The Facts

Frequently Asked Questions About the HMS Faculty Policies on Integrity in Science

Q: Does Harvard Medical School (HMS) have a conflict of interest policy?

A: Yes. HMS’s Faculty Policy on Conflicts of Interest and Commitment is one of the oldest policies amongst medical schools in the country that requires disclosure and resolution of potential conflicts, including financial interests, by its faculty members. The policy was originally adopted in 1990 and is part of the Integrity in Science policies that govern all HMS faculty members. A copy of this policy and other Integrity in Science policies to which HMS faculty members are subject can be found at http://www.hms.harvard.edu/public/coi/policy/integritypolicy.html.

Q: Has the HMS Faculty Policy on Conflicts of Interest and Commitment ever been revised?

A: Yes. In an effort to ensure that the Policy appropriately evolves with the continually changing biomedical field, the Policy is periodically reviewed and updated every three to four years. The last review of the policy was completed in 2003. In January 2009, HMS appointed a faculty committee to reopen the HMS Policy, and it is in the process of reviewing and making recommendations for revisions to the Policy and the financial interest disclosure process.

Q: What does the HMS Faculty Policy on Conflicts of Interest and Commitment cover?

A: The HMS Policy provides guidelines for HMS faculty members in structuring outside activities and relationships so as not to impinge or call into doubt the HMS faculty’s primary responsibility to teaching, research and patient care. Specifically, the policy requires all members to disclose their financial interests to HMS on a regular basis and to publicly disclose financial interests and other potential conflicts when presenting research results or expert commentary. Activities are categorized into those that are generally not allowed (Category I), those that are allowed only after disclosure, review and approval by HMS or its affiliated institutions (Category II), those that are allowable only after disclosure, and, if necessary, oversight procedures (Category III), and activities that are routinely allowable (Category IV). The HMS Policy also includes a section on mentors’ obligations to trainees.

Q: Does the public disclosure requirement of the HMS Faculty Policy on Conflicts of Interest and Commitment also extend to lectures to medical students?

A: Yes. In addition, as of October 2008, the HMS Curriculum Committee requires that “all faculty and students must disclose any financial interests they may have in a pharmaceutical, biotechnology, medical instrument company, or other business which owns or has a contractual relationship to the subject matter being reported or discussed in a presentation, lecture, tutorial, paper, or other teaching exercise or assignment.”  This is codified in Section 4.14 (PDF) of the 2008-2009 Student Handbook.

Q: Does the HMS Faculty Policy on Conflicts of Interest and Commitment address financial interests in clinical care?

A: Although other policies at HMS and its affiliated medical centers cover financial interests in clinical care that may raise conflicts, the current HMS Policy does not specifically address this. The policy was first adopted in response to a growing trend of collaboration between academic medical centers and industry. The Bayh-Dole Act, passed in 1980, encouraged this collaboration by allowing medical schools and academic medical centers to retain the rights in intellectual property that might result from a faculty members’ federally sponsored research. More than five years prior to the enactment of any federal law to address the topic, HMS recognized that while these interactions often facilitate the efficient transfer of laboratory discoveries into novel treatments and cures for disease, the increased industry collaboration could also have the potential of biasing or appearing to bias decision making in academic research. Therefore, while the HMS Policy covers a number of topics, the strict prohibitions of the Policy primarily address conflicts of interest in research. Even today, the HMS Policy carries more stringent restrictions upon industry interaction than required by law in the interest of avoiding research tainted by potential conflict or the appearance thereof.

Q: What does the HMS Faculty Policy on Conflicts of Interest and Commitment prohibit?

A: There are two very important restrictions in the HMS Policy. First, a faculty member cannot help to design a study, participate in the conduct of the study, or be an author on a journal article or other paper reporting on the results of the study involving a company’s drug or device if he or she accepts more than $20,000 per year in consulting or other income from that company.

Second, a faculty member may not accept sponsored research support (for either clinical or basic research) at HMS or any of its affiliated institutions from a company if he or she owns equity in the company. If that company is privately held, this restriction is absolute. If the company is publicly traded, the faculty member can own stock, stock options, partnership shares, or other equity provided that (1) the value of that equity does not exceed $30,000, and (2) the equity was obtained separate and apart from the sponsored research agreement.

The HMS Policy also prohibits a faculty member from taking an executive position with any for-profit business engaged in biomedical commercial activities or research and from serving on the board of directors of a company from whom he or she receives sponsored research support or on whose drug or device he or she conducts clinical research.

Q: Does the HMS Policy cover conflicts of commitment?

A: Yes. The HMS Policy states that full time faculty members “are expected to devote their primary professional loyalty, time, and energy to their teaching, research, administrative responsibilities and, where applicable, patient care at the School and its affiliated Hospitals.” With that in mind, the Policy does allow its faculty members to spend 20 percent of their time on activities outside of their responsibilities to HMS and affiliated hospitals. This is generally interpreted to mean that a faculty member may spend one day in seven on outside activities provided they are consistent with the other requirements of the HMS Policy.

Q:  Does HMS have a policy addressing potential conflicts in providing patient care services?

A:  No. HMS does not provide patient care services, nor does it own or operate any hospital that provides patient care services. HMS has 17 affiliated institutions, but those institutions are managed entirely separate from HMS and Harvard University. This is a model that is quite unusual in this country. Most other medical schools either own their affiliated hospital or, if not owned, do provide a central administrative role in patient care activities and in the administration of research projects. HMS does not. The large majority of HMS faculty members are directly employed by the affiliated hospitals. Federal grants and industry-sponsored projects are awarded directly to the hospitals and HMS plays no role in their administration.

The HMS Faculty Policy on Conflicts of Interest and Commitment applies to all approximately 10,500 full and part-time faculty members regardless of where they are located or by whom they are employed. Because HMS does not own or have operational authority over its affiliated institutions, the HMS Policy has not historically extended to areas (e.g., patient care) for which HMS has no or little authority for oversight. However, HMS’s affiliated hospitals have adopted policies on outside activities and conflicts of interest that address the important areas of patient care, gifts, meals, and access of pharmaceutical and device manufacturers to hospital personnel, and HMS has adopted separate policies that relate to industry influence on medical education.

Q: Does HMS have a policy governing access to students or sponsorship of events for students by pharmaceutical company sales and marketing personnel?

A: Yes. Section 4.14 (PDF) of the 2008-2009 Student Handbook states that pharmaceutical sales personnel are “not permitted to interact with medical and dental students on the HMS campus.” Further, sponsorship of student events by pharmaceutical companies is also prohibited.

Q: Does HMS have a policy that covers receiving gifts or meals from pharmaceutical and device marketing personnel?

A: Yes. Section 4.14 (PDF) of the 2008-2009 Student Handbook prohibits medical and dental students from accepting “any gifts from pharmaceutical companies, and pharmaceutical companies may not provide meals or refreshments for any student function.”

Q: Does HMS allow pharmaceutical and device companies to influence the types of CME courses given?

A: HMS has a number of safeguards in place to protect against influence of pharmaceutical and device companies over the content of courses offered. First, the topic of any new course must be suggested by a faculty member, not a pharmaceutical or device company, and must be based on a needs assessment (e.g., potential gaps in physician knowledge that need to be addressed and/or  any advances in the field). The content of the proposed program is reviewed informally by the HMS CME Office to determine whether it has merit. A formal written proposal is then reviewed by the chair of the faculty member’s department and presented to the Standing Committee on Continuing Education, which is comprised of approximately 30 faculty members from across HMS and its affiliated institutions. The Committee may reject a course outright or require a faculty member to implement changes or modifications before receiving full approval.

Q: Do you contract with any commercial entities to provide CME services?

A: HMS currently contracts with MC Communications for the seven Current Clinical Issues in Primary Care (PriMed) courses. There currently are no contracts with other entities. This program involves collaborations with CME departments at six other academic institutions — Baylor College, Columbia University College of Physicians and Surgeons, Johns Hopkins Medical School, the University of Miami, Northwestern University, and UCLA. This program enables HMS and its academic partners to offer accessible and affordable tuition of $35 for the three-day course that features approximately 60 clinical lectures with themes such as pediatric and adolescent medicine, women's health and multiple specialties including gastroenterology, cardiology, neurology and infectious disease. The courses are free of commercial influence.

HMS and its academic partners have absolute independence in selecting course content and speakers. Topics are selected after thousands of attendee evaluations are reviewed.

Attendance varies based on region. For example, whereas in Boston the course draws approximately 7,000 participants, Baltimore and Houston generally draw about 4,000 participants. The courses are designed for primary care physicians, nurse practitioners, physician assistants and nurses, who represent the largest single group of clinicians in the country.

Q: What happens if a HMS faculty member does not comply with the HMS Faculty Policy on Conflicts of Interest and Commitment?

A: An allegation of noncompliance with the HMS Policy is initially reviewed by the Office of the Dean. Noncompliance may include (i) a breach of the disclosure process or a failure to abide by such process, whether by refusing to make the periodic required disclosures or by responding with incomplete or inaccurate information, (ii) a failure to remedy prohibited conflicts or (iii) a failure to comply with a prescribed oversight plan. If this preliminary review demonstrates that a case has merit, it is forwarded to the Standing Committee on Conflicts of Interest and Commitment for subsequent review. This Committee is comprised of representatives from both clinical and preclinical faculty. The Committee is responsible for investigating the claim of noncompliance and for making recommendations to the Dean regarding disciplinary actions, where appropriate. HMS takes any claim of noncompliance seriously and independently investigates each claim thoroughly. Faculty members are given ample opportunity to respond to claims and to comment on any recommended action. An effort is made to keep the existence and status of all such proceedings confidential.