Review and Recommendations
Since its adoption in 1990, the Harvard Medical School Policy on Conflicts of Interest and Commitment (HMS COI Policy) has acknowledged that interactions between academia and industry are crucial to scientific progress. Collaboration facilitates the translation of knowledge from the research bench to the hospital bedside and helps achieve the institution's mission "to create and nurture a diverse community of the best people committed to leadership in alleviating human suffering caused by disease." For more than two decades, the HMS COI Policy has reflected this faculty's steadfast commitment to the highest ethical standards when teaching, conducting research or engaging in patient care activities. Such commitment, however, requires periodic re-evaluation and review. Dean Jeffrey S. Flier initiated the most recent review of the HMS COI Policy in January 2009 when he appointed a committee, comprising 34 faculty members, senior administrators and students, to reevaluate the policy's scope and content in light of the increasing complexities of industry and academic collaboration. The HMS committee served as a subcommittee to a larger, University-wide group led by David Korn, Harvard University vice provost for research.
Following more than a year of rigorous discussion and deliberation, the Faculty Committee on Conflicts of Interest and Commitment has presented Dean Flier with a series of recommendations to revise and clarify the HMS COI Policy. Following careful deliberation and review, Dean Flier has accepted the committee's recommendations and changes will be formally incorporated into a revised policy within the next year. The university-wide group has simultaneously released a set of principles intended to guide the policies of all Harvard Schools.
The committee's recommendations, as accepted by Dean Flier, reflect a careful consideration of how the policy can better guide faculty members in structuring specific relationships to emphasize transparency and eliminate marketing influence. While the revised policy will continue to contain specific limited prohibitions, the policy will not prevent or unduly limit the numerous productive interactions faculty may continue to have with their industrial partners. Faculty can still:
- Conduct research sponsored and supported by industry.
- Collaborate with industry on research protocols, and 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 the scientific advisory boards of pharmaceutical, device, and biotechnology companies.
- Hold equity in most pharmaceutical, device, and biotechnology companies.
The following summarizes the key recommendations and anticipated changes:
Required Public Disclosure of Faculty Financial Interests
Relevant faculty financial interests will be made public on the HMS Catalyst website. A description of the specific categories and specificity of the dollar ranges for disclosure will be determined by the standing committee during the implementation period. Faculty are reminded that the vast majority of financial interests and activities to be disclosed on the website are neither inappropriate nor prohibited by the HMS COI policy.
Plain Language and Development of a Central Reporting System
HMS will streamline implementation of its COI policy with other periodic faculty financial reporting requirements of its affiliated institutions. An implementation plan will be developed to create one uniform financial reporting system that provides faculty with a single point of entry for meeting all affiliated institutions' reporting requirements. The policy and reporting form will be rewritten in plain language and comprehensive educational outreach will occur. Additional local review of disclosures and increased compliance monitoring is also anticipated. The HMS Standing Committee on Conflicts of Interest will be reconstituted to review cases and provide ongoing advice to the community on issues related to industry interaction.
No Speakers Bureaus
Faculty participation in an industry speakers bureau 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.
Continue and Strengthen Research Restrictions
Clinical research restrictions:
Faculty members will continue to be prohibited from conducting clinical research on a technology owned by or licensed to a business with which the faculty member has a financial interest in excess of predetermined thresholds.
For income — Under the revised policy, a faculty member is limited to personal earnings of up to $10,000 per year from the relevant business. Income may include honoraria, pre-market royalties or other payments from a company in exchange for consulting or other services. Payments made to the faculty member by a company or person that represents or is an agent of a prohibited business will be included in determining whether the $10,000 annual limit has been met.
For equity — If the relevant business is publicly traded, the faculty member may hold equity if the equity is valued at less than $30,000. If the relevant business is privately traded, the faculty member cannot hold any equity.
Modification to definition of clinical research — The definition of clinical research for the purpose of applying the clinical research restriction shall be revised to exclude certain defined nominal-risk clinical research if so reviewed and approved by HMS or the affiliated institution's IRB and/or Conflicts of interest committee.
- Limited exception for dual-career family by formal petition — In support of the increased role of dual career families in our community, limited exceptions to the clinical research income restriction may be granted by petition to, and formal review and management by, the Standing Committee on Conflicts of Interest if the faculty member's financial interest is solely by reason of his or her spouse or domestic partner's earnings resulting from independent professional activities. The relevant professional activities cannot have any nexus with the faculty member's proposed research. To request an exception, please complete this petition.
Basic research restrictions:
Industry-sponsored research under institutional agreements continues to be encouraged; however current limits on receipt of sponsored research support from a business with which a faculty member holds equity shall remain. The prohibition is absolute if the business is privately held, but if the business is publicly traded, then a faculty member may receive company support provided that the stock, stock options or other equity interest are not valued at more than $30,000 at any time.
- Limited exception for certain SBIR/STTR grants — The standing committee will consider petitions for exception to the prohibition on a faculty member holding equity in a business that sponsors his or her basic research if the sponsorship is pursuant to a grant or subgrant under the Small Business Innovation Research (SBIR) Program or the Small Business Technology Transfer (STTR) Program. The standing committee may require other management in such cases.
Limit Industry Funding of Continuing Medical Education (CME)
Funding from industry may be accepted if there are multiple industry sponsors and no one industry sponsor funds more than 50 percent of a particular course budget, with sponsorship among the industry sponsors being relatively equitable. HMS will establish a dean's fund to accept general industry support for CME to be used at the sole discretion of HMS/HSDM. All donors must be cited, and reports about the funding of courses and uses of the dean's fund must be periodically provided to and reviewed by the HMS Standing Committee on Conflicts of Interest.
Restrict Industry Advertising/Exhibition at CME Programs
Specific restrictions on industry-sponsored exhibits and advertising will be imposed for all Harvard CME programs. Industry exhibits will 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 must be marketed separately from Harvard programs and cannot be held in competing locations and at competing times with Harvard content.
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. These prohibitions will be extended to non-clinical faculty to the same extent that they currently apply to clinical faculty under state law.
Curricula shall 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, following into continuing medical education.
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 will be reinforced. Biomedical company representatives, such as those who provide training and education on the proper use of laboratory materials and/or devices are welcome provided they have been invited by a member of the HMS/HSDM faculty or designated staff, and they wear an identifying badge setting forth the individual's company affiliation.
Board of Directors
HMS will review any faculty member's proposed participation on the fiduciary board of a for-profit business engaged in commercial or research activities of a biomedical nature. 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.