Although the Department of Health and Human Services (HHS) issued the final conflict of interest rule last year, many entities conducting research that is funded under Public Health Service (PHS) grants, cooperative agreements, and contracts struggle to ensure compliance with the increasingly stringent requirements. HHS amended the original financial conflict of interest in research regulations to address the increasingly complex and prevalent financial interests held by biomedical and behavioral researchers, and the resulting interactions between government, research institutions, and the private sector. Its goal is to promote objectivity in research and to ensure that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements, and contracts will be free from bias stemming from investigator financial conflicts of interest. Under the new rules, institutions take a larger role in ensuring compliance and training related to conflict of interests in research. Institutions that apply for or receive funding from a PHS grant, cooperative agreement, or contract were required to be in compliance with all of the revised regulatory requirements no later than August 24, 2012.

Background

The final rule amended the PHS regulations Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR Part 94) (collectively known as the Conflict of Interest in Research (or COI) regulations). The original conflict of interest regulations promulgated in 1995 imposed obligations on institutions, investigators, and PHS awards. Under the original regulations, institutions maintained responsibility for conflict of interest compliance, including:

• maintaining a written and enforced COI policy
• managing, reducing, or eliminating identified conflicts
• reporting identified conflicts to the PHS awarding component.

Investigators are responsible for complying with their institution’s written COI policy and for disclosing their significant financial interests to the institution. Each PHS awarding component is responsible for overseeing institutional compliance with the regulations. The amendments to these regulations address the increasingly complex financial relationships between government, research institutions, and the private sector.

Key Changes to the Rule

The new regulations include several comprehensive changes to the existing COI regulations, including changes to the definition of significant financial interest, the extent of investigators’ disclosure requirements, institutional management of identified financial conflicts of interest, information reported to the PHS funding component, information made accessible to the public, and investigator training. For example, the revised regulations:

• Require investigators to disclose to their institutions all significant financial interests related to their institutional responsibilities.
• Decrease the threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
• Require institutions to report additional information on identified financial conflicts of interest and how they are being managed to the PHS awarding component.
• Require institutions to make certain information accessible to the public concerning identified significant financial interests held by senior or key personnel.
• Require investigators to complete training related to the COI regulations and their institution’s COI policy.

HHS emphasized that the revisions were not designed to prevent or hinder relationships among government, academia, and industry. Many aspects of the new rule only prescribe certain required elements or outcomes, permitting institutions to design specific implementation processes and approaches

Implementation Requirements and Hurdles

The new conflict of interest regulations apply prospectively to grants or cooperative agreements issued after August 24, 2012, and to contracts awarded after that date. However, institutions may elect to apply the revised regulations to all active PHS awards through their institutional policies. Below is a list of implantation hurdles facing institutions in complying with the new conflict of interest rule.

Significant Financial Interest

Compliance with the new regulations requires many institutions to revise their definitions of significant financial interest and clarify what is meant by institutional responsibilities Under the 1995 regulations, investigators were required to disclose significant financial interests to the extent the investigator deemed them to be related to research that is funded by the PHS. In contrast, the new rule defines significant financial interest to include any financial interest of the investigator, and those of the investigator’s spouse and dependent children, that reasonably appears to be related to the investigator’s institutional responsibilities. Institutions should review and likely modify, clarify, or overhaul their existing policies and procedures to comport with this broader definition. Institutions should review the current definition in their research conflict of interest policy. Possible approaches include using a broad definition of institutional responsibilities, enumerating a prescriptive list of activities that constitute institutional responsibilities, or requiring investigators to disclose all financial interests, regardless of the relationship to institutional responsibilities.

Locus of Responsibility

An important change under the new regulations is that institutions – not investigators – are now responsible for determining which significant financial interests relate to an investigator’s PHS-funded research. Under the new rule, a significant financial interest is related to PHS-funded research if the institution reasonably determines that the significant financial interest could be affected by the PHS-funded research. Under the previous regulations, many institutions relied on investigators to report only those significant financial interests that related to their research. Now that institutions are charged with determining which significant financial interests are related to PHS-funded research, they will require additional resources and expertise to make countless relatedness determinations. Institutions should carefully consider how to assign responsibility for relatedness determinations, including engaging department chairs or using tiered approaches to internal review, including formation of an independent committee. In addition, institutions should consider how to document relatedness determinations and perhaps engage electronic solutions for tracking information.

Training

Each investigator is required to complete financial conflicts of interest training prior to engaging in research that is funded by a PHS grant, cooperative agreement, or contract, and immediately under certain designated circumstances, including:

• Institutional financial conflict of interest policies change in a manner that affects investigator requirements
• An investigator is new to an institution
• An institution finds that an investigator is not in compliance with the institution’s financial conflict of interest policy or management plan.

Institutions can use resources available on the NIH’s Office of Extramural Research Financial Conflict of Interest Web page to satisfy some of the training requirements. However, institutions also are required to provide additional training concerning their investigators’ responsibility to disclose significant financial interests, as well as training on their specific financial conflicts of interest policies.

Check Your Institution’s Compliance – A Five-step Plan

It is time to review your institution’s compliance with the new conflict of interest regulations.

• Step 1: Determine if and the extent to which your institution conducts research as defined by the conflict of interest regulations.
• Step 2: Draft or review and revise existing policies related to conflict of interest in research.
• Step 3: Review and audit reporting mechanisms related to research conflict of interest, including expanded definitions and their impact on reporting.
• Step 4: Understand your public reporting obligations.
• Step 5: Evaluate current training related to conflict of interest.

Regardless of the size of your institution or current compliance efforts, these five steps will assist you with ensuring your institution meets the current conflict of interest requirements.