gift meets the requirements of this policy, if acceptance could inappropriately
influence or appear to inappropriately influence a decision to be made by an OHSU Member, the Gift
must not be accepted.
2. PURPOSE OF THIS POLICY
This policy establishes rules and guidelines for Gifts to OHSU Members from a business and/or industry
representative with or seeking a business relationship with OHSU ("Vendor").
3. STATEMENT OF POLICY
A. Except as provided at section 5: OHSU Members (definition below) who are in a Position of Authority
(definition below) relative to a business decision with a Vendor (definition below):
1) May not accept or solicit a Gift (definition below) from such Vendor; and
2) Must instruct their Relatives (definition below) that those Relatives may not accept or solicit Gifts from
such Vendor.
B. OHSU Members, regardless of Position of Authority, may not accept Gifts from Vendors that are
promotional in nature (items displaying company logos or symbols). Logos/symbols on purchased items
are allowed.
C. The OHSU Integrity Office shall post and periodically update:
1) Information related to compliance with federal, state, and local laws; national guidance; and best
practices related to the acceptance of Gifts from industry; and
2) A compilation of questions, answers (FAQs), and resources regarding gifting issues.
4. DEFINITIONS
A. Gift: Something with financial value including items of token value such as notepads, pens, coffee
mugs, clocks, or similar items; food; beverages; travel; entertainment such as (but not limited to)
attendance at or tickets to theater or sporting events, movies, concerts, or similar events; but excluding
informational material, publications, or subscriptions related to the OHSU Member's official duties.
B. Honoraria: Money or other items of monetary value provided for presentations, serving on panels,
mediating events, and similar work.
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C. OHSU: In the context of this policy "OHSU" refers to OHSU as an institution, its Schools, Units,
Research Institutes, Hospitals and Clinics, Divisions, and Departments or their respective parts, subparts, or sub-units, but does not include the OHSU Foundation or Doernbecher Foundation.
D. OHSU Member: As defined in Policy No. 01-01-000 excluding vendors while doing business with
OHSU, and OHSU Foundation and Doernbecher Children's Hospital Foundation employees. Visiting
healthcare practitioners and contracted non-permanent individuals are also excluded if they do not have
an OHSU appointment. Those with an appointment at OHSU are included in this policy while serving in
their OHSU role.
E. Position of Authority: A position in which one does or may influence the selection, retention,
evaluation, direction, or supervision of a Vendor, including influencing the decision to place business,
increase or decrease business, or continue, modify, or terminate a relationship with a Vendor. This
includes but is not limited to:
1) Prescribing OHSU health care providers relative to pharmaceutical Vendors;
2) OHSU Members with grants relative to Vendor suppliers;
3) OHSU Members with fiscal authority relative to a specific business decision with a Vendor; and
4) Each OHSU employee as to all Vendor relationships:
a. Within the employee's oversight authority;
b. Where the Vendor relationship is a part of a Vendor selection process in which the employee
participates such as an RFP; and/or
c. Where the employee exerts or attempts to exert influence over the awarding of business to the vendor.
F. Product, Service, and/or Project Evaluation Activity: Activity, participation, or other effort
associated with evaluation of a product, service, project, or potential business arrangement, where the
final decision to purchase the item or service or initiate the project has not been made or where additional
education about the product, service, or project is needed to meet obligations in a business agreement.
G. Relative: The spouse, registered domestic partner, domestic partner, child (including adult children),
siblings, spouses of siblings, parents of an OHSU Member, or parents of the spouse of an OHSU
Member.
H. Representing OHSU: An OHSU Member who attends a meeting, event, business negotiation, product
evaluation, or similar activity in his/her official OHSU capacity as a part of his/her OHSU position and
responsibilities is representing OHSU.
I. Vendor: An, industry, business, or representative of same that currently has a business relationship
with OHSU or is seeking a business relationship with OHSU including, but not limited to, a business that
is selling products or services to OHSU or that is seeking to sell products or services to OHSU.
J. Vendor Fair: An event on OHSU premises where a vendor or several vendors provide information
related to their products and/or services.
5. EXCEPTIONS
The following are exceptions to the prohibitions in Section 3. OHSU Members:
Page 48 of 73
A. Who provide presentations at professional meetings or institutions may accept expense
reimbursement and reasonable honoraria for their participation. (Honoraria for attendance only are not
permitted);
B. Who are invited to speak or serve on a panel at a reception or meeting and who are listed as part of
the scheduled program may accept a meal and beverages;
C. Who are Representing OHSU at a product, service, and/or project evaluation activity; business
negotiation; business meeting; reception; or charitable event may accept admission, travel expenses,
food, and beverages so long as reimbursement for travel and lodging is reasonable and appropriate for
the time spent in the OHSU-related activity;
D. Who are Representing OHSU by delivering a speech, making a presentation, participating on a panel,
or attending a convention, fact-finding mission, or other meeting may accept reasonable expense
reimbursement, food, and beverages.
E. Who are involved in meetings for the review or closing of a borrowing, investment, or other financial
transaction or for a business agreement may accept food and beverages during such meetings;
F. May accept a token of appreciation for service or a presentation, such as a plaque, if its resale value is
no more than $25.00;
G. May accept food incidental to Vendor Fairs (definition above) when that food/beverage is served
reception style and the attendees do not sit to consume a plated meal, and may accept items of
educational or scientific value, but not items that are solely promotional of one or more Vendors;
H. May participate in meetings of professional societies as part of their continuing education and other
professional obligations even when the meetings are partially sponsored by industry but organized by
professional societies.
I. And their Relatives who receive Gifts from a source that could not reasonably be known to have or be
seeking a business relationship or financial interest in OHSU are excepted from section 3-A of this policy.
J. And their Relatives may accept Gifts offered to them as part of (i) the usual and customary practices of
their private business, or (ii) their employment or volunteer activity outside of OHSU, when the items bear
no relationship to their official position at OHSU.
K. Who have or whose Relatives have a personal relationship (friendship, spouse/domestic partner) with
a Vendor are not expected to alter those relationships to comply with this policy, but should consult with
the OHSU Integrity Office for advice should they have questions about such relationships.
6. MONITORING AND ENFORCEMENT
The OHSU Integrity Office (OIO) is responsible for enforcing and monitoring compliance with this policy
and, in coordination with the Legal Department, will serve as a resource for implementing the policy.
Background:
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•
ORS 244.010 through 244.040
Related policies, procedures and forms:
•
Fact Sheet: Acceptance of Gifts from Industry/Vendors by Individuals at OHSU
Implementation date: August 27, 2001
Revision dates: December 23, 2002; October 25, 2004; November 14, 2006; January 1, 2008;
January 1, 2009;
August 12, 2009; February 3, 2010
Responsible office: OHSU Integrity Office
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Institutional Conflicts of Interest;
Executive and Board Member Conflict of
Interest Disclosure
Policy No. 10-01-021
Effective Date: August 21, 2012
1. CONFLICT OF INTEREST
An Institutional Conflict of Interest (ICOI) may exist when Board of Director members,
institutional executives, or the institution have external relationships or financial interests
(hereinafter defined as "significant financial interests") in a company or organization that
has significant business transactions with OHSU. These dual relationships may interfere,
or appear to interfere, with the obligation to act in OHSU or the public's best interest.
Because the appearance of a conflict may be as damaging to the public trust as an actual
conflict, potential conflicts must be disclosed, evaluated, and managed with the same
thoroughness as actual conflicts.
2. REVIEW OF POTENTIAL INSTITUTIONAL CONFLICTS OF
INTEREST
The Integrity Program Oversight Council (IPOC) is the board-designated body to review
potential ICOI's as described above. Potential ICOI's will be identified through the
Executive and Board Member Conflict of Interest disclosures and other sources.
3. EXECUTIVE AND BOARD MEMBER CONFLICTS OF INTEREST
A. TO WHOM THIS POLICY APPLIES
This policy applies to all OHSU Board of Directors Members and OHSU Executives
(herein after called "OHSU executives"), including the President, Vice Presidents, Deans,
and all who report directly to a Vice President (excluding those reporting to Associate or
Assistant Vice President), Dean or member of the Executive Leadership Team, except
administrative support personnel.
B. DEFINITIONS
Significant Financial Interests of OHSU Executives include the following interests of the
OHSU executive and his or her spouse or registered domestic partner and any dependent
children:
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(1) Equity interest or entitlement to equity (e.g. stocks, stock options, warrants, or
contractual rights to acquire or receive ownership interests other than interests in a
diversified mutual fund) of any amount in a non-publicly traded company.
(2) Equity interest or entitlement to equity greater than five thousand US dollars ($5,000)
in aggregate over the last twelve (12) months in a publicly traded company.
(3) Compensation (anything of monetary value) including, but not limited to, salary, gifts,
consulting fees, honoraria or other payments for services that is more than five thousand
US dollars ($5,000) in aggregate over the last twelve (12) months.
(4) The aggregated value of equity interest and compensation, as defined above, that
exceed $5,000 over the last twelve (12) months in a publicly-traded company.
(5) Royalty income or the right to receive future royalties under a patent license, or
copyright agreement with an entity.
(6) Serving in an executive position (any position that includes responsibilities for a
material segment of the operation or management of a business, including a position on a
Board of Directors).
C. EXCEPTIONS
Significant Financial Interests do not include the following:
(1) Salary and other payments for services from the institution, including approved
faculty practice plan earnings and the distribution of those earnings that may be
established by departmental or other similar agreements provided that those agreements
and departmental/divisional group plans are approved by the President.
(2) Income from seminars, lectures, or teaching engagements sponsored by a federal,
state, or local government agency, and Institution of higher education as defined at 20
U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute
that is affiliated with an Institution of higher education; or
(3) Income from service on advisory committees or review panels for a federal, state, or
local government agency, an Institution of higher education as defined at 20 U.S.C.
1001(a), an academic teaching hospital, a medical center, or a research institute that is
affiliated with an Institution of higher education.
D. ANNUAL DISCLOSURE BY OHSU EXECUTIVES
OHSU executives shall, in addition to complying with the other Conflict of Interest
policy requirements outlined in Chapter 10, disclose to the IPOC annually, on a form
approved by the IPOC, relationships and circumstances that could, to the best of the
executive's knowledge, pose a potential or actual conflict of interest under this policy. If
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the IPOC believes a disclosure poses a potential or actual conflict, it shall indicate to the
OHSU executive how to dispose of or manage the conflict.
Disclosures are due annually. If the responses to any of the questions change during the
year, the disclosure form must be revised and resubmitted.
4. INSTITUTIONAL CONFLICTS OF INTEREST IN OHSU
RESEARCH
The Technology Transfer and Business Development (TTBD) Office shall provide the
OHSU Integrity Office (OIO) with updates of OHSU's financial interests acquired
through university licensing agreements and similar business arrangements on a quarterly
basis. The IPOC shall review all cases where OHSU has a significant financial interest in
an entity that sponsors or could otherwise benefit from a research project being
conducted at OHSU.
A. DEFINITIONS
Significant Financial Interests of the Institution include the following interests of OHSU:
(1) Receipt of royalties from the sale of a product/technology that is the subject of
research currently being conducted at OHSU;
(2) Equity interest or entitlement to equity of any amount in a non-publicly traded
company that is currently sponsoring research at OHSU;
(3) Equity interest or entitlement to equity greater than $100,000 in a publicly traded
company that is currently sponsoring research at OHSU;
(4) Receipt of gifts from any entity with which OHSU places business that in total over
one calendar year exceeds $100,000.
5. CONDITIONS TO MANAGE POTENTIAL ICOI'S
Any real or apparent ICOI must be reviewed by the IPOC, which may impose
management conditions including, but not limited to:
A. Ensuring that institutional financial interests and investments are being managed by
individuals/departments that are not involved in purchasing, procurement, contracting,
research, or other operations decisions and oversight;
B. Requiring public disclosure of the institutional CoI in publications, presentations, or
other public announcements;
C. Imposing an escrow period for realizing a financial gain ("cashing out");
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D. Divesting the financial interest;
E. Reassigning, removing, or otherwise making a firewall for executives who may be
conflicted or perceived as not having "clean hands" for any business decisions or
activities involving any entity with which the executive has a significant financial
interest;
F. Notification to a donor that gifts to OHSU will not be taken into account for future
business relationships, or refusal or return of gifts, entertainment, or other perquisites
from an entity that has a business relationship with OHSU or in which OHSU and/or an
executive has an investment; and/or
G. Other management plans that the IPOC may design. ICOI Management is in addition
to any management that might apply for individual conflicts of interest.
6. APPEAL
An OHSU Executive who disagrees with the directive of the IPOC may appeal the
directive under processes established by the Council.
Background:
Related policies, procedures and forms:
OHSU Board Resolution No. 2004-03-06
OHSU Board Resolution No. 2004-03-05
ICOI Disclosure Form
Institutional Conflict of Interest Information and Definitions
Implementation date:
November 3, 2004
Revision date:
November 19, 2010; August 21, 2012
Responsible office:
Integrity Office
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Outside Activity/Outside Compensation
Policy No. 10-01-015
Effective Date: March 13, 2013
1. GENERAL
OHSU recognizes the value of and encourages its faculty and other employees to
undertake outside activities that will benefit the employee, support the missions of the
University and be of service to the community. An activity is considered an "outside"
activity when it is "outside" of the requirements and/or scope of the individual's
employment with OHSU.
No OHSU employee may engage in an outside activity that:
A. Does not comport with or is in conflict with the missions of the University;
B. Substantially interferes with the employee's duties to the University;
C. Compromises the ability of OHSU to achieve its missions;
D. Compromises the ability of any employee to fulfill the academic, professional, or
institutional responsibilities for which OHSU employs him/her;
E. Damages the reputation or compromises the integrity of OHSU or any of its
employees;
F. Diverts any education, research, or clinical practice activity that might appropriately be
conducted within OHSU; or
G. Violates any of the provisions of the OHSU Conflict of Interest Policy of 10-01-020.
When an outside activity is, or could be, related to the role of an OHSU employee who is
a "Disclosing Employee" (defined below), the employee must disclose the activities and
receive appropriate approval prior to initiating such activity. In addition, if such an
employee's related outside activity could create an actual, potential, or perceived conflict
of interest, the employee must also comply with the Conflicts of Interest (Policy 10-01020) and/or Conflicts of Interest in Research (Policy 10-01-035) policy requirements.
For purposes of this policy a "Disclosing Employee" means and includes the following
individuals:
A. OHSU faculty members;
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B. Other persons who serve in a management capacity at OHSU (including without
limitation directors, supervisors, managers, and department administrators);
C. Other persons who have delegated contracting authority or delegated fiscal authority;
D. Clinicians, including OHSU employees who provide clinical care to patients and can
prescribe medications or therapy, such as Licensed Independent Practitioners;
E. Other persons designated by an OHSU Officer or Unit Leader. The Officer or Unit
Leader must notify the OHSU Integrity Office when designating these additional persons.
2. DETERMINATION OF NEED FOR DISCLOSURE/APPROVAL OF
RELATED OUTSIDE ACTIVITIES
The Disclosing Employee shall evaluate the "outside activity" and determine whether it is
related to the employee's OHSU employment and requires disclosure and/or approval in
advance or on an annual basis. For purposes of this policy, an activity shall be considered
a "related outside activity" requiring disclosure and approval when the activity:
A. Requires the employee to use the same academic, professional or institutional
expertise for which he or she is employed by OHSU; or
B. Is conducted at OHSU owned or controlled premises, or uses OHSU facilities or
support, unless for incidental use specifically permitted by OHSU policies.
3. RELATED OUTSIDE ACTIVITIES NOT NEEDING DISCLOSURE
OR APPROVAL; EXCEPTIONS
The specific "outside activities" listed below are considered to be outside the scope of
this policy and do not require disclosure or approval as long as the activities do not fall
within A through G of Section 1 of this policy. Additionally, researchers may have
disclosure requirements for sponsored travel and receipt of honoraria for certain not-forprofit organizations, as specified in Policy 10-01-035:
A. Pro-bono professional activities by any employee or faculty member; or
B. Unpaid (other than expense reimbursements and modest honoraria defined as $5000 or
less annually) service for, or on behalf of, governmental or other not-for-profit
organizations related to the employee's work, including but not limited to scientific and
technical groups, commissions and professional associations.
C. Reimbursed or sponsored travel must be disclosed by researchers as described in the
Conflict of Interest in Research policy, 10-01-035.
4. RELATED OUTSIDE ACTIVITIES NEEDING ANNUAL
DISCLOSURE
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Note for Researchers: Disclosures for outside activities must be disclosed as described
in the Conflict of Interest in Research policy, 10-01-035.
The specific "related outside activities" listed below must be disclosed annually but are
considered approved as a class as long as they do not fall within A through G of Section 1
of this policy:
A. Receipt of royalties for published scholarly work developed using minimal University
resources.
B. Occasional lecture or seminar participation with receipt of no more than modest
honoraria (defined as $5000 or less annually) and expense reimbursement. See section 6
below for specific requirements for participating in industry-sponsored lectures.
C. Occasional expert witness testimony that is not on a contract basis.
Such disclosure may be made on an annual basis (retroactively).
5. RELATED OUTSIDE ACTIVITIES NEEDING ADVANCED
DISCLOSURE AND APPROVAL
Examples of activities that must be disclosed and approved in advance include but are not
limited to (examples include paid or unpaid activities unless exempt under section 3):
A. Consulting agreements
B. Contract appointments to serve as "on-call" expert witnesses
C. Taking a position in a related outside entity (including but not limited to a board
position, ownership, or other employment)
D. Appointment to a scientific advisory board
E. Any other related outside activity where a signed contractual agreement will be
required.
6. REQUIREMENTS FOR PARTICIPATION IN INDUSTRY
SPONSORED LECTURES AND MEETINGS
The following section applies to all OHSU Members (including non-employee or
affiliates with an appointment at OHSU while serving in their OHSU role):
A. For all lectures and meetings (on- and off-campus) sponsored directly by industry or
by intermediate educational companies subsidized by industry, OHSU members should
evaluate carefully their attendance because of the potential for perceived or real conflict
or interest. They should be especially cognizant of this potential when considering
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whether to play a leadership role in such meetings and conferences by giving a lecture,
organizing the meeting and the like. Except as noted, these activities are allowed if the
following criteria are met:
(1) Financial support by industry is fully disclosed at the meeting by either the event
organizer or the OHSU Member giving a presentation:
(2) OHSU Members participating as lecturers:
a. May not participate in industry sponsored "speakers bureaus" (i.e., contractual
relationships to give one or more talks in which the topic(s) and/or content are provided
by the company) or other dedicated marketing, educational or training programs designed
solely or predominately for sales or marketing purposes for a product of an outside
commercial entity;
b. Must determine the content of the presentation, including preparation of slides and
written materials, which reflect a balanced assessment of the current science, treatment
options, or other content area; and
c. Must make clear to the audience that the content of the lecture reflects the views of the
lecturer and not OHSU or any sponsor.
(3) To the knowledge of the lecturer, attendees are not compensated solely for attendance
(e.g., through payment of travel expenses or other compensation);
(4) Compensation for services of the lecturer are reasonable, travel and lodging provided
by industry is limited to that required for the event, and food and beverages provided are
modest; and
(5) The outside activity is appropriately disclosed and approved as required in section 7
of this policy.
7. OUTSIDE ACTIVITIES OBLIGATIONS GENERALLY
A. All Disclosing Employees must complete and file an annual disclosure statement in
the form provided and electronically posted by the OHSU Integrity Office. Those who
have nothing to disclose will be provided with an expedited method to indicate this.
B. Disclosing Employees who engage in a related outside activity that requires advanced
disclosure/approval (as in section 5 above) shall:
(1) Complete and file an "Outside Activity Disclosure" prior to initiating involvement in
the related outside activity and update it if the activity is modified; and
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(2) Complete an updated disclosure annually throughout the duration of the employee's
involvement in the activity.
C. Disclosing Employees who engage in related outside activities that do not require
advanced approval (as in section 4 above) may disclose these activities retroactively on
an annual basis. On the annual disclosure, an estimate of the continuation and frequency
of those activities for the next 12 months should be provided.
D. Clinicians who receive payment of any amount for outside activities with a Health
Care Vendor (or have an immediate family member who receives payment from a Health
Care Vendor:
(1) May not be involved in institutional decision-making related to the use of any product
or service (including in education, research or healthcare) provided to OHSU by that
Health Care Vendor; and
(2) Must certify in their CoI disclosure that any such payments are pursuant to a written
agreement between the Health Care Vendor and the Clinician that describes the specific
services provided, sets in advance compensation that reflects fair market value for the
services rendered, has a term of as least one year, and is not determined in a manner that
takes into account the volume or value of any referrals or other business generated
between the parties.
(3) For purposes of this policy, a Health Care Vendor is defined as any person or entity
that (a) produces, manufactures, distributes, provides or sells a health care related product
or service, including health care devices, implants, pharmaceutical products, or other
health care related products or services including inpatient, outpatient and physician
services; and (b) has a business relationship with OHSU (including purchasing or selling
items, goods or services to or from OHSU) or provides or receives patient referrals or
transfers to or from OHSU.
8. SPECIFIC DISCLOSURES ABOUT ACTIVITIES
The "Outside Activity Disclosure" shall contain sufficient documentation and detail to
allow the approving authority to make an informed decision regarding the
appropriateness of the activity. The disclosure form contained within the electronic
conflict of interest system must be used. The disclosure form will be electronically routed
for approval to the appropriate approving authority.
A copy of the proposed agreement between the employee and the outside organization or,
if the agreement is oral, a written summary may be required. However, information
subject to reasonable confidentiality agreements between the employee and the outside
organization may be redacted to honor the confidentiality requirements.
9. REVIEW AND APPROVAL OF DISCLOSURES
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Approving authorities shall promptly review disclosure statements appropriately
submitted to them. In determining the appropriateness of approving the related outside
activity, the approving authority shall evaluate:
A. Whether the related outside activity is, or could be, in conflict with the missions of the
University.
B. Whether the activity, alone or through cumulative effect, materially interferes with the
employee's ability to fulfill assigned duties to the University by:
(1) Requiring a substantial time commitment that materially detracts from the employee's
assigned work;
(2) Negatively impacting the needs of the employee's assigned unit/ department; or
(3) Detracting from the time allocation required by the employee's current FTE status.
C. The nature and extent of prospective benefits to the employee, the University and the
community.
D. Whether it can be assured that the outside activity will not have a negative impact on
students or interfere with the employee's instructional, research, and other related
institutional responsibilities.
E. The appropriateness of the proposed use of institutional facilities and support
personnel, including written documentation that the reasonable cost thereof will be
reimbursed to the University. Use of institutional facilities and support personnel must
comply with all other applicable OHSU policies.
F. Determining whether a management plan should be instituted to monitor the
employee's related outside activities and, if so, developing that plan with the employee.
A time commitment to related outside activities that materially interferes with the
employee's duties to the University shall ordinarily require a reduction in FTE status. A
reduction in FTE must be approved by the approving authority and may be approved only
if the reduction will not, in the judgment of the approving authority, be detrimental to the
unit the employee serves. Any subsequent increase in FTE must also be approved by the
approving authority and is dependent on verification that the time commitment to related
outside activities no longer materially interferes with the employee's duties to the
University, and adequate funding is available from institutional or other resources to
support the employee's salary.
10. APPEALS
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A. An employee (other than a Unit Leader) who disagrees with the decision of an
approving authority may appeal that decision in writing within twenty (20) calendar days
of the decision.
B. The appeal shall be directed to the Dean or Director in charge of the employee's unit.
The decision of the Dean or Director shall be final.
C. In circumstances where the Dean or Director was involved in making the original
decision, and the employee who disagrees is a faculty member, any appeal shall be
directed to the Provost. If the employee is not a faculty member, the appeal shall be
directed to the Chief Administrative Officer.
D. An officer to whom an appeal is made shall, within thirty (30) calendar days, reverse,
affirm or modify the decision. The officer may, at his or her discretion, appoint a panel of
three persons to review the issue and information and make recommendations regarding
the decision.
E. In a case where an appeal is to the Provost or Chief Administrative Officer, the appeal
shall be in writing only and only upon grounds of:
(1) Procedural irregularity that resulted in prejudice to the faculty member;
(2) New material information that could not have been presented to the Dean or Director;
or
(3) That the decision is in conflict with applicable laws, rules or OHSU policies.
The decision of the Provost or Chief Administrative Officer shall be final.
F. A Unit Leader who disagrees with the decision of the officer to whom he or she is
accountable may appeal that decision in writing to the President. The decision of the
President shall be final.
G. If the Unit Leader is appealing a decision originally made by the President, the Unit
Leader may appeal in writing to the Board but only upon grounds of:
(1) Procedural irregularity that resulted in prejudice to the Unit Leader;
(2) New material information that could not have been presented to the President; or
(3) The decision is in conflict with applicable laws, rules or OHSU policies.
11. RELATIONSHIP TO STATE LAW AND DISCIPLINE
OHSU employees are public officials subject to the Oregon law concerning conflict of
interest and ethics of public officials. Therefore, failure to observe this policy, in addition
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to subjecting an employee to standard institutional disciplinary actions including
withdrawal of the privilege to receive outside compensation, also subjects the employee
to potential sanctions by the Oregon Government Standards and Practices Commission.
12. EDUCATION AND AWARENESS
At initial hire, all OHSU directors, supervisors, managers and department administrators
or their designees are required to inform all employees in their areas about the content of
this policy and to provide them an opportunity for questions and answers. In addition,
Schools, units, divisions, and departments are required to provide annual reminders of the
policy to all employees. The OHSU Integrity Office will provide education and
reminders related to this policy and all other related policies upon request.
Background:
ORS 244.040
ORS 353.270
Related policies, procedures and forms:
Policy No. 01-50-001, Authority to Enter into Agreements
Policy No. 03-30-060, Terms and Conditions Relating to Faculty Clinicians
Policy No. 10-01-020, Conflicts of Interest
Policy No. 10-01-035, Conflicts of Interest in Research
Implementation date:
August 27, 2001
Revision dates:
October 11, 2001; February 20, 2002; December 23, 2002; July 11,
2006;January 1, 2009; April 16, 2010; August 21, 2012; March 13, 2013
Responsible office:
Integrity Office
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Requirements for Solicitation and
Acceptance of Gifts to OHSU
Policy No. 10-01-030
Effective Date: March 13, 2013
1. BACKGROUND
Acceptance of Institutional Gifts by OHSU from OHSU Vendors and others seeking a
business relationship with OHSU can compromise or appear to compromise the
obligation to act in the best interests of OHSU, OHSU patients, or OHSU research
subjects. Even if acceptance of an Institutional Gift meets the requirements of this policy,
if acceptance could inappropriately influence or appear to inappropriately influence a
decision to be made by OHSU, the Institutional Gift must not be accepted.
2. PURPOSE OF THIS POLICY
This policy establishes rules and guidelines for Institutional Gifts to OHSU departments,
divisions, schools, operational units, or any other sub-part of OHSU from a Vendor.
3. STATEMENT OF POLICY
Institutional Gifts (definition below) to OHSU (definition below) from Vendors
(definition below) may be accepted if all of the following conditions are met:
A. The Institutional Gift is for use in promoting one or more of OHSU's missions;
B. The OHSU Member (definition below) accepting or soliciting the Institutional Gift for
OHSU does not have sole fiscal, contracting, or decision-making authority to enter into a
business relationship with the Vendor for at least two years after receipt of the
Institutional Gift unless competitive procurement processes are followed in any
transactions leading up to creation of a business relationship;
C. If the Institutional Gift is a scholarship, educational fund, or sponsorship for all or a
portion of an educational event, it meets the requirements of Section 4; and
D. Those Institutional Gifts that fall within the definitions and conditions in OHSU
policies 03-30-040 (Foundations and Use of Gift, Grant and Contract Funds; Use of
Practice Related Revenue), 04-40-015 (Distinguishing Gifts from Grants, Contracts and
Other Sponsored Projects), and 12-01-015(5) (Foundation and Institutional Operational
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Procedures, Gifts, Accounts, Institution Support, Contracts) meet the requirements of
those policies.
4. SCHOLARSHIPS, EDUCATIONAL FUNDS, AND EDUCATIONAL
EVENTS
Industry support for the purpose of education, seminars, continuing education programs,
or similar events oriented toward the missions of OHSU must comply with all of the
following provisions:
A. The support is provided to OHSU as an Institutional Gift;
B. OHSU selects the OHSU Member(s) who receive or benefit from the support;
C. The recipient OHSU Member is not required or expected to provide something to the
donor in return for the support;
D. The OHSU School, department, or division accepting the support has determined that
the support has educational merit;
E. Any food provided at an educational event is paid for with funds provided to OHSU
and is not directly provided to OHSU Members by Vendors;
F. The event is compliant with applicable professional standards, such as ACCME, CME,
CDE, CNE, or similar professional standards related to continuing professional education
(regardless of whether or not formal CME, CDE, CNE, or similar credit is awarded);
G. Printed materials, announcements, and/or projected images serve a genuine
educational purpose and are not solely promotive of a Vendor or Vendor's products;
H. Token items containing the Vendor's logo(s) (pens, notepads, mugs, paper weights,
etc.) are not available or distributed at the session; and
I. Vendors with promotional informational materials are physically separated from the
educational or lecture space (e.g., next room, down the hall, or otherwise outside of the
meeting space).
5. DEFINITIONS
A.Institutional Gift: Something with financial value provided to OHSU or any of its subparts. Such gifts include monetary funds, scholarships, sponsorship of educational events,
textbooks, subscriptions, equipment, devices, and similar gifts of value in promoting one
or more of OHSU's missions.
B. OHSU: In the context of this policy, the term "OHSU" refers to OHSU as an
institution, its Schools, Units, Research Institutes, Hospitals and Clinics, Divisions, and
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Departments or their respective parts, sub-parts, or sub-units, but does not include the
OHSU Foundation or Doernbecher Foundation.
C. OHSU Member: As defined in Policy No. 01-01-000 excluding vendors while doing
business with OHSU, and OHSU Foundation and Doernbecher Children's Hospital
Foundation employees. Visiting healthcare practitioners and contracted non-permanent
individuals are also excluded if they do not have an OHSU appointment. Those with an
appointment at OHSU are included in this policy while serving in their OHSU role.
D. Vendor: An industry, business, or representative of same that currently has a business
relationship with OHSU or is seeking a business relationship with OHSU including, but
not limited to, a business that is selling products or services to OHSU or that is seeking to
sell products or services to OHSU.
6. MONITORING AND ENFORCEMENT
A. The OHSU Integrity Office (OIO) is responsible for enforcing and monitoring
compliance with this policy and, in coordination with the Legal Department, will serve as
a resource for implementing the policy.
B. OHSU Schools, departments, divisions, and units that receive industry funds totaling
greater than $100,000 in a fiscal year from any individual Vendor as Institutional Gifts
(excluding industry funds provided for research or other sponsored projects) must
provide an annual accounting of those funds to the OIO on a form approved by the OIO.
Schools, departments, divisions, or units may elect to provide this accounting as one
consolidated report. Records of Institutional Gifts received (other than research or other
sponsored project support) that do not meet the annual $100,000 threshold should be
maintained by the department or unit and should be available for review upon request.
C. The OIO will provide an annual summary report on Institutional Gifts reported in
section 6.B to executive leadership and the OHSU Board of Directors.
Background:
ORS 244.010 through 244.040
Related policies, procedures and forms:
Policy 03-30-040
Policy 04-40-015
Policy 12-01-015
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Implementation date:
December 23, 2002
Revision dates:
August 5, 2009; February 3, 2010; March 13, 2013
Responsible office:
Integrity Office
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OHSU HEALTHCARE
Policy # HC-MM-139-POL
Title:
Sample Medications
Effective Date: 6/10/2011
Category: Medication Management
Origination Date: 5/1997
Next Review Date: 6/10/2014
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PURPOSE:
This policy describes OHSU Healthcare’s position regarding use of sample medications.
PERSONS AFFECTED:
This policy applies to any member of the OHSU Healthcare workforce who may interact with a vendor distributing
sample medications or who may discover sample medications in the clinical setting.
POLICY:
OHSU Healthcare and faculty are prohibited from receiving and accepting supplies of sample medications from
pharmaceutical representatives for redistribution or dispensing. Pharmacy may dispense medications only.
DEFINITIONS:
1. Medications: includes prescription medications, sample medications, herbal remedies, vitamins, nutraceuticals,
over-the-counter drugs, vaccines, diagnostic and contrast agents used on or administered to persons to
diagnose, treat, or prevent disease or other abnormal conditions; radioactive medications; respiratory therapy
treatments; parenteral nutrition; blood derivatives; intravenous solutions (plain, with electrolytes and/or drugs);
and any product designated by the Food and Drug Administration (FDA) [http://www.fda.gov/ ] as a drug. The
definition of medication does not include enteral nutrition solutions (which are considered food products),
oxygen, and other medical gases.
2. Note: The FD&C Act defines drugs by their intended use, as "(A) articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease... and (B) articles (other than food) intended to affect the
structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].
3. National Drug Code (NDC) Number: The easiest discriminator to use in determining if a product is a drug is the
NDC number, which is part of the FDA approved labelling. If the bottle/box/tube has an NDC number on it, it is a
drug. If there is not one, then it is a cosmetic or food. For example, bottles of Lubriderm, Eucerin, Cetaphil and
White Petrolatum (generic Vaseline) in the OHSU Pharmacy all have NDC numbers and therefore are considered
medications.
4. National Drug Code Directory: The FDA searchable website [ http://www.fda.gov/cder/ndc/ ] for medications
used to determine if a product is a drug and obtain more information on a medication.
RESPONSIBILITIES:
It is the responsibility of OHSU Healthcare workers who may interface with vendors who distribute sample medications
or who may find sample medications in the clinical setting to comply with OHSU’s policy to not use sample medications
in the provision of patient care.
RELEVANT REFERENCES:
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


Joint Commission Standards, Medication Management
Food, Drug, and Cosmetic (FD&C) Act, sec. 201(g)(1) [http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm]
The National Drug Code Directory [http://www.fda.gov/cder/ndc/ ], Center for Drug Investigation and Research,
Food and Drug Administration (FDA)
RELATED DOCUMENTS/EXTERNAL LINKS:
Vendor Representative
TITLE, POLICY OWNER:
Pharmacy Services Director
APPROVING COMMITTEE(S):


Ambulatory Practice Committee
Medication Safety Committee
FINAL APPROVAL:
Medication Safety Committee
Supersedes: May 15, 1997; Reviewed 5/7/99; March 2001 Amb-Risk 6.02; August 20, 2001; March 4, 2004 formerly R&R
IV.15; September, 2007; 8/20/2009;
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OHSU HEALTHCARE
Policy # HC-LD-131-POL
Title:
Vendor Representative
Effective Date: 7/6/2010
Category: Leadership
Origination Date: 3/1998
Next Review Date: 7/6/2013
Pages 1 of 5
PURPOSE:
This policy provides rules concerning the business relationship between OHSU, its Vendors, and Vendor
Representatives.
PERSONS AFFECTED:
This policy applies to any OHSU Workforce Member in contact with Vendor Representatives accessing OHSU operating
sites.
POLICY:
By defining expectations for access and visitation to OHSU facilities and/or departments, members of the OHSU
workforce will have appropriate contact with Vendor Representatives. Appropriate access and visitation facilitates
OHSU Workforce Members to continue their assigned responsibilities while avoiding unwarranted, inappropriate, and
unnecessary visits by Vendor Representatives. It is essential that Vendor visits to OHSU comply with applicable laws and
regulations including, but not limited to, The Health Insurance Portability and Accountability Act (HIPAA), The Joint
Commission, Oregon laws, and other regulatory agencies.
DEFINITIONS:
1. Vendor: Any outside agency or company in the business of supplying products, devices, equipment, and/or
services that may be purchased for use by OHSU in performing clinical, research, education, or administrative
operations.
2. Vendor Representative: Any agent working for or on behalf of a Vendor.
3. Unescorted: Supervision is not required when accessing controlled or restricted areas in accordance with OHSU
policies (see listings at bottom). Additionally, unescorted access allows for non-fixed or unscheduled
appointments. The Transportation & Parking Customer Service Office will issue an OHSU access badge with
endorsement from the requesting OHSU department. See guidelines, Visiting Professors, Scientists & Other
Affiliates (OHSU Integrity Office), for example characteristics of unescorted visitor.
4. Escorted: Access is by appointment only and supervision is required at a level appropriate to the area/s to be
accessed in accordance with department procedures. Any visitor with a legitimate purpose can access common
areas without restrictions (e.g., waiting areas, lobbies, food service areas, etc.). See guidelines, Visiting
Professors, Scientists & Other Affiliates (OHSU Integrity Office), for example characteristics of escorted visitor.
5. Vendor Fair: An event on OHSU premises where a Vendor or several Vendors provide information related to
their products and/or services.
RESPONSIBILITIES:
PROCEDURES:
1. Visitor Badges and Patient Confidentiality Statement
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a. Vendor Representatives who wish to enter OHSU Hospitals and Clinics premises must first check in with
the Transportation and Parking Customer Service Center to obtain a dated visitor identification badge
and to sign the OHSU Statement of Confidentiality. The identification badge and the representative's
company-provided identification badge must be worn at all times while visiting OHSU. Representatives
will be given a copy of this policy with their identification badge.
b. OHSU Vendor badges may be issued by the Transportation and Parking Customer Service Center to
Vendor Representatives whose work is considered vital for daily operations (eg. maintenance,
contracted consultant). This request must be initiated and sponsored by an OHSU department and
approved by the Director of Public Safety. A Vendor Representative with an OHSU Vendor badge is
granted unescorted access in situations deemed vital to daily operations or after hours support. Vendor
badges will not be issued for greater than 30 days and must be re-evaluated for appropriateness by the
OHSU department requesting their service and the Director of Public Safety
c. Badges for Vendor Representatives of medication or medical devices whose composition contains
legend medications (ie, prescription medications), must be approved by the Director of Pharmacy or
their designee.
d. Vendor Representatives will not visit any area of the Hospitals and Clinics on the main OHSU campus
(including, but not limited to the Physician's Pavilion, Outpatient Clinic, Emma Jones Hall, Dillehunt Hall,
Multnomah Pavilion, Casey Eye Institute, Child Development and Rehabilitation Center, OHSU Hospital
South, Doernbecher Children's Hospital, and the Center for Health and Healing) unless registered for
each visit as above.
e. Vendor Representatives contacting individuals or departments without the appropriate identification
badge shall be informed of the policy and requested to proceed to the Transportation and Parking
Customer Service Center.
f. OHSU Logistics Center or Pharmacy should also be notified of Vendor Representatives who do not follow
the policy and process. Continued non-compliance with this policy and procedure by Vendor
Representatives will lead to verbal or written warning, restriction of visiting privileges, or, if necessary,
written proscription sent to the representative's company by OHSU Logistics Center or Pharmacy.
2. Parking
a. Vendor Representatives must have a scheduled appointment to visit any department and/or staff
member in OHSU Hospitals and Clinics and must sign-in at the designated area within the department
upon arrival.
b. Vendor Representatives wishing to park on campus may purchase a parking permit at the
Transportation and Parking Customer Service Center. Because of the critical shortage of patient and
employee parking, Vendor Representatives shall not park in patient, patient visitor, or metered spaces
3. Appointments and On-Site Expectations
a. Escorted Vendor Representatives require an appointment prior to arrival and activities are limited only
to scheduled appointments. Additionally, Vendor Representatives must sign-in at the designated area
within the department upon arrival.
b. Vendor Representatives for medications or medication devices with medications must first report to the
Pharmacy Administrative Office to sign the log to discuss who they are meeting with and what will be
discussed.
c. Vendor Representatives must visibly display a valid OHSU identification badge or day pass issued by the
Transportation & Parking Customer Service Center.
d. Department Director approval is required for Vendor displays, exhibits, and demonstrations in
conference rooms or entry ways to conference rooms. Adherence to the OHSU Gift policies (No. 10-0125 and No. 10-01-30) and guidelines posted on the OHSU Integrity Office’s Gifts and Conflicts of Interest
web page is required for these activities.
e. Vendors or Vendor Representatives may sponsor educational events and Vendor fairs at OHSU by
providing textbooks, printed material on formulary pharmaceuticals, or conference speakers, in
compliance with OHSU policies relating to these matters and only after signing an agreement that
stipulates compliance to those policies. Vendors may not distribute items that are solely promotional in
nature.
f. Vendor Representatives may not bring food or beverages to distribute on campus.
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4.
5.
6.
7.
8.
g. Vendor Representatives shall not attend meetings or conferences where information is presented that
could compromise patient care, research subject activities, or intellectual property confidentiality.
h. Vendor Representatives are prohibited from operating equipment or administering supplies, including
opening of sterile supplies, or otherwise participating in the delivery of direct patient care or human
subject interventions.
Solicitation of New Products
a. All uninvited or “cold” solicitations for devices, supplies and/or equipment must be directed to the Value
Analysis Department in OHSU’s Logistics Center for formal product review, approval and reporting on
ongoing status of solicited products.
b. All solicitations for new drugs, pharmaceuticals or pharmaceutical devices must be directed to the OHSU
Department of Pharmacy Services.
i. Vendor Representatives must respect the Pharmacy & Therapeutics Committee process for
evaluation of medications for addition to the formulary.
ii. Vendor Representatives may not complete formulary request forms.
iii. There are times when the Vendor Representative may need to advise on their product that has
already been approved and purchased or leased. The Vendor Representative must limit this
consultation and must solely advise on the specific product. He/she may not attempt to market
other products
Restricted Access and Patient Confidentiality
a. In order to enter a patient area, a Vendor Representative must have a signed a Confidentiality
Statement on file with the Customer Service Center, as required above.
b. Vendor Representatives are prohibited from entering any patient care area unless accompanied by an
OHSU employee. Vendor Representatives are only allowed in patient areas for a sanctioned purpose,
such as providing education on new products or devices, or by invitation to act as technical consultants
to the physicians and/or nursing staff. Vendor Representatives may not detail their products or services
for other purposes and/or in other locations than for the purpose and in the location for which the
Vendor Representative was scheduled.
c. Vendor Representatives shall not attend meetings or conferences where information that could violate
patient confidentiality is presented.
d. Vendor Representatives are prohibited from operating equipment or administering supplies, including
opening of sterile supplies, or otherwise participating in the delivery of direct patient care.
Conflicts of Interests
a. Vendor Representatives may not knowingly promote or actively sell products or services to OHSU
through an OHSU employee who is or whose immediate family member (spouse, domestic partner, or
dependent child) is related to the Vendor Representative or who may have a significant financial interest
with the Vendor as defined in the OHSU Conflict of Interest policy 10-01-020.
Endorsement of Vendor Products
a. Product or service information distributed by Vendor Representatives or OHSU departments must avoid
the implication or perception of endorsement by OHSU.
b. Vendors or OHSU departments that wish to endorse a particular product or service must seek approval
from the Vice President for Public Affairs and Marketing.
c. OHSU staff and employee statements may not be used for marketing purposes in brochures or
advertising without approval from the Vice President for Public Affairs and Marketing.
Evaluations
a. Evaluations of supplies and/or equipment are not permitted without the expressed approval of the a
Value Analysis Committee. Evaluations that take place without the permission of the a Value Analysis
Committee will be considered null and void.
b. OHSU may at its discretion ask Vendor Representatives to provide information and demonstrations of
their products. Such requests should not be construed as an evaluation or permission to begin an
evaluation without direct authorization of the a Value Analysis Committee.
c. All products and equipment represented to and/or sold to OHSU must meet all FDA regulations and
must have FDA 510(k) clearance; exceptions may be granted on a case-by-case basis for humanitarian or
palliative purposes as approved by the OHSU Medical Board, or with IRB approval.
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d. All medical equipment must be evaluated and safety-checked by the Clinical Technology Service
Department prior to delivery into a patient care area and prior to use in patient care.
e. All products and equipment represented to and/or sold to OHSU must meet all Federal, State, and Local
codes.
9. Other
a. Vendor Representatives may be subject to additional policies and procedures as may be promulgated by
Hospital and Clinics individual departments or committees.
10. Policy Violation Actions
a. Violations of this policy or any other OHSU policy will result in the following:
i. First violation: verbal and written warning sent to the vendor and vendor representative by
OHSU Logistics, Pharmacy, Integrity Office, or Public Safety.
ii. Second violation: suspension of OHSU visitation privileges for thirty (30) days and written
warning sent to the Vendor and Vendor Representative by OHSU Logistics, Pharmacy, Integrity
Office, or Public Safety.
iii. Third violation: permanent loss of visitation privileges at OHSU as a vendor representative.
b. The Director of Logistics, Pharmacy Services, or Public Safety or the Chief Integrity Officer may escalate
of violation actions at their discretion based on the severity the policy violation.
c. The Directors of OHSU Logistics, Pharmacy, or Public Safety and the OHSU Chief Integrity Officer (or
their delegates) have the right, at any time, to require a Vendor Representative to leave OHSU premises
immediately. Such circumstances may include, but are not limited to:
i. The conduct or health status of a Vendor Representative is determined to have a detrimental
effect on OHSU’s staff or patients or clinical, research, or educational operations;
ii. A Vendor Representative performed an act exposing OHSU to liability for personal injury or
property damage;
iii. A Vendor Representative violated OHSU’s rules, policies, or procedures.
11. Exceptions
a. Any exceptions to any part of this policy including escalation of violation actions may be made at the
discretion of the following representatives of OHSU, as appropriate:
i. Director of Logistics;
ii. Director of Pharmacy Services;
iii. Director of Public Safety;
iv. Value Analysis Committee;
v. Chief Integrity Officer.
RELEVANT REFERENCES:

Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices, p. 64093 "Guidance for Industry:
Industry-Supported Scientific and Educational Activities"
RELATED DOCUMENTS/EXTERNAL LINKS:







OHSU Policy: Chapter 1 - Administration: Solicitation, No. 01-10-020
OHSU Policy: CHAPTER 10 - CONFLICTS OF INTEREST AND COMMITMENT: GIFTS TO INSTITUTION, SCHOOLS,
UNITS, DIVISIONS, DEPARTMENTS AND PARTS, No. 10-01-030 3. Payment of Expenses for Seminars, Continuing
Education and Other Events
OHSU Formulary
Pharmacy and Therapeutics Committee Guidelines
OHSU Patient Confidentiality Statement
OHSU Notice of Privacy Practices:
Permitted Uses and Disclosures of Protected Health Information
TITLE, POLICY OWNER:
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Public Safety, Director
APPROVING COMMITTEE(S):



Value Analysis Committee
Public Safety
Pharmacy Services
FINAL APPROVAL:
Value Analysis Committee
Supersedes: 3/1988; 4/1998; 10/1998; 3/5/2001 Reviewed w/o edits; 10/15/2003;
Page 73 of 73