Sponsors and the government hold the University responsible for ensuring that any conflicts related to research they sponsor are identified and responsibly managed or eliminated.
There are many federal and state laws and regulations, as well as sponsor requirements, regarding conflicts of interest (COI), including from the National Institutes of Health (NIH), National Science Foundation (NSF), Food and Drug Administration (FDA), and Department of Defense (DOD).
Cornell's COI procedures are in place to ensure timely and complete disclosures of outside interests, and review and management of conflicts for any research funded by outside agencies.
- Before a proposal can be submitted, each person listed as PI, Co-PI or Key Personnel on the proposal must have a current, active COI report on file in the eCOI system. OSP and COI staff work together to check reports and communicate with PIs and Department Liaisons to ensure all necessary reports have been submitted. OSP staff can submit a proposal once all required COI reports are filed, or an exception is approved by the COI office or the Vice Provost for Research.
- Before an award can be accepted, all real or apparent conflicts of interest for each person listed as PI, Co-PI or Key Personnel must be reviewed, and either managed or eliminated. OSP and COI staff work together to review award materials and COI reports, and identify any real or apparent conflicts that might be connected to the sponsored project. If such a conflict appears to exist, the COI office will work with the FCOI Committee and the conflicted individual to develop or update a conflict management plan (see How Conflicts of Interest are Reviewed and Managed). Once that plan has been approved by the Committee, the award can be released. Note: this can take a few weeks or more, depending on the nature of the relationship and the extent of the conflict.
- PHS (including NIH) awards: If the award is from the NIH, or another agency of the Public Health Service (PHS), there are additional regulatory requirements, including award-specific COI reporting, travel reporting, and training. OSP and COI staff work together to check required reporting and training; PHS awards cannot be released until these requirements are met. For more information, visit COI Requirements for NIH (PHS) Funded Researchers.
- Subawards (incoming or outgoing): For most subawards (incoming or outgoing), there are no special COI-related requirements. The main exception to that rule is for subawards connected to funding from NIH or another PHS agency, as PHS policy requires that all recipients of their funding (including subaward recipients) comply with their policy; Cornell must confirm that each subawardee is compliant. If there are any questions or concerns related to a PHS-funded subaward, OSP or COI staff will contact the PI.
- SBIR/STTR awards: COI considerations for Small Business Innovation Research ("SBIR") or Small Business Technology Transfer ("STTR") awards to Cornell from private entities are no different from any other awards, except when a member of the Cornell team has a financial interest in the sponsoring entity. In that case, because the Cornell researcher has a financial interest in the company sponsoring the research, this intersection of interests presents a conflict of interest that must be managed under a management plan. For details, see COI Guidance for SBIR/STTR projects.
- COI considerations when sponsored research involves Human Participants: Visit Managing COI For Research Involving Human Participants to learn about requirements pertaining to potential conflicts of interest for this type of project.
- COI considerations for funding in the form of gifts: Research funding in the form of gifts to the university is subject to the same considerations for conflict of interest as sponsored funding. In particular, a COI may arise when the investigator whose research will benefit from the gift has a financial interest or another significant relationship with the donor. University policy 4.14 describes some additional considerations for gifts. However, since gifts are not processed by the Office of Sponsored Programs, reviews of gifts for conflicts of interests are generally done at the unit level. Management practices (see How COI Are Reviewed and Managed) for gifts are similar to those for sponsored research. Investigators and units should contact the COI office if there is a potential COI with regards to a research gift, and work with the FCOI Committee to implement appropriate conflict management practices.