Page 301 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q019
SOP Title: Non-Regulated & Non-Human Research
7. NOTE TO FILE – TEMPLATE (FOR PROJECTS PRIOR TO DEVELOPMENT OF THIS SOP)
Non-Regulated & Non-Human Subjects Research NOTE TO FILE
October 7, 2020
On September 03, 2019, Children’s Research Administration in collaboration with UTSW HRPP developed a standard operating procedure to assess non-regulated as well as non-human subjects research being conducted at Children’s Health. In addition to documentation of HRPP review in the form of a “Letter of Determination”, CHRA finalized an abbreviated review and approval process which includes assessment of research staff for credentialing verification, review of the project to determine research cost implications, and assessment of the data collection methodology to ensure any data being collected will not leave the covered entity without an agreement in place between the local institution and the collaborating site receiving the data.
For projects that were reviewed prior to the approval of the CHRA SOP, no such review occurred. This letter is documentation to memorialize that Children’s secondary review was not performed on this study at the time the UTSW HRPP issued a “Letter of Determination” as the study was initiated before the aforementioned date.
Victoria Brown, Ph.D.
Director, Research Administration
Children’s Health Children’s Medical Center at Dallas
SOP No. 21, 09-03-2019, 06-09-2020, 10-07-2020; 06-03-2022