Page 297 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
5. RESPONSIBILITIES 5.1 Researcher
Research Administration SOP No: Q019
SOP Title: Non-Regulated & Non-Human Research
A. For “Non-Human Research” projects, a member of the research team will need to complete UTSW eIRB form Y1 and submit it to UTSW HRPPO for review and determination. A letter will be issued from the UTSW IRB if the project meets the definition of “Non-Human Research”.
B. For“Non-RegulatedResearch”projects,amemberoftheresearchteamwillneed to complete UTSW eIRB form Y2 and submit it to UTSW Human Research Protection Program Office (HRPPO) for review and determination. A letter will be issued from the UTSW IRB if project meets the definition of “Non-Regulated Research”.
5.2 Children’s Health Research Administration
For both “Non-Human Research” and “Non-Regulated Research” projects, members of CHRA will work with UTSW IRB to review the research application (Form Y1 or Y2) and finalize determination.
CHRA will apprise the Quality Specialist team about said projects that require performance site review. Quality Specialist team will be responsible to review these projects.
5.3 Children’s Quality Specialist
A. For “Non-Human Research” and “Non-Regulated Research” projects, Quality Specialist will ensure the following:
− Quality Specialist will seek for the following documents to review:
1. 2. 3. 4.
Copy of the UTSW IRB Form Y1 or Y2
Copy of the protocol (if available)
Copy of the UTSW IRB acknowledgement letter
Names and credentials of the team working on the project
− Assigned
project and depending on affiliation and credentials, QS team member will either review the project or route it to the Director of Evidence Based Practice (EBP) and Nursing Research for review and approval consideration.
• QS Responsibility to Review – Projects where the PI is a UTSW Faculty, Student (Medical Student, Resident, Fellow), or CMC Allied Health Professional (APP, OT, etc.)
• EBP and Nursing Research to Review – Projects where the PI is a CMC Nurse or non-affiliated nursing student
− For project where RA has oversight, the assigned Quality Specialist will log project in CHRA RedCAP (see example in section 6);
Quality Specialist will identify the principal investigator on the
SOP No. 21, 09-03-2019, 06-09-2020, 10-07-2020; 06-03-2022