Texas Tech University

PHS (e.g., NIH) Research Funded Investigators

The Public Health Service (PHS) has made major changes in financial disclosure requirements for all investigators and personnel involved in PHS-funded projects (e.g. NIH). Faculty or other personnel who have applied or plan to apply for PHS funding must complete training and disclose business or financial interests before submitting proposals or receiving funds (including noncompetitive renewal awards).*

PHS guidelines define "Investigator" as 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 PHS (e.g., NIH), or proposed for such funding. Depending on their roles, collaborators or consultants may be considered investigators.

Training Requirement:

You need to complete training before submitting new PHS proposals or receiving new awards (including noncompetitive renewal awards), and renew your training every four years.

Two FCOI training options are available (either of which can be completed in ~30 minutes):

  1. “Conflict of Interest mini-course” CITI training (preferred) - https://www.citiprogram.org 
    1. Current Users 
      1. Click “Add a course or update your learner groups for Texas Tech University.”
      2. On the next screen select “Yes” to Question 2 – Would you like to take the “Conflict of Interest mini-course”?
      3. On the next screen click the appropriate action under “My Courses” to begin the course.
    2. New Users
      1. Click “Register Here.”
      2. Complete the steps to register.
      3. On the next screen select “Yes” to Question 2 – Would you like to take the “Conflict of Interest mini-course”?
      4. On the next screen click the appropriate action under “My Courses” to begin the course.
  2. NIH Tutorial - http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
    Upon completion, print the certificate and forward a copy to Amy Baugh, amy.baugh@ttu.edu or MS 1075. To print your certificate, press the "Print Screen" key and paste into the email or an attached Word document, or scan and email. KEEP A COPY OF THE CERTIFICATE FOR YOUR RECORDS. Trainees who select this option must send Any Baugh a copy of current and future training certificates because TTU cannot access NIH Tutorial training records.

Disclosure Requirement:

Investigators need to disclose business or financial interests before submitting a PHS proposal, and annually thereafter. Investigators need to provide updates throughout the year, as necessary, to the Office of the Vice President for Research (OVPR).

In order to streamline the financial disclosure procedure, the OVPR has created a secure online disclosure site available via an eRaider-authenticated link. Disclose using the secure online disclosure site and follow the prompts to complete and submit the required PHS-specific disclosure documents. Electronic Financial Disclosure

The forms are also available in hard copy for faculty who wish to use the current procedure.  The PDF forms below have preloaded fields that can accept typed answers and electronic signatures.

  1. Form OP 70.37D – PHS-Specific Confidential General Disclosure of Either Significant or No Significant Business or Financial Interests in Any External Entity
  2. Form OP 70.37E – PHS-Specific Confidential Supplemental Detailed Disclosure of Significant Business or Financial Interest for Each Entity and Travel that would Reasonably Appear to be Affected by your Institutional Responsibilities

Contact Amy Baugh, amy.baugh@ttu.edu, to determine the most efficient way to submit updated information.

Travel Disclosure Requirement

Investigators who are planning to participate in PHS (NIH)-funded research must submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence (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). You may easily disclose sponsored travel here.

Note: Travel paid by NIH funds, government agencies, U.S. institutions of higher education and related research institutes, medical centers, and academic teaching hospitals DOES NOT need to be reported.

 

*New For FY 2012-2013

“The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94) (commonly known as the Financial Conflict of Interest (FCOI) regulations). These regulations establish 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. The 2011 revised regulations were written to increase accountability, add transparency, enhance regulatory compliance and effective Institutional management of Investigators’ financial conflicts of interest, and strengthen NIH’s compliance oversight. The primary goal is to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements and contracts will be free from bias resulting from Investigator financial conflicts of interest.”

Find more information about the PHS requirements, including FAQs, a PowerPoint presentation and the Code of Federal Regulations in the Federal Register, here: http://grants.nih.gov/grants/policy/coi/