External Relationships and Conflicts of Interest

Philosophy/purpose

Relationships between Henry Ford Health System (HFHS) and Industry can support the mission, vision, and values of HFHS and its commitment to professionalism, patient care, education, research, and the communities served. However, HFHS workforce must at all times maintain their primary professional commitment and responsibility to HFHS. Any relationship between the HFHS workforce and industry that primarily serve to promote or market industry’s products or services are prohibited under this policy.

Opportunities for professional interactions with industry also present the potential for conflicting interests. The HFHS Policy on External Relationships establishes the guidelines for individuals to follow when considering such relationships, and the approval, review and reporting process. The HFHS workforce is expected to be transparent with regard to all external relationships. Transparency and timely disclosure is fundamental, since not every situation can be set forth in a policy statement.

Scope

This summary incorporates HFHS primary policy as well as its supplemental statement with regard to federally funded research.

All external business activities of the HFHS workforce are subject to the terms of this policy. Relationships are considered in the following categories:

• Financial Interests – ownership interests in external organizations including those that directly compete with HFHS.
• Governance - membership on governing bodies of external organizations, including those that do business with HFHS or are considered competitors.
• Financial Relationships - receiving compensation from any external organization doing business with HFHS or considered to be a competitor to HFHS.
• Any other interaction with industry that may create a potential conflict.

Education

Education regarding this policy is conducted through several means. Industry receives education through the Vendor Training program, Workforce members receive education upon hiring and in periodic updates, federally funded researchers also receive targeted education prior to the receipt of funding, and no less frequently than every 4 years.

Policy

Financial interests

HFHS workforce and their family members may not hold any financial interest in Competitor Health Care Organizations or Industry if such interest could in any way appear to influence their decision-making on behalf of HFHS.

Investments in publicly traded organizations are allowable up to an aggregate of 5% of the outstanding equity and based on terms available to the general public.

Investments in privately held organizations or competitors must be evaluated based on the specific facts and circumstances.

Financial interests with industry when the workforce member is the developer or principle owner pose particular issues. Care must be taken to:

• Comply with the HFHS Intellectual Property Policy.
• Maintain independence between the individual’s role within HFHS and role representing the external organization.
• Not utilize the individual’s role within HFHS to gain access to or influence any member of the workforce regarding the decision to utilize the subject product or services.
• Not utilize any HFHS resources to market or sell the product or services.
• Disclose the interest to the Conflict of Interest Panel and adhere to any established management plan.

The primary means of ensuring independence with regard to allowable financial interests is to require participants to abstain from related key decisions within HFHS.

Loans from competitor organizations or industry of either a personal or business nature are prohibited unless the organization is a commercial lending institution and all terms are based on prevailing market terms. Discounted purchases of goods or services from industry for personal use are only permitted if they are part of a bona-fide HFHS sponsored program.

Board memberships

Membership on boards of directors or advisory boards of any external organization is allowable under the condition that the individual obtain approval from their immediate supervisor and abstain from any decisions that may appear to adversely impact the interests of HFHS or any relationship between the organization and HFHS.

Membership on governing bodies of competitor health care organizations must be evaluated on a case by case basis. Paid memberships are considered external consulting and are subject to the guidelines of the applicable section below.

Financial relationships

Financial relationships between industry and HFHS workforce are allowable under certain circumstances.

• Presenters must have control over the content of work product and presentations and be able to incorporate their personal professional judgment.
• Sharing of results of research is not considered a restriction of content.
• Compensation or honoraria must be reasonable when considering the audience, topic, and expertise of the presenter and be paid for by the CME sponsoring organization. Industry funding can be given to the sponsoring CME organization but not directly to the HFHS member.
• Settings must be appropriate for the business being conducted.
• Non-presenting HFHS workforce may not be compensated solely to attend the industry meeting or industry-sponsored CME meeting.
• Arrangements must be in writing.

Financial arrangements between members of the workforce and industry that do not meet the applicable stated criteria may not be accepted. Much discussion has occurred with regard to industry funded speaker’s bureaus. Although these arrangements may take many forms, it is difficult for them to meet the criteria with regard to presenter control. Other than honoraria for CME, these relationships are not allowed. Exception will only be made based on appeal and favorable determination by the Conflict of Interest Panel.

Activities that are approved based on mutual benefit to the individual and to HFHS may be conducted during work hours. Otherwise the activity must be conducted during off hours or vacation time and cannot refer to HFHS and/or HFMG, and must not be supported by system resources.

Honoraria or compensation received in connection with all acceptable external financial relationships up to $25,000 in aggregate per annum (for each of the three categories described below and regardless if received from one or more sources) are to be approved by the individual’s supervisor or chair. Any payment resulting in the annual aggregate exceeding the above threshold is to be approved in advance by the applicable Chief Executive or Chief Operating Officer.

The categories in which acceptable external financial relationships are considered are as follows:

Education - Honoraria paid to the workforce for conducting education is acceptable to the extent the education meets ACGME standards and the activity is in support of a non-profit or educational organization (e.g., medical schools, grand rounds, invited lecturer for a specialty association, etc.). Payments for any other acceptable activity considered to be education but not meeting the above criteria are considered as “external consulting” under this policy. Members of the workforce may not personally accept honoraria from external sources for conducting education at any HFHS location or HFHS sponsored activity.

External consulting - Acceptable categories include a broad range of advisory and personal service relationships including compensated Board positions. The COI Panel is responsible for the assessment of the external consulting relationships. Individual business unit or departmental policies specify additional criteria with regard to acceptable external consulting and must be considered in conjunction with this policy.

Expert medical legal testimony - Members of the workforce may provide expert medical legal testimony as long as HFHS is not a named party to the litigation or in any known way stands to be adversely impacted by the outcome of the litigation.

Other interactions creating risks of conflict

Industry funding of HFHS CME is acceptable, but must be coordinated through the Department Chair, Vice President of Medical Education and the Director of CME. Such support must follow all ACGME accreditation criteria including the Standards for Commercial Support and must be disclosed to the participants prior to the start of the activity.

No gifts, of any type or amount, may be accepted by the HFHS workforce from industry. This includes, but is not limited to, companies currently engaged in or under consideration to do business with HFHS.

Industry funding of educational activities and research (including scholarships and fellowships) may be accepted if processed through the Chair, Vice President of Medical Education or Vice President of Research as appropriate.

Any type of meetings funded by the unrestricted grant must not include presentations by industry, and industry must not select the speakers or content of any presentation.

Funding of the cost of HFHS workforce attending lectures or conferences supported by an unrestricted grant is allowable. .

Industry Funding of programs designed to “educate” on clinical or medical practices within HFHS are considered to be payment for access and are not allowed under any circumstance.

Industry sponsorship of philanthropic activities of HFHS

All solicitation of industry for sponsorship must be conducted in accordance with standards established through the Office of Philanthropy to ensure that the philanthropic support is unrelated to any business relationship. Members of the workforce may accept invitations to be the guest of the sponsor at a philanthropic activity providing such invitations are infrequent, and the sponsor is in attendance; otherwise the invitation constitutes a gift. No contractual arrangements between HFHS and the sponsor may be currently under negotiation or anticipated to be under negotiation within a six-month period.

Participation in business meetings

The primary purpose of all business meetings between members of the workforce and industry must be to advance the business of HFHS. Whenever possible meetings should be held at HFHS facilities. Off-site meeting should be held only when absolutely necessary, be infrequent, and the location and any food provided must be reasonable and conducive to the business purpose.

Invitations from industry to attend activities that are predominantly of a social or entertainment nature may be accepted only if the actual fair market value associated with participation is personally paid by the workforce member.

Political activities

No HFHS resources may be used to induce action or bribe any public official, government employee, agency, or other organization either for the benefit of HFHS or the individual employee. Any efforts to influence legislation must comply with all applicable local, state, and/or federal laws and policies.

Disclosure and review requirements

The Audit and Compliance Committee of the HFHS Board of Trustees has delegated responsibility for this policy to the HFHS Chief Compliance Officer, who has established a Conflict of Interest Review Panel (COI Panel - Institutional Body). Certain job categories within HFHS, including those individuals with significant research roles are required to make regular and no less frequent than annual disclosures of relationships creating the potential for conflict of interest. All PHS funded researchers are responsible to update these disclosures with any significant changes.

The COI Panel oversees the review of all disclosure statements. With regard to federally funded researchers, all external relationships are presumed to be “related”. The COI Panel will ascertain if the external relationship creates a financial conflict of interest (FCOI) based upon its review of disclosed information, the structure of the research protocol and interviews with the involved researcher. When necessary the COI Panel will work with the researcher, the Office of Research Administration and other appropriate parties to establish a Management Plan (PHS funded research requires a Federal Management Plan ” FMP”).

All FMP’s shall be reported to appropriate PHS officials prior to the expenditure of any funds, within 60 days of identification of any qualified person newly participating in the research and within 60 days of any newly identified FCOI’s.

Sub-recipients shall provide certification of independent compliance with the regulations, including copies of any related FMP or shall agree to comply with the applicable HFHS policies and procedures.

The discovery of new factors or relationships may require a retrospective review. Such reviews will be completed no more than 120 days after identification of an event of non-compliance and should a FMP be necessary, the FCOI will be disclosed in all public presentations regarding the research as well as an addendum to any previously published information. The COI Panel shall also promptly notify the appropriate PHS official in the event of the determination of bias in any PHS funded research or any failure to comply with an FMP.

Maintenance of records

Minutes of the COI Panel shall document processes followed in evaluating all disclosure statements including those related to research programs and all such records and any resulting FMP’s shall be maintained for no less than 3 years.

Enforcement and remedies

All members of the workforce agree to comply with all elements of the policy on External Relationships. Failure to comply will result in progressive discipline as outlined in HFHS Human Resource Policies and as appropriate, evaluation under the HFHS policy on research misconduct.