NIH requires recipient institutions and investigators (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of 42 CFR 50, Subpart F, Promoting Objectivity in Research (FCOI Regulation), as implemented in the 2011 Final Rule for grants and cooperative agreements.
The requirements promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from any conflicting financial interest of an investigator. An “investigator” is someone:
• defined as the PD/PI and any other person, regardless of title or position
• who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding
• which may include, for example, collaborators or consultants.
Each Institution shall maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with the regulation and make the policy available via a publicly accessible Web site.