Harvard to initiate strict conflict of interest rules for faculty

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Image source: Harvard Medical School

Harvard Dean Jeffrey S. Flier has accepted the recommendations of the Harvard University Faculty of Medicine Committee on Conflicts of Interest and Commitment to revise and clarify the existing Policy on Conflicts of Interest and Commitment (COI).

The university said the recommendations reflect a consideration of how the policy can guide faculty members in “structuring relationships to emphasize transparency and eliminate marketing influence.”

Also, faculty is prohibited from receiving all personal gifts, travel or meals from industry, other than travel and meals in the course of allowed activities. Nor can faculty participate in industry speakers bureaus. Further, faculty will not be able to accept compensation for a speaking engagement that limits the faculty member’s intellectual independence in presenting content.

Faculty now is required to publicly disclose all relevant financial interests on the Harvard Medical School (HMS) Catalyst Profiles website.

Seeking to streamline the existing HMS COI policy and disclosure form and process, the medical school has developed a central reporting system for disclosures with other required disclosures from affiliated teaching hospitals and institutions, in which many faculty members have joint appointments.

The university said it developed an education and disclosure-monitoring system to assist faculty with understanding the new policy and disclosure requirements.

HMS’ recommendations limit industry funding of continuing medical education (CME), so no one sponsor can fund a course. In no event will any single sponsor be able to support more than 50 percent of a particular course’s budget, according to HMS. In addition, HMS will establish a dean’s fund to allow for industry donation to be used at its sole discretion.

Restricting industry advertising and exhibitions at CME events, according to the medical school, will ensure that “industry programs and exhibits are marketed separately from Harvard programs.”

The recommendations, HMS said, also reinforce research restrictions that have been in place for years, such as:

  • Limiting sponsorship of a research project by a business in which a faculty member holds equity. The prohibition is absolute if the business is privately held. If the business is publicly traded, then a faculty member’s financial interest in the company cannot exceed $30,000.
  • Prohibiting clinical research on a technology owned by or licensed to a business from which the faculty member receives more than $10,000 annually (down from $20,000).
  • Reconfirming the already existing restrictions upon guest and ghost authorship.

According to HMS, the faculty can:

  • Conduct research sponsored and supported by industry;
  • Collaborate with industry on research protocols;
  • Co-author publications derived from these collaborations;
  • Consult for industry;
  • Found biotechnology companies;
  • License technology to or from pharmaceutical, medical device and biotechnology companies;
  • Serve on scientific advisory boards of pharmaceutical, device and biotechnology companies; and
  • Hold equity in most pharmaceutical, device and biotechnology companies.

Over the next year, these recommendations will be formally incorporated into the HMS COI policy.

The review committee, comprising 34 faculty members, senior administrators and students, met approximately 30 times to consider the existing policy and numerous topics not previously covered by the policy.