Page 296 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q019
SOP Title: Non-Regulated & Non-Human Research
B. Non-Regulated Research – Non-regulated research such as “Health Surveillance”, “Quality Improvement”, “Medical Quality Improvement”, “Program Evaluation”, “Satisfaction Surveys”, “Academic Projects”, “Case Reports”, “Community Outreach”, and other non-regulated “Research on Human Subjects” must meet all of the following requirements:
1. 2.
3. 4. 5.
6. 7. 8. 9. 10.
The intent of the project is not to test a novel hypothesis or to replicate another researcher’s original study;
Patients or personnel will not be exposed to additional discernable risks or burdens beyond those of usual care at the institution where this project is taking place;
Project involve not involve withholding of any aspect of conventional care shown to be beneficial in prior well-conducted clinical trials;
Project will not seek to test interventions, practices or treatments that are not standard of care (neither consensus-based nor evidence-based);
UTSW (or an affiliated institution) will not receive any direct federal (DHHS) award to conduct human subjects’ research, even where all activities involving human subjects are carried out by a non-UTSW entity (e.g., subcontractor or collaborator);
Project will not involve a drug or device used outside of usual medical practice, including non-FDA-approved agents, or off-label uses of FDA-approved drugs or devices;
The safety and/ or effectiveness of a drug (FDA approved or non-FDA approved) or regulated device will not be evaluated or be compared to that of another agent or device;
Data from the activity of an active group or a control group will not be submitted to, or held for inspection by the FDA in support of a marketing or research application for an FDA-regulated product (drug or device);
Data obtained from use of a device on tissue specimens will not be submitted to, or held for inspection by, the FDA in support of a marketing application or research application for an FDA regulated product;
Project does not have funding from an organization with a commercial interest in the use of the results.
3. INTRODUCTION
For “Non-Human Research” and “Non-Regulated Research” projects, CHRA requires that a performance site review and approval process be in place prior to initiation of project activities at Children’s Health.
4. SCOPE
This SOP applies to all individuals conducting research at Children’s Health.
SOP No. 21, 09-03-2019, 06-09-2020, 10-07-2020; 06-03-2022