Human Subjects Policies, Procedures, & Guidelines

Human Subjects Policies, Procedures, & Guidelines

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

Standard Operating Procedures

• 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 using the form available on IRBNet. 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

IRB Reviewing Procedures

• 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.

Exempt Research

• Exempt Research – A description of which research activities are considered exempt from IRB review.
  • Exempt Study Modification Chart – A description of when modifications may or may not need to be submitted for IRB review for exempt protocols. All modifications for expedited and full board studies are required to submit to the IRB for review.
  • If you have an approved study that was deemed exempt by the IRB and need to submit modifications, click here to watch a tutorial video on how to submit the change(s) via RAMP.

Helpful Resources

• 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.

Off-site links

• 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.

As you review the policies, procedures, and guidelines on this page, you may encounter terms with which you are unfamiliar.  Please check the glossary of terms for definitions.  If you still have a question about a term used that is not answered on the glossary page, please e-mail [email protected].