Conflict of Interest: The term “Conflict of Interest” (COI) refers to situations in which financial, professional, or other personal considerations may compromise, or may have the appearance of compromising an individual’s professional judgment in exercising NJH duties and responsibilities. A COI arises when a Covered Individual or NJH has a direct or indirect interest in an organization doing business with NJH. Many types and degrees of interest may create a conflict, for example: Financial Interest in a vendor—including employment with a vendor—and/or the prospect of professional advancement or financial or business reward in any form.
Consulting: The situation wherein a Covered Individual spends any time or effort in assisting, advising, and/or in any way facilitating the mission or enterprise of any kind of company, whether or not there is compensation or other considerations and whether or not the Consulting is done on the Covered Individual’s own time.
Controlled Entity: A for profit entity, publicly traded or not, in which the Covered Individual and/or an Immediate Family member has a material ownership position. Material ownership is considered to be an estimated 5 percent or greater ownership and/or management influence through Board representation, advisory role, and/or similar role. A Controlled Entity is considered to be a Significant Financial Interest.
Covered Individual: Includes, but is not limited to, NJH faculty (employed or otherwise), research staff, management staff, all other staff and their immediate families, and affiliates who spend a majority of their time at NJH. Individuals who are employed by other institutions (such as the University of Colorado) (“third parties”) but work at NJH must complete a COI declaration for the third party and provide a copy of COI declaration for such third party to the NJH CCO.
Corporate Compliance Committee (CCC): A group of NJH senior executives, directors, faculty, other staff, and/or lay individuals selected by the CEO and/or CCO to review actual or potential COI, that may be either individual or institutional, and make recommendations to resolve or manage a COI.
Corporate Compliance Officer (CCO): An individual appointed by the NJH CEO to oversee and manage all issues of individual or corporate compliance, including COIs. The NJH CEO has appointed the EVP and Chief Operating Officer (COO) of NJH as the CCO.
Equity Interest: Includes, but is not limited to, stock, stock options, warrants, and ownership rights in any entity whether or not the entity is publicly traded. An Equity Interest in a publicly traded corporation will not be considered a Financial Interest if the Equity Interest exists through ownership of shares in a publicly traded mutual fund. A Financial Interest of the Covered Individual’s Immediate Family is considered to be a Financial Interest of the Covered Individual.
External Activity Review Form: The form shown in Exhibit C of this policy used by faculty and staff when required to request review and approval of external agreement and presentations.
Financial Interest: Anything of financial or monetary value that is associated either directly or indirectly with an activity that is directly related to a Covered Individual’s responsibilities to NJH. Financial or monetary value includes, but is not limited to compensation, consulting fees, honoraria, Equity Interest, intellectual property rights, royalties, Gifts, gifts in kind, or forgiveness of debts. Certain economic benefits are excluded, including: salary, royalties, or other funding provided through NJH; income from academic activities, such as speaking, teaching engagements for non profit entities; fees for participating in advisory roles for other non profit entities; and direct grant support for the research project being undertaken. A Financial Interest of the Covered Individual’s Immediate Family is considered to be a Financial Interest of the Covered Individual.
Gifts: Refers to anything that is transferred from one individual or entity to another without the expectation of receiving something in return. Gifts do not include charitable donations as referenced in Section 12 of this policy. In the context of this policy Gifts include both Gifts from patients and Gifts from third parties’ representatives. Examples of Gifts would include, but are not limited to meals/food, free CME, free registration to events, sporting events tickets, pens, coffee mugs, instruments, and supplies. Generally, modest meals or financial support sponsored by third parties provided for on campus activities in association with in-service training for non-physician staff is acceptable.
Immediate Family: Includes the Covered Individual’s spouse, children, parents, and siblings, including the spouses of any of them.
Industry: Refers to any vendor or potential vendor, or contractor who sells, or may sell products or services to the public and/or to NJH. This refers to, but is not necessarily limited to, pharmaceutical manufacturers, medical device manufacturers, and medical and laboratory suppliers, contractors or consultants.
Management Plan: A plan set forth by the Chief Compliance Officer, the Compliance Committee or Institutional Review Board (IRB) containing conditions that the Covered Individual must follow to ensure that the Conflict of Interest does not jeopardize the integrity of NJH.
Presentation Review Committee: A committee of NJH faculty and administration charged with review and approval of all externally sponsored or compensated presentations by faculty and staff to insure the presentations conform to NJH COI policy guidelines.
Significant Financial Interest: Is a financial interest that could directly and significantly affect the design, conduct, or reporting of Public Health Service funded (NIH) research or industry sponsored research. Generally this is defined as a financial interest of $5,000 or more in an entity involved with PHS-funded research. A Significant Financial Interest (SFI) exists when the economic value of compensation, consulting fees, honoraria, intellectual property rights, non NJH related royalties, or services and/or gifts in kind exceed $5,000 per year from a single for-profit entity or an Equity Interest, or the lesser of $5,000 and/or 5 percent ownership.
COI can occur in many situations. The guidelines described below are principles which faculty and staff are obligated to follow.
Industry and Business Relationships
When Covered Individuals have a Financial Interest in a business, such as an owner, board member, executive or employee they must be aware that a COI may occur if the business has a relationship with or is a competitor of NJH. If the organization does business, is considering doing business, or is a competitor with NJH, the individual is expected to disclose that relationship.
- NJH faculty, students, and trainees may accept free drug samples from industry for distribution to patients, only when the free samples are provided directly to the NJH pharmacy. All distribution of free samples to patients must be administered by the NJH pharmacy.
- Free drug samples may never be sold.
- Free drug samples may not be used by clinicians for themselves, clinical faculty, family members, or NJH employees unless they are registered patients of NJH.
Site Access by Pharmaceutical Representatives
Vendor representatives from pharmaceutical, biotechnology or other industries may visit NJH faculty and staff to discuss and demonstrate their products. While generally acceptable as straightforward sales visits, an appointment is highly encouraged (See Vendor Visit Policy – Procurement). Visits with faculty and staff in clinical areas are generally discouraged and vendors are not allowed in clinical areas unless escorted by NJH staff. Vendors may not access any patient-specific information (See HIPAA policy).
Participation in Industry-Sponsored Programs: Presentations Sponsored by Industry (Speakers Bureaus) and Industry Support of Educational Programs
Educational Program Support
Vendors and other industry representatives may provide unrestricted funds to departments or divisions at NJH for education programs. The funds will be managed according to the following NJH standards:
- All support for educational programs must be free of actual or perceived COI (individuals and institutional).
- All such funds must be given to NJH as an unrestricted grant or Gift. The funds cannot be given to an individual faculty member, student or staff. This requirement applies to all funds for meals and refreshments, speaker’s honoraria, and any other expense related to an educational program and includes noon conferences, grand rounds, and lectures at all NJH sites. Funds that are provided by educational groups or other entities that act as “intermediaries” for associations, professional societies, or industry must also be provided as unrestricted grants.
- No gifts may be accepted in exchange for listening to a lecture or presentation by a representative of a commercial entity that produces health care or medical goods and services.
- The content of all educational programs will be determined by the NJH department planning the event or when appropriate the Continuing Medical Education (CME) department. Industry sponsors of educational programs may not determine the content or selection of speakers for educational programs.
- These requirements do not apply to meetings governed by the Accreditation Council for Continuing Medical Education (ACCME) Standards or meetings of professional societies or other professional organizations that may receive partial industry support.
Presentations and Speakers Bureaus
Presentations or speaker’s bureaus are defined as any compensation to an individual by any pharmaceutical company, medical device manufacturer, or manufacturer of other health or nutritional related products, or their subsidiaries, for presenting or speaking on that company’s behalf whether on a one-time or recurring basis.
NJH faculty and staff are prohibited from making presentations that are sponsored by industry as defined in the above paragraph unless the presentation is prepared and presented within specified guidelines and with appropriate institutional approval.
Talks on scientific discovery, research, clinical presentation of disease, disease recognition and treatment guidelines are permitted. Talks focused on specific products or devices, or talks that contain sales or marketing promotional information are prohibited. The NJH Presentation Review Committee shall review and approve the format and content of all outside presentations where sponsorship or compensation is provided to the speaker by industry. This includes slide-based talks and non-slide based forums. Non-slide based presentations/ talks include such forums as guided panel discussions and open question and answer forums.
This speaker’s bureau policy does not preclude faculty members from receiving compensation from academic institutions when paid for by the institution, or presentation of Grand Rounds. If these events are industry sponsored the above guidelines apply.
Consulting and service on Scientific Advisory Boards, and compensation for those services, are not prohibited by this policy.
Individuals who speak in meetings and conferences supported in part or in whole by industry (e.g., by giving a lecture, organizing the meeting) must follow these guidelines:
- Financial support by industry is fully disclosed to the audience by the speaker and the meeting sponsor.
- The meeting or lecture content is determined by the speaker and not the industry sponsor and preapproved by the NJH Presentation Review Committee. Industry sponsors may work in collaboration with NJH in developing materials (slides) for non-marketing, non-promotional educational faculty presentations. Outside industry sponsors may help support the development of these non-promotional, non-branded presentation materials and their support may be acknowledged during the presentation. Industry sponsors shall not be permitted to provide product or device marketing, sales, or promotional materials before or after presentations. Procedures for obtaining review of contracts and speaking engagement are found in Exhibits B and C of this policy.
- An NJH Presentation Review Committee shall review and approve the format and content of all outside talks, including associated AV materials, which are compensated by industry.
- The lecturer is expected to provide a fair and balanced assessment of therapeutic options and promote objective scientific and educational activities and discourse.
- Product or sales promotional talks are prohibited.
- The NJH participant must not be required by an industry sponsor to accept advice or services concerning speaker, content, etc. as a condition of the sponsor’s contribution of funds or services.
- Compensation for services shall be at fair market value. Fair market value is the generally accepted contract rate for speaking as shall be determined through NJH review of speaking engagement contracts.
- The use of the NJH name in non-NJH events is limited to the identification of the individual by his or her title and affiliation.
NJH faculty, trainees, or staff may not accept compensation, including the defraying of costs, for simply attending a CME program or other activity or conference (that is, if the individual is not speaking or otherwise actively participating or presenting at the event). Faculty, trainees, and staff should very carefully evaluate their own participation in meetings and conferences that are fully or partially sponsored or run by industry because of the high potential for perceived or real conflict of interest. This paragraph does not apply to meetings of professional societies that may receive partial industry support and meetings governed by ACCME Standards.
Industry-Sponsored Scholarships and Other Educational Funds for Trainees
Industry support of students and trainees should be free of any actual or perceived conflict of interest, must be specifically for the purpose of education and must comply with all of the following provisions:
- NJH Department, Division, or Program selects the student or trainee.
- The funds are provided to NJH and not directly to the student or trainee.
- The Department, Division or Program has determined that the funded conference or program has educational merit.
- The recipient is not subject to any implicit or explicit expectation of providing something in return for the support, i.e., a “quid pro quo”.
This provision shall not apply to national or regional merit-based awards, which are considered on a case-by-case basis.
NJH personnel shall not accept or use personal gifts or gratuities from representatives of Industry regardless of the nature or dollar value of the gift whether on-campus or off-campus, or accept complimentary tickets to sporting or other events, or other hospitality from Industry, except as noted in section 7 below. Exceptions to this policy are events organized and sponsored by NJH and other non-profit organizations for the purposes of fundraising (e.g., Beaux Arts Ball), or professional society meetings. All charitable gifts to NJH must be approved by the NJH Finance department before being accepted.
Industry wishing to make charitable contributions to NJH may contact the NJH Development Department. Such contributions shall be subject to any applicable policies maintained by NJH.
Meals or other types of food directly funded or supplied by industry may not be provided at NJH events, on or off campus, unless in connection with an ACCME-accredited program and in compliance with ACCME guidelines. Modestly priced meals/food in the context of legitimate business meetings or non-commercial scientific meetings are an exception to these guidelines as are modest food/meals provided by established vendors to non-physician staff in the course of in-service training or business operations.
Individuals are prohibited from publishing articles under their own names that are written in whole or material part by industry employees. See NJH policy on Guidelines for Authorship (Ghostwriting).
NJH faculty, trainees, and employees who are involved in the purchase of, or approval of, medications, supplies or equipment, or the negotiation of other purchasing decisions or contractual relationships with industry must not have any Financial Interest (e.g., equity ownership, compensated positions on advisory boards, a paid consultancy or other forms of compensated relationship) in the vendor that might benefit from the institutional decision. This provision is not intended to preclude an employee’s indirect ownership, through mutual funds or other investment vehicles.
NJH Faculty, Trainees and Employees must disclose their actual and potential conflicts of interest related to any institutional deliberations and generally may participate in deliberations in which he or she has an actual or potential conflict of interest if they have unique knowledge of the products’ merits and demerits and if the conflict is disclosed both to the Corporate Compliance Officer and to the manager in charge of the purchasing recommendation or decision making.
Outside Speakers Sponsored by Industry
Presentations by outside speakers sponsored by the pharmaceutical or device manufacturing industry are allowed at events sponsored by NJH (whether on NJH campus or off-campus) as long as (A) the speaker discloses his/her sponsorship by the industry sponsor; (B) the talk is not a promotional talk designed to market any particular product or device; and (C) the industry sponsor does not display any promotional, sales or marketing materials before or after the event.
No Product Endorsements
Because of real or perceived personal and/or institutional COI associated with product endorsements, faculty and staff are prohibited from publicly endorsing any consumer product, service, or device. This is not meant to prohibit any physician from expressing his or her individual opinion and preferences to their patients, or endorsing methods of treatment (e.g. classes of drugs for certain conditions, or types of testing for diagnostic purposes) as long as no specific product is publicly endorsed. NJH Committee approved speaking formats and contents that might include product references are not considered product endorsement under this policy.
Grants and Other Charitable Donations
Health care professionals may accept donations to the institution for a charitable purpose, such as supporting independent research or training for the advancement of medical science or education, indigent care, patient education public education, or the sponsorship of events where proceeds are intended for charitable purposes. To protect the charitable status and nature of the donation, such gifts must be made only to NJH, and not to the individual.
All donations should be appropriately documented and must be preapproved by the finance department prior to acceptance if there are any conditions or restrictions on the use or purpose of the donation.
It is not appropriate for healthcare professionals to accept donations for the purpose of inducing health care professionals to purchase, lease, recommend, use, or arrange for the purchase, lease or prescription of products. No grants, scholarships, subsidies, support, consulting contracts, educational or practice-related items should be provided or accepted by a healthcare professional in exchange for prescribing products or for a commitment to continue prescribing products. Nothing should be accepted or provided in a manner or on conditions that would interfere with the independence of a healthcare provider.
Research Guidelines and Requirements
As a medical research institution, NJH has experienced ever increasing opportunities to collaborate with private industry in sponsorship of research. While collaboration most often results in the advancement of science, the application of new technologies and enhanced patient care, it can raise troublesome COIs for those engaged in research. In order to maintain its reputation, it is critical that NJH apply its high ethical standards to the identification and resolution of these COIs as they arise. Examples of situations in which a COI may arise that need to be reported and COI s that would generally require a management plan are outlined in Exhibit A to this policy.
Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and Industry COIs.
NJH values and requires the expertise of faculty with research and scientific experience to review grant applications related to human subjects’ research and animal research that are supported through both Federal and industry grants.
NJH faculty who receive industry financial support (e.g., receive compensation for speaking engagements, participate on scientific advisory boards, or on other industry boards, receive industry grants, or other services for compensation) have a real or perceived conflict of interest in fairly and impartially adjudicating industry sponsored research from an entity from whom they receive compensation, regardless of the amount.
Faculty members participating on any IRB or the IACUC must disclose their conflict of interest to the IRB or IACUC and recuse themselves from any deliberations and decisions related to any research protocol sponsored by a company with whom they receive compensation or have a Financial Interest.
Institutional Conflict of Interest
NJH itself can have interests in the outcome of research. This can arise because of actual or potential Financial Interests, intellectual property rights, or potential future grants or otherwise. Disclosure of Institutional COI will be required by any NJH employee as they become known. The CEO can delegate the investigation and management plan of the actual or potential COI to an appropriate individual. When there is such a conflict, the decision about how to handle it should be made by a group appointed by the CEO including members of the Board of Directors and individuals outside of NJH.
Conflicts of Commitment
Another type of conflict is Conflict of Commitment (COC). A conflict of commitment occurs when an executive, faculty member, manager, or employee participates in activities, whether or not they enhance their knowledge and skills for their NJH position, that interfere with the individual’s responsibilities in meeting their job responsibilities at NJH. It is the policy of NJH that all full-time staff and employees devote their primary professional loyalty, time, and energy to their position at NJH. External activities should be conducted in a manner that will not discredit NJH, distract individuals from their primary responsibilities at NJH, or compromise intellectual property owned by NJH.
Faculty who do not accrue vacation must consider external activity time as time away from their NJH responsibilities and as time that does not count toward the expectation of work on behalf of NJH.
Activities of other staff and employees that could create a conflict of commitment should be disclosed as described in this policy and discussed with the staff member’s supervisor to ensure they won’t cause a conflict of commitment.
This policy is not meant to prohibit employment outside NJH by any employee as long as no COI exists; the activity meets the above guidelines, and is conducted outside of NJH compensated time.
Mandatory Industry Contract Review
All contracts between NJH faculty and staff and outside industry must be reviewed and approved by the Grants and Contracts Department, the Purchasing Department, the Chief Financial Officer (CFO) or Chief Operating Officer (COO) before being signed. NJH CFO and COO shall review the language and obligations of the agreements to insure that the terms are consistent with NJH conflict of interest policies, conflict of commitment policies, and meet basic legal guidelines. Procedures for obtaining contract review are found in Appendices B and C of this policy.
Contracts requiring review and approval include, but are not limited to, the following type of agreements.
- Non-disclosure agreements
- Material transfer agreement
- Research agreements
- Presentation and speaking agreements
- Consulting agreements
- Scientific Advisory Committee or Board of Director Agreements or Appointments for for- profit companies.
- U.S. or Foreign Patent Applications
Disclosure and Implementation Policy
- It is the responsibility of all staff to consider the potential effect a conflict of any kind might have on their ability to carry out their job responsibilities. All manner of relationships should be considered, including such clear cut issues such as financial interests in an NJH vendor, relatives employed by an NJH vendor, and other relationships that might suggest something other than an arm’s length business relationship. Because the perception of COI may vary from one individual to another, employees and staff should disclose all real and potential COIs which could be deemed by others to be significant.
- An annual disclosure statement will be required of all NJH officers, Board members, directors, faculty, and employees. Covered Individuals are obligated to update this form promptly as potential conflicts arise. To complete the form, click on this link: Conflict of Interest Declarations on the NJH Spyderweb. Every Covered Individual must complete a COI Declaration form, providing specific information regarding the Covered Individual’s relationships with individuals or entities that could pose a possible COI. This declaration must identify the specific relationship and the nature of the relationship. In the event that the covered individual is employed by an affiliated organization (University of Colorado, Howard Hughes), the individual may provide NJH with a copy of the conflict of interest disclosure completed for his or her direct employer in lieu of completing a COI Declaration on the NJH platform. Each Covered Individual shall complete a Conflict of Interest Declaration promptly following the event by which he/she becomes subject to this policy.
- Certain economic benefits are excluded from these reporting requirements, including: salary or other compensation paid by NJH; income for academic activities, such as speaking or teaching engagements at other non profit entities; fees for participating in advisory roles for other non profit entities; direct grant support received by NJH for the research project being undertaken; and Equity Interest in the sponsoring entity that has been acquired through a publicly traded mutual fund.
- All Financial Interests must be disclosed so that they can be addressed.
- Applicants for IRB approval must file a statement of changes in their COI since the last filing.
- The Covered Individual will not be expected to make the determination of whether or not an actual COI exists. That decision will reside with the CCO. The CCO may request additional information pertinent to the potential conflict from the Covered Individual. The CCO may use the CCC in a consultative manner to help determine if a COI exists and what, if any, plan of correction or management needs to be implemented.
- Communications regarding disclosures and determinations of COI shall be held in confidence unless the COI policy itself calls for notice to certain people or to the public.
- Because this COI policy cannot describe all potential COIs by specific provisions all Covered Individuals should seek advice on transactions or activities that present a potential COI or issues of confidentiality before committing to them. Questions concerning this COI policy should be addressed to the CCO, CFO or CEO.
CCO – Management of Conflicts
The Corporate Compliance Officer (CCO) shall review each COI declaration in which actual or potential conflicts are identified, and if it is determined that a COI exists, the CCO will decide how it might best be managed. The CCO will determine that one or more of the following courses of action will be required:
- Nothing needs to be done, since a COI does not exist or is insignificant.
- With suitable constraints and cross checks, the relationship or project should be permitted to proceed as planned.
- The conflicting Financial Interests involved are divested or the relationships that created the COI are severed.
- The reporting individual should be removed from any involvement with the activity.
- CCO may convene the Corporate Compliance Committee (CCC) to review specific conflicts and assist in the development of a COI management plan.
- A COI on occasion may be so significant that the only recourse to resolve the conflict may be termination of the individual’s employment with NJH.
Consequences of Failure to Comply
All Covered Individuals shall promptly complete their annual COI Declaration Form by the date specified by the CCO. Individuals who fail to complete their COI forms in a timely manner shall be subject to loss or reduction of their annual merit increases. Assigned reviewers who fail to complete their reviews by specified deadlines shall be subject to loss or reduction of their merit increases. Faculty members who fail to complete their COI forms in a timely manner will be subject to loss or reduction of departmental bonus.
Failure to file a Conflict of Interest Declaration or omission or misrepresentation of the facts in COI disclosures will be considered a violation of NJH policy and may result in disciplinary action or fines at the discretion of the CCO or CEO including any of the actions described below.
Staff disciplinary actions may include:
- Reduction or loss of merit pay
- Reduction or loss of incentive compensation
- Termination of employment
Faculty disciplinary actions may include:
- Reduction or loss of bonus
- Fines depending on the degree and frequency of the policy violation:
- The lesser of $10,000 or 10% of base salary.
- The lesser of $20,000 or 20% of base salary.
- Loss of Faculty Privileges and/or Termination of Employment
To ensure and maintain the public trust, all NJH faculty and staff are encouraged to divulge any actual or potential COI they have to patients, professional colleagues, and in public forums where the COI is relevant to the context of the public forum (for example - speaking engagements or publications).
NJH will disclose industry relationships on its public faculty profile web pages. These faculty disclosures shall be updated at least annually.
Colorado Department of Regulatory Agencies (DORA) Reporting Requirements and Michael Skolnik Medical Transparency Act of 2010
The Michael Skolnik Medical Transparency Act, administered by DORA, requires all individuals applying for the following licensure types (new or renewal licensure) to complete on-line profiles. Information about DORA requirement and be found on the DORA web site or through the NJH Medical Staff office. Beginning July 1, 2011 the following licensure applications and renewal types are subject to this requirement.
- Hearing Aid Providers
- Dental Hygiene
- Physician Assistant
- Direct-Entry Midwifery
- Practical Nursing
- Professional Nursing
- Advanced Practice Nursing
- Physical Therapy
- Social Work
- Marriage and Family Therapy
- Professional Counseling
- Addiction Counseling
- Registered Psychotherapy
COI Policy Exceptions
Exceptions to this Conflict of Interest and Commitment Policy should be rare and can only be made by the CCO or CEO.