Standard Operating Procedures
Standard operating procedures (SOPs) describe policies and procedures related to IRB review, management, or function.
IRB 101 Workshop Video
Note: This link will take you the video hosted on Panopto. You will need your UT ID to access the content.
Guidance for Investigators on Recruitment Materials
ClinicalTrials.gov Requirements Summary
Includes information on the NIH’s revised definition of clinical trial that may impact your research involving health outcomes, its related ClinicalTrials.gov registration requirements and penalties for noncompliance. This document also covers journal requirements, FDA requirements.
The Human Subjects Research (HSR) Determination worksheet is intended to assist students, faculty, and staff in determining if an activity they are planning fits the definition of human subjects research, or other activity requiring review, such as accessing HIPAA-covered information, devices falling under FDA requirements, etc.
A short, captioned video is also available. The video introduces the tool (select UTK Canvas (main) to sign in). The video provides instructions for how to request a more formal determination from the Human Research Protection Program (HRPP) if needed.