Last updated: November 2026
A financial conflict of interest (FCOI) program for PHS-funded research is the written policy and working process an institution uses to collect investigator disclosures, decide which relate to funded research and manage the conflicts that result. The governing text is 42 CFR Part 50, Subpart F, Promoting Objectivity in Research, which applies to an institution that applies for or receives Public Health Service (PHS) research funding by grant or cooperative agreement.
Integral Healthcare Solutions (IHS) tests your policy and process against Subpart F and drafts what is missing. Your institution and its counsel approve every document and make every determination. IHS was founded in 2002 by Thomas G. Goddard, JD, PhD, former URAC COO and General Counsel. IHS is a consulting firm with three practice lines: accreditation consulting, compliance services and program development.
What does 42 CFR Part 50 Subpart F require of an institution?
Subpart F requires an institution to keep a written, enforced policy, review investigator disclosures before it spends PHS funds, manage the conflicts it finds and report them to the PHS awarding component. We read 50.602 through 50.607 in the eCFR (text current as of November 4, 2026; pages opened November 5, 2026). In our own words:
- Applicability (50.602). The subpart applies to an institution applying for or receiving PHS research funding by grant or cooperative agreement, and through it to each investigator. It does not apply to SBIR Program Phase I applications.
- Policy (50.604(a)). The policy must be up to date, written, enforced and compliant with the subpart, and posted on a publicly accessible web site. Only an institution with no current web presence may instead give the policy to any requestor within five business days of a request. An institution that gains a web presence during the award has 30 calendar days to post it.
- Certification (50.604(k)). Each application for funding to which the subpart applies must certify that the institution has an up-to-date, written and enforced process to identify and manage conflicts.
What counts as a significant financial interest, and what is the dollar threshold?
The dollar line is 5,000 dollars: section 50.603 sets two money tests around it and one test, intellectual property income, with no dollar floor. Both money tests reach interests of the investigator, spouse and dependent children that reasonably appear related to the investigator's institutional responsibilities.
- Publicly traded entity: the remuneration received in the 12 months before the disclosure plus the value of equity as of the disclosure date, added together, exceeds 5,000 dollars.
- Entity not publicly traded: the remuneration received in the 12 months before the disclosure exceeds 5,000 dollars, or the investigator, spouse or dependent children hold any equity interest.
- Intellectual property rights, such as patents and copyrights: upon receipt of related income.
- Travel: reimbursed or sponsored travel related to institutional responsibilities must be disclosed, except travel paid by a Federal, state or local government agency, an institution of higher education (as defined at 20 U.S.C. 1001(a)), an academic teaching hospital, a medical center or a research institute affiliated with an institution of higher education.
The definition excludes pay and royalties from an institution to an investigator it currently employs or appoints, the investigator's ownership interest in the institution if it is commercial or for-profit, mutual fund and retirement account income unless the investigator directly controls the investment decisions, and income from seminars, lectures or teaching engagements sponsored by, and from service on advisory committees or review panels for, a Federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical center or a research institute affiliated with an institution of higher education.
A significant financial interest is a financial conflict of interest only when the institution's designated officials reasonably determine it could directly and significantly affect the design, conduct or reporting of the research (50.604(f)).
When must investigators disclose, train and report, and when must the institution act?
Investigators disclose no later than the time of application, at least annually and within 30 days of a new interest; the institution reviews before it spends funds and reports to PHS on the schedule below (50.604, 50.605).
| Event | What the text requires | Section |
|---|---|---|
| Disclosure | No later than the time of application; at least annually; within 30 days of discovering or acquiring a new interest | 50.604(e) |
| Training | Before PHS-funded research and at least every four years; at once on a policy change that affects investigators, a new investigator or a finding of noncompliance | 50.604(b) |
| Review before spending | Before any funds are spent, officials review disclosures, decide relatedness and whether a conflict exists and, if one does, put a management plan in place | 50.605(a)(1) |
| New investigator or interest mid-award | Review and decide within 60 days; interim plan if a conflict exists | 50.605(a)(2) |
| Interest missed or unreviewed | Review within 60 days. If a conflict was not identified or managed on time, a retrospective review within 120 days of the noncompliance determination | 50.605(a)(3) |
| FCOI reports | For a conflict found: first, before funds are spent (none if it is eliminated first); later ones within 60 days of identifying it; annual through the project period | 50.605(b) |
| Records | At least three years from the final expenditures report, or other dates in 2 CFR 200.334 where they apply | 50.604(i) |
An FCOI report must let the PHS awarding component understand the conflict and assess the management plan. Its listed elements, which are not a limit, include the project number, the investigator, the entity, the nature and value of the interest (dollar ranges are permitted), the basis for finding a conflict and the key elements of the plan (50.605(b)(3)). The institution must monitor compliance with each plan until the project is complete (50.605(a)(4)).
Example plan conditions include public disclosure, disclosure directly to participants in human subjects research, an independent monitor, a changed research plan or staffing, reducing or eliminating the interest, and severing relationships that create conflicts (50.605(a)(1)).
Who needs this program, and what triggers it?
Any domestic or foreign, public or private institution other than a federal agency that applies for or receives PHS research funding by grant or cooperative agreement needs it, except for SBIR Program Phase I applications (50.602, 50.603). Triggers:
- A new application, which carries the certification in 50.604(k).
- A policy that is not posted, current or enforced.
- An undisclosed interest found mid-award.
- An inquiry from PHS, which may come before, during or after the award and requires records or on-site review (50.606(b)).
How IHS helps
IHS compares your policy and process with Subpart F and drafts what is missing. The steps:
- Gap assessment of policy, forms and workflow against 50.604 and 50.605.
- Policy drafting, with a plan to post it publicly, for your and your counsel's approval.
- A disclosure form and a review workflow that puts review ahead of spending.
- A management plan template and an FCOI report outline built on 50.605(b)(3).
- A mock file review of selected projects and a training outline.
You supply your policy and forms, a roster of PHS-funded investigators and awards, subrecipient agreements and past plans and reports. The real limit: your institution submits every report and answers every inquiry. IHS makes no determination about any investigator and gives no legal advice.
What to have ready
- A written, enforced, public policy (50.604(a)).
- Disclosure forms covering the thresholds, equity, intellectual property income and travel in 50.603.
- Training records (50.604(b)).
- A management plan template and a way to monitor each plan (50.605(a)).
- FCOI report elements and a calendar for initial, 60-day and annual reports (50.605(b)).
- A public accessibility procedure (50.605(a)(5)).
- Disclosure and review records kept at least three years (50.604(i)).
How does Subpart F compare with 45 CFR Part 94 and with an institution's own policy?
Subpart F covers grants and cooperative agreements. 45 CFR 94.2, for an institution that submits a proposal for or receives PHS research funding by contract, excludes SBIR Program Phase I applications as well. The Part 94 sections we read (94.4 and 94.5) carry the same four-year training, 30-day disclosure and 60-day review periods.
An institution can restate the regulation in its policy or incorporate it by reference. We found no government source comparing the two, so this page does not rank them. Either way, 50.604(a) requires a written, enforced policy that complies with the subpart.
What does it cost?
The sections we read state no fee for adopting a policy or filing an FCOI report. Cost drivers are the number of PHS-funded investigators, awards and subrecipients and the condition of the current policy and records. IHS scopes each engagement after a free introductory call.
What this is not
- It is not legal advice. IHS is a consulting firm, and counsel reviews every policy.
- It is not a determination about any investigator. The institution's designated officials decide, and the institution submits every FCOI report.
- It is not a guarantee of compliance or of any PHS decision.
Frequently asked questions
What does 42 CFR Part 50 Subpart F require of an institution?
A written, enforced conflict of interest policy posted on a public web site, investigator disclosures, review of those disclosures before PHS funds are spent, a management plan for each financial conflict of interest, and reports to the PHS awarding component. It applies to an institution applying for or receiving PHS research funding by grant or cooperative agreement, and not to SBIR Program Phase I applications (50.602).
What is the dollar threshold for a significant financial interest?
For a publicly traded entity, 12 months of remuneration plus the value of equity at the date of disclosure, added together, exceeding 5,000 dollars. For a non-publicly traded entity, 12 months of remuneration exceeding 5,000 dollars, or any equity interest held by the investigator, spouse or dependent children (50.603).
When must investigators disclose and train?
Disclosure is due no later than the time of application, at least annually, and within 30 days of discovering or acquiring a new significant financial interest. Training is due before PHS-funded research, at least every four years, and at once on a relevant policy change, a new investigator or a finding of noncompliance (50.604(b), (e)).
What does the institution report to PHS, and when?
For a conflict it finds, an FCOI report before funds are spent; for a conflict identified later, one within 60 days; and, for each conflict previously reported, an annual report through the project period, including extensions with or without funds. If the institution eliminates a conflict before spending PHS-awarded funds, it submits no initial report (50.605(b)).
What must be made public?
The significant financial interests that senior or key personnel still hold and that the institution finds related to the research and a financial conflict of interest. Before funds are spent, it goes on a public web site or to any requestor within five business days. If it uses a web site, the posting is updated at least annually and within 60 days of a new conflict (50.605(a)(5)).
How does this differ for PHS research contracts?
Subpart F covers grants and cooperative agreements. A separate part, 45 CFR Part 94, applies to an institution that submits a proposal for, or receives, PHS research funding by contract (94.2).
What happens if a conflict is missed or disclosed late?
The institution reviews the interest within 60 days and, if it is a conflict, puts an interim management plan in place. If a conflict was not identified or managed in time, it completes a retrospective review within 120 days of determining noncompliance and, if bias is found, notifies the PHS awarding component promptly and submits a mitigation report (50.605(a)(3)).
What does IHS draft, and what does the institution approve?
IHS drafts the gap assessment, policy, disclosure form, review workflow, management plan template and training outline. The institution and its counsel approve each one, decide every question about every investigator and submit every report.