Page 27 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A002 SOP Title: Conflict of Interest
1. PURPOSE
The purpose of the current standard operating procedure (SOP) is to define a conflict of interest (COI) and the rules and procedures for making ethical decisions regarding involvement connected to a covered individual’s interests outside of their primary affiliation (please, refer to the introduction section below for definitions of “covered individual” and “primary affiliation”). The procedures for managing and reporting acceptable COI are integrated from the relevant institutional and governmental mandates as it relates to employment with Children’s Health System of Texas (CHST) and to participation in research under the governance of the University of Texas Southwestern Medical Center (UTSW).
2. INTRODUCTION
As defined in CHST policy AD 1.08 Conflict of Interest, Association of American Medical Colleges (AAMC), and UTSW policy RES-401 Financial Conflicts of Interests in Research: Disclosure, Management, and Reporting, a COI is any form of action by a covered person that could potentially influence their professional judgment or expected fulfilment of their responsibilities to their primary affiliation, or place of employment and its affiliations. A covered person is the employed individual, and a COI extends to the covered employee and their immediate family members including, parents, grandparents, spouse (domestic partners and significant others), children, grandchildren, and siblings (all by birth, adoption, or marriage).
As the current SOP pertains to all CHST employees and investigators, or those who participate in research at UTSW or its affiliated institutions, there are different criteria that define a financial conflict of interest (FCOI). Additionally, there are many forms of COI that can knowingly or unknowingly occur to influence the integrity of research. Please, see the table below for reference of a FCOI and the subsequent definitions for the various other forms of COI that pertain to research.
A. Financial Interests- anything of monetary value including salary or other payments for services, investment interests, intellectual property rights, reimbursements including travel expenses, gifts, or other income.
• FCOI pertain to the covered person and their immediate family.
• A business entity is any organization that obtains income and is
recognized by law.
CHST Employment
(Policy AD 1.08 Conflict of Interest)
UTSW Research
(UTSW Policy RES-401 Financial Conflicts of Interests in Research...)
Ownership of a Vendor or Competitor ≥ 5% of voting power, profit, or beneficial interest.
From any single, publicly traded business entity- any salary or payment ≥ $5,000.
The interests in the vendor or competitor are valued at ≥ 5% of the person’s income.
From any single, non-publicly traded business entity- any salary or payment ≥ $5,000.
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