What is NIH conflict of interest?

Q: What determines a conflict of interest?

A conflict of interest occurs when an individuals personal interests – family, friendships, financial, or social factors – could compromise his or her judgment, decisions, or actions in the workplace. Government agencies take conflicts of interest so seriously that they are regulated.

NIH Guide NoticeDateTitleNOT-OD-22-2109/16/2022Financial Conflict of Interest (FCOI) and Other Support: RemindersNOT-OD-21-002 9/30/2020 Required Submission of Financial Conflict of Interest Policy into the eRA Commons Institution Profile (IPF) ModuleNOT-OD-19-1147/10/2019NIH Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign ComponentsNOT-OD-18-1603/30/2018Financial Conflict of Interest: Investigator Disclosures of Foreign Financial InterestsNOT-OD-15-05101/08/2015 Notice of NIH Requirement for Federal Recognition of Same-Sex Spouses/Marriages by Grant and Research and Development Contract RecipientsNOT-OD-14-08104/18/2014Notice of NIH Improving the Financial Conflict of Interest (FCOI) Module for Submission of Financial Conflict of Interest Reports to the NIH Beginning on April 25, 2014NOT-OD-13-00410/18/2012NIH Provides Policy Clarification Concerning Disclosure Requirements for Reimbursed and Sponsored Travel - 42 CFR Part 50 Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought"NOT-OD-12-15909/21/2012Proactive Compliance Oversight Program-Financial Conflict of Interest Requirements for NIH-Supported InstitutionsNOT-OD-12-14308/24/2012NIH Guide Notice Announces One-time Financial Conflict of Interest (FCOI) Reporting Guidance for Certain Fiscal Year 2012 Awards Issued On Or After August 24, 2012.NOT-OD-12-11806/25/2012NIH Announces Changes to the eRA Commons Financial Conflict of Interest (FCOI) Module to Accommodate Additional Reporting Requirements Required by the 2011 Revised FCOI RegulationNOT-OD-12-1034/18/2012NIH Announces the Posting of a Checklist for Policy Development Related to the 2011 Revised Regulation on Promoting Objectivity in Research (Financial Conflict of Interest)NOT-OD-12-0793/21/2012NIH Announces the Posting of New and Updated Frequently Asked Questions (FAQs) applicable to the 2011 revised regulation on Promoting Objectivity in Research (42 CFR Part 50 Subpart F

) for all NIH-supported Institutions.NOT-OD-12-08003/09/2012NIH Announces the posting of a Web-based tutorial applicable to the 2011 revised regulation on Promoting Objectivity in Research for all NIH-supported Institutions.NOT-OD-12-01211/14/2011NIH Announces FCOI Webinar: What NIH Grantees Need to Know about the 2011 Revised Financial Conflict of Interest Regulation.NOT-OD-11-12109/30/2011NIH Announces the Posting of Frequently Asked Questions (FAQs) applicable to the 2011 revised regulation on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought for All NIH-Supported InstitutionsFederal Register Notice

8/25/2011Issuance of the Final Rule on Financial Conflict of Interest Regulations - Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors.NOT-OD-11-10908/23/2011NIH Guide Notice to announce the publication of the Final Rule on Financial Conflict of Interest Regulations - Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors.NOT-OD-09-07203/27/2009Mandatory use of eRA Commons FCOI module begins July 1, 2009

Table of Contents Show

What is the main focus of NIH's conflict of interest policy?
What determines a conflict of interest?
Which is an example of a financial conflict of interest?
How often are investigators funded by the US NIH required to receive conflict of interest training?

A recent study from the HHS Office of Inspector General (OIG) affirmed that NIH grant recipients play a key role in protecting the integrity and security of U.S. biomedical research, in part through requiring Investigators to disclose all of their significant financial interests and all sources of their other support. As noted by the OIG, failures by some recipients to disclose substantial contributions of resources from foreign entities (including foreign governments) have raised concerns about threats to the integrity of NIH-supported research. In response to the OIG recommendations, we are reminding grant applicants and recipients again today of NIH’s Financial Conflict of Interest (FCOI) and Other Support grant requirements.

Today we released NOT-OD-22-210 that provides important reminders about the FCOI regulation and Other Support policy requirements. We encourage all those involved in the NIH grants process to review this information carefully to ensure compliance.

Financial Conflict of Interest (FCOI)

The FCOI regulation (42 CFR Part 50 Subpart F) applies to all foreign and domestic NIH grants and cooperative agreements (applications and awards), excluding Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR). The FCOI regulation also applies to subrecipient institutions and their investigators.

Investigator Disclosure

Investigators, as defined by regulation, are required to completely and accurately disclose all foreign and domestic significant financial interests (SFIs) (and those of the investigator’s spouse and dependent children) that are related to the investigator’s institutional responsibilities (professional responsibilities the investigator performs on behalf of the organization such as research, research consultation, teaching, clinical) and that are received from or held in an entity outside the institution. Investigators must disclose their SFIs to their institution by the time an application is submitted to the NIH for funding, within thirty days of discovering or acquiring a new SFI, and on an annual basis.

It is important to note that disclosure of foreign financial interests differs from disclosure of domestic financial interests. Investigators, including subrecipient investigators, must disclose all foreign financial interests received from any foreign entity, including Institutions of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country). Required disclosures include income from seminars, lectures, or teaching engagements, and income from service on advisory committees or review panels. However, investigators are not required to disclose these same interests when they are domestic.

Institutional Responsibilities

Maintain an up-to-date, written, and enforced policy on FCOI that complies with the FCOI regulation that is posted on a publicly accessible Web site.
Upload and submit a PDF copy of the FCOI policy to the NIH via the eRA Commons Institution Profile Module (see the NIH Grants Policy Statement, Section 4.1.10, Financial Conflicts of Interest).
Train investigators on the requirements of the FCOI regulation, the institution’s FCOI policy, and their disclosure responsibilities . The NIH FCOI webpage includes a training module that satisfies the portion of the training requirement related to the Federal regulation.
Designate at least one official to review each investigator SFI disclosure to determine if it is (1) related to the NIH-funded research and (2) an FCOI. When FCOIs are identified, institutions are required to develop a management plan, monitor investigator compliance, and report the identified FCOI to the NIH via the eRA Commons FCOI Module. FCOI reports are due prior to the expenditure of funds under a new award or within 60 days of identifying an FCOI during the period of an award.

Other Support

Other Support is required for all individuals designated in an application as senior/key personnel and includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes but is not limited to:

What is the main focus of NIH's conflict of interest policy?

In terms of the NIH policy, a financial conflict of interest exists when, after investigation, the College reasonably determines that an Investigator has a Significant Financial Interest ('SFI') that is related to an NIH-funded research project and that could directly and significantly affect the design, conduct or ...

What determines a conflict of interest?

A conflict of interest occurs when an individual's personal interests – family, friendships, financial, or social factors – could compromise his or her judgment, decisions, or actions in the workplace. Government agencies take conflicts of interest so seriously that they are regulated.

Which is an example of a financial conflict of interest?

Examples of Potential Financial Conflicts of Interest: An institution's researcher holds an executive position with a company that stands to benefit from the research being conducted at the institution.

How often are investigators funded by the US NIH required to receive conflict of interest training?

There is no uniform standard regarding how frequently COI training should occur. However, with regard to the PHS FCOI regulations, investigators “must complete training prior to engaging in NIH-funded research and at least every four years, and immediately under the designated circumstances.”