Policy Recommendations Regarding Interactions With Industry
DRAFT
October 13, 2008
Definitions
"Conflict of Interest" (COI) involves a situation in which faculty, staff, or student employees have financial or other personal considerations that may compromise, or have the appearance of compromising, their professional judgment or integrity in teaching, clinical care, conducting or reporting research, or performing other University obligations.
(Adapted from UI Operations Manual; http://www.uiowa.edu/~our/opmanual/ii/18.htm )
"Conflict of Commitment" (COC) occurs when an employee engages in an outside activity that interferes, or appears to interfere, with fulfillment of the employee's obligations to the University, even if the outside activity is valuable to the University or contributes to the employee's professional development and competence.
(From UI Operations Manual; http://www.uiowa.edu/~our/opmanual/ii/18.htm ).
"Industry"is defined as any person or company seeking to do or doing business with University of Iowa Health Care or its employees or trainees, including any pharmaceutical, medical device, medical publishing, or medical equipment companies.
“Restricted Donor” is defined as an industry representative who seeks to do business with University of Iowa Health Care employees or trainees when the employee’s action or inaction can influence a decision-making process. (see Iowa Code §68B.2(24).
Purpose and Scope
This policy establishes guidelines for interactions with the health care industry for faculty (including adjunct faculty), fellow and resident physicians, all staff employed by UI Health Care and all of its student trainees. Associated entities include: all departments within The University of Iowa Roy J. and Lucille A. Carver College of Medicine (CCOM), University of Iowa Hospital and Clinics (UIHC), UI Physicians (UIP), UI – CMS, and the University of Iowa Children’s Hospital.
The Policy is intended to supersede existing departmental policies on COI and COC and it complements existing University of Iowa policies related to COI and COC. It provides additional specification for UI Health Care employees and students on issues related to unique complexities within our medical care, education and research endeavors. Individual departments within UI Health Care may choose to adopt more stringent boundaries or monitoring based on unique specialty-based circumstances or local faculty preferences.
Interactions with industry in an academic medical center may contribute to research, education, and patient care and some of these interactions may lead to important clinical and educational innovations. However, these interactions must be held to high ethical standards including complete transparency to ensure that they do not create unintended conflicts of interest or compromise the integrity of the institution’s mission. It should also be said that because academic physicians have allowed themselves to be exposed to the “profound influence from the pharmaceutical and medical device industries” (DeAngelis, JAMA 2008), we need to take seriously the possibility of unintentional bias in favor of industry that results from such interactions (Cain & Detsky, JAMA 2008).
UI Health Care has a professional responsibility to provide exceptional patient care, outstanding educational programming, and rigorous independent scientific inquiry – and to accomplish these missions with high ethical standards. To ensure the integrity of UI Health Care’s core missions, its interactions with industry must prevent conflicts of interest and avoid the appearance of such conflicts.
COC is another important component of this policy and is often closely linked to conflict of interest. The Task Force believes that the primary responsibility of faculty, staff, and trainees at UI Health Care is to participate in core missions of UI Health Care; the Task Force therefore believes that extramural activities that create conflicts of commitment should be disclosed (whether such conflicts occur inside or outside of official employment hours or during vacation.)
Methodology to Devise this Policy:
In October, 2007 a broadly representative Task Force was commissioned by the Vice-President for Medical Affairs to assess the content of existing University and departmental policies and to make recommendations for a new more comprehensive and improved policy for UI Health Care. In addition to review of local COI policies, the Task Force reviewed multiple publications in academic and lay press venues as well as recently adopted COI policies from other Academic Medical Centers. Extensive discussions were held among task force members and the resulting early drafts were vetted to faculty and Departmental Executive Officers, UIHC Director’s Staff, Dean’s Staff, as well as representatives from the various groups of trainees at UI Health Care.
Because of the wide range of issues related to conflicts of interest, the Task Force concluded that no single policy could address all relevant current or future practices. The Task Force believes that, in addition to providing specific guidance where feasible, UI Health Care should have a framework for ongoing institutional discussion and responses to questions about interactions with industry based on core institutional values. The Task Force offers the following Core Values and beliefs to help build such a framework.
- Decision-making about the core missions of UI Health Care - patient care, educational programming, and research activities – should be unfettered by relationships with industry and the conduct of UI Health Care employees and trainees should avoid even the appearance of COI.
- Gifting relationships – regardless of the size of the gift – are well documented to influence decision-making of the recipient. Since all gifting induces feelings of a need for reciprocity, even indirect gifts from industry (e.g. unrestricted educational grants) can invoke a gifting relationship where one should be avoided.
- Faculty and staff employment within UI Health Care is usually a full-time appointment and endeavor; it is therefore inappropriate to assume that reimbursed activities with industry ‘after hours’ or during ‘vacation time’ avoids any effect on an employee’s behavior and decision-making during an employee’s regular working hours.
- Faculty and staff who choose to engage in outside compensated professional activities must be able to document clearly what services were provided in return for compensation, and any potential COI and COC must be disclosed and managed. Outside activities should only be entered into if they improve patient care or contribute to the clinical and academic missions of UI Health Care.
- Complete avoidance of financial conflicts with industry can be accomplished only by eschewing financial ties with industry. Alternatively, any risk of conflicts may be minimized by full disclosure and adherence to the parameters of this policy. Full disclosure of potential conflicted relationships is critical, but disclosure alone does not eliminate COI or constitute its full management.
The content of this policy is organized according to domains of commonly cited challenges regarding relationships with industry. For each domain, we include a few bulleted statements to help judge the appropriateness of current or contemplated practices and provide a few action recommendations for our institutional leaders.
The major domains of COI addressed herein are:
- Gifting, in its many forms
- Industry Compensation
- Formulary Review & Purchasing Committees
- Site Access and Industry Displays
- Continuing Medical Education
- Research
- Publishing
- Transparency of Industry Ties
- Communication & Governance
I) Gifts
- Any gifts from industry directly to physicians, staff, or trainees are not allowed.
- Compensation for listening to marketing programs or attending hospitality events funded by industry is not allowed.
- Indirect gifts from industry (e.g. unrestricted educational grants) should be avoided. These gifts are only acceptable in those situations where an explicit and transparent process exists to minimize the potential for COI and is approved by the VPMA, or his designee.
A) Small Gifts
- Items exempt from the Iowa Gift Law (i.e. those under $3 in value) may not be accepted from industry representatives. Trinkets such as pens, post-its, coffee mugs, notepads, calendars, refrigerator magnets, etc are not allowed.
Action:
- Departmental leaders throughout UI Health Care should survey their clinical, educational, and research environments and ensure that all trinkets are removed from our facilities.
B) Meals
- Provision of ‘drug rep lunches’ (or other situations where industry representatives bring food into the institution) are not allowed for faculty, staff, or trainees.
- Meals from industry representatives – whether at local restaurants, national meetings, or elsewhere – cannot be accepted by UI Health Care faculty, staff, or trainees, consistent with the Iowa Gift Law.
C) Travel Stipends, Educational Scholarships, Visiting Professorships, and GME Stipends
- Industry funding for these items most often takes the form of ‘unrestricted educational grants’. Since these gifts are susceptible to COI, there must be an explicit and transparent process to minimize any perceived or real COI.
- These gifts might be permissible only if managed by the VPMA, or his designee, with monies going directly into an educational account and not directly to individuals, divisions, or departments.
- There must be explicit written agreements to accompany such interactions, including confirmation of the educational merit of these opportunities.
- Decision-making about who receives a stipend or scholarship must occur without any input from industry representatives. No quid pro quo can be required or expected from awardees. No stipend, scholarship, or professorship at UI Health Care can be labeled as an industry-sponsored award since that would directly connect industry with our physicians, staff members, or students.
- UI Health Care does not support using industry monies to fund stipends or benefits for Graduate Medical Education (GME). We recruit resident and fellow physicians to join educational programs that further professional capabilities through activities in patient care and research. Connecting this institutional core mission with a gift from industry would unnecessarily introduce a need for reciprocity and send ambiguous messages to trainees about appropriate interactions with industry.
Action:
- The VPMA should clarify how unrestricted educational grants will be managed in the future at UI Health Care. Consideration should be given to the creation of a new, centrally-controlled, educational foundation to manage all of these grants in order to avoid potential COI at the departmental level.
- Institutional leadership should continue to prohibit industry-funded resident physician stipends, including travel.
D) Medical or Educational Equipment, Supplies, Resources, or Programming
- UI Health Care discourages accepting gifts of equipment and materials from industry. In circumstances in which leaders of departments believe that gifts are unique and important to meet patient care, education, and/or research missions, a Written Letter of Agreement must accompany the gift to clarify the intention and to document that no quid quo pro is expected, and must be approved by the VPMA, or his designee. Obtaining equipment for patient care must also be vetted with institutional purchasing and/or procurement departments.
- Promotional industry logos are not acceptable on any gifted equipment and materials (e.g. anatomical models).
- Gifts of textbooks or medical journals may not be provided from industry representatives to individual faculty, staff, and trainees, or to their departments, divisions, or units.
- Faculty, staff, and trainees, and departments may only accept patient education materials from industry if the therapy involved has already been endorsed by the Pharmacy & Therapeutics or Product Review Committees and the material has been judged to provide educational benefit beyond what can be produced locally.
Action:
- Departmental leaders throughout UI Health Care should conduct an annual survey of any gifted equipment, supplies, or resources within their clinical, educational, and research environments and submit their findings to either the Dean’s or CEO’s Office. If indicated, documentation must include how and why their department is accepting these gifts for use in patient care, research or educational arenas.
E) Drug Samples
- The provision of drug samples is a significant component of pharmaceutical marketing efforts.
- Clinical care sites of UI Health Care will not distribute drug samples from industry.
- UI Health Care faculty, staff, and trainees should not seek or accept drug samples for personal or family use.
- Assisting patient application for compassionate release of a medication from a pharmaceutical company may be appropriate; these free drug access programs are distinct from the use of drug samples in clinics, and must follow institutional guidelines, policies, etc..
Action:
- UI Health Care leadership should audit the practices of outpatient clinics to ensure compliance.
II) INDUSTRY COMPENSATION
- Decisions about involvement in additional compensated professional activity should be governed by whether the activity contributes to the clinical and academic missions of the department and University.
- Employment at UI Health Care should be considered a full-time endeavor. Additional professional activities may distract an employee's attention from his/her UI Health Care responsibilities, even if that activity is only engaged after normal working hours or during vacation.
- It is inappropriate to assume that reimbursed activities with industry ‘after hours’ or during ‘vacation time’ avoids any effect on an employee’s behavior and decision-making during an employee’s regular working hours.
- “Individual physicians must be free of financial influences of pharmaceutical and medical device companies, including serving on speaker’s bureaus or accepting gifts.” (DeAngelis, JAMA 2008)
A) Consulting Expertise
- Consultative relationships between our faculty, staff, and trainees and industry may provide valuable avenues to speed development and dissemination of innovations.
- All consulting arrangements with industry (including scientific advisory boards, data safety monitoring boards, other advisory/scientific boards) must be accompanied by a time-limited contract that outlines specific deliverables, tasks, responsibilities, and compensation that is consistent with the expertise provided.
- Disclosure of consulting relationships must be fully transparent, including the amount of financial compensation received.
Action:
- The VPMA should monitor faculty, staff, and trainee consulting activities annually to ensure that (i) absenteeism is not impeding commitment to UI Health Care; (ii) disclosure of financial payments is complete and explicit; and (iii) the faculty/staff member is not involved in on-campus activities related to this external remuneration (e.g. serving on committees that make decisions about purchasing or selection of therapeutics for formularies.
- Although serving as an expert witness in legal matters is not the focus of this policy on COI and COC associated with industry interactions, this opportunity for outside professional compensation must also be disclosed and monitored.
- Formal consulting agreements should be reviewed by someone with expertise in the area involved, especially related to issues of publishing, future research, and ownership of intellectual property. All new consulting contracts should be pre-approved by the VPMA, or designee, as appropriate.
- Institutional leadership should encourage faculty, staff, and trainees to create UI Foundation Accounts in which they can deposit consulting fees and honoraria. The use of the monies in these accounts would be at the discretion of the individual employee and would be devoted to patient care, education, or research. Providing streamlined mechanisms for outside organizations to contribute monies directly into such accounts will help faculty and staff manage the potential for COI and COC that can arise from the subtle inducements associated with personal payments.
B) Honoraria
- Academic institutions and professional associations frequently offer honoraria to our faculty, staff, and trainees to recognize special additional effort to travel and make a scholarly presentation. All of these activities must be disclosed and monitored. Faculty may receive honoraria from other academic institutions, scientific organizations, government, or non-industry organizations up to a total annual compensation of $10,000 per year. Annual honoraria totals that exceed $10,000 will be reviewed in more detail.
- Faculty, staff, and trainees can not accept honoraria from industry, either directly or indirectly.
Action:
- The VPMA should review each faculty member’s annual outside professional compensation to ensure that frequent absences do not create a COC. Total time commitment, services provided, and level of compensation should be disclosed.
C) Industry Speakers’ Bureaus
- UI Health Care faculty, staff, and trainees may not participate on paid speakers’ bureaus as these arrangements are often promotional activities and are at high risk for COI or for presentations biased in favor of the for-profit company.
- Related participation on informal or loosely defined ‘advisory boards’ for additional compensation are not allowed since these activities are common marketing approaches and fall short of legitimate consulting relationships which require explicit contracts containing specific deliverables and responsibilities. Faculty, staff, and trainees who propose to participate in such activities must obtain permission from the VPMA, or his designee, beforehand
- Guest speakers from other institutions should conform to this policy; if they participate on paid speaker’s bureaus, another speaker should be invited or full disclosure - including financial compensation - must be submitted prior to their visit.
- Institutional leaders throughout UI Health Care must actively publicize that speaker’s bureaus are not allowed, and attestation of compliance within each department should be sent to the VPMA.
III) FORMULARY REVIEW & PURCHASING COMMITTEES
- Faculty, staff, and trainees are not eligible to participate in Pharmacy and Therapeutics or Product Evaluation Committee meetings if they have a personal financial relationship or funded research with a related pharmaceutical or medical device company that is being considered or discussed at that meeting.
- This ineligibility shall be in place for at least 5 years after the relationship with industry has ended.
- Decision-making regarding purchasing for pharmaceuticals, medical equipment, and devices is covered extensively in UIHC procurement policies.
- cf: http://www.uihealthcare.com/depts/procurementservices/vendorpolicy.pdf (UIHC Vendor Policy)
Action:
- Pharmacy & Therapeutics and Product Review, and Procurement Committees should review their current by-laws to ensure that they adequately address COI issues consistent with the specific details and core values of this Conflict of Interest policy.
IV) SITE ACCESS & INDUSTRY DISPLAYS
- Industry displays are not allowed in patient care areas.
- Vendor displays at UI Health Care continuing education events are discouraged. If industry displays are pursued at CME events, they must comply with ACCME Standards for Commercial Support and the UIHC Vendor Policy.
- Non-CME Departmental displays are allowed at the discretion of DEOs if they comply with the UIHC vendor policy.
- Further information on site access and displays is available at http://www.uihealthcare.com/depts/procurementservices/vendorpolicy.pdf
V) CONTINUING MEDICAL EDUCATION
- All CME activities sponsored by the Carver College of Medicine must be in compliance with ACCME regulations, requirements, standards, and guidelines.
- Continuing education efforts within other departments of UI Health Care (e.g. nursing, pharmacy, social services) are expected to adhere to expectations of their accrediting bodies and to the requirements of this policy.
- UI faculty, staff, and trainees are expected to respect the CME regulations (e.g. honoraria limits) at other institutions where they may be invited to make presentations.
Action:
- Currently, ~60% of UI Healthcare’s CME activities are funded by industry. Institutional leadership should develop alternative approaches to fund continuing education in order to reduce our heavy reliance on industry funding.
VI) RESEARCH
Action:
VII) PUBLISHING
- Faculty, staff, and trainee participation in ghost-written (or guest-written) articles is not allowed.
- Faculty, staff, and trainees cannot be included as an author on articles arising from multi-center research contracts if final data analysis, editorial, or approval rights are ceded to industry sponsors.
- Faculty, staff, and trainees should neither seek nor have authorship in an industry-sponsored research publication and a personal financial interest in the company.
- When submitting manuscripts, UI faculty, staff, and trainees must disclose all relevant financial interests to journal editors.
- Further information on appropriate publishing practices is contained in UI’s policy on COI in Research http://www.uiowa.edu/~our/opmanual/ii/18.htm#186
Action:
- The VPMA should include new educational interventions in faculty, staff, and trainee development activities regarding responsible publishing practices that can protect the institution and individual faculty from real or perceived COI.
VIII) TRANSPARENCY OF INDUSTRY TIES
- By adhering to our institution’s core values related to COI/COC and the specific requirements contained in this Policy, most activities at high risk for COI or COC will be avoided.
- Any potential for COI or COC must be explicitly managed. Full disclosure – including financial disclosure – of all industry relationships (e.g. consulting) must occur at least annually. Patents and Inventions are handled as per the UI Operations Manual. http://www.uiowa.edu/~our/opmanual/v/30.htm
Action:
- UI Health Care should create a master database that tracks all industry-related activities across all clinical, educational, and research missions. This database should also allow the reporting of all external activities in order to address potential conflict of commitment. It must be complete and easily interpreted as access to this database will likely be in the public domain.
- The VPMA should establish a new mechanism (e.g. Management Committee) to plan and implement educational interventions, and monitor and manage conflicted relationships or those at high potential for COI or COC.
IX) COMMUNICATION & GOVERNANCE
- The Vice-President for Medical Affairs, Dean of Carver College of Medicine, Chief Executive Officer of University Hospitals, and Departmental Executive Officials, and other leaders are responsible for dissemination, implementation, monitoring, and responding to questions and/or complaints regarding this policy.
- Education and compliance monitoring must occur.
Action:
- The VPMA should establish a COI/COC Management Committee to serve as a resource to DEOs and other institutional leaders. This Committee will address non-compliant faculty and the consequences of non-compliance.
- The VPMA should require web-based education on issues of COI & COC in general and about those specifically addressed in this policy. This education and compliance documentation should be required at least annually for all physicians, staff, and students.
