Investigators applying for funding from the National Institutes of Health or another Public Health Service component must complete Financial Conflict of Interest training and submit the required financial disclosure before a proposal is submitted or funds are released.

The significant change to Financial Conflict of Interest (FCOI) policy of the National Institutes of Health (NIH) and other Public Health Service (PHS) departments has raised numerous questions. The source for most of these questions is the NIH FAQ website and Texas Tech Operating Policy 74.17.

What must I complete before submitting a PHS proposal?

Before submitting a proposal to the National Institutes of Health or another Public Health Service funding component, investigators must complete Financial Conflict of Interest training and submit the required financial interest disclosure.

All investigators must complete the applicable training and PHS-specific disclosure requirements before submitting a new PHS proposal or receiving funds from a new award, including a noncompetitive renewal.

When must FCOI training be completed?

Financial Conflict of Interest training must be completed before an investigator submits a new PHS proposal or receives funds from a new PHS award, including a noncompetitive renewal.

Complete one of the available training options described on the PHS Investigator Requirements page.

How often must FCOI training be renewed?

Investigators must renew their Financial Conflict of Interest training every four years.

Additional training may also be required when institutional policies change, when an investigator is new to Texas Tech, or when an investigator is found not to be in compliance with applicable requirements.

When must I submit my financial disclosure?

Investigators must submit the required financial disclosure before submitting a PHS proposal or receiving PHS funds.

The disclosure must also be updated annually and within 30 days of discovering or acquiring a new significant financial interest.

Complete or update your disclosure through the secure Investigator Financial Disclosure system.

For assistance with PHS training or disclosure requirements, contact FinancialConflictofInterest.vpr@ttu.edu.

Financial Conflict of Interest requirements apply to anyone who meets the definition of an investigator, regardless of job title, employment classification, institutional affiliation, or location.

Who is considered an investigator?

An investigator is the project director, principal investigator, or any other person responsible for the design, conduct, or reporting of research funded by the NIH or another PHS component, or proposed for such funding.

Is the determination based on a person's job title?

No. The determination should be based on the individual's role, responsibilities, and degree of independence rather than a specific title or designation.

Anyone who is independently responsible for a substantive part of the design, conduct, or reporting of the research may meet the definition of an investigator.

Do collaborators, consultants, key personnel, students, and postdoctoral fellows count as investigators?

They may be considered investigators when their responsibilities include independently contributing to the design, conduct, or reporting of the research.

Depending on their roles, collaborators, consultants, key personnel, postdoctoral fellows, graduate students, and other project participants may therefore be subject to Financial Conflict of Interest requirements.

Do these requirements apply to subrecipients and subcontractors?

Yes. The requirements apply to investigators working through subrecipient, subgrant, subcontract, consortium, contractor, consultant, or collaborative arrangements when they will conduct a substantive portion of the PHS-funded research and are responsible for its design, conduct, or reporting.

A person does not have to be employed directly by the institution receiving the primary award. A collaborator, consultant, subcontractor, subrecipient, postdoctoral fellow, or graduate student who meets the definition of investigator is subject to the requirements.

Do the requirements apply to foreign institutions and international organizations?

Yes. The regulation applies to domestic and foreign institutions and international organizations that apply for or receive NIH research funding as either a primary award recipient or a subrecipient institution.

Additional requirements for institutional agreements with subrecipients are described in 42 CFR 50.604(c).

Investigators participating in PHS-funded research must disclose applicable reimbursed or sponsored travel related to their institutional responsibilities.

What sponsored or reimbursed travel must be disclosed?

Investigators planning to participate in PHS-funded research must disclose reimbursed or sponsored travel related to their institutional responsibilities for the preceding 12 months no later than the time they apply for PHS funding.

Sponsored travel includes travel paid on behalf of an investigator when the investigator may not know the exact monetary value. Initial sponsored or reimbursed travel should be included with the investigator's detailed financial disclosure.

When must sponsored travel be reported?

Applicable sponsored or reimbursed travel from the preceding 12 months must be disclosed no later than the time an investigator applies for PHS funding.

After the initial disclosure, each new occurrence of reportable sponsored or reimbursed travel must be disclosed within 30 days.

How do I report new travel after my initial disclosure?

Investigators must update their disclosure within 30 days of discovering or acquiring a new significant financial interest, including each reportable occurrence of sponsored or reimbursed travel.

Investigators may access the reporting system as often as necessary during the proposal and award process and must continue to update their disclosure annually throughout the award period.

Report sponsored or reimbursed travel.

What travel does not need to be reported?

Travel paid from NIH award funds does not need to be reported through this process.

The disclosure requirement also does not apply to travel reimbursed or sponsored by a federal, state, or local government agency; a qualifying institution of higher education; an academic teaching hospital; a medical center; or a research institute affiliated with an institution of higher education.

Texas Tech investigators involved in externally funded research or educational activities must complete an annual Investigator Financial Disclosure and report significant changes when they occur.

Who must submit a non-PHS financial disclosure?

All employees planning to act as investigators must disclose significant business or financial interests, including applicable interests held by a spouse, dependent relative, or household member.

For non-PHS-funded activities, an investigator includes the principal investigator, co-principal investigator, and any other person at Texas Tech University—or working through a TTU subgrantee, contractor, or collaborator—who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by an external entity.

When is the annual disclosure due?

Investigators must submit their annual Investigator Financial Disclosure by October 1 of each year and annually thereafter.

When must an existing disclosure be updated?

Investigators must update their disclosure during the year whenever there is a significant change to previously reported financial activities or interests.

A disclosure should not remain unchanged until the next annual submission when a new significant financial interest has been discovered or acquired.

Who is considered an investigator for non-PHS activities?

An investigator includes anyone responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by an external entity.

This may include principal investigators, co-principal investigators, collaborators, contractors, subgrantees, and other individuals whose responsibilities meet the definition, regardless of their formal job title.

What if I also plan to apply for PHS or NIH funding?

Investigators who have applied or plan to apply for NIH or other PHS funding must also follow the additional PHS-specific training and disclosure requirements.

Investigator Financial Disclosures are submitted and maintained through the secure IRBManager disclosure system using Texas Tech eRaider credentials.

Where do I submit my disclosure?

Submit or update your Investigator Financial Disclosure through the secure IRBManager disclosure system.

Sign in using your Texas Tech eRaider username and password.

How do I submit my first disclosure?

To submit a new disclosure, follow the instructions in the First-Time Investigator Financial Disclosure guide.

How do I update a previous disclosure?

To revise an existing disclosure or report a change in your financial activities, follow the instructions in the Update a Previous Investigator Financial Disclosure guide.

When should I update my disclosure?

Update your disclosure whenever there is a significant change to your financial activities or interests and within any applicable reporting deadline, including the 30-day reporting requirement for new significant financial interests associated with PHS-funded research.

Who should I contact for help?

Contact FinancialConflictofInterest.vpr@ttu.edu for assistance with the disclosure system, reporting requirements, training requirements, or determining how additional information should be submitted.

Review the following Texas Tech policies, institutional guidance, federal requirements, and supporting resources for additional information about Investigator Financial Disclosure and the management of potential financial conflicts of interest.

Which Texas Tech policy governs financial conflicts of interest?

OP 74.17: Disclosure of Significant Business or Financial Interests That May Represent Conflicts of Interest establishes Texas Tech requirements for disclosing and reviewing significant business or financial interests that may create a conflict of interest.

Where can I find guidance about managing a financial conflict of interest?

Review the FCOI Management Plan Guidance for information about developing and implementing an appropriate management plan.

Where can I find information about review requirements?

Review the FCOI Requirements by Funding Agency and Department or College Review for information about applicable review pathways.

Where can I find PHS and NIH requirements?

Texas Tech requirements for investigators applying for or receiving PHS funding are available on the PHS and NIH Investigator Requirements page.

Additional federal guidance is available through the NIH Financial Conflict of Interest information page and the NIH Financial Conflict of Interest FAQs.