Stanford School of Medicine

Policy and Guidelines for Interactions between the Stanford University School of Medicine, the Stanford Hospital and Clinics, and Lucile Packard Children's Hospital with the Pharmaceutical, Biotech, Medical Device, and Hospital and Research Equipment and Supplies Industries ("Industry")

Purpose of Policy

The purpose of this policy is to establish guidelines for interactions with industry representatives for medical staff, faculty, staff, students, and trainees of the Stanford School of Medicine, Stanford Hospital and Clinics and the Lucile Packard Children's Hospital. Interactions with industry occur in a variety of contexts, including marketing of new pharmaceutical products, medical devices, and research equipment and supplies on-site, on-site training of newly purchased devices, the development of new devices, educational support of medical students and trainees, and continuing medical education. Faculty and trainees also participate in interactions with industry off campus and in scholarly publications. Many aspects of these interactions are positive and important for promoting the educational, clinical and research missions of the Medical Center. However, these interactions must be ethical and cannot create conflicts of interest that could endanger patient safety, data integrity, the integrity of our education and training programs, or the reputation of either the faculty member or the institution.

Statement of Policy

It is the policy of the Stanford School of Medicine, Stanford Hospital and Clinics and the Lucile Packard Children's Hospital that interactions with industry should be conducted so as to avoid or minimize conflicts of interest. When conflicts of interest do arise they must be addressed appropriately, as described herein.

Scope of Policy

This policy incorporates the following types of interactions with industry. It does not include faculty research and related activities, which are included in the Stanford University Faculty Policy on Conflict of Commitment and Interest (http://www.stanford.edu/dept/DoR/rph/4-1.html).

  1. Gifts and compensation
  2. Site access by sales and marketing representatives
  3. Provision of scholarships and other educational funds to students and trainees
  4. Support for educational and other professional activities
  5. Disclosure of relationships with industry
  6. Training of students, trainees, and staff regarding potential conflict of interest in industry interactions
  1. Gifts and Compensation

    1. Personal gifts from industry may not be accepted anywhere at the Stanford School of Medicine, Stanford Hospital and Clinics, the Lucile Packard Children's Hospital, the Menlo Clinic or at any other clinical facility operated by either hospital, such as the LPCH Pediatric Unit at El Camino Hospital. In addition, Stanford faculty, staff and trainees may also not accept gifts at any non-Stanford-operated clinical facility such as other hospitals, outreach clinics and the like. Non-faculty medical staff are strongly discouraged from accepting gifts at non-Stanford-operated clinical facilities but are not proscribed by this policy from doing so.

      1. It is strongly advised that no form of personal gift from industry be accepted under any circumstances. Individuals should be aware of other applicable policies, such as the AMA Statement on Gifts to Physicians from Industry (http://www.ama-assn.org/ama/pub/category/4001.html) and the Accrediting Council for Continuing Medical Education Standards for Commercial Support (www.accme.org).

    2. Individuals may not accept gifts or compensation for listening to a sales talk by an industry representative.

    3. Individuals may not accept gifts or compensation for prescribing or changing a patient's prescription.

    4. Individuals must consciously and actively divorce clinical care decisions from any perceived or actual benefits expected from any company. It is unacceptable for patient care decisions to be influenced by the possibility of personal financial gain.

    5. Individuals may not accept compensation, including the defraying of costs, for simply attending a CME or other activity or conference (that is, if the individual is not speaking or otherwise actively participating or presenting at the event).

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  2. Site Access by Sales and Marketing Representatives
    1. Sales and marketing representatives are not permitted in any patient care areas except to provide in-service training on devices and other equipment and then only by appointment.

    2. Sales and marketing representatives are permitted in non-patient care areas by appointment only. Appointments will normally be made for such purposes as:
      1. In-service training of Stanford Hospital and Clinic or Lucile Packard Children's Hospital personnel for research or clinical equipment or devices already purchased.

      2. Evaluation of new purchases of equipment, devices, or related items.

    3. Appointments to obtain information about new drugs in the formulary will normally be issued by the hospital pharmacy or by Pharmaceutical and Therapeutics Committees.

    4. Appointments may be made on a per visit basis or as a standing appointment for a specified period of time, at the discretion of the faculty member, his or her division or department, or designated hospital personnel issuing the invitation and with the approval of appropriate hospital management.

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  3. Provision of Scholarships and Other Educational Funds to Students and Trainees
    1. 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:
      1. The School of Medicine department, program or division selects the student or trainee.

      2. The funds are provided to the department, program, or division and not directly to student or trainee.

      3. The department, program or division has determined that the funded conference or program has educational merit.

      4. 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."

    2. This provision may not apply to national or regional merit-based awards, which are considered on a case-by-case basis.

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  4. Support for Educational and Other Professional Activities

    1. Individuals should be aware of the ACCME Standards for Commercial Support. They provide useful guidelines for evaluating all forms of industry interaction, both on and off campus and including both Stanford- sponsored and other events. The Standards are appended to this policy and may be found at www.accme.org.

    2. All education events sponsored by the Stanford School of Medicine, Stanford Hospital and Clinics or the Lucile Packard Children's Hospital must be compliant with ACCME Standards for Commercial Support whether or not CME credit is awarded.

      1. Educational grants that are compliant with the ACCME Standards may be received from industry but must be administered by departments or divisions and not by individual faculty.

      2. Divisions and departments must maintain records of compliance with the ACCME Standards.

    3. Meals or other types of food directly funded by industry may not be provided at Stanford School of Medicine, Stanford Hospital and Clinics, the Lucile Packard Children's Hospital, or the Menlo Clinic.

    4. Faculty and medical staff should evaluate very carefully 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 provision does not apply to meetings of professional societies that may receive partial industry support, meetings governed by ACCME Standards, and the like.

    5. Individuals who actively participate in meetings and conferences supported in part or in whole by industry (e.g., by giving a lecture, organizing the meeting) should follow these guidelines:

      1. Financial support by industry is fully disclosed by the meeting sponsor.

      2. The meeting or lecture content is determined by the speaker and not the industrial sponsor.

      3. The lecturer is expected to provide a fair and balanced assessment of therapeutic options and to promote objective scientific and educational activities and discourse.

      4. The Stanford participant is not required by an industry sponsor to accept advice or services concerning speakers, content, etc., as a condition of the sponsor's contribution of funds or services.

      5. The lecturer makes clear that content reflects individual views and not the views of Stanford School of Medicine, Stanford Hospital and Clinics or the Lucile Packard Children's Hospital

      6. The use of the Stanford name in non-Stanford event is limited to the identification of the individual by his or her title and affiliation.

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  5. Disclosure of Relationships with Industry

    1. Individuals are prohibited from publishing articles under their own names that are written in whole or material part by industry employees.

    2. In scholarly publications, individuals must disclose their related financial interests in accordance with the International Committee of Medical Journal Editors (http://www.icmje.org).

    3. Faculty with supervisory responsibilities for students, residents, trainees or staff should ensure that the faculty's conflict or potential conflict of interest does not affect or appear to affect his or her supervision of the student, resident, trainee, or staff member.

    4. Individuals having a direct role making institutional decisions on equipment or drug procurement must disclose to the purchasing unit, prior to making any such decision, any financial interest they or their immediate family have in companies that might substantially benefit from the decision. Such financial interests could include equity ownership, compensated positions on advisory boards, a paid consultancy, or other forms of compensated relationship. They must also disclose any research or educational interest they or their department have that might substantially benefit from the decision. The purchasing unit will decide whether the individual must recuse him/herself from the purchasing decision.
      1. This provision excludes indirect ownership such as stock held through mutual funds.

      2. The term "immediate family" includes the individual's spouse or domestic partner or dependent children.

    5. For disclosure requirements related to educational activities, see the ACCME Standards for Commercial Support (www.accme.org).

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  6. Training of Students, Trainees, and Staff Regarding Potential Conflict of Interest in Interactions with Industry

    1. All students, residents, trainees, and staff shall receive training regarding potential conflicts of interest in interactions with industry.

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