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GUIDELINES REGARDING GIFTS FROM INDUSTRY TO SUPPORT
EDUCATIONAL PROGRAMS

Executive Summary

These Guidelines apply to gifts to BWH and MGH to support educational programs. They do not apply to gifts to support research programs or research training.

Educational gifts to BWH and MGH must be processed through the BWH or MGH Development Office except for the following, which can be processed through the office of the appropriate Service/Department Chief or Division/Unit Chief:

• Food/beverages (or funds to purchase food/beverages) for educational lectures with a value of less than $20 per expected attendee and $5000 in aggregate;<.li>
  
  
• Funds to be used to pay reasonable stipends to and reimburse reasonable travel expenses for speakers at educational lectures sponsored by BWH or MGH in an amount less than $5000 per speaker ($10,000 per speaker for speakers traveling from the west coast or from abroad); <.li>
  
  
• Educational materials (or funds to purchase educational materials) with a value of less than $50 per intended recipient and $5000 in aggregate. (Specific guidelines for gifts of educational materials are set forth in section F.)

Guidelines
Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH) are committed to improving patient care through medical education. Members of the medical industry may wish to support the educational mission of BWH and MGH by providing financial and intellectual assistance to support BWH and MGH educational programs. These Guidelines have been developed to promote a consistent relationship between BWH, MGH and the medical industry with respect to support of such educational programs.

A. Applicability of Guidelines
As used in these Guidelines, the term "educational gift" means a donation or grant (which may take the form of a cash payment or may involve the donation of tangible items such as text books or food) made to BWH or MGH that imposes no obligation on the part of BWH or MGH other than to use the money or tangible items in support of its charitable educational activities. Educational gifts may fall into a number of categories, including gifts to fund broad-based educational initiatives, gifts to fund specific lectures and seminars, gifts to fund CME programs, gifts of textbooks and other educational materials, and gifts to provide salary support for residents and fellows. Types of educational programs that may be supported through such gifts include educational programs for physicians, non-physicians and non-professional staff.

Gifts whose purpose is to fund research activities, including gifts to fund research fellowships, are not covered under these Guidelines and should be handled through the Offices of Corporate Sponsored Research and Licensing of BWH and MGH as research gifts pursuant to a process which includes Development Office oversight. Payments in connection with which BWH or MGH is obligated to grant the donor any intellectual property rights, or to give the donor preferential access to research results, are not considered gifts and are not covered under these Guidelines, nor are payments under consulting arrangements between industry sponsors and BWH or MGH personnel. Any such payments or consulting arrangements should be handled through the Offices of Corporate Sponsored Research and Licensing of BWH and MGH.

These Guidelines do not apply to educational gifts made directly to Harvard Medical School, even if the funds from such gifts may ultimately be expended at BWH or MGH. Such gifts are subject to and should be administered in accordance with applicable policies of Harvard Medical School.

These Guidelines are also not intended to apply to situations in which BWH or MGH, in exchange for payment, provides direct training or educational services to the employees or other representatives or agents of a company or other entity.

B. Procedures for Processing Educational Gifts
Pursuant to existing policy, with certain limited exceptions described in these Guidelines, all charitable gifts made to BWH or MGH, including educational gifts from industry, must be processed through the BWH or MGH Development Office. This policy is intended to assure appropriate receipting, recognition and overall tracking/stewardship of such gifts. If a company expresses interest in making an educational gift to support a broad-based educational effort across Partners HealthCare System (Partners), the company should be referred to the Chief Development Officer at Partners. If a company expresses interest in making an educational gift to BWH or MGH, the following procedures should be followed:

1. Except in the limited instances described in Section B.2. below, each educational gift to BWH or MGH must be processed through the BWH or MGH Development Office in the following manner:

• a. The appropriate Service/Department Chief or Division/Unit Chief shall initiate processing of the educational gift by providing certain information regarding the gift to the BWH or MGH Development Office. Information sheets for this purpose shall be available from the BWH and MGH Development Offices.
  
  
• b. The check related to the educational gift shall be forwarded to the BHW or MGH Development Office.
  
  
• c. The BWH or MGH Development Office shall deposit the funds received in the appropriate account and shall document the educational gift by sending a gift acknowledgement letter to the donor.

• a. gifts consisting of or for the purpose of purchasing food and beverages for educational lectures and conferences with a fair market value of less than $20 per expected attendee and $5000 in the aggregate,



• b. gifts for the purpose of paying reasonable stipends to persons speaking at educational lectures sponsored by BWH or MGH and for reimbursing reasonable travel expenses for visiting speakers in an amount less than $5000 per speaker ($10,000 per speaker for speakers traveling from the west coast or from abroad), and



• c. gifts consisting of or for the purpose of purchasing educational materials with a fair market value of less than $50 per book or videotape and $5000 in the aggregate.

Each Service/Department Chief or Division/Unit Chief processing such educational gifts under these Guidelines shall provide information to the BWH or MGH Development Office upon request regarding the educational gifts he/she has processed.

3. Physicians and staff affiliated with BWH and MGH must abide by the Partners Code of Conduct (including its Conflict of Interest Policy) and the Harvard University Policy on Conflicts of Interest and Commitment, as applicable. Physicians and staff who are involved in accepting and/or administering educational gifts from industry under these Guidelines or in setting up and/or running any educational programs supported by such educational gifts and who have a financial or other relationship with the sponsoring company must make full disclosure of that relationship to the appropriate Service/Department Chief or Division/Unit Chief and to the attendees, and shall abstain from decisions about institutional purchases of goods or services from the sponsoring company. A Service/Department Chief or Division/Unit Chief with a financial or other relationship with a sponsoring company should designate another physician from the Service/Department/Division/Unit to make decisions for him/her regarding educational gifts from that company.

C. Legal Compliance
Individuals involved in soliciting, accepting, receiving, or administering educational gifts under these Guidelines need to be aware that it is illegal to solicit or receive any funds or other remuneration from a company in return for, or if one purpose of the remuneration is to induce, the purchase of goods or services from the company, or the referral of business to the company. Accordingly, all educational gifts received under these Guidelines must meet the following criteria:

• 1. All educational gifts from industry sponsors must be made solely for the purpose of supporting the charitable educational mission of BWH or MGH. The individual responsible for final acceptance of any educational gift is responsible for ensuring that this requirement is met.



• 2. Any educational gift in excess of $50,000 must also be referred to the Partners Education Committee or its designated subcommittee which, in consultation with the Office of General Counsel as necessary, shall confirm that the requirements of these Guidelines have been met. Upon request, the Partners Education Committee or its designated subcommittee shall give physicians and staff who are involved in accepting and/or who would be involved in administering an educational gift in excess of $50,000 the opportunity to discuss the proposed educational gift with the Partners Education Committee or such designated subcommittee.

D. Educational Support for Scheduled Lectures
Educational gifts may be made to support scheduled lectures, usually from visiting speakers. (CME credit for such lectures is typically provided by the Harvard Medical School Department of Continuing Education.) The following additional guidelines apply to educational gifts for this purpose:

• 1. The selection of overall content, specific topics and speakers for such lectures must be made by the Service/Department Chief or his/her designee. It is the responsibility of the Service/Department Chief or his/her designee to assure that balanced, objective information will be presented at the lecture.

• 2. Gifts from industry sponsors to pay reasonable stipends to persons speaking at educational lectures sponsored by BWH or MGH and to reimburse reasonable travel expenses for visiting speakers must be made to BWH or MGH, which will arrange to pay the speaker. Industry sponsors should not pay the speakers directly. The Service/Department Chief or his/her designee is responsible for ensuring that the stipend paid to each speaker represents reasonable, fair market value compensation for the services provided by such speaker and that any travel expenses for which reimbursement is sought are reasonable and appropriate.

• 3. The industry sponsor’s support should be acknowledged in the program materials or verbally if no program materials are being distributed.

• 4. Industry representatives may attend these lectures with consent of the Service/Department Chief or his/her designee. If space is limited, industry representatives may be denied access to the lecture.

• 5. Industry representatives should not be present at lectures or conferences where specific patients are named or discussed.

• 6. These lectures should not be perceived or used as an opportunity to market products or in any other way discuss industry-specific issues with BWH or MGH staff. Industry representatives should not delay staff from entering or leaving the lecture, nor should their attendance be or be perceived as being disruptive to the purpose of the lecture.

• 7. The Service/Department Chief or his/her designee may elect to distribute reprints from peer review journals supplied by the industry representative that have been prescreened and approved by the Service/Department Chief or his/her designee.

• 8. Speakers must disclose any financial or other relationship they have with the sponsoring company.

• 9. The distribution of advertising materials at such events is not permitted.
  

E. Educational Support For CME Programs
Continuing Medical Education programs are an important component of the educational missions of BWH and MGH. The following additional guidelines apply to educational gifts from industry in support of formal continuing medical education programs:

• 1. The selection of overall content, specific topics and speakers for such programs must be made by the Service/Department Chief or his/her designee. It is the responsibility of the Service/Department Chief or his/her designee to assure that balanced, objective information will be presented at the program.

• 2. Gifts from industry sponsors to pay reasonable stipends to persons serving as faculty members for educational programs sponsored by BWH or MGH and to reimburse reasonable travel expenses for visiting faculty members must be made to BWH or MGH, which will arrange to pay the faculty member. Industry sponsors should not pay the faculty member directly. The Service/Department Chief or his/her designee is responsible for ensuring that the stipend paid to each faculty member represents reasonable, fair market value compensation for the services provided by such faculty member and that any travel expenses for which reimbursement is sought are reasonable and appropriate.

• 3. Any device, product, drug or procedure that is the focus of a course should be widely recognized and accepted as worthwhile for the betterment of human health. The Service/Department Chief or his/her designee should review the available evidence to make this determination. FDA approval is generally required. (In general, single product oriented programs will not be granted Category 1 approval by the Harvard Medical School Department of Continuing Education.)

• 4. Any company associated with the device, product, drug or procedure discussed at the course must be regarded as a legitimate and reputable organization adhering to high ethical standards, as judged by the Service/Department Chief or his/her designee.

• 5. Devices, products or drugs produced by more than one company should be discussed at the course to prevent the appearance of endorsing a single product.

• 6. At times it may be appropriate to require that the company providing devices, products, drugs, equipment, materials, etc. hold BWH and MGH harmless for any damage that may arise from defects in the products, etc. or from misuse by people who have attended the course. Liability issues should be negotiated with the advice of the Partners Office of the General Counsel.

• 7. Faculty members must disclose any financial or other relationship they have with the sponsoring company.

• 8 The industry sponsor’s support should be acknowledged in the course materials.

• 9. Participants should pay a reasonable fee for the course. Reduced enrollment fees may be allowed for BWH and MGH staff and trainees.
  

F. Educational Materials
Educational gifts may also be made consisting of or for the purpose of purchasing educational materials such as textbooks or videotapes. The following additional guidelines apply to educational gifts from industry for this purpose:

• 1. The selection of the educational materials to be purchased or provided must be made by the Service/Department Chief or his/her designee.

• 2. Any such educational materials should be deemed by the Service/Department Chief or his/her designee to be worthwhile and appropriate for the proposed recipients from an educational and scientific perspective.

• 3. The Service/Department Chief or his/her designee will take responsibility for distributing the selected materials to the proposed recipients and shall distribute the materials in such a way that all similarly situated personnel (e.g., all trainees in a particular program) have an equal opportunity to receive the materials.

• 4. The educational gift may be acknowledged by an appropriate "bookplate."
  

G. Resident and Fellow Salary Support
Educational gifts may also be made to provide salary support for residents or fellows. As stated above, gifts to provide salary support for research-related residency and fellowship positions should be referred to the Offices of Corporate Sponsored Research and Licensing of BWH and MGH for processing as research gifts. Gifts to provide salary support for clinical residency and fellowship positions should be processed under these Guidelines through the BWH or MGH Development Office. Payments under such educational gifts may not be made directly to a trainee, or earmarked for a specific individual. No clinical trainee should be specifically designated as an industry supported resident or fellow. The applicable Service/Department Chief or his/her designee shall have the discretion to determine whether it is appropriate to acknowledge the educational gift in ways beyond the customary gift acknowledgement letter, such as announcing the educational gift at key functions and including mention of the educational gift in residency brochures. Any such additional disclosures regarding such educational gift must comply with all applicable guidelines of Partners, BWH, MGH, and Harvard Medical School.

H. Privacy of Residents
BWH and MGH GME programs will not share lists of resident names, addresses or other information with commercial entities.
Educational Gift Information Sheet

This information sheet has been developed as a tool to assist in the processing of educational gifts pursuant to the Guidelines Regarding Gifts from Industry to Support Educational Programs (the "Guidelines"). Copies of the Guidelines are available from the BWH and MGH Development Offices. The information sheet should be filled out by the appropriate Service/Department Chief or his/her designee and returned to the BWH or MGH Development Office. Attach a separate sheet, if needed to answer questions 8 through 15.

1. Your name, address, phone number and email address: ________________________________________________________________________________________________________________________________________________________

2. Your service or department: __________________________________________________

3. Your hospital (BWH or MGH): ________________________________________________

4. Name of company offering gift: _______________________________________________

5. Name, address, title, phone number and email address of company contact person:
________________________________________________________________________________________________________________________________________________________

6. Amount of proposed gift: $ ________________

7. Date upon which funds have been, or you expect will be, made available: _____________

8. Educational program to be funded using the gift:
_________________________________________________________________________

9. Are you aware of any expectation on the part of the company that the funds will be spent for any particular purpose, other than the expectation that the funds will be used to support educational programs? ________ If yes, what is your understanding of the company’s expectations regarding how the funds will be spent?

10. Are you aware of any expectation on the part of the company that the company will have any control over the content of such programs? ________ If yes, what is your understanding of the company’s expectations regarding what control the company will have over the educational programs?

11. Are you aware of any expectations on the part of the company that the company will receive anything of value in exchange for the funds? ________ If yes, what is your understanding of the company’s expectations regarding what they will receive?

12. Is the giving of this gift in any way conditioned on or related to (i) any pre-existing or future business relationships between the company and BWH or MGH or (ii) any business or other decisions BWH or MGH has made or may make in the future relating to the company or its products? ________

13. Has there been any communication between the company and any persons associated with BWH or MGH regarding the purchase of goods or services from, or the referral of business to, the company in exchange for (or in connection with) the gift? ________

14. Are you or any of your colleagues who will be involved in (i) setting up and/or running any educational programs which will be supported by this gift or (ii) making the decision to accept this gift, engaged in any other activities which are funded or supported by the company? ________ If yes, please describe these activities (e.g., consulting; collaboration; sponsored research; clinical trials), and explain any relationship between those activities and the educational programs which this gift will be used to fund.

15. Are you or any of your colleagues who will be involved in (i) setting up and/or running any educational programs which will be supported by this gift or (ii) making the decision to accept this gift, involved in decisions regarding the purchase by or on behalf of BWH or MGH of goods or services from, or the referral of business to, the company (e.g., through participation on a formulary committee or purchasing task force)? ________ If yes, describe the nature and extent of your involvement.