Ethical, Legal, and Policy Best Practices
Conflicts of Interest
A financial COI exists, according to Public Health Service (PHS) regulations, when a designated institutional official(s) reasonably determines that an extramural Investigator’s significant financial interest could directly and significantly affect the design, conduct, or reporting of PHS-funded research (42 CFR § 50, Part F and 45 CFR § 94) . 9 An Investigator is defined by these regulations as the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS or proposed for such funding. For purposes of the requirements of the regulations, the term Investigator includes the Investigator’s spouse and dependent children. Generally, it is the awardee institution that is responsible for maintaining compliance with the requirements of the regulations, identifying and managing Investigator Financial Conflicts of Interest and reporting them to the PHS-awarding component. Investigators disclose their Significant Financial Interests, as defined in 42 CFR § 50.63 and 45 CFR § 94.3, to their institutions. Extramural investigators conducting biospecimen research activities supported by PHS grants, cooperative agreements, or research contracts are subject to the requirements of these regulations (see the NIH Office of Extramural Research Web site for more information on COIs) . Federal employees are subject to different regulations related to COI, as described in 18 USC 208, the Standards of Ethical Conduct for Employees of the Executive Branch, and agency-specific regulations (see the NIH Conflict of Interest Web site for more information related to federal employees) .
C.6.1. Investigator Financial COIs
The regulations governing extramural research contain examples of conditions or restrictions that might be imposed by an awardee institution to manage Investigator financial conflicts of interest, which includes public disclosure of a significant financial interest. The responsibility of COI management rests with the awardee institution as described in the regulations. Awardee institutions and Investigators should adhere to institutional and PHS regulations governing COIs.
C.6.2. Institutional Financial COIs
Institutional financial COIs should be considered and managed as appropriate. Any known or likely financial benefit to the institution or biospecimen resource should be disclosed accordingly, for example on the biospecimen resource Web site or in a clear and concise manner in a brochure that accompanies the informed consent document. (Also see Section C.2.3, NCI Recommendations on Key Informed Consent Elements and Supplementary Materials.)
C.6.3. Nonfinancial COIs
Nonfinancial COIs should be identified and managed to the extent practicable. An example of a nonfinancial COI includes situations in which the individual managing the biospecimen resource is also a researcher seeking access to biospecimens. In cases where nonfinancial COIs are unavoidable (e.g., small biospecimen collections) , biospecimen resources should manage the COIs by adhering to NIH policies and, if deemed necessary, publicly disclosing the COIs; e.g., via the resource's Web site or written materials.
9 NIH is currently in the process of proposed rule-making related to Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors. The NCI Best Practices will be updated as needed once these regulations are finalized.
