July 21, 2010 — Following more than one year of rigorous discussion and deliberation, the Harvard University Faculty of Medicine Committee on Conflicts of Interest and Commitment has presented Dean Jeffrey S. Flier with a series of recommendations to revise and clarify the existing Policy on Conflicts of Interest and Commitment (COI policy). Dean Flier, who convened the committee in January 2009, has carefully reviewed and accepted the committee’s recommendations, which over the next year will be formally incorporated into the HMS COI policy.
The HMS committee served as a subcommittee to a larger, University-wide group led by David Korn, Harvard University Vice Provost for Research. The University-wide group has simultaneously released a set of principles intended to guide the policies of all Harvard schools.
“Harvard Medical School’s newly revised financial conflict of interest policy streamlines and strengthens what has been a longstanding concern with this issue,” says Steven Hyman, Provost of Harvard University. “Its policy not only meets the requirements of Harvard’s new University policy on financial conflicts of interest, but also exceeds them in many key areas. Dean Flier and his committee have set a terrific example for the rest of Harvard’s schools to consider as they craft their own implementations of the University policy.”
“At HMS, we have a proud history of unwavering commitment to high professional standards of ethical conduct,” says Flier. “Within and outside industry, many recognize that industry and academia must seek a new model of academia–industry collaboration to achieve greater success at discovery and development of new treatments while fully protecting academic values and those of the medical profession. It is incumbent upon us to create a culture that is open to creative new approaches to collaboration on scientific development, based on transparency, rather than one that makes novel interactions more difficult.”
First approved in 1990, the HMS COI policy has guided faculty interactions with industry for more than two decades. The HMS policy, which preceded federal regulations, was principally designed to address individual conflicts arising in research. Through the years, the policy has been periodically updated and amended. Dean Flier asked the present faculty review committee to re-evaluate the policy’s scope and content in light of the increasing complexities of industry and academic collaborations.
The review committee, comprising 34 faculty members, senior administrators and students, met more than 30 times to consider both the existing policy and numerous topics not previously covered by the policy. The subcommittees looked primarily at education, research and compliance.
The committee’s recommendations, as accepted by Dean Flier, reflect a careful consideration of how the policy can better guide faculty members in structuring appropriate industry relationships. While reaffirming the undisputed benefits of academic–industry collaboration for translating basic laboratory discoveries into therapies benefiting patients, the recommendations emphasize transparency and the reduction of marketing influence.
The recommendations accepted by Dean Flier include, but are not limited to, the following:
- Streamlining the existing HMS COI policy and disclosure form and process and developing a central reporting system that streamlines HMS COI disclosures with other required disclosures from affiliated teaching hospitals and institutions in which many faculty members have joint appointments. This will result in one uniform and far more accessible, easy-to-understand reporting system.
- Developing an education and disclosure-monitoring system to assist faculty with understanding the new policy and disclosure requirements.
- Publicly disclosing all relevant faculty financial interests on the HMS Catalyst Profiles website.
- Prohibiting all personal gifts, travel or meals from industry, other than travel and meals in the course of allowed activities. This is consistent with requirements of Massachusetts law and guidance issued by PhRMA and AdvaMed.
- Prohibiting faculty participation 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.
- Continuing to develop and implement curricula about critical decision-making throughout the educational trajectory and training of students, trainees and faculty, while continuing to restrict access to the HMS and Harvard School of Dental Medicine (HSDM) campus by sales and marketing representatives from pharmaceutical and medical device companies.
- Reinforcing ACCME standards ensuring academic independence in the creation and delivery of Continuing Medical Education (CME) course content and limiting industry funding of CME so that 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. HMS will establish a dean’s fund to allow for industry donation to be used at the sole discretion of HMS and HSDM.
- Restricting industry advertising and exhibitions at CME events, ensuring that industry programs and exhibits are marketed separately from Harvard programs.
- Reviewing and assessing any faculty member’s proposed participation on the fiduciary board of a for-profit biomedical business. The Standing Committee on Conflicts of Interest and Commitment will evaluate whether the arrangement gives rise to actual or potential conflicts of interest and may make recommendations to the dean.
The recommendations also reinforce the research restrictions that have been in place for many years, such as:
- Limiting sponsorship of a research project, regardless of the type of research, 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 that $10,000 in annual income (down from $20,000).
- Reconfirming the already existing restrictions upon guest and ghost authorship.
These recommended policy revisions and restrictions will be put into effect and practice on a rolling basis starting in January 2011. The HMS Integrity in Academic Medicine website will have regular updates as the Office for Professional Standards and Integrity works to implement the committee’s recommendations to reinforce HMS’s longstanding commitment to integrity in science. It also includes an array of related resources.
“We are confident that these recommendations are consistent with the mission of the Faculty of Medicine and represent a balanced approach to a challenging and complex set of issues,” says committee co-chair and chair of the Standing Committee on Conflicts of Interest Robert Mayer, HMS professor of medicine at Dana-Farber Cancer Institute. “HMS faculty are committed to the highest ethical standards in research, patient care and the education of current and future health care providers, and we believe that these policy revisions will guide them as they fulfill their commitment.”