Overview

Conflicts of interest are inherent and ubiquitous in academic life. Most of these conflicts are not driven by the prospect of personal financial gain, but those that are so driven are well understood by the public and tend to garner much interest and concern in the popular press and among state and federal policymakers.  Researchers engaged in federally funded research must be aware of and compliant with federal financial conflict of interest regulations, while those conducting industry-sponsored research may be subject to both federal as well as state regulations in this area.  As an influential center of discovery and learning, Harvard University's scholarly activities extend far beyond the campus. University faculty members are engaged in a wide array of extramural interactions with external constituencies, ranging from consulting to the application or translation of newly discovered knowledge for public benefit.  Although such interactions largely advance one of the core missions of the University, they may also raise financial conflict of interest issues that can threaten Harvard's reputation for scholarly integrity, credibility and trustworthiness. To protect against such occurrences, Harvard has adopted a University-wide policy on Individual Financial Conflicts of Interest. All faculty investigators are subject to this policy and the procedures described therein.

External Oversight

Since 1995, the federal government has regulated issues of financial conflict of interest in federally-funded research.  On May 21, 2010, in response to criticism from the Office of Inspector General of the Department of Health and Human Services (DHHS) of compliance by both NIH and the university community, DHHS proposed substantial modifications to the 1995 regulation affecting institutions seeking and/or receiving Public Health Service (“PHS”) funds.  These changes were finalized in August, 2011.  In addition, also reflecting increased public concern, physician researchers who receive payments from industry vendors are affected by new state and federal legislation that require vendors to publicly disclose payments to physicians and academic medical centers and, in some instances, sharply limit the nature and amounts of such payments.

Federally Funded Research:

   Public Health Service (PHS)

• For grants and cooperative agreements: Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought (42 CFR 50 Subpart F)
• For research contracts: Responsible Prospective Contractors (45 CFR 94)

   National Science Foundation (NSF)

• Grantee Standards (Grant Policy Manual, Chapter V, 510 - Conflict of Interest Policies)

   Food and Drug Administration (FDA)

• Financial Disclosures by Clinical Investigators (21 CFR 54).  See also the FDA’s Guidance for Industry- Financial Disclosures by Clinical Investigators, updated through July of 2010.

Industry Funded Research:

 

• Massachusetts has taken a strong interest in financial conflicts of interest as they apply to industry-sponsored medical and health sciences research.  See Pharmaceutical and Medical Device Manufacturer Conduct  and the MA Department of Public Health regulations. The Massachusetts law regulates interactions between industry (pharmaceutical and medical device companies) and healthcare practitioners, bans certain gifts, restricts meals and entertainment, limits sponsorship of continuing medical education (CME), and requires disclosure of industry payments and grants.  Industry disclosure of payments will be posted on a publicly accessible and searchable website developed by the MA Department of Public Health.
• The federal Patient Protection and Affordable Care Act, otherwise known as the Health Care Reform Act, passed in March of 2010, contains a Sunshine Act requiring pharmaceutical and medical device manufacturers to disclose payments, including research grants, provided to physicians and teaching hospitals. These payments will be posted on a publicly accessible web site to be developed by DHHS.

Harvard Policies, Procedures & Guidance

On May 26, 2010, the President and Fellows of Harvard College approved a University-wide policy on Individual Financial Conflicts of Interest.  This policy provides guidance for school deans, faculty and other individuals holding teaching appointments, in identifying, evaluating, and managing conflicts of interest.  The policy is confined to issues arising from a financial conflict of interest, defined as:

“…a set of circumstances that reasonable observers would believe creates an undue risk that an individual’s judgment or actions regarding a primary interest of the University will be inappropriately influenced by a secondary financial interest.”

The University has a primary interest in preserving and furthering institutional integrity, ethical conduct, and public confidence and trust in all academic and research pursuits, an interest it shares with every faculty member.   Faculty members inevitably hold legitimate secondary interests as well, ranging from career advancement to obtaining or renewing sponsored research funding.  Although these secondary interests often align with the core mission and values of the University, they may at times occasion a departure from the University's and faculty member’s shared primary interests.

Structured around a set of 12 operating principles rooted in core values of the University, the university-wide policy provides a framework for implementation that allows for some flexibility among the various Schools in recognition of their wide variance in culture, mission, and the nature of acceptable faculty interactions with external entities. 

Each School is in the process of developing an implementation plan for this new policy. A Model Implementation Plan is provided as guidance to schools and can be viewed by clicking here.  Additional information will be available during the 2010-11 academic year.

Faculty at the Medical School should consult the  HMS Faculty Policy on Conflicts of Interest and Commitment.  In addition to complying with the Medical School's conflict of interest policy, Medical School faculty are also expected to comply with their hospital's conflict of interest rules.