What happens if someone who is participating in a Research Project funded by the PHS/NIH does not comply with the Conflicts of Interest & Commitment Policy?
In accord with PHS/NIH policy (42 CFR § 50.605(3)), a retrospective review will be conducted if the Office for Responsible Outside Interests determines that an Investigator participating in any University project funded by the PHS/NIH (excluding Phase I SBIR/STTR grants) has not (a) complied with this Policy; or (b) complied with a required FCOI management plan; or (c) disclosed a SFI or SPI in a timely manner to allow appropriate review and management. Consistent with PHS/NIH grants policy 42 CFR § 50.606(c), “in any case in which a determination is made that a PHS/NIH-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by the Institution as required, the Investigator will be required to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.”