Page 267 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

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-Regulated Research” projects, a member of the research team will need to complete UTSW eIRB form Y2 and submit it to UTSW Human Research Protection Program Of f ice (HRPPO) f or 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 needs to ensure the following:
− QualitySpecialistwillseekforthefollowingdocumentstoreview:
1. Copy of the UTSW IRB Form Y1 or Y2
2. Copy of the protocol (if available)
3. Copy of the UTSW IRB acknowledgement letter
4. Names and credentials of the team working on the project
− Assigned Quality Specialist will identify the principal investigator on the 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 f or 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
SOP No. 21, 09-03-2019, 06-09-2020, 10-07-2020, 08-25-2021