Page 295 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q019
SOP Title: Non-Regulated & Non-Human Research
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the steps involved to review and acknowledge “Non-Regulated” as well as “Non-Human” research projects at Children’s Health. The process is first initiated at UTSW HRPP and later completed at CHRA.
For projects that were initiated at Children’s Health prior to the development of this SOP, CHRA review did not take place for projects that received HRPP “Letter of Determination” acknowledgment. For these projects, a “Note To File” was created to memorialize that Children’s secondary review was not performed. NTF template can be found in section 7 of this SOP.
2. DEFINITIONS
A. Non-Human Research - DHHS and the FDA define “non-human” research as meeting all the following requirements:
1. UTSW or an affiliated institution will not receive 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);
2. The 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 being administered to one or more humans;
3. The project will not evaluate or compare the safety and/ or effectiveness of a drug (FDA approved or non-FDA approved) or regulated device being administered to one or more humans to another drug or device;
4. 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);
5. Data obtained from use of a device on human 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;
6. Researchers will not obtain data through intervention or interaction with living individuals. Intervention is defined as both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction is defined as communication or interpersonal contact between investigator and subject;
7. ALL data/specimens in the research will be anonymous to the researcher;
8. Researcher is not obtaining new-born screening blood spots for research purposes (regardless of funding or identifiability)
SOP No. 21, 09-03-2019, 06-09-2020, 10-07-2020; 06-03-2022