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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

 

 

Guiding Principles

"As to methods there may be a million and then some, but principles are few. The man who grasps principles can successfully select his own methods. The man who tries methods, ignoring principles, is sure to have trouble" -- Ralph Waldo Emerson

Three overarching principles guide our recommendations. Investigators must: 1) conduct research activities objectively, 2) operate with transparency, and 3) be accountable to all stakeholders, especially when relationships with industry exist.

Guiding Principle 1: Investigators must conduct research activities objectively.

All investigators participating in research (industry-funded or not) have a professional obligation to the integrity of their studies.
When relationships with industry exist, investigators should pay careful attention to objectivity in research. What is objective is based on observable phenomena, presented factually, and without bias (1).  In science, objectivity is intimately related to the aim of verifiability and reproducibility. Investigators maintain the objectivity of their investigations by their intellectual honesty in proposing and performing research (including research design, data collection, and data analyses) and reporting research results to the public and scientific community. Intellectual honesty entails conducting and reporting research so that it is uninfluenced by competing interests, including financial interests.

Guiding Principle 2: Investigators must operate with transparency.

Transparency in academia-industry relationships in research is important to advance research and promote trust of colleagues and the public.
Transparency describes openness and willingness to accept scrutiny. Transparency is achieved through full and regular internal reporting and external disclosure of financial interests that would reasonably appear to affect the welfare of subjects or the conduct or communication of research (2). This includes disclosure of industry relationships when communicating to the public, other investigators, their institutions, and journals. While failure to disclose relationships as required does not invalidate the research, it creates the perception that the investigator had something to hide and decreases public trust.

Guiding Principle 3: Investigators must be accountable to all stakeholders.

Investigators are accountable to all stakeholders including the public, sponsors of research, home institutions, research teams, and human subjects and patients
. Accountability means that there is an obligation to take responsibility for one's actions in accordance with agreed expectations and may be required to explain them to others. Acceptance of state and federal funds for research is a contract with the public that involves trust. Individual investigators are personally accountable for complying with the requirements of the funding agreements and their institution's policies. Some investigators are responsible for the care and safety of human subjects or serve as mentors to trainees. These relationships involve trust but are typically an unequal distribution of power and influence. Investigators may have multiple roles (e.g., mentor, member of institutional committees, administrator, or consultant). Outside activities, such as industry relationships, should complement, not compromise, primary responsibilities.


(1) Remarks of Ruth Kirschstein, Conference on Human Subject Protection and Financial Conflict of Interest, 2000.

(2) Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research. Association of American Medical Colleges, 2001 (PDF)






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