Implementation of New HMS Policy

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Implementation of New HMS Policy on Conflicts of Interest and Commitment

January 20, 2011

Dear Members of the Harvard Medical School Faculty,

I am writing to share with you details about the implementation of the new requirements on conflicts of interest and commitment. As you are aware, in July, Harvard Medical School announced my acceptance of the recommendations of the Faculty of Medicine Committee on Conflicts of Interest and Commitment. Since then, significant implementation efforts have been underway, and policies and handbooks are being revised.

Some of the recommendations will be implemented effective January 1, 2011. Others will continue to be implemented throughout the coming months. Let me share with you the anticipated schedule so that, to the extent any of the changes may affect your own outside activities, you can plan accordingly:

Research

  • Clinical Research
    • Lowering the Clinical Research Income Limit. As of April 1, 2011, HMS will be lowering the clinical research income limit from $20,000 to $10,000. This means that a faculty member who is participating in clinical research on a technology owned by or contractually obligated to a business will not be able to accept more than $10,000 per year in honoraria, consulting or other income from that business.
      • Existing faculty obligations as of April 1, 2011, that have the potential for payments exceeding the $10,000 per-year limit for 2011 will be reviewed on a case-by-case basis by the Standing Committee.
    • Narrowing the Definition of Clinical Research. As of January 1, 2011, the definition of clinical research for purpose of applying the clinical research income restriction shall be revised to exclude certain clinical research defined as nominal risk, if so reviewed and approved by HMS or the affiliated institution’s IRB and/or conflict of interest committee.
    • Dual Career Families. As of April 1, 2011, the Standing Committee will begin to entertain petitions for exceptions from the clinical research income restrictions if the faculty member’s financial interest violates policy solely by reason of his or her spouse or domestic partner’s earnings from independent professional activities. The relevant professional activities cannot have any nexus with the faculty member’s proposed research. Please check the HMS Integrity in Academic Medicine website in the coming months for details regarding this petition process.
  • Basic Research
    • As of January 1, 2011, sponsorship pursuant to a grant or subgrant under the Small Business Innovation Research Program or the Small Business Technology Transfer Program will no longer be subject to the rule prohibiting a faculty member from holding equity in a business that sponsors his/her basic research. This is a limited exception to the prohibition and it will be reviewed by the Standing Committee following an initial trial period.

Continuing Medical Education

  • Effective January 1, 2011, funding from industry to support a specific continuing education course may only be accepted if there are two or more industry sponsors. No one industry sponsor may fund more than 50 percent of a particular course budget, with sponsorship among all industry sponsors being relatively equitable.
  • HMS will implement the restriction upon industry involvement in advertising and exhibits over the next six months. Specific restrictions on industry-sponsored exhibits and advertising will be imposed for all Harvard CME programs. Industry exhibits will have to be located in a separate room from Harvard CME content and have a separate entrance/exit from that used by participants of the Harvard course. In addition, industry programs and exhibits will have to be marketed separately from Harvard programs and cannot be held in competing locations and at competing times with Harvard content.

Education

  • Curricula for Medical Students. Curricula has been and will continue to be developed to offer students multiple and continuous opportunities to develop critical decision making skills, including evaluating factors of potential bias, beginning at the orientation to medical school and continuing throughout their careers, into continuing medical education.
  • Access to HMS. The existing restriction that no medical or dental drug, device or supply company sales and marketing representative shall have access to medical students on campus has already been reinforced. Effective July 1, 2011, biomedical company representatives, such as those who provide training and education on the proper use of laboratory materials and/or devices are welcome provided that they have been invited by a member of the HMS/HSDM faculty or designated staff and wear an identifying badge setting forth the individual’s company affiliation.

Other

  • No Gifts/Travel/Meals. Consistent with guidance issued by PhRMA and AdvaMed, all HMS faculty will be prohibited from receiving personal gifts, travel or meals from industry—other than travel and meals in the course of allowed activities. This prohibition currently applies to all clinical faculty. Effective July 1, 2011, the prohibitions will be extended to non-clinical faculty to the same extent that they currently apply to clinical faculty under state law.
  • Speakers Bureaus Prohibition. Effective July 1, 2011, faculty participation in industry speakers bureaus will be prohibited. Further, faculty may not accept compensation for a speaking engagement that unduly limits the faculty member’s intellectual independence with regard to presentation content.
  • Board of Directors Review. Effective January 1, 2011, HMS may review a faculty member’s participation on the fiduciary board of a for-profit business engaged in commercial or research activities of a biomedical nature when such relationship is disclosed to HMS in the course of its annual faculty financial disclosure process. The Standing Committee will evaluate whether the arrangement gives rise to actual or potential conflicts of interest and may make recommendations to the Dean as it deems appropriate in any case, including managing, reducing or eliminating the conflict.

The HMS Office for Professional Standards and Integrity will be issuing additional guidance in the coming weeks and months. Please check in to the HMS Integrity in Academic Medicine website for more information as it becomes available. If you have any questions, please do not hesitate to contact us at conflict_support@hms.harvard.edu.

Sincerely,

Jeffrey S. Flier
Dean, Faculty of Medicine
Harvard Medical School

Gretchen A. Brodnicki
Dean, Faculty and Research Integrity
Harvard Medical School