Human Subjects Policies, Procedures, & Guidelines

Note: All human subjects related documents are to be submitted through our online protocol management system RAMP.

Human Subjects SOPs – Approved Standard Operating Procedures to be followed by ORIA, the IRB, and researchers conducting human subjects research.
- Includes Mason’s Adverse Event Reporting. Any unexpected problem that occurs during the course of a research activity that relates to that research activity must be reported to ORIA via RAMP. See Human Subjects SOP 2.6.5
- Includes Classroom Projects SOP. Guidelines for ORIA/IRB review of projects conducted by students taking pedagogy classes. See Human Subjects SOP 1.3.5

Human Subjects Research Review Process – The process that a project undergoes from the submission to review.
IRB Basics – A tutorial video for researchers new to the GMU IRB on how to use protocol templates and RAMP.
RAMP IRB Submission – A tutorial video for researchers on how to use RAMP IRB, including submitting a new study for review.

Human Subjects (Definition) – The federal definition of “human subject” and “research.”
Research in VA Schools – Information on doing research in Virginia public schools.
2017-2018 Updates to Human Subjects Regulations – An overview of new changes to federal polices concerning research with human subjects.
Research with Prisoners – FAQ Involving Prisoners in Research – An FAQ document for conducting research with prisoners.

Clinical Trials Registration information – Information about registering a study on the ClinicalTrials.gov website.
FERPA – Information about FERPA regulations
Mandatory Reporting of Child Abuse and Neglect – All Mason employees are required by law to report abuse and neglect.