Texas Tech University
Scholarly Messenger
What You Need to Know About Annual Financial Conflict of Interest Disclosure
By Amy Baugh

New financial conflict of interest disclosure and education requirements are in effect for all investigators on proposals submitted to the National Institutes of Health (NIH) and other Public Health Service (PHS) sponsors. The new regulations, effective August 2012, have raised numerous questions. Below are updated frequently asked questions and answers to help clarify Texas Tech’s disclosure policy and the new PHS financial conflict of interest (FCOI) regulations. The source for most of these questions is the NIH FAQ website and Texas Tech Operating Policy 70.37.

Questions should be directed to Amy Baugh, financial disclosure administrator, in the Office of the Vice President for Research. More information is available at the Texas Tech Financial Disclosure website.

Who needs to complete financial conflict of interest disclosure forms, and when are the forms due?
All investigators involved in sponsored research projects, including non-NIH or PHS funded research projects, are required to complete a Confidential General Disclosure of Either Significant or No Significant Business or Financial Interests in any External Entity (and additional documentation if necessary) by Oct. 1 of each year. If you have not already done so for the 2012-2013 year, please complete the appropriate form and submit it now.

All investigators who have current or pending PHS-NIH support, or plan to apply for PHS-NIH funding, are required to complete the PHS-Specific Confidential General Disclosure of Either Significant or No Significant Business or Financial Interests in any External Entity (and additional documentation if necessary) by Oct. 1 of each year. If you have not already done so for the 2012-2013 year, please complete the appropriate form and submit it now.

Forms may be completed electronically and can be found on the electronic disclosure website.

What is the Public Health Service (PHS)?
PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the NIH.

How do I know if my research project is funded by PHS/NIH?
There are 27 centers and institutes within the National Institutes of Health, each with a specific research agenda.

The Public Health Service includes 11 additional agencies. Other non-PHS agencies also have adopted the PHS regulations. Contact Amy Baugh, financial disclosure administrator, to verify the agencies on this list. 

Who is considered an investigator for PHS-funded research?
Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS-NIH, or proposed for such funding, which may include, for example, collaborators or consultants. Institutions should consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of investigator is limited to titles or designations-for example: principal investigators, key personnel, faculty-the risk is that an unidentified FCOI may compromise the research enterprise.

Why are there two sets of financial disclosure forms?
The Public Health Service (PHS) forms are required of all investigators who currently are funded by PHS-NIH or are applying for PHS-NIH funding. These regulations, established August 2012, include new standards and clarify previously established standards to be followed by institutions that apply for or receive research funding from PHS Awarding Components, including the National Institutes of Health (NIH), for grants, cooperative agreements, and research contracts.

What are the most significant differences between the PHS FCOI 1995 regulation and the 2011 revised regulation?
The 2011 revised regulations include comprehensive changes, focusing on these areas in particular:
  • Definition of significant financial interest (SFI)
  • Lower financial disclosure thresholds ($5,000 minimum threshold)
  • Increased transparency for travel reimbursement
  • New conflict of interest training (every four years for investigators receiving PHS funds)
  • Institutions’ management of identified financial conflicts of interest
  • Information reported to the PHS-NIH funding component
  • Information made accessible to the public, such as institutional FCOI policy and FCOIs of senior/key personnel
What is the travel disclosure requirement for PHS Investigators?
Investigators who are currently involved in or are planning to participate in PHS-NIH funded research must disclose their reimbursed or sponsored travel related to their institutional responsibilities over the previous 12-month period. Investigators must submit an updated disclosure of reimbursed or sponsored travel within 30 days after each occurrence. Sponsored or reimbursed travel means that you were reimbursed for travel or had ANY of your travel costs sponsored by an entity.

The initial disclosure of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available) is included with the detailed disclosure forms. Instructions regarding updating travel disclosures are below.

Note: Travel paid by your NIH funds is not required to be reported. The reported travel is sponsored or reimbursed travel that is paid to you or for you by an entity. The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following: 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 that is affiliated with an Institution of higher education.

The provisions in the revised regulations are not intended to discourage this type of travel but require the disclosure of the occurrence of any reimbursed or sponsored travel related to the investigator’s institutional responsibilities provided the travel is not sponsored or reimbursed by those identified sources excluded in the final rule.

What is an “entity” as used in the Financial Conflict of Interest regulation?
Entity means any domestic or foreign, public or private, organization (excluding a federal agency) from which an investigator (and spouse and dependent children) receives remuneration, including travel costs, or in which any person has an ownership or equity interest.

How do I disclose reimbursed or sponsored travel after I have submitted my initial disclosure?
Once investigators have made their initial disclosure, they are required to update their disclosures within 30 days of discovering or acquiring a new Significant Financial Interest (SFI) and annually during the period of award. Sponsored or reimbursed travel is considered an SFI. Investigators may report reimbursed or sponsored travel at the travel disclosure website. Investigators may access the system at any time and as often as necessary throughout the proposal and award process to provide details of each occurrence of sponsored/reimbursed travel.

Amy Baugh is the administrator for financial disclosure in the Office of the Vice President for Research.