=20

= Site=20 Name

= =20

The External Relationships Disclosure Form must be = completed=20 by all eligible UI Health Care faculty and staff members. To access the = form, click=20 here.

F= requently=20 Asked Questions=20
Text=20 of the Conflict of Interest Policy=20
References:=20 Journal Articles and Other Links=20
View=20 UI Health Care Faculty and Staff Disclosures=20
= COI=20 Home

Contact Us

The policy is administered by the:
Conflict of Interest=20 Office
Joint Office for Compliance
University of = Iowa=20 Health Care
200 Hawkins Drive
Iowa City, Iowa=20 52242
319-384-5252
e-mail: coi@healthcare.uiowa.edu=20

Topics you will find covered in the Conflict of = Interest and=20 Conflict of Commitment Policy:

Conflict=20 of Commitment=20
Conflict=20 of Interest=20
Consulting=20 Expertise=20
Continuing=20 Medical Education=20
Drug=20 Samples=20
Educational=20 Scholarships=20
Expert=20 Witness Compensation=20
Formulary=20 Review and Purchasing Committees=20
Gifts=20
GME=20 Stipends=20
Honoraria/Speakers'=20 Bureau=20
Industry=20
Industry=20 Compensation=20
Meals=20
Medical=20 or Educational Equipment, Supplies, Resources, or Programming=20
Non-Clinical=20 Evaluation=20
Outside=20 Non-Professional Activities=20
Patient=20 Education Materials=20
Policy=20 Violations=20
Professional=20 Services and Affiliations=20
Publishing=20
Research=20
Site=20 Access and Industry Displays=20
Training=20 Assistance=20
Travel=20 Stipends=20
Visiting=20 Professorships=20
Who=20 Is Affected

The Policy

University of Iowa Health Care
Conflict of Interest and Conflict = of=20 Commitment Policy
Regarding Interactions with Industry

Date Approved: January 2009
Date Revised: March 2010
Date = Effective:=20 July 1, 2010
See a Summary=20 of Changes in the revised policy

Introduction

The success of University of Iowa Health Care depends on a talented = and=20 creative faculty and staff who earn regional, national and international = recognition for their contributions to teaching, research, clinical care = and the=20 advancement of their diverse clinical and scientific specialties. As a = result of=20 their expertise and experience, faculty and staff have opportunities to = engage=20 in professional activities with commercial entities, professional and = scientific=20 organizations and journals, as well as other universities and = governmental=20 agencies. Such activities can help faculty and staff develop their = knowledge and=20 skills; contribute to the growth and development of their area of = expertise;=20 enhance the academic and clinical missions of the department, college = and=20 university; and improve patient care. Participation in these activities = may also=20 create real and/or perceived conflicts of interest and conflicts of = commitment.=20 For the reasons outlined, University of Iowa Health Care must continue = to make=20 it possible for faculty and staff to advance teaching, service and = research=20 through collaborations with industry in a manner that avoids real or = perceived=20 conflicts of interest or commitment.

Definitions

"Conflict of Interest" (COI) involves a = situation in=20 which faculty, staff, or student employees have financial or other = personal=20 considerations that may compromise, or have the appearance of = compromising,=20 their professional judgment or integrity in teaching, clinical care, = conducting=20 or reporting research, or performing other University obligations. = (Adapted from=20 UI Operations Manual; http://www.uiowa.ed= u/~our/opmanual/ii/18.htm=20 )

"Conflict of Commitment" (COC) occurs when = an employee=20 engages in an outside activity that interferes, or appears to interfere, = with=20 fulfillment of the employee's obligations to the University, even if the = outside=20 activity is valuable to the University or contributes to the employee's=20 professional development and competence. (From UI Operations Manual; http://www.uiowa.ed= u/~our/opmanual/ii/18.htm=20 ).

"Industry" is defined as any = person or=20 company that produces health care goods and services, including any=20 pharmaceutical, medical device, medical publishing, or medical equipment = company. It also includes any person or company seeking to do or doing = business=20 with University of Iowa Health Care.

Purpose and Scope

This Policy establishes guidelines for = interactions with the health care industry and other opportunities for = outside=20 professional compensated activities. It applies to faculty (including = adjunct=20 faculty), fellow and resident physicians, all staff employed by UI = Health Care,=20 and all of its student trainees. Associated entities include all = departments=20 within The University of Iowa Roy J. and Lucille A. Carver College of = Medicine=20 (CCOM), University of Iowa Hospitals and Clinics (UIHC), UI Physicians = (UIP),=20 and the University of Iowa Children's Hospital.

The Policy is intended to supersede existing departmental policies on = COI and=20 COC and it complements existing University of Iowa policies related to = COI and=20 COC. It provides additional specifications for UI Health Care employees = and=20 students on issues related to unique complexities within our medical = care,=20 education and research endeavors. Individual departments within UI = Health Care=20 may choose to adopt more stringent boundaries or monitoring based on = unique=20 specialty-based circumstances or local faculty preferences.

Interactions with industry in an academic medical center may = contribute to=20 research, education, and patient care, and some of these interactions = may lead=20 to important clinical and educational innovations. However, these = interactions=20 must be held to high ethical standards including complete transparency = to ensure=20 that they do not create unintended conflicts of interest or compromise = the=20 integrity of the institution's mission. A growing body of literature = suggests=20 that because academic physicians have allowed themselves to be exposed = to=20 "profound influence from the pharmaceutical and medical device = industries"=20 (DeAngelis, JAMA 2008), academic medical centers need to take seriously = the=20 possibility of unintentional bias in favor of industry that results from = such=20 interactions (Cain & Detsky, JAMA 2008).

UI Health Care has a professional responsibility to provide = exceptional=20 patient care, outstanding educational programming, and rigorous = independent=20 scientific inquiry, and to accomplish these missions with high ethical=20 standards. To ensure the integrity of UI Health Care's core missions, = its=20 interactions with industry must prevent conflicts of interest as well as = avoid=20 the appearance of such conflicts.

COC is another important = component of=20 this policy and is often closely linked to conflict of interest. The = primary=20 responsibility of faculty, staff, and trainees at UI Health Care is to=20 participate in core missions of UI Health Care; extramural activities = that=20 create conflicts of commitment must be disclosed (whether such conflicts = occur=20 inside or outside of official employment hours or during vacation).

Disclosure

The relationship we have with our patients is in part a fiduciary=20 relationship. Patients trust us and rightly expect us to act in their = best=20 interest. Patients should be confident that decisions regarding their = care are=20 not influenced by the self-interest of their health care providers.

The following employees, if employed 50% time or greater, must = complete the=20 External Relationships Disclosure Form at least annually:

Faculty=20
Professional and Scientific Staff=20
SEIU Staff=20
Merit Exempt Staff

Additionally, the form must be updated on a quarterly basis, if = necessary, to=20 reflect any new relationships or changes to existing external = relationships.=20 Data from the disclosures will be published on a public web site. This=20 information is available at https://webapps1.healthcare.uiowa.edu/conflictofinterest/public/
=

Core Values:

Faculty and staff should be contributing to advances in teaching, = research=20 and clinical care and their clinical and research specialties. In some = instances, these advances will best be accomplished by collaboration = with=20 industry. The value of these efforts should be recognized by the = University=20 and the public.=20
Decision-making about the core missions of UI Health = Care=97patient care,=20 educational programming, and research activities=97should be = unfettered by=20 relationships with industry and the conduct of UI Health Care = employees and=20 trainees should avoid even the appearance of a COI. Patients, trainees = and the=20 public should be aware of this principle.=20
Gifting relationships=97regardless of the size of the gift=97are = well=20 documented to influence decision-making of the recipient. Since all = gifting=20 has the potential to induce feelings of a need for reciprocity, = faculty,=20 trainees and staff should not accept gifts from industry sources. = However,=20 unrestricted educational grants may be donated by industry to = department,=20 division or Foundation accounts.=20
Faculty and staff employment within UI Health Care is usually a = full-time=20 appointment and endeavor. Reimbursed activities with industry 'after = hours' or=20 during 'vacation time' have the potential to affect an employee's = behavior and=20 decision-making during an employee's regular working hours. The = conduct of UI=20 Health Care employees and trainees should avoid COI or the appearance = of COI.=20
Faculty and staff who choose to engage in outside compensated = professional=20 activities must be able to document clearly what services were = provided and=20 any compensation received. Any potential COI and COC must be disclosed = and=20 managed.=20
Complete avoidance of financial conflicts with industry can be=20 accomplished only by eschewing financial ties with industry. However, = the risk=20 of conflicts may be minimized by full disclosure and adherence to the=20 parameters of this policy. Full disclosure of potential conflicted=20 relationships is critical, but disclosure alone does not eliminate COI = or=20 constitute its full management.=20
In the course of their work as UI Health Care employees, faculty = and staff=20 may not refer anyone to outside businesses if the referral will = generate a=20 benefit to the employee.

I) Gifts

Faculty, staff, and trainees cannot accept any gifts from = industry.=20
Faculty, staff and trainees may not accept any compensation for = attending=20 marketing programs and cannot attend hospitality events funded by=20 industry.

A) Small Gifts

Gifts cannot be accepted from industry representatives, including = small=20 gifts that would otherwise be permissible under the Iowa Gift Law. = Accepting=20 trinkets such as pens, post-its, coffee mugs, notepads, calendars, and = refrigerator magnets is not allowed.

B) Meals

Faculty, staff, trainees, and departments or divisions cannot = accept food=20 provided at no cost by industry representatives. This includes both = meals=20 brought on-site and meals provided at local restaurants or national = meetings.=20
Meals, snacks, or refreshments at UI Health Care events are = allowable only=20 when purchased through a UI Health Care department, division, or = Foundation=20 account.

C) Travel, = Educational=20 Scholarships or Educational Events, Training, Visiting Professorships, = and GME=20 Stipends

Industry support for these items and events may only be provided = in the=20 form of unrestricted educational grants with monies going directly to = the UI=20 Foundation or into a department or division account. While requests = for=20 unrestricted grants and gifts may be directed in a specific area, they = should=20 be worded in general terms, e.g., "for trainee travel to meetings," = "for=20 trainee educational retreats" "for grand rounds speakers," "for = support of CME=20 activities," etc., clearly indicating that department, division, = and/or=20 individual recipients will be completely free of any industry = influence in all=20 of their decision-making relative to the disbursement of the = educational=20 grant.=20
Decision-making about who receives a stipend or scholarship must = occur=20 without any input from industry representatives. No quid pro quo can = be=20 required or expected from awardees.=20
No stipend, scholarship, or professorship at UI Health Care can be = labeled=20 as an industry-sponsored award without the approval of the = Departmental=20 Executive Officer and the VPMA/Conflict of Interest = Office.

D) Medical or = Educational=20 Equipment, Supplies, Resources, or Programming

A written Letter of Agreement must accompany gifts of equipment = and=20 materials from industry to clarify intent and to document that no quid = pro quo=20 is expected. The agreement must be approved by the Departmental = Executive=20 Officer (DEO) prior to being forwarded for approval to the = VPMA/Conflict of=20 Interest Office. Obtaining equipment for patient care must also be = vetted by=20 institutional purchasing and/or procurement departments.=20
Gifts of textbooks or medical journals cannot be accepted from = industry=20 representatives by individual faculty, staff, and trainees, or by = their=20 departments, divisions, or units.

E) = Patient=20 Education Materials

UI Health Care will accept for distribution to patients only those = industry-supplied patient education materials that relate to therapies = approved by the appropriate reviewing body, e.g., UIHC Pharmacy and=20 Therapeutics Subcommittee.=20
Marketing materials cannot be accepted for distribution to = patients.=20

F) Drug = Samples

Industry-supplied drug samples and vouchers cannot be accepted or=20 distributed to patients at UI Health Care.=20
UI Health Care faculty, staff, and trainees cannot seek or accept=20 industry-supplied drug samples for personal or family use.=20
UI Health Care staff may assist patients in applying for = pharmaceutical=20 companies' assistance programs.

G) Training = Assistance

Off-site training on new equipment or devices cannot be provided = at=20 industry expense unless the training is specifically included in the = contract=20 under which the equipment or device is acquired.=20
Industry representatives providing on-site training or assistance = must=20 comply with applicable policies regarding vendor representative = presence in=20 the hospital and operating rooms.=20
Training activities must be clearly differentiated from sales = activities.=20

II) Professional Services = and=20 Professional Affiliations

Outside professional service activities are a normal expectation = of=20 employees at an academic medical center. Participation in, and receipt = of=20 compensation for, these activities is allowed and generally does not = require=20 disclosure.=20
The following activities generally do not require = disclosure:
(1)=20 Holding office in, or undertaking an editorial office or duties for a=20 scholarly journal, academic press, or professional organization =
(2)=20 Serving as a referee for a scholarly journal or an academic press =
(3)=20 Serving on a professional review board or peer review bodies
(4) = Attending=20 or presenting at events sponsored by professional organizations or = academic=20 institutions, such as professional meetings, workshops, colloquia, = symposia,=20 seminars, or training programs
(5) Visiting other sites in = connection with=20 accreditation, audits, sponsored project reviews, or like activities =

III) Outside=20 Non-Professional Activities

Participation in outside non-professional activities generally = does not=20 require disclosure unless the time devoted to them interferes with the = employee's University obligations.

IV) Compensation for = Serving as=20 an Expert Witness

Although serving as an expert witness in legal matters is not the = focus of=20 this policy on COI and COC associated with industry interactions, this = outside=20 professional compensation must also be disclosed and monitored. =

V) Industry = Compensation

Consultative relationships between faculty, staff, and trainees = and=20 industry may provide valuable avenues to speed development and = dissemination=20 of innovations.

A) = Consulting=20 Expertise

All consulting arrangements with industry (including, but not = limited to,=20 scientific advisory boards, data safety monitoring boards, other=20 advisory/scientific boards, product evaluation/development) must be=20 accompanied by a time-limited contract or letter of = invitation/agreement that=20 outlines specific deliverables, tasks, responsibilities, and = compensation that=20 is consistent with the expertise provided.=20
All consulting agreements must be submitted to the Departmental = Executive=20 Officer prior to being forwarded to the VPMA/Conflict of Interest = Office for=20 review and approval prior to execution.=20
Consulting agreements that involve the assignment of intellectual = property=20 rights must comply with the University of Iowa Intellectual Property = Policy:=20 http://www.uiowa.edu= /~our/opmanual/v/30.htm=20
Disclosure of consulting relationships must be fully transparent = and=20 documented, including the amount of financial compensation received. =

B) Speaking = and Training=20 for Industry

UI Health Care faculty, staff, and trainees may not participate on = industry speakers' bureaus.=20
Participation on informal or loosely defined 'advisory boards' = must comply=20 with the requirements for consulting agreements.=20
Faculty, staff, and trainees who provide training and/or = educational=20 presentations for industry, Medical Education Communication Companies = (MECCs),=20 or similar commercial enterprises must comply with the requirements = for=20 consulting agreements. Presentations or training in which the primary = purpose=20 is to promote company products is prohibited.=20
Content of training or educational presentations must be = controlled by the=20 trainer/educator and must be the original work of the = trainer/educator.=20

C) Attendance at Industry-Sponsored Events

UI Health Care faculty, staff, and trainees cannot accept any form = of=20 compensation (e.g., travel expenses, lodging, meals, or gifts) = directly from=20 industry, MECCs, or similar commercial enterprises for attending a=20 professional meeting or conference.=20
Educational or promotional programs developed by industry = representatives,=20 MECCs, or similar commercial entities are not allowed at a UI Health = Care=20 event, whether the event is held within or outside of UI Health Care=20 facilities.=20
All outside speakers must disclose to the audience any relevant=20 relationships they have with industry prior to their presentation. =

VI) Formulary Review and = Purchasing=20 Committees

Faculty, staff, and trainees are not eligible to participate in = Pharmacy=20 and Therapeutics or Product Evaluation Committee meetings if they or = members=20 of their immediate family have, or have had within the prior 5 years, = a=20 personal financial relationship or funded research with a related=20 pharmaceutical or medical device company that is being considered or = discussed=20 at that meeting.

VII) Site Access and Industry = Displays

Industry displays must meet the following requirements:
o = Compliance=20 with the UIHC Vendor Policy (e.g., not displayed in patient = areas);
o=20 Permission from the DEO;
o Compliance with the Accreditation = Council for=20 Continuing Medical Education (ACCME) standards if the event is a CME=20 program
Further information on site access and displays is available at http://www.uihealthcare.com/depts/procurementservices/vendorpolicy= .pdf=20

VIII) Continuing Medical Education

All CME activities sponsored by the Carver College of Medicine = must be in=20 compliance with ACCME regulations, requirements, standards, and = guidelines.=20
Educational grants for CME events must be accompanied by a Written = Agreement of Commercial Support signed prior to the event by a = representative=20 of the College and a representative of the Company providing the = Grant.=20
Continuing education efforts within other departments of UI Health = Care=20 (e.g. nursing, pharmacy, social services) are expected to adhere to=20 expectations of their accrediting bodies and to the requirements of = this=20 Policy.=20
UI faculty, staff, and trainees are expected to comply with the = CME=20 regulations (e.g. honoraria limits) at other institutions where they = may be=20 invited to make presentations.

IX) Research

Conflict of interest in research is governed by the University of = Iowa's=20 Policy on Conflicts of Commitment and Interest, Operations Manual = II-18.6. http://www.uiowa.ed= u/~our/opmanual/ii/18.htm=20
Research-related travel expenses to investigator meetings prior or = subsequent to the establishment of a research contract may be paid for = by=20 industry.

X) Basic = Research/Non-Clinical=20 Product Evaluation

All gifting rules and regulations apply to basic/non-clinical = research=20 except where noted below.=20
No gifts/donations of any value that are personal in nature (e.g., = coffee=20 mugs, calendars, tee shirts, food, etc.) may be received.=20
A vendor may donate laboratory consumables for evaluation purposes = only by=20 completing the Prod= uct=20 Donation Form available from the UI Purchasing Department.=20
Donations exceeding $5,000 (vendor list price or equivalent) must = receive=20 prior approval from UI Purchasing by completing the Prod= uct=20 Donation Form and returning the form to the Purchasing Department = prior to=20 making the donation.=20
A vendor can offer promotional discounts, but gifts of a personal = nature=20 (e.g., gift cards, tee shirts, etc.) cannot be included with the = promotion.=20

XI) Publishing

Faculty, staff, and trainees cannot participate in ghost = authorship. Ghost=20 authorship is the failure to name, as an author, an individual who has = made=20 substantial contributions to a scientific manuscript.=20
When submitting manuscripts, UI Health Care faculty, staff, and = trainees=20 must disclose all relevant financial interests to journal editors.=20
Further information on appropriate publishing practices is = contained in=20 UI's policy on COI in Research http://www.uiow= a.edu/~our/opmanual/ii/18.htm#186

XII) Policy Violations

Any UI Health Care employee who violates this policy is subject to = disciplinary action in accordance with University policy. =

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