Graduate Medical Education

Conduct, Integrity, Corporate Responsibilities (CR)

Policy #:

AD.CR.040

Applies To:

All MCW Employees, Residents, Trainees

PURPOSE

This policy has been approved by the President and the Board of Trustees for the Medical College of Wisconsin. The purpose of this policy is to establish standards for interactions with health care product industry representatives for MCW Covered Personnel. Interactions with industry occur in a variety of contexts through the promotion of the educational, clinical and research missions of the College. However, at times these interactions may also create conflicts of interest, improper influence on decision-making, or the appearance of impropriety. Recent research indicates that industry activities such as the provision of gifts may affect health care provider behavior and decisions. MCW believes that this policy will enhance positive and constructive working relationships with industry and minimize questions about improper influence of sales and marketing activities at the College. Our goal is to raise awareness among Covered Personnel of the challenges to professionalism and to help them build critical evaluation skills that reinforce high individual standards, norms and behaviors.

DEFINITIONS

The following definitions are used for the purposes of this policy.

• Compensation provided by Industry: Compensation shall mean remuneration or consideration provided directly to a Covered Person for services they provide to Industry.
   
• Covered Person or Personnel (also referred to as Person or Personnel): The scope of this policy includes all classes of individuals identified within this definition, unless specifically identified by category within the applicable provision. This policy is intended to include but is not limited to all paid Faculty, Staff Physicians, Residents, Students, Post-Doctoral Fellows, Executives and Officers, Exempt and Non-Exempt Staff.
   
• Gifts provided by Industry: Gifts shall be defined as any item(s) of value received by a Covered Person or made for the benefit of a Covered Person, for which the recipient has not paid fair market value or was not earned through the provision of services, and which are not otherwise available to the public at large on the same basis. Gifts shall also include free drug samples, meals, and equipment or other items which may be used in the course of the Covered Person’s work if such items are provided to the individual. Gifts do not include:
  • Competitive grants.
  • Informational materials that have been produced under the Accreditation Council for Continuing Medical Education (ACCME) guidelines or published under a peer review process,
     
  • Donations made directly to MCW which provide a benefit to the College.
    
    For further clarification on Gifts see MCW policy Conflicts of Interest, Outside Professional Activities and Consulting (AD.CR.030).
     

• Health Care Products Industry or Industry: Any organization or person that has an interest in selling clinical products or services related to the health care work being done at any MCW location. This shall include but not be limited to: pharmaceutical companies, device manufacturers, health care service or provider organizations, research sponsors, health care information system developers, etc. Industry shall not include any non-profit, professional society, where such organization takes appropriate measures to ensure that its organization and activities are free from commercial influence, or litigation firms seeking to retain an individual for litigation purposes.
   
• MCW Location: This shall be defined as premises which are owned, controlled or leased by MCW.
   

POLICY

MCW has Covered Persons working at multiple locations throughout Wisconsin. This policy shall apply to all MCW Covered Persons regardless of where they work. In places which are not an MCW Location, it is expected that Covered Personnel will comply with the terms of this policy as the minimum standard of expected behavior. Additionally, if that site has rules which are more restrictive on the issues covered in this policy, it is expected the Covered Person will comply with those requirements as well.

1. Gifts to Individuals: Gifts from Industry may not be accepted by any Covered Person at any time. Examples of gifts include free drug samples, textbooks, equipment, meals, travel costs, or monetary payment.
    
2. Donations to the College: Under certain circumstances, donations of certain equipment or other items of value may be made to MCW by Industry. However, these gifts must be evaluated and approved on behalf of the institution before they may be accepted. Donations to MCW should be referred to the following locations for approval:
   1. CME Sponsorship: Under certain circumstances, MCW may accept financial support provided to a College-wide, departmental or divisional educational event or program. Donations of this nature must be reviewed and accepted as outlined under Section 4 below.
       
   2. Pharmaceutical Donations: MCW may accept samples of pharmaceuticals for use in MCW clinics or clinical research ventures provided the appropriate following donation standards are met.
      1. Donations may be accepted by any Medical Director or delegate.
      2. Pharmaceutical sample donations must be cataloged and/or tracked.  The tracking sheets must be retained for a minimum of 6 months for audit purposes.
   3. Equipment Donations: Research or clinical equipment may be donated to MCW at the request of the receiving department and with the approval of the Compliance Office.
       
   4. Educational training grants: Grants for the promotion of education among trainees, students, post-doctoral fellows, or residents may be provided by contacting the appropriate central educational office which may include: Academic Affairs, the Graduate School, Graduate Medical Education or the Office of Post-Doctoral Fellows. Grants funding the establishment of a permanent training position within a particular division must be reviewed by the Office of Faculty Affairs.  The Corporate Compliance Office shall approve all unrestricted educational grants.
       
   5. Other donations: Other donations may be made by contacting the Corporate Compliance Office.
       
3. Site Access: The requirements of this section are intended to apply to Industry representatives coming to MCW for the purposes of selling or marketing clinical products. The restrictions below are not intended to limit individuals coming in to repair or maintain equipment already purchased by MCW or for some other legitimate business purpose.
   1. Clinical Areas: Sales and marketing representatives from pharmaceutical Industry are not permitted in any clinical (patient care) areas. Device Industry representatives are not permitted in clinical areas except to provide in-service training on devices and other equipment already purchased, to provide demonstrations that may be of benefit to patients where no purchase is required, or to provide necessary technical advice involving the use of devices or equipment. These kinds of appointments may be scheduled in advance.  If necessary due to an urgent patient care situation (or) to assist with the device insertion or use and consent has been obtained from the patient, then no appointment or additional permission is necessary.
       
   2. Non-Clinical Areas: Sales and marketing representatives from Industry are permitted in non-clinical areas by appointment only for the limited purpose of in-service training of personnel for equipment already purchased or for the evaluation of new equipment or pharmaceuticals for possible purchase or education.
       
   3. Scheduling Industry Representatives: When an Industry representative is scheduled to be on-site, the faculty member interested in the training or product evaluation or education is responsible for scheduling the representative and must ensure the following standards are met:
      1. The Industry Representative is supervised while in the designated location and leaves after the particular purpose has been completed.
          
      2. The Industry Representative may not be allowed access to Covered Personnel or their mail boxes or other sources of information distribution outside of the scheduled meeting time. This prohibits the release of electronic email addresses or other contact information as well.
          
      3. It is the responsibility of the faculty member scheduling the Industry representative to ensure he/she has the appropriate credentials to perform the education or training requested.
          
   4. Food: With the exception of food provided in connection with ACCME-accredited programming and in compliance with ACCME guidelines, Industry may not provide food at any MCW Location.
       
   5. Students and Trainees: Students and trainees should only be involved in programs with Industry Representatives for educational purposes and when such program is conducted under the supervision of a faculty member.
       
4. Continuing Medical Education, Professional Meetings & Industry Events:
   1. ACCME Standards: All events that receive Industry support and that are sponsored by the College, a department or a division of MCW must be conducted in a manner compliant with the ACCME standards, whether or not CME credit is awarded. This includes not only educational events, but also other professional activities such as faculty meetings, regardless of where such events occur.
       
   2. Departmental Coordination: Industry sponsored donations to support educational programming may not be accepted or managed by an individual. Such contributions must be managed by the department or division.  The Corporate Compliance Office shall approve all unrestricted educational grants.  Non-approved or inappropriate funds will be returned to the Industry sponsor.  Appropriate records of the use of such funds must be kept in accordance with Sponsored Programs procedures and meet the ACCME standards.
       
   3. Industry Prohibitions: With the exception of food provided during ACCME-accredited programs, Industry representatives may not provide meals, goods or monetary donations, or the direct or indirect funding of such, for attendance at any educational or professional activity at any MCW-affiliated location. Covered Persons are strongly encouraged not to accept food at any location under any circumstances (with the exception of food provided during ACCME-accredited programs).
       
   4. Industry Program Participation: Covered Persons should only participate in Industry sponsored programs, meetings or conferences if the following standards are met:
      1. The educational program is ACCME accredited.  ACCME accreditation is limited to the United States of America.  Therefore, this standard does not apply to events outside the country.
          
      2. Covered Persons do not accept Compensation for attending an Industry-sponsored meeting.
          
      3. Covered Persons do not accept personal Gifts at such events, with the exception of food provided during ACCME-accredited programs.
          
      4. Covered Persons receive fair market value for any services they provide related to such an event. Such services must then be disclosed under Section 6 below.
          
      5. Any presentation made by a Covered Person must be the result of his/her own work and is not allowed to be authored by Industry.
          
   5. Industry Sponsorship of Professional Societies: Covered Persons may be officers on professional Societies that receive Industry support as long as Industry does not have influence or control on the content of the meetings or lectures.  Professional Society activities do not need to be compliant with ACCME standards in order for Covered Persons to attend these activities.
       
   6. Industry Sponsorship of Education of Trainees, Students, Residents or Post-Doctoral Fellows: Industry may provide financial support for the educational benefit of trainees, students, residents or post-doctoral fellows provided such funds comply with the following requirements:
      1. Such funds are held by a central authority within the department or division providing oversight to such trainee, student or resident;
          
      2. The MCW department or division determines which individual receives the educational support and how such funds are to be expended.
          
      3. There is no expectation of any quid pro quo or direct benefit being provided to the Industry sponsor in return for their funding.
          
5. Travel: Covered Persons are prohibited from accepting direct reimbursement of travel funds from industry, other than for legitimate reimbursement for contractual services and associated expenses, including required training and educational events specific to a current clinical trial.
    
6. Disclosure: Covered Persons are expected to make full disclosure concerning any Industry relationships pursuant to the procedure outlined below.

PROCEDURE

REPORTING:
The procedure below is set forth to explain the process by which Covered Personnel must report participation in Industry sponsored events or interactions. The goal of reporting is to create transparency in an individual’s activities, as they may relate to the work performed in the course of their employment.

1. Publications: Covered Persons must disclose their financial interests associated with Industry in relation to scholarly publications.
    
2. Conflict of Interest: Covered Persons must file all appropriate disclosures as required under MCW policy Conflicts of Interest, Outside Professional Activities and Consulting (AD.CR.030) and pursuant to the Financial Conflicts of Interest in Research Policy (RS.GN.020).
    
3. Failure to comply with this policy, to make complete disclosure, or to comply with timely filing of the required reporting requirements may constitute grounds for termination or any other penalties which may be assessed under other College policies, procedures or the faculty handbook.

For any questions concerning the content of this policy or the reporting requirements please contact the Corporate Compliance Office for clarification.

REFERENCES

Conflicts of Interest, Outside Professional Activities and Consulting (AD.CR.030)
Financial Conflicts of Interest in Research Policy (RS.GN.020)
ACCME Standards for Commercial Support

ATTACHMENTS

Health Care Industry Product Interactions Policy - Frequently Asked Questions
Health Care Industry Product Interactions Policy - Summary Document 
Annual Certificate Disclosure Form

Effective Date:

03/01/2009

Revision History:

04/01/2009, 10/01/2009, 10/11/2011

Supersedes Policy:

N/A

Review Date:

N/A

Approved By:

/S/ John R. Raymond, Sr. MD, President and CEO
Medical College of Wisconsin