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COI Toolkit
 

Recommendations, tools, and resources for the conduct and management of financial relationships between academia and industry in biomedical research

 

 

 

References and Resources

(1) See Chapter 3 in Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct, Institute of Medicine-National Research Council, 2002.

Investigators

Complying with Policies and Requirements

Be fully aware of your institution's conflict of interest policies, including applicability, definitions, procedures, sanctions for non-compliance, and what the policies attempt to achieve. Likewise, be familiar with sponsor requirements. The conduct of academic-industry relationships is a shared duty involving reciprocal responsibilities between investigators, institutions, and sponsors of research. To achieve the best outcome and to protect all stakeholders, full disclosure and an open, problem-solving approach is desired. While institutions are responsible for the review and oversight of industry relationships, individual investigators are personally accountable for complying with the requirements of the funding agreements.

Tool. Points for consideration about institutional requirements for the oversight and management of academic-industry relationships (PDF): Tool to promote awareness of institutional policies when participating in an academic-industry relationship

Covered individuals: Institutional policies should apply to all investigators involved in the conduct and reporting of research and consider significant financial interests held by them and their immediate family members. Federal law gives academic institutions the authority to decide whether an investigator's significant financial interests are related to university research and represent a conflict of interest.

Reporting of financial interests: Reporting of significant financial interests by investigators is an important first step. Complete and accurate reporting is absolutely essential to ensure appropriate oversight. Per their institution's policy, investigators will reporting annually and/or upon initiation, change, or termination of an industry relationship.

Institution's role: The institution will review these disclosures and based on the facts provided may either reject the relationship, approve the relationship, or suggest modifications that will make the relationship allowable. If approved, the institution may decide if a management plan is necessary. Some relationships cannot be managed and will, thus, be prohibited. For example, an investigator may not be able to participate as a Principal Investigator in research involving human subjects if he/she has a significant financial interest in the outcome of the research. However, many relationships can be managed with appropriate safeguards. Investigators should understand that the review process involves judgment about whether or not to approve the relationship. Each case is individual and unique.

Tool. "Who-to-contact" card (Microsoft Word): A template for institutional contacts on industry relationships and technology transfer that investigators and institutions can use as a quick reference 


Carefully consider and understand contract terms, and enter into agreements only if you accept these terms. Important terms include data access and analysis and the ability to publish research results in a timely manner. Sometimes the institution acts on behalf of an investigator. In these cases, the institution and investigator should work together to make sure all important terms are understood before entering into the agreement.

Tool. Points for consideration in academic-industry agreements (PDF): Tool to promote awareness of important terms in academic-industry agreements



Promote a culture of objectivity, transparency, and accountability, including strict compliance with institutional policies. Institutional leaders serve as role models for integrity in research and the importance of compliance with requirements (1).  Investigators are responsible for sustaining the institutional community in part by participating in the application of policies and procedures (e.g., serving on institutional conflict-of-interest committees).

 

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