This page covers the COI process and procedure for submission and review of COI disclosures. Researchers must submit financial disclosure forms at the time of proposal submission for research funding, when research gift funding is received, and when an application for protocol is submitted for a clinical study. “Funding” includes money and/or materials.; “Conflicts” include intellectual property (“IP”), income, investments, service on a Scientific Advisory Board (or its equivalent), member of Board of Directors, employee of a company or entity, ownership of a company, and so forth. Conflicts must be reviewed and approved before funding can be accepted and the research can begin.
Proposals for Research Funding submitted through Contracts and Grants, Industry Contracts Division, or Business Research Units:
Public Health Service (PHS) or PHS-adoptive agency funded researchers are required to submit their disclosures annually and within 30 days of acquiring new financial interests electronically via COI-SMART. First time users must have their access initiated by COI staff.
Non Public Health Service government funded research requires a PI Certification form at the appropriate time in the proposal/award process.
Principal Investigators of privately sponsored research will complete a Form 700U at the appropriate time in the proposal/award process.
The instructions for submission of paperwork for research gifts are located on the COI web page about Research Gifts, which web page links to the Gift Administration website for detailed instructions.
Review by COI Staff:
COI staff reviews incoming disclosure forms. "Positive" disclosures may result in a request for additional information and/or further review.
Review by COIAC:
The COIAC reviews certain conflicts or previously reviewed conflicts on an expedited basis, and authorizes the COI staff to release the funding or to notify the IRB about the status of the conflict review. For other disclosed conflicts, the COIAC reviews these at its monthly meeting. See the COIAC Meeting Schedule under the COIAC web page.